Trial Outcomes & Findings for Delicious Eating for Life in Southern Homes (NCT NCT04302727)
NCT ID: NCT04302727
Last Updated: 2025-11-03
Results Overview
Weight will be collected by study staff who are masked to treatment using scales tested monthly for accuracy up to 350 pounds.
COMPLETED
NA
360 participants
Baseline, Month 24
2025-11-03
Participant Flow
Participant milestones
| Measure |
Med-South Weight Loss Intervention
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
Augmented Usual Care (WW)
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
|---|---|---|
|
Overall Study
STARTED
|
182
|
178
|
|
Overall Study
COMPLETED
|
118
|
129
|
|
Overall Study
NOT COMPLETED
|
64
|
49
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Delicious Eating for Life in Southern Homes
Baseline characteristics by cohort
| Measure |
Total
n=360 Participants
Total of all reporting groups
|
Augmented Usual Care (WW)
n=178 Participants
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
Med-South Weight Loss Intervention
n=182 Participants
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
|---|---|---|---|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 12.0 • n=18 Participants
|
55.0 years
STANDARD_DEVIATION 11.6 • n=15 Participants
|
54.3 years
STANDARD_DEVIATION 12.5 • n=3 Participants
|
|
Sex/Gender, Customized
Male
|
158 Participants
n=18 Participants
|
80 Participants
n=15 Participants
|
78 Participants
n=3 Participants
|
|
Sex/Gender, Customized
Female
|
200 Participants
n=18 Participants
|
96 Participants
n=15 Participants
|
104 Participants
n=3 Participants
|
|
Sex/Gender, Customized
Non-Binary
|
2 Participants
n=18 Participants
|
2 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=18 Participants
|
12 Participants
n=15 Participants
|
6 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
342 Participants
n=18 Participants
|
166 Participants
n=15 Participants
|
176 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=18 Participants
|
1 Participants
n=15 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=18 Participants
|
3 Participants
n=15 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
119 Participants
n=18 Participants
|
64 Participants
n=15 Participants
|
55 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
215 Participants
n=18 Participants
|
102 Participants
n=15 Participants
|
113 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
16 Participants
n=18 Participants
|
7 Participants
n=15 Participants
|
9 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=18 Participants
|
1 Participants
n=15 Participants
|
2 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
360 Participants
n=18 Participants
|
178 Participants
n=15 Participants
|
182 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 24Weight will be collected by study staff who are masked to treatment using scales tested monthly for accuracy up to 350 pounds.
Outcome measures
| Measure |
Med-South Weight Loss Intervention
n=118 Participants
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
Augmented Usual Care (WW)
n=129 Participants
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
|---|---|---|
|
Percent Weight Change From Baseline to Month 24
|
-4.4 percentage weight change
Standard Deviation 7.45
|
-3.8 percentage weight change
Standard Deviation 6.00
|
SECONDARY outcome
Timeframe: Baseline, Months 4 and 12Population: Data reported for all participants who returned for follow-up measures.
Weight will be collected by study staff who are masked to treatment using scales tested monthly for accuracy up to 350 pounds.
Outcome measures
| Measure |
Med-South Weight Loss Intervention
n=146 Participants
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
Augmented Usual Care (WW)
n=152 Participants
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
|---|---|---|
|
Percent Weight Change From Baseline to Months 4 and 12
Baseline, Month 4
|
-0.9 percentage weight change
Standard Deviation 3.96
|
-4.4 percentage weight change
Standard Deviation 5.01
|
|
Percent Weight Change From Baseline to Months 4 and 12
Baseline, Month 12
|
-4.6 percentage weight change
Standard Deviation 6.20
|
-4.3 percentage weight change
Standard Deviation 6.18
|
SECONDARY outcome
Timeframe: Baseline, Months 4, 12, and 24Population: Data reported for all participants who returned for follow-up measures.
Weight will be collected by study staff who are masked to treatment using scales tested monthly for accuracy up to 350 pounds. Assess difference between study groups in percentage losing ≥ 5% body weight for all participants and across 3 pre-specified subgroups: 1) participants with vs. without diabetes; 2) females vs. males; and 3) Whites vs. African Americans.
