Trial Outcomes & Findings for Latinos Combating Diabetes (NCT NCT01831921)
NCT ID: NCT01831921
Last Updated: 2019-08-28
Results Overview
Mean hemoglobin A1c in both treatment groups at 6, 12, 18, and 24 months will be assessed.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
225 participants
Primary outcome timeframe
6, 12, 18, and 24 months
Results posted on
2019-08-28
Participant Flow
Baseline and randomization visits began in January 2014 and concluded in June 2016. In a roughly 26-month period, 225 participants were randomized (150 lifestyle intervention; 75 enhanced usual care) to take part in La Comunidad.
Participant milestones
| Measure |
Lifestyle Weight-Loss
Participants in the Behavioral: Lifestyle Weight Loss arm will take part in a group program aimed at achieving modest weight loss (5-7%) through promoting healthy eating and increasing physical activity. The intervention sessions will take place at churches and other community locations and will be coordinated and facilitated by Latino Health Advisors (LHAs). The lifestyle intervention will be delivered in 2 phases: Phase 1 will last for 6 months and consist of weekly group meetings; Phase 2 will last for 18 months and consist of one LHA-led group session or one telephone contact from the LHA per month. Participants in this treatment arm will also receive individual visits with a registered dietitian during months 1, 3, and 6 of phase 1.
Lifestyle Weight Loss: Changing diet, physical activity, and self-regulatory behaviors to promote weight loss.
|
Enhanced Usual Care
Participants in the Behavioral: Counseling arm will receive two individual sessions with a registered dietitian and monthly newsletters that focus on existing community resources.
Counseling: Individual nutrition counseling will be delivered by a registered dietitian.
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
75
|
|
Overall Study
6 Months
|
122
|
63
|
|
Overall Study
12 Months
|
120
|
62
|
|
Overall Study
18 Months
|
90
|
49
|
|
Overall Study
COMPLETED
|
66
|
36
|
|
Overall Study
NOT COMPLETED
|
84
|
39
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Latinos Combating Diabetes
Baseline characteristics by cohort
| Measure |
Lifestyle Weight-Loss
n=150 Participants
Participants in the Behavioral: Lifestyle Weight Loss arm will take part in a group program aimed at achieving modest weight loss (5-7%) through promoting healthy eating and increasing physical activity. The intervention sessions will take place at churches and other community locations and will be coordinated and facilitated by Latino Health Advisors (LHAs). The lifestyle intervention will be delivered in 2 phases: Phase 1 will last for 6 months and consist of weekly group meetings; Phase 2 will last for 18 months and consist of one LHA-led group session or one telephone contact from the LHA per month. Participants in this treatment arm will also receive individual visits with a registered dietitian during months 1, 3, and 6 of phase 1.
Lifestyle Weight Loss: Changing diet, physical activity, and self-regulatory behaviors to promote weight loss.
|
Enhanced Usual Care
n=75 Participants
Participants in the Behavioral: Counseling arm will receive two individual sessions with registered dietitian and monthly newsletters that focus on existing community resources.
Counseling: Individual nutrition counseling will be delivered by a registered dietitian.
