Trial Outcomes & Findings for Enhanced DPP-GLB to Promote Weight Loss Among Nonresponders in a Community-Based Lifestyle Intervention. (NCT NCT04757519)
NCT ID: NCT04757519
Last Updated: 2026-01-23
Results Overview
Weight will be measured in pounds using a cellular scale at baseline and at 12 weeks.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
403 participants
Primary outcome timeframe
12 weeks (at baseline and12 weeks)
Results posted on
2026-01-23
Participant Flow
Unit of analysis: Churches
Participant milestones
| Measure |
DPP-GLB Standard
Participants in this group will receive the standard Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
DPP-GLB Standard: The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer.
|
DPP-GLB Enhanced
Participants in this group will receive the enhanced Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
DPP-GLB Enhanced: The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer. Intervention week 4, weight loss non-responders defined as weight loss less than 1% receive weekly telephone intervention, using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Additionally, this intervention includes