Outcome measures
| Measure |
Med-South Weight Loss Intervention
n=146 Participants
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
Augmented Usual Care (WW)
n=152 Participants
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
|---|---|---|
|
Percentage Weight From Baseline Through Follow-Up by Sub-Groups
Males-Baseline, Month 4
|
-1.7 percentage weight change
Standard Deviation 4.08
|
-4.8 percentage weight change
Standard Deviation 5.29
|
|
Percentage Weight From Baseline Through Follow-Up by Sub-Groups
Whites-Baseline, Month 4
|
-1.2 percentage weight change
Standard Deviation 3.96
|
-5.6 percentage weight change
Standard Deviation 5.38
|
|
Percentage Weight From Baseline Through Follow-Up by Sub-Groups
African Americans-Baseline, Month 4
|
-0.5 percentage weight change
Standard Deviation 3.95
|
-2.5 percentage weight change
Standard Deviation 3.68
|
|
Percentage Weight From Baseline Through Follow-Up by Sub-Groups
Participants with diabetes-Baseline, Month 12
|
-4.2 percentage weight change
Standard Deviation 5.97
|
-3.9 percentage weight change
Standard Deviation 6.78
|
|
Percentage Weight From Baseline Through Follow-Up by Sub-Groups
Participants without diabetes-Baseline, Month 12
|
-4.8 percentage weight change
Standard Deviation 6.32
|
-4.5 percentage weight change
Standard Deviation 5.87
|
|
Percentage Weight From Baseline Through Follow-Up by Sub-Groups
Males-Baseline, Month 12
|
-6.2 percentage weight change
Standard Deviation 6.06
|
-5.0 percentage weight change
Standard Deviation 6.44
|
|
Percentage Weight From Baseline Through Follow-Up by Sub-Groups
Whites-Baseline, Month 12
|
-5.4 percentage weight change
Standard Deviation 6.85
|
-5.6 percentage weight change
Standard Deviation 6.53
|
|
Percentage Weight From Baseline Through Follow-Up by Sub-Groups
African Americans-Baseline, Month 12
|
-3.0 percentage weight change
Standard Deviation 4.09
|
-2.5 percentage weight change
Standard Deviation 5.19
|
|
Percentage Weight From Baseline Through Follow-Up by Sub-Groups
Participants with diabetes-Baseline, Month 24
|
-4.7 percentage weight change
Standard Deviation 6.57
|
-5.0 percentage weight change
Standard Deviation 6.30
|
|
Percentage Weight From Baseline Through Follow-Up by Sub-Groups
Participants without diabetes-Baseline, Month 24
|
-4.3 percentage weight change
Standard Deviation 7.87
|
-3.1 percentage weight change
Standard Deviation 5.78
|
|
Percentage Weight From Baseline Through Follow-Up by Sub-Groups
Females-Baseline, Month 24
|
-3.6 percentage weight change
Standard Deviation 7.69
|
-3.6 percentage weight change
Standard Deviation 6.40
|
|
Percentage Weight From Baseline Through Follow-Up by Sub-Groups
Males-Baseline, Month 24
|
-5.5 percentage weight change
Standard Deviation 7.08
|
-3.9 percentage weight change
Standard Deviation 5.54
|
|
Percentage Weight From Baseline Through Follow-Up by Sub-Groups
Whites-Baseline, Month 24
|
-4.9 percentage weight change
Standard Deviation 7.73
|
-4.2 percentage weight change
Standard Deviation 5.99
|
|
Percentage Weight From Baseline Through Follow-Up by Sub-Groups
African Americans-Baseline, Month 24
|
-3.5 percentage weight change
Standard Deviation 6.81
|
-3.1 percentage weight change
Standard Deviation 6.02
|
|
Percentage Weight From Baseline Through Follow-Up by Sub-Groups
Participants without diabetes-Baseline, Month 4
|
-0.6 percentage weight change
Standard Deviation 4.06
|
-4.7 percentage weight change
Standard Deviation 5.19
|
|
Percentage Weight From Baseline Through Follow-Up by Sub-Groups
Females-Baseline, Month 4
|
-0.3 percentage weight change
Standard Deviation 3.77
|
-4.0 percentage weight change
Standard Deviation 4.77
|
|
Percentage Weight From Baseline Through Follow-Up by Sub-Groups
Females-Baseline, Month 12
|
-3.3 percentage weight change
Standard Deviation 6.04
|
-3.7 percentage weight change
Standard Deviation 5.98
|
|
Percentage Weight From Baseline Through Follow-Up by Sub-Groups
Participants with diabetes-Baseline, Month 4
|
-1.7 percentage weight change
Standard Deviation 3.63
|
-3.7 percentage weight change
Standard Deviation 4.56
|
SECONDARY outcome
Timeframe: Baseline, Months 4, 12, and 24Population: Data reported for all participants who returned for follow-up measures.
Weight will be collected by study staff who are masked to treatment.
Outcome measures
| Measure |
Med-South Weight Loss Intervention
n=146 Participants
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
Augmented Usual Care (WW)
n=152 Participants
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
|---|---|---|
|
Mean Weight Change From Baseline Through Follow-Up
Baseline, Month 4
|
-1.1 Kg
Standard Deviation 4.38
|
-4.8 Kg
Standard Deviation 5.60
|
|
Mean Weight Change From Baseline Through Follow-Up
Baseline, Month 12
|
-5.1 Kg
Standard Deviation 6.85
|
-4.6 Kg
Standard Deviation 6.81
|
|
Mean Weight Change From Baseline Through Follow-Up
Baseline, Month 24
|
-5.1 Kg
Standard Deviation 8.57
|
-4.1 Kg
Standard Deviation 6.36
|
SECONDARY outcome
Timeframe: Baseline, Months 4, 12, and 24Population: Blood pressure assessed by Omron-907xl if an average of 3 error-free readings were obtained.
Blood pressure assessed by Omron-907xl, average of 3 readings.
Outcome measures
| Measure |
Med-South Weight Loss Intervention
n=142 Participants
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
Augmented Usual Care (WW)
n=152 Participants
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
|---|---|---|
|
Mean Change in Systolic Blood Pressure From Baseline Through Follow-Up
Baseline, Month 12
|
-6.5 mm Hg
Standard Deviation 13.62
|
-5.2 mm Hg
Standard Deviation 13.14
|
|
Mean Change in Systolic Blood Pressure From Baseline Through Follow-Up
Baseline, Month 24
|
-4.7 mm Hg
Standard Deviation 14.23
|
-3.9 mm Hg
Standard Deviation 14.23
|
|
Mean Change in Systolic Blood Pressure From Baseline Through Follow-Up
Baseline, Month 4
|
-4.1 mm Hg
Standard Deviation 12.37
|
-4.5 mm Hg
Standard Deviation 12.17
|
SECONDARY outcome
Timeframe: Baseline, Months 4, 12, and 24Population: Blood pressure assessed by Omron-907xl if an average of 3 error-free readings were obtained.