|
Total
n=225 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
147 Participants
n=93 Participants
|
71 Participants
n=4 Participants
|
218 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Age, Continuous
|
41.6 years
STANDARD_DEVIATION 9.0 • n=93 Participants
|
41.8 years
STANDARD_DEVIATION 9.1 • n=4 Participants
|
41.6 years
STANDARD_DEVIATION 9.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
127 Participants
n=93 Participants
|
64 Participants
n=4 Participants
|
191 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
150 Participants
n=93 Participants
|
75 Participants
n=4 Participants
|
225 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
150 Participants
n=93 Participants
|
75 Participants
n=4 Participants
|
225 Participants
n=27 Participants
|
|
Hemoglobin A1c
|
6.0 percent
STANDARD_DEVIATION .30 • n=93 Participants
|
5.9 percent
STANDARD_DEVIATION .20 • n=4 Participants
|
5.9 percent
STANDARD_DEVIATION .3 • n=27 Participants
|
|
Body Weight
|
81.9 kilograms
STANDARD_DEVIATION 14.10 • n=93 Participants
|
80.3 kilograms
STANDARD_DEVIATION 13.1 • n=4 Participants
|
81.4 kilograms
STANDARD_DEVIATION 13.80 • n=27 Participants
|
|
Systolic Blood Pressure
|
118.5 mmHg
STANDARD_DEVIATION 13.8 • n=93 Participants
|
116.5 mmHg
STANDARD_DEVIATION 14.5 • n=4 Participants
|
117.8 mmHg
STANDARD_DEVIATION 14.0 • n=27 Participants
|
|
Diastolic Blood Pressure
|
71.9 mmHg
STANDARD_DEVIATION 8.5 • n=93 Participants
|
69.9 mmHg
STANDARD_DEVIATION 9.8 • n=4 Participants
|
71.3 mmHg
STANDARD_DEVIATION 9.0 • n=27 Participants
|
|
Fasting Glucose
|
97.7 mg/dL
STANDARD_DEVIATION 9.9 • n=93 Participants
|
96.6 mg/dL
STANDARD_DEVIATION 9.6 • n=4 Participants
|
97.4 mg/dL
STANDARD_DEVIATION 9.8 • n=27 Participants
|
|
High Density Lipoprotien (HDL)
|
45.3 mg/dL
STANDARD_DEVIATION 10.5 • n=93 Participants
|
46.5 mg/dL
STANDARD_DEVIATION 10.9 • n=4 Participants
|
45.7 mg/dL
STANDARD_DEVIATION 10.6 • n=27 Participants
|
|
Low Density Lipoprotein (LDL)
|
109.9 mg/dL
STANDARD_DEVIATION 28.50 • n=93 Participants
|
106.7 mg/dL
STANDARD_DEVIATION 28.10 • n=4 Participants
|
108.8 mg/dL
STANDARD_DEVIATION 28.40 • n=27 Participants
|
|
Triglycerides
|
142.1 mg/dL
STANDARD_DEVIATION 68.70 • n=93 Participants
|
140.1 mg/dL
STANDARD_DEVIATION 61.60 • n=4 Participants
|
141.4 mg/dL
STANDARD_DEVIATION 66.30 • n=27 Participants
|
|
Total Cholesterol
|
183.6 mg/dL
STANDARD_DEVIATION 33.10 • n=93 Participants
|
181.3 mg/dL
STANDARD_DEVIATION 36.6 • n=4 Participants
|
182.8 mg/dL
STANDARD_DEVIATION 34.30 • n=27 Participants
|
PRIMARY outcome
Timeframe: 6, 12, 18, and 24 monthsPopulation: Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 18 and 24 month data was collected.
Mean hemoglobin A1c in both treatment groups at 6, 12, 18, and 24 months will be assessed.
Outcome measures
| Measure |
Lifestyle Weight-Loss
n=150 Participants
Participants in the Behavioral: Lifestyle Weight Loss arm will take part in a group program aimed at achieving modest weight loss (5-7%) through promoting healthy eating and increasing physical activity. The intervention sessions will take place at churches and other community locations and will be coordinated and facilitated by LHAs. The lifestyle intervention will be delivered in 2 phases: Phase 1 will last for 6 months and consist of weekly group meetings; Phase 2 will last for 18 months and consist of one LHA-led group session or one telephone contact from the LHA per month. Participants in this treatment arm will also receive individual visits with a registered dietitian during months 1, 3, and 6 of phase 1.
Lifestyle Weight Loss: Changing diet, physical activity, and self-regulatory behaviors to promote weight loss.
|
Enhanced Usual Care
n=75 Participants
Participants in the Behavioral: Counseling arm will receive two individual sessions with a registered dietitian and monthly newsletters that focus on existing community resources.
Counseling: Individual nutrition counseling will be delivered by a registered dietitian.
|
|---|---|---|
|
Hemoglobin A1c
6 Months
|
5.9 percent HbA1c
Standard Deviation .30
|
5.8 percent HbA1c
Standard Deviation .30
|
|
Hemoglobin A1c
12 Months
|
5.9 percent HbA1c
Standard Deviation .30
|
5.9 percent HbA1c
Standard Deviation .30
|
|
Hemoglobin A1c
18 Months
|
5.9 percent HbA1c
Standard Deviation .30
|
5.9 percent HbA1c
Standard Deviation .30
|
|
Hemoglobin A1c
24 Months
|
6.0 percent HbA1c
Standard Deviation .40
|
6.0 percent HbA1c
Standard Deviation .50
|
SECONDARY outcome
Timeframe: 6, 12, 18, and 24 monthsPopulation: Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 18 and 24 month data was collected.
Mean body weight in both treatment groups at 6, 12, 18, and 24 months will be assessed.
Outcome measures
| Measure |
Lifestyle Weight-Loss
n=150 Participants
Participants in the Behavioral: Lifestyle Weight Loss arm will take part in a group program aimed at achieving modest weight loss (5-7%) through promoting healthy eating and increasing physical activity. The intervention sessions will take place at churches and other community locations and will be coordinated and facilitated by LHAs. The lifestyle intervention will be delivered in 2 phases: Phase 1 will last for 6 months and consist of weekly group meetings; Phase 2 will last for 18 months and consist of one LHA-led group session or one telephone contact from the LHA per month. Participants in this treatment arm will also receive individual visits with a registered dietitian during months 1, 3, and 6 of phase 1.
Lifestyle Weight Loss: Changing diet, physical activity, and self-regulatory behaviors to promote weight loss.
|
Enhanced Usual Care
n=75 Participants
Participants in the Behavioral: Counseling arm will receive two individual sessions with a registered dietitian and monthly newsletters that focus on existing community resources.
Counseling: Individual nutrition counseling will be delivered by a registered dietitian.
|
|---|---|---|
|
Body Weight
6 Months
|
79.2 kilograms
Standard Deviation 14.3
|
77.4 kilograms
Standard Deviation 13.1
|
|
Body Weight
12 Months
|
79.7 kilograms
Standard Deviation 14.1
|
79.1 kilograms
Standard Deviation 13.9
|
|
Body Weight
18 Months
|
79.9 kilograms
Standard Deviation 14.5
|
78.7 kilograms
Standard Deviation 13.6
|
|
Body Weight
24 Months
|
80.0 kilograms
Standard Deviation 13.7
|
77.3 kilograms
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: 6, 12, 18, and 24 monthsPopulation: Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 18 and 24 month data was collected.
Mean systolic blood pressure in both treatment groups at 6, 12, 18, and 24 months will be assessed.
Outcome measures
| Measure |
Lifestyle Weight-Loss
n=150 Participants
Participants in the Behavioral: Lifestyle Weight Loss arm will take part in a group program aimed at achieving modest weight loss (5-7%) through promoting healthy eating and increasing physical activity. The intervention sessions will take place at churches and other community locations and will be coordinated and facilitated by LHAs. The lifestyle intervention will be delivered in 2 phases: Phase 1 will last for 6 months and consist of weekly group meetings; Phase 2 will last for 18 months and consist of one LHA-led group session or one telephone contact from the LHA per month. Participants in this treatment arm will also receive individual visits with a registered dietitian during months 1, 3, and 6 of phase 1.
Lifestyle Weight Loss: Changing diet, physical activity, and self-regulatory behaviors to promote weight loss.
|
Enhanced Usual Care
n=75 Participants
Participants in the Behavioral: Counseling arm will receive two individual sessions with a registered dietitian and monthly newsletters that focus on existing community resources.
Counseling: Individual nutrition counseling will be delivered by a registered dietitian.
|
|---|---|---|
|
Systolic Blood Pressure
6 Months
|
117.0 mmHg
Standard Deviation 14.5
|
113.7 mmHg
Standard Deviation 12.9
|
|
Systolic Blood Pressure
12 Months
|
116.7 mmHg
Standard Deviation 13.2
|
114.3 mmHg
Standard Deviation 11.9
|
|
Systolic Blood Pressure
18 Months
|
117.1 mmHg
Standard Deviation 12.6
|
115.6 mmHg
Standard Deviation 12.8
|
|
Systolic Blood Pressure
24 Months
|
119.7 mmHg
Standard Deviation 16.6
|
116.8 mmHg
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: 6, 12, 18, and 24 monthsPopulation: Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 18 and 24 month data was collected.
Mean diastolic blood pressure in both treatment groups at 6, 12, 18, and 24 months will be assessed.
Outcome measures
| Measure |
Lifestyle Weight-Loss
n=150 Participants
Participants in the Behavioral: Lifestyle Weight Loss arm will take part in a group program aimed at achieving modest weight loss (5-7%) through promoting healthy eating and increasing physical activity. The intervention sessions will take place at churches and other community locations and will be coordinated and facilitated by LHAs. The lifestyle intervention will be delivered in 2 phases: Phase 1 will last for 6 months and consist of weekly group meetings; Phase 2 will last for 18 months and consist of one LHA-led group session or one telephone contact from the LHA per month. Participants in this treatment arm will also receive individual visits with a registered dietitian during months 1, 3, and 6 of phase 1.