Blood pressure assessed by Omron-907xl, average of 3 readings.
Outcome measures
| Measure |
Med-South Weight Loss Intervention
n=142 Participants
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
Augmented Usual Care (WW)
n=151 Participants
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
|---|---|---|
|
Mean Change in Diastolic Blood Pressure From Baseline Through Follow-Up
Baseline, Month 4
|
-3.4 mm Hg
Standard Deviation 7.78
|
-3.3 mm Hg
Standard Deviation 7.72
|
|
Mean Change in Diastolic Blood Pressure From Baseline Through Follow-Up
Baseline, Month 12
|
-4.6 mm Hg
Standard Deviation 8.74
|
-3.9 mm Hg
Standard Deviation 7.62
|
|
Mean Change in Diastolic Blood Pressure From Baseline Through Follow-Up
Baseline, Month 24
|
-3.2 mm Hg
Standard Deviation 8.93
|
-3.2 mm Hg
Standard Deviation 9.24
|
SECONDARY outcome
Timeframe: Baseline, Month 4, 12, and 24Population: Data reported for all participants with successful phlebotomy.
Total cholesterol assessed by commercial lab (LabCorp).
Outcome measures
| Measure |
Med-South Weight Loss Intervention
n=140 Participants
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
Augmented Usual Care (WW)
n=142 Participants
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
|---|---|---|
|
Mean Change in Total Cholesterol From Baseline Through Follow-Up
Baseline, Month 4
|
-1.4 mg/dL
Standard Deviation 24.34
|
-4.3 mg/dL
Standard Deviation 22.47
|
|
Mean Change in Total Cholesterol From Baseline Through Follow-Up
Baseline, Month 24
|
-2.6 mg/dL
Standard Deviation 31.89
|
-10.2 mg/dL
Standard Deviation 35.32
|
|
Mean Change in Total Cholesterol From Baseline Through Follow-Up
Baseline, Month 12
|
-5.1 mg/dL
Standard Deviation 29.86
|
-3.6 mg/dL
Standard Deviation 28.43
|
SECONDARY outcome
Timeframe: Baseline, Month 4, 12, and 24Population: Data reported for all participants with successful phlebotomy.
HDL-Cholesterol assessed by commercial lab (LabCorp).
Outcome measures
| Measure |
Med-South Weight Loss Intervention
n=140 Participants
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
Augmented Usual Care (WW)
n=142 Participants
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
|---|---|---|
|
Mean Change in HDL-Cholesterol From Baseline Through Follow-Up
Baseline, Month 4
|
-0.1 mg/dL
Standard Deviation 6.16
|
-0.1 mg/dL
Standard Deviation 6.60
|
|
Mean Change in HDL-Cholesterol From Baseline Through Follow-Up
Baseline, Month 12
|
1.7 mg/dL
Standard Deviation 7.42
|
1.4 mg/dL
Standard Deviation 3.73
|
|
Mean Change in HDL-Cholesterol From Baseline Through Follow-Up
Baseline, Month 24
|
3.0 mg/dL
Standard Deviation 8.43
|
2.9 mg/dL
Standard Deviation 7.43
|
SECONDARY outcome
Timeframe: Baseline, Month 4, 12, and 24Population: Participants with successful phlebotomy who reported fasting.
Triglycerides as assessed by commercial lab (LabCorp).
Outcome measures
| Measure |
Med-South Weight Loss Intervention
n=125 Participants
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
Augmented Usual Care (WW)
n=123 Participants
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
|---|---|---|
|
Mean Change in Triglycerides From Baseline Through Follow-Up
Baseline, Month 4
|
-6.1 mg/dL
Standard Deviation 52.6
|
-9.4 mg/dL
Standard Deviation 34.40
|
|
Mean Change in Triglycerides From Baseline Through Follow-Up
Baseline, Month 12
|
-8.6 mg/dL
Standard Deviation 115.9
|
-5.8 mg/dL
Standard Deviation 44.30
|
|
Mean Change in Triglycerides From Baseline Through Follow-Up
Baseline, Month 24
|
-10.4 mg/dL
Standard Deviation 64.07
|
-4.2 mg/dL
Standard Deviation 48.09
|
SECONDARY outcome
Timeframe: Baseline, Month 4, 12, and 24Population: Participants with successful phlebotomy who reported fasting.
Calculated from above lipid assessments by commercial lab (LabCorp).
Outcome measures
| Measure |
Med-South Weight Loss Intervention
n=124 Participants
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
Augmented Usual Care (WW)
n=123 Participants
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
|---|---|---|
|
Mean Change LDL-cholesterol From Baseline Through Follow-up
Baseline, Month 4
|
-1.7 mg/dL
Standard Deviation 20.81
|
-2.6 mg/dL
Standard Deviation 21.98
|
|
Mean Change LDL-cholesterol From Baseline Through Follow-up
Baseline, Month 12
|
-5.59 mg/dL
Standard Deviation 21.80
|
-4.97 mg/dL
Standard Deviation 25.84
|
|
Mean Change LDL-cholesterol From Baseline Through Follow-up
Baseline, Month 24
|
-5.87 mg/dL
Standard Deviation 24.47
|
-13.90 mg/dL
Standard Deviation 31.25
|
SECONDARY outcome
Timeframe: Baseline, Month 4, 12, and 24Population: Data reported for all participants with successful phlebotomy.