Lifestyle Weight Loss: Changing diet, physical activity, and self-regulatory behaviors to promote weight loss.
|
Enhanced Usual Care
n=75 Participants
Participants in the Behavioral: Counseling arm will receive two individual sessions with a registered dietitian and monthly newsletters that focus on existing community resources.
Counseling: Individual nutrition counseling will be delivered by a registered dietitian.
|
|---|---|---|
|
Diastolic Blood Pressure
6 Months
|
69.5 mmHg
Standard Deviation 9.4
|
69.2 mmHg
Standard Deviation 9.5
|
|
Diastolic Blood Pressure
12 Months
|
70.0 mmHg
Standard Deviation 9.9
|
71.2 mmHg
Standard Deviation 8.9
|
|
Diastolic Blood Pressure
18 Months
|
69.3 mmHg
Standard Deviation 9.3
|
70.4 mmHg
Standard Deviation 8.1
|
|
Diastolic Blood Pressure
24 Months
|
70.5 mmHg
Standard Deviation 9.7
|
70.7 mmHg
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: 6, 12, 18, and 24 monthsPopulation: Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 18 and 24 month data was collected.
Mean fasting plasma glucose in both treatment groups at 6, 12, 18, and 24 months will be assessed.
Outcome measures
| Measure |
Lifestyle Weight-Loss
n=150 Participants
Participants in the Behavioral: Lifestyle Weight Loss arm will take part in a group program aimed at achieving modest weight loss (5-7%) through promoting healthy eating and increasing physical activity. The intervention sessions will take place at churches and other community locations and will be coordinated and facilitated by LHAs. The lifestyle intervention will be delivered in 2 phases: Phase 1 will last for 6 months and consist of weekly group meetings; Phase 2 will last for 18 months and consist of one LHA-led group session or one telephone contact from the LHA per month. Participants in this treatment arm will also receive individual visits with a registered dietitian during months 1, 3, and 6 of phase 1.
Lifestyle Weight Loss: Changing diet, physical activity, and self-regulatory behaviors to promote weight loss.
|
Enhanced Usual Care
n=75 Participants
Participants in the Behavioral: Counseling arm will receive two individual sessions with a registered dietitian and monthly newsletters that focus on existing community resources.
Counseling: Individual nutrition counseling will be delivered by a registered dietitian.
|
|---|---|---|
|
Fasting Glucose
6 Months
|
96.3 mg/dL
Standard Deviation 10.3
|
96.3 mg/dL
Standard Deviation 8.7
|
|
Fasting Glucose
12 Months
|
98.1 mg/dL
Standard Deviation 10.1
|
96.1 mg/dL
Standard Deviation 11.6
|
|
Fasting Glucose
18 Months
|
98.0 mg/dL
Standard Deviation 11.7
|
98.6 mg/dL
Standard Deviation 14.2
|
|
Fasting Glucose
24 Months
|
98.2 mg/dL
Standard Deviation 10.5
|
99.9 mg/dL
Standard Deviation 17.9
|
SECONDARY outcome
Timeframe: 12, and 24 monthsPopulation: Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 24 month data was collected.
Mean total cholesterol in both treatment groups at 12 and 24 months will be assessed.
Outcome measures
| Measure |
Lifestyle Weight-Loss
n=150 Participants
Participants in the Behavioral: Lifestyle Weight Loss arm will take part in a group program aimed at achieving modest weight loss (5-7%) through promoting healthy eating and increasing physical activity. The intervention sessions will take place at churches and other community locations and will be coordinated and facilitated by LHAs. The lifestyle intervention will be delivered in 2 phases: Phase 1 will last for 6 months and consist of weekly group meetings; Phase 2 will last for 18 months and consist of one LHA-led group session or one telephone contact from the LHA per month. Participants in this treatment arm will also receive individual visits with a registered dietitian during months 1, 3, and 6 of phase 1.
Lifestyle Weight Loss: Changing diet, physical activity, and self-regulatory behaviors to promote weight loss.
|
Enhanced Usual Care
n=75 Participants
Participants in the Behavioral: Counseling arm will receive two individual sessions with a registered dietitian and monthly newsletters that focus on existing community resources.
Counseling: Individual nutrition counseling will be delivered by a registered dietitian.
|
|---|---|---|
|
Total Cholesterol
12 Months
|
181.1 mg/dL
Standard Deviation 35.5
|
180.3 mg/dL
Standard Deviation 36.9
|
|
Total Cholesterol
24 Months
|
184.7 mg/dL
Standard Deviation 40.0
|
174.4 mg/dL
Standard Deviation 40.3
|
SECONDARY outcome
Timeframe: 12, and 24 monthsPopulation: Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 24 month data was collected.
Mean HDL in both treatment groups at 12 and 24 months will be assessed.
Outcome measures
| Measure |
Lifestyle Weight-Loss
n=150 Participants
Participants in the Behavioral: Lifestyle Weight Loss arm will take part in a group program aimed at achieving modest weight loss (5-7%) through promoting healthy eating and increasing physical activity. The intervention sessions will take place at churches and other community locations and will be coordinated and facilitated by LHAs. The lifestyle intervention will be delivered in 2 phases: Phase 1 will last for 6 months and consist of weekly group meetings; Phase 2 will last for 18 months and consist of one LHA-led group session or one telephone contact from the LHA per month. Participants in this treatment arm will also receive individual visits with a registered dietitian during months 1, 3, and 6 of phase 1.
Lifestyle Weight Loss: Changing diet, physical activity, and self-regulatory behaviors to promote weight loss.
|
Enhanced Usual Care
n=75 Participants
Participants in the Behavioral: Counseling arm will receive two individual sessions with a registered dietitian and monthly newsletters that focus on existing community resources.
Counseling: Individual nutrition counseling will be delivered by a registered dietitian.
|
|---|---|---|
|
High Density Lipoprotein (HDL)
24 Months
|
46.8 mg/dL
Standard Deviation 10.5
|
45.5 mg/dL
Standard Deviation 9.8
|
|
High Density Lipoprotein (HDL)
12 Months
|
47.3 mg/dL
Standard Deviation 11.6
|
47.5 mg/dL
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: 12, and 24 monthsPopulation: Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 24 month data was collected.
Mean LDL in both treatment groups at 12 and 24 months will be calculated.
Outcome measures
| Measure |
Lifestyle Weight-Loss
n=150 Participants
Participants in the Behavioral: Lifestyle Weight Loss arm will take part in a group program aimed at achieving modest weight loss (5-7%) through promoting healthy eating and increasing physical activity. The intervention sessions will take place at churches and other community locations and will be coordinated and facilitated by LHAs. The lifestyle intervention will be delivered in 2 phases: Phase 1 will last for 6 months and consist of weekly group meetings; Phase 2 will last for 18 months and consist of one LHA-led group session or one telephone contact from the LHA per month. Participants in this treatment arm will also receive individual visits with a registered dietitian during months 1, 3, and 6 of phase 1.
Lifestyle Weight Loss: Changing diet, physical activity, and self-regulatory behaviors to promote weight loss.
|
Enhanced Usual Care
n=75 Participants
Participants in the Behavioral: Counseling arm will receive two individual sessions with a registered dietitian and monthly newsletters that focus on existing community resources.
Counseling: Individual nutrition counseling will be delivered by a registered dietitian.
|
|---|---|---|
|
Low Density Lipoprotein (LDL)
12 Months
|
106.7 mg/dL
Standard Deviation 27.9
|
106.5 mg/dL
Standard Deviation 31.8
|
|
Low Density Lipoprotein (LDL)
24 Months
|
108.3 mg/dL
Standard Deviation 31.4
|
101.5 mg/dL
Standard Deviation 25.4
|
SECONDARY outcome
Timeframe: 12, and 24 monthsPopulation: Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 24 month data was collected.
Mean triglycerides in both treatment groups at 12 and 24 months will be calculated.
Outcome measures
| Measure |
Lifestyle Weight-Loss
n=150 Participants
Participants in the Behavioral: Lifestyle Weight Loss arm will take part in a group program aimed at achieving modest weight loss (5-7%) through promoting healthy eating and increasing physical activity. The intervention sessions will take place at churches and other community locations and will be coordinated and facilitated by LHAs. The lifestyle intervention will be delivered in 2 phases: Phase 1 will last for 6 months and consist of weekly group meetings; Phase 2 will last for 18 months and consist of one LHA-led group session or one telephone contact from the LHA per month. Participants in this treatment arm will also receive individual visits with a registered dietitian during months 1, 3, and 6 of phase 1.
Lifestyle Weight Loss: Changing diet, physical activity, and self-regulatory behaviors to promote weight loss.
|
Enhanced Usual Care
n=75 Participants
Participants in the Behavioral: Counseling arm will receive two individual sessions with a registered dietitian and monthly newsletters that focus on existing community resources.