A1c assessed by commercial lab (LabCorp).
Outcome measures
| Measure |
Med-South Weight Loss Intervention
n=138 Participants
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
Augmented Usual Care (WW)
n=141 Participants
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
|---|---|---|
|
Mean Change in A1c From Baseline Through Follow-Up
Baseline, Month 12
|
-0.1 percent
Standard Deviation 0.58
|
-0.2 percent
Standard Deviation 0.75
|
|
Mean Change in A1c From Baseline Through Follow-Up
Baseline, Month 24
|
0.0 percent
Standard Deviation 0.60
|
-0.2 percent
Standard Deviation 0.80
|
|
Mean Change in A1c From Baseline Through Follow-Up
Baseline, Month 4
|
0.0 percent
Standard Deviation 0.62
|
-0.2 percent
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: Baseline, Month 4, 12, and 24Population: Data reported for all participants with successful phlebotomy.
CRP assessed by commercial lab (LabCorp).
Outcome measures
| Measure |
Med-South Weight Loss Intervention
n=139 Participants
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
Augmented Usual Care (WW)
n=143 Participants
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
|---|---|---|
|
Mean Change in CRP (C-Reactive Protein) From Baseline Through Follow-Up
Baseline, Month 4
|
0.1 mg/L
Standard Deviation 2.61
|
-0.6 mg/L
Standard Deviation 4.72
|
|
Mean Change in CRP (C-Reactive Protein) From Baseline Through Follow-Up
Baseline, Month 12
|
1.0 mg/L
Standard Deviation 5.27
|
0.4 mg/L
Standard Deviation 8.28
|
|
Mean Change in CRP (C-Reactive Protein) From Baseline Through Follow-Up
Baseline, Month 24
|
-0.7 mg/L
Standard Deviation 3.22
|
-1.1 mg/L
Standard Deviation 5.30
|
SECONDARY outcome
Timeframe: Baseline, Month 4, 12, and 24Population: Participants with successful phlebotomy who reported fasting and who had a measurable level.
Assessed by independent lab blinded to participant arm.
Outcome measures
| Measure |
Med-South Weight Loss Intervention
n=126 Participants
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
Augmented Usual Care (WW)
n=126 Participants
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
|---|---|---|
|
Mean Change in Interleukin (IL) IL-6 From Baseline Through Follow-Up
Baseline, Month 4
|
-0.63 pg/mL
Standard Deviation 4.21
|
-0.35 pg/mL
Standard Deviation 3.30
|
|
Mean Change in Interleukin (IL) IL-6 From Baseline Through Follow-Up
Baseline, Month 12
|
-0.64 pg/mL
Standard Deviation 4.90
|
-0.14 pg/mL
Standard Deviation 5.55
|
|
Mean Change in Interleukin (IL) IL-6 From Baseline Through Follow-Up
Baseline, Month 24
|
-0.20 pg/mL
Standard Deviation 3.37
|
-1.60 pg/mL
Standard Deviation 3.82
|
SECONDARY outcome
Timeframe: Baseline, Month 4, 12, and 24Population: Participants with successful phlebotomy who reported fasting and who had a measurable level. The numbers differ from IL-6 due to number of participants with results below the lower limit of the assay.
Assessed by independent lab blinded to participant arm.
Outcome measures
| Measure |
Med-South Weight Loss Intervention
n=128 Participants
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
Augmented Usual Care (WW)
n=129 Participants
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
|---|---|---|
|
Mean Change in Tumor Necrosis Factor (TNF) TNF-alpha From Baseline Through Follow-Up
Baseline, Month 4
|
-0.39 pg/mL
Standard Deviation 6.87
|
-0.03 pg/mL
Standard Deviation 3.20
|
|
Mean Change in Tumor Necrosis Factor (TNF) TNF-alpha From Baseline Through Follow-Up
Baseline, Month 12
|
-0.69 pg/mL
Standard Deviation 10.52
|
-0.30 pg/mL
Standard Deviation 3.14
|
|
Mean Change in Tumor Necrosis Factor (TNF) TNF-alpha From Baseline Through Follow-Up
Baseline, Month 24
|
-1.27 pg/mL
Standard Deviation 10.94
|
-0.16 pg/mL
Standard Deviation 3.25
|
SECONDARY outcome
Timeframe: Baseline, Month 4, 12, and 24Population: Data reported for all participants who returned for follow-up measures.
Evaluated as the sum of 3 measures assessed by veggie-meter by Longevity Link Corporation. The Veggie Meter produces a score from 0 to 800, with higher scores indicating greater skin carotenoid levels, which suggest a greater intake of fruits and vegetables.
Outcome measures
| Measure |
Med-South Weight Loss Intervention
n=143 Participants
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
Augmented Usual Care (WW)
n=152 Participants
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
|---|---|---|
|
Mean Change in Skin Carotenoids From Baseline Through Follow-Up
Baseline, Month 12
|
24.3 score on a scale
Standard Deviation 69.87
|
30.8 score on a scale
Standard Deviation 81.07
|
|
Mean Change in Skin Carotenoids From Baseline Through Follow-Up
Baseline, Month 24
|
13.5 score on a scale
Standard Deviation 62.67
|
12.6 score on a scale
Standard Deviation 70.85
|
|
Mean Change in Skin Carotenoids From Baseline Through Follow-Up
Baseline, Month 4
|
8.5 score on a scale
Standard Deviation 50.23
|
31.8 score on a scale
Standard Deviation 66.43
|
SECONDARY outcome
Timeframe: Baseline, Month 4, 12, and 24Population: Data reported for all participants who returned for follow-up measures.