Counseling: Individual nutrition counseling will be delivered by a registered dietitian.
|
|---|---|---|
|
Triglycerides
12 Months
|
139.7 mg/dL
Standard Deviation 76.6
|
131.3 mg/dL
Standard Deviation 56.7
|
|
Triglycerides
24 Months
|
147.7 mg/dL
Standard Deviation 74.8
|
139.3 mg/dL
Standard Deviation 153.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6, 12, and 24 monthsMean change in fasting insulin from baseline between treatment groups at 6, 12, and 24 months will be assessed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6, 12, and 24 monthsMean change in the HOMA IR model from baseline between treatment groups at 6, 12, and 24 months will be assessed.
Outcome measures
Outcome data not reported
Adverse Events
Lifestyle Weight-Loss
Serious events: 4 serious events
Other events: 13 other events
Deaths: 2 deaths
Enhanced Usual Care
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lifestyle Weight-Loss
n=150 participants at risk
Participants in the Behavioral: Lifestyle Weight Loss arm will take part in a group program aimed at achieving modest weight loss (5-7%) through promoting healthy eating and increasing physical activity. The intervention sessions will take place at churches and other community locations and will be coordinated and facilitated by LHAs. The lifestyle intervention will be delivered in 2 phases: Phase 1 will last for 6 months and consist of weekly group meetings; Phase 2 will last for 18 months and consist of one LHA-led group session or one telephone contact from the LHA per month. Participants in this treatment arm will also receive individual visits with an RD during months 1, 3, and 6 of phase 1.
Lifestyle Weight Loss: Changing diet, physical activity, and self-regulatory behaviors to promote weight loss.
|
Enhanced Usual Care
n=75 participants at risk
Participants in the Behavioral: Counseling arm will receive two individual sessions with an RD and monthly newsletters that focus on existing community resources.
Counseling: Individual nutrition counseling will be delivered by a registered dietitian.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
death from non-study related causes (colon cancer)
|
0.67%
1/150 • Number of events 1 • Information on adverse events and serious adverse events was collected every 6 months for up to 24 months.
|
0.00%
0/75 • Information on adverse events and serious adverse events was collected every 6 months for up to 24 months.
|
|
Vascular disorders
death from non-study related causes (aneurysm)
|
0.67%
1/150 • Number of events 1 • Information on adverse events and serious adverse events was collected every 6 months for up to 24 months.
|
0.00%
0/75 • Information on adverse events and serious adverse events was collected every 6 months for up to 24 months.
|
|
Surgical and medical procedures
Inpatient hospitalization for surgery
|
1.3%
2/150 • Number of events 2 • Information on adverse events and serious adverse events was collected every 6 months for up to 24 months.
|
1.3%
1/75 • Number of events 1 • Information on adverse events and serious adverse events was collected every 6 months for up to 24 months.
|
Other adverse events
| Measure |
Lifestyle Weight-Loss
n=150 participants at risk
Participants in the Behavioral: Lifestyle Weight Loss arm will take part in a group program aimed at achieving modest weight loss (5-7%) through promoting healthy eating and increasing physical activity. The intervention sessions will take place at churches and other community locations and will be coordinated and facilitated by LHAs. The lifestyle intervention will be delivered in 2 phases: Phase 1 will last for 6 months and consist of weekly group meetings; Phase 2 will last for 18 months and consist of one LHA-led group session or one telephone contact from the LHA per month. Participants in this treatment arm will also receive individual visits with an RD during months 1, 3, and 6 of phase 1.
Lifestyle Weight Loss: Changing diet, physical activity, and self-regulatory behaviors to promote weight loss.
|
Enhanced Usual Care
n=75 participants at risk
Participants in the Behavioral: Counseling arm will receive two individual sessions with an RD and monthly newsletters that focus on existing community resources.
Counseling: Individual nutrition counseling will be delivered by a registered dietitian.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Joint/Musculoskeletal Pain
|
8.7%
13/150 • Number of events 150 • Information on adverse events and serious adverse events was collected every 6 months for up to 24 months.
|
13.3%
10/75 • Number of events 75 • Information on adverse events and serious adverse events was collected every 6 months for up to 24 months.
|
Additional Information
Mara Z. Vitolins, DrPH, MPH, RDN
Wake Forest School of Medicine
Phone: (336) 716-2886
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place