The Euro Quality of Life Three Dimensions Questionnaire EQ-5D-3L ( EuroQol five-dimensional three-level questionnaire) scale measures patients' quality of healthy living. It has 5 items (Mobility, Self-care, Usual activities, Pain/discomfort, Depression/anxiety). Each item contains 3 levels: 1=no problems; 2=some problems; 3=extreme problems. The higher the score has the worse the health. Then, the score calculation of the European Five-Dimensional Health Scale is based on the calculation formula published for U.S. populations. Based on 3 combinations of different severity for the 5 items, a score of 0 to 1 is obtained which is called the EQ-5D-3L index and reported here. 0 is the least healthy and 1 is the most healthy.
Outcome measures
| Measure |
Med-South Weight Loss Intervention
n=140 Participants
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
Augmented Usual Care (WW)
n=147 Participants
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
|---|---|---|
|
Mean Change in Quality of Life Scale From Baseline Through Follow-Up
Baseline, Month 4
|
0.009 score on a scale
Standard Deviation 0.11
|
0.012 score on a scale
Standard Deviation 0.11
|
|
Mean Change in Quality of Life Scale From Baseline Through Follow-Up
Baseline, Month 12
|
0.005 score on a scale
Standard Deviation 0.12
|
0.012 score on a scale
Standard Deviation 0.13
|
|
Mean Change in Quality of Life Scale From Baseline Through Follow-Up
Baseline, Month 24
|
-0.009 score on a scale
Standard Deviation 0.16
|
0.000 score on a scale
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: Baseline, Month 4, 12, and 24Population: Data reported for all participants who returned for follow-up measures, completed the Harvard-Willett Food Frequency Questionnaire, and had plausible daily energy intake. For women this was defined as daily kcal intake between 500 and 3500 kcal inclusive. For men this was defined as daily kcal intake between 800 and 4200 kcal inclusive.
The AHEI-2010 is calculated from items on the Willett Food Frequency Questionnaire. It addresses intake of foods and nutrients consistently associated with lower risk for chronic diseases in the literature. The AHEI-2010 score is comprised of 11 sub-scales, each scored from 0 to 10, yielding a total score with a range of 0-110. A higher score indicates a more healthful dietary pattern.
Outcome measures
| Measure |
Med-South Weight Loss Intervention
n=140 Participants
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
Augmented Usual Care (WW)
n=147 Participants
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
|---|---|---|
|
Mean Change in Alternate Healthy Eating Index (AHEI)-2010 From Baseline Through Follow-Up
Baseline, Month 12
|
8.8 score on a scale
Standard Deviation 9.18
|
2.4 score on a scale
Standard Deviation 9.51
|
|
Mean Change in Alternate Healthy Eating Index (AHEI)-2010 From Baseline Through Follow-Up
Baseline, Month 4
|
8.2 score on a scale
Standard Deviation 8.97
|
2.8 score on a scale
Standard Deviation 9.67
|
|
Mean Change in Alternate Healthy Eating Index (AHEI)-2010 From Baseline Through Follow-Up
Baseline, Month 24
|
6.6 score on a scale
Standard Deviation 9.68
|
3.0 score on a scale
Standard Deviation 9.35
|
SECONDARY outcome
Timeframe: Baseline, Month 4, 12, and 24Population: The reduced number at follow-up reflects participants that did not return for the measurement visit and those who did not report any moderate or vigorous activity.
The GPAQ was developed by the World Health Organization (WHO) for physical activity surveillance. It collects information on physical activity participation in three settings (or domains) as well as sedentary behavior. The domains are: activity at work, travel to and from places, and recreational activities. The summary measure will be the sum of all moderate and vigorous activity per week (measured in hours) for the domains mentioned with a higher score indicating more physical activity.
Outcome measures
| Measure |
Med-South Weight Loss Intervention
n=104 Participants
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
Augmented Usual Care (WW)
n=114 Participants
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
|---|---|---|
|
Mean Change in Global Physical Activity Questionnaire (GPAQ) From Baseline Through Follow-Up
Baseline, Month 12
|
1.67 hours/week
Interval -0.67 to 6.33
|
1.00 hours/week
Interval -1.83 to 5.5
|
|
Mean Change in Global Physical Activity Questionnaire (GPAQ) From Baseline Through Follow-Up
Baseline, Month 24
|
0.17 hours/week
Interval -4.53 to 6.0
|
0.90 hours/week
Interval -2.16 to 5.5
|
|
Mean Change in Global Physical Activity Questionnaire (GPAQ) From Baseline Through Follow-Up
Baseline, Month 4
|
0.92 hours/week
Interval -3.04 to 3.5
|
1.00 hours/week
Interval -2.75 to 3.25
|
SECONDARY outcome
Timeframe: Baseline, Month 4, 12, and 24Population: Data reported for all participants who returned for follow-up measures.
The Weight Efficacy Lifestyle Questionnaire Short-Form (WEL-SF1) is a short version of the original Weight-Efficacy Lifestyle Questionnaire and includes 8 questions and 1 situational component representing "confidence in ability to resist eating." Three of the questions are related to emotional eating situations, two to availability, one to social pressure, one to positive activities, and one to physical discomfort. Scoring: The instrument range scores on a Likert-scale from 0 (not at all confident) to 10 (very confident), with sum scores between 0 and 80. High scores are associated with high eating self-efficacy.
Outcome measures
| Measure |
Med-South Weight Loss Intervention
n=141 Participants
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
Augmented Usual Care (WW)
n=151 Participants
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
|---|---|---|
|
Mean Change in Weight Loss Self-Efficacy From Baseline Through Follow-Up
Baseline, Month 4
|
2.9 score on a scale
Standard Deviation 14.57
|
1.60 score on a scale
Standard Deviation 13.50
|
|
Mean Change in Weight Loss Self-Efficacy From Baseline Through Follow-Up
Baseline, Month 12
|
5.0 score on a scale
Standard Deviation 14.60
|
0.4 score on a scale
Standard Deviation 16.90
|
|
Mean Change in Weight Loss Self-Efficacy From Baseline Through Follow-Up
Baseline, Month 24
|
5.3 score on a scale
Standard Deviation 16.09
|
2.8 score on a scale
Standard Deviation 14.97
|
SECONDARY outcome
Timeframe: Baseline, Month 4, 12, and 24Population: Data reported for all participants who returned for follow-up measures.
Treatment Self-regulation Questionnaire (TSRQ) measures the quality of motivation for a particular health goal. Motivation is psychological energy directed at a particular goal such as weight loss. The autonomous self-regulation sub-scale of the TSRQ was used.This 6-item scale will focus on the reasons why people would either start eating a healthier diet or continue to do so. Scoring: Participants rate each statement on a 7-point Likert scale ranging from 1 (not at all true) to 7 (very true). It assesses the degree to which a person's motivation for eating a healthy diet is autonomous or self-determined. Possible scores range from 6 to 42 wtih higher scores indicating greater motivation.
Outcome measures
| Measure |
Med-South Weight Loss Intervention
n=141 Participants
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
Augmented Usual Care (WW)
n=151 Participants
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
|---|---|---|
|
Mean Change in Dietary Self-Regulation From Baseline Through Follow-Up
Baseline, Month 4
|
0.1 score on a scale
Standard Deviation 0.90
|
0.0 score on a scale
Standard Deviation 1.05
|
|
Mean Change in Dietary Self-Regulation From Baseline Through Follow-Up
Baseline, Month 24
|
0.1 score on a scale
Standard Deviation 1.07
|
-0.3 score on a scale
Standard Deviation 1.08
|
|
Mean Change in Dietary Self-Regulation From Baseline Through Follow-Up
Baseline, Month 12
|
0.2 score on a scale
Standard Deviation 0.93
|
-0.1 score on a scale
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: Baseline, Month 4, 12, and 24Population: Data reported for all participants who returned for follow-up measures.
The Cognitive Restraint subscale of the Three Factor Eating Questionnaire has 6 items and measures one of the three dimensions of eating attitudes. The instrument scoring range for each item is based on a Likert-scale from 1 (definitely false) to 4 (definitely true) with scores ranging from 6 and 24. Higher scores indicate greater cognitive restraint.
Outcome measures
| Measure |
Med-South Weight Loss Intervention
n=141 Participants
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
Augmented Usual Care (WW)
n=151 Participants
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
|---|---|---|
|
Mean Change in Eating Attitudes From Baseline Through Follow-Up (Cognitive Restraint)
Baseline, Month 12
|
2.5 score on a scale
Standard Deviation 3.75
|
1.6 score on a scale
Standard Deviation 3.18
|
|
Mean Change in Eating Attitudes From Baseline Through Follow-Up (Cognitive Restraint)
Baseline, Month 24
|
2.3 score on a scale
Standard Deviation 3.79
|
1.8 score on a scale
Standard Deviation 2.93
|
|
Mean Change in Eating Attitudes From Baseline Through Follow-Up (Cognitive Restraint)
Baseline, Month 4
|
1.7 score on a scale
Standard Deviation 3.34
|
2.3 score on a scale
Standard Deviation 3.09
|
SECONDARY outcome
Timeframe: Baseline, Month 4, 12, and 24Population: Data reported for all participants who returned for follow-up measures.
The uncontrolled eating subscale of the Three Factor Eating Questionnaire has 9 items and measures one of the three dimensions of eating attitudes. The instrument scoring range for each item is based on a Likert-scale from 1 (definitely false) to 4 (definitely true) with scores ranging from 9 and 36. Higher scores indicate greater uncontrolled eating.
Outcome measures
| Measure |
Med-South Weight Loss Intervention
n=141 Participants
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
Augmented Usual Care (WW)
n=151 Participants
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
|---|---|---|
|
Mean Change in Eating Attitudes From Baseline Through Follow-Up (Uncontrolled Eating)
Baseline, Month 24
|
-1.9 score on a scale
Standard Deviation 3.76
|
-0.1 score on a scale
Standard Deviation 3.57
|
|
Mean Change in Eating Attitudes From Baseline Through Follow-Up (Uncontrolled Eating)
Baseline, Month 12
|
-2.0 score on a scale
Standard Deviation 3.87
|
-0.8 score on a scale
Standard Deviation 3.88
|
|
Mean Change in Eating Attitudes From Baseline Through Follow-Up (Uncontrolled Eating)
Baseline, Month 4
|
-1.2 score on a scale
Standard Deviation 3.40
|
-0.5 score on a scale
Standard Deviation 3.19
|
SECONDARY outcome
Timeframe: Baseline, Month 4, 12, and 24Population: Data reported for all participants who returned for follow-up measures.
The emotional eating subscale of the Three Factor Eating Questionnaire has 3 items and measures one of the three dimensions of eating attitudes. The instrument scoring range for each item is based on a Likert-scale from 1 (definitely false) to 4 (definitely true) with scores ranging from 3 and 12. Higher scores indicate greater emotional eating.
Outcome measures
| Measure |
Med-South Weight Loss Intervention
n=141 Participants
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
Augmented Usual Care (WW)
n=151 Participants
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
|---|---|---|
|
Mean Change in Eating Attitudes From Baseline Through Follow-Up (Emotional Eating)
Baseline, Month 12
|
-0.6 score on a scale
Standard Deviation 1.66
|
-0.3 score on a scale
Standard Deviation 1.98
|
|
Mean Change in Eating Attitudes From Baseline Through Follow-Up (Emotional Eating)
Baseline, Month 4
|
-0.4 score on a scale
Standard Deviation 7.71
|
-0.6 score on a scale
Standard Deviation 1.69
|
|
Mean Change in Eating Attitudes From Baseline Through Follow-Up (Emotional Eating)
Baseline, Month 24
|
-0.6 score on a scale
Standard Deviation 1.84
|
-0.5 score on a scale
Standard Deviation 1.91
|
SECONDARY outcome
Timeframe: Baseline, Month 4, 12, and 24Population: Data reported for all participants who returned for follow-up measures.
Perceived self-efficacy is regarded as a suitable predictor of reported health behaviors. This 5-item scale of perceived self-efficacy measures self-efficacy related to healthful eating behaviors. Responses are on a 4-point scale of 'very uncertain' to 'very certain.' Total scores range from 5-20 with higher scores indicating higher perceived self-efficacy.
Outcome measures
| Measure |
Med-South Weight Loss Intervention
n=142 Participants
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
Augmented Usual Care (WW)
n=151 Participants
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
|---|---|---|
|
Mean Change in Diet Self-Efficacy From Baseline Through Follow-Up
Baseline, Month 4
|
0.5 score on a scale
Standard Deviation 3.78
|
-0.1 score on a scale
Standard Deviation 3.28
|
|
Mean Change in Diet Self-Efficacy From Baseline Through Follow-Up
Baseline, Month 12
|
0.5 score on a scale
Standard Deviation 4.21
|
-0.4 score on a scale
Standard Deviation 3.51
|
|
Mean Change in Diet Self-Efficacy From Baseline Through Follow-Up
Baseline, Month 24
|
-0.1 score on a scale
Standard Deviation 4.58
|
-0.8 score on a scale
Standard Deviation 3.58
|
SECONDARY outcome
Timeframe: Baseline, Month 4, 12, and 24Population: Data reported for all participants who returned for follow-up measures.
EARLY Self-Weighing Questionnaire: This is a 1-item screener measures frequency of self-weighing. It was adapted from the Pound of Prevention Health Habits Questionnaire. Those reporting a higher weighing frequency had greater 24-month weight loss or less weight gain. Scoring: Higher scores indicate higher frequency of self-weighing. Responses are based on a 7-point scale ranging from 1 = never; 2 = once a year or less; 3= every couple of months; 4 = about once a month; 5 = about once a week; 6 = about once a day; and 7 = more than once a day.
Outcome measures
| Measure |
Med-South Weight Loss Intervention
n=141 Participants
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
Augmented Usual Care (WW)
n=151 Participants
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
|---|---|---|
|
Mean Change in Self-Weighing Behaviors From Baseline Through Follow-Up
Baseline, Month 4
|
1.1 score on a scale
Standard Deviation 1.60
|
0.6 score on a scale
Standard Deviation 1.25
|
|
Mean Change in Self-Weighing Behaviors From Baseline Through Follow-Up
Baseline, Month 12
|
1.7 score on a scale
Standard Deviation 1.64
|
0.5 score on a scale
Standard Deviation 1.24
|
|
Mean Change in Self-Weighing Behaviors From Baseline Through Follow-Up
Baseline, Month 24
|
1.5 score on a scale
Standard Deviation 1.57
|
0.3 score on a scale
Standard Deviation 1.28
|
SECONDARY outcome
Timeframe: Month 24Computed as the incremental cost per kilogram of weight loss relative to control. The budgetary assessment will quantify the total and per participant costs of intervention delivery from the health system perspective using an Activity Based Costing (ABC) approach and cost tracking forms that the health economist (Finkelstein) has developed and refined in past behavioral trials. Using this approach, all relevant labor, materials and supplies, contracted services, and other relevant costs required to deliver the interventions will be captured by key activities
Outcome measures
| Measure |
Med-South Weight Loss Intervention
n=118 Participants
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
Augmented Usual Care (WW)
n=129 Participants
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
|---|---|---|
|
Economic Outcome--Incremental Cost-Effectiveness
|
NA U.S. dollars/Kg
Below the level of detection since the adjusted difference in percent weight change between study arms was minimal. The effectiveness results were equivalent, resulting in a zero denominator in the Incremental Cost-Effectiveness Ratio (ICER) calculation. This made the ICER mathematically undefined, and no participants were analyzed for this outcome
|
NA U.S. dollars/Kg
Below the level of detection since the adjusted difference in percent weight change between study arms was minimal. The effectiveness results were equivalent, resulting in a zero denominator in the Incremental Cost-Effectiveness Ratio (ICER) calculation. This made the ICER mathematically undefined, and no participants were analyzed for this outcome
|
SECONDARY outcome
Timeframe: Month 24The numerator for this analysis will be the incremental program delivery costs of the intervention relative to control, minus any cost offsets based on differences in health services and medication use across arms. The denominator will be the incremental QALYs based on average differences in Euro Quality of Life five Dimensions Questionnaire (EQ-5D-5L) scores across arms collected at each assessment point. These scores can be used to quantify net QALY differences during the intervention period. EQ-5D-5L scale measures patients' quality of healthy living. It has 5 items (Mobility, Self-care, Usual activities, Pain/discomfort, Depression/anxiety). The score calculation of the European Five-Dimensional Health Scale is based on the calculation formula published by the EuroQol Group. Based on 5 combinations of different severity levels, a score of 0 to 1 is obtained. 0 is the least healthy and 1 is the most healthy.
Outcome measures
| Measure |
Med-South Weight Loss Intervention
n=118 Participants
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
Augmented Usual Care (WW)
n=129 Participants
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
|---|---|---|
|
Economic Outcome--Incremental Cost Per Quality Adjusted Life Year (QALY) Gained
|
NA U.S. dollars per QALY
Below the level of detection since the adjusted difference in percent weight change between study arms was minimal. The effectiveness results were equivalent, resulting in a zero denominator in the Incremental Cost-Effectiveness Ratio (ICER) calculation. This made the ICER mathematically undefined, and no participants were analyzed for this outcome.
|
NA U.S. dollars per QALY
Below the level of detection since the adjusted difference in percent weight change between study arms was minimal. The effectiveness results were equivalent, resulting in a zero denominator in the Incremental Cost-Effectiveness Ratio (ICER) calculation. This made the ICER mathematically undefined, and no participants were analyzed for this outcome.
|
Adverse Events
Augmented Usual Care (WW)
Med-South Weight Loss Intervention
Serious adverse events
| Measure |
Augmented Usual Care (WW)
n=178 participants at risk
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
Med-South Weight Loss Intervention
n=182 participants at risk
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Psychiatric disorders
Depression
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
1.1%
2/182 • Number of events 2 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
1.1%
2/182 • Number of events 5 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Nervous system disorders
Subdural Hematoma
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 2 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Infections and infestations
Meningitis
|
0.56%
1/178 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.00%
0/182 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Nervous system disorders
Seizure
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Infections and infestations
Abscess
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Gastrointestinal disorders
Dysphasia
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 2 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
Hip Fracture
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Hepatobiliary disorders
Acute Cholecystitis
|
0.56%
1/178 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.00%
0/182 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
Lung nodule
|
0.56%
1/178 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.00%
0/182 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Cardiac disorders
Superventricular Tachycardia (SVT)
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Injury, poisoning and procedural complications
Intrabdominal hematoma secondary to bike accident
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Cardiac disorders
Heart failure
|
0.56%
1/178 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.00%
0/182 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Pregnancy, puerperium and perinatal conditions
Birth by Caesarian Section
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Vascular disorders
Possible Stroke
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Psychiatric disorders
Fall while intoxicated
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Psychiatric disorders
Left sided weakness
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Psychiatric disorders
Fell out of Bed
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.56%
1/178 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.00%
0/182 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Infections and infestations
Ehrlichiosis
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 2 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Pregnancy, puerperium and perinatal conditions
Preeclampsia
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Pregnancy, puerperium and perinatal conditions
Induction of Labor
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Surgical and medical procedures
Septoplasty
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Surgical and medical procedures
Arthrodesis
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Surgical and medical procedures
Cervical stenosis
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Surgical and medical procedures
Laminectomy
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Surgical and medical procedures
Surgery with finding of diffuse astrocytoma
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Surgical and medical procedures
Cervical myelopathy
|
0.56%
1/178 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.00%
0/182 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Surgical and medical procedures
Sleeve gastrectomy
|
0.56%
1/178 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.00%
0/182 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Surgical and medical procedures
Elective hysterectomy
|
0.56%
1/178 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.00%
0/182 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Surgical and medical procedures
Cerebral spinal fluid leak
|
0.56%
1/178 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.00%
0/182 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Surgical and medical procedures
Hemicholectomy
|
0.56%
1/178 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.00%
0/182 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Surgical and medical procedures
Spinal stenosis
|
0.00%
0/178 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
0.55%
1/182 • Number of events 1 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
Other adverse events
| Measure |
Augmented Usual Care (WW)
n=178 participants at risk
The intervention that will be offered to control group participants is WW™ (also known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
WW: If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
|
Med-South Weight Loss Intervention
n=182 participants at risk
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Med-South Weight Loss Intervention: Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycemia
|
7.3%
13/178 • Number of events 21 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
7.7%
14/182 • Number of events 19 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
|
Cardiac disorders
Dizziness
|
13.5%
24/178 • Number of events 33 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
12.1%
22/182 • Number of events 30 • From the time of randomization to the final follow-up visit, a total of approximately 24 months (the defined window for the final follow-up was 23-30 months). For those who did not attend the final follow-up visit, reports for hospitalization were reviewed from the electronic health record for 2 years post randomization.
Adverse events were captured using the electronic health record report for hospitalizations and by participant-completed surveys at follow-up visits.
|
Additional Information
Thomas Keyserling, MD
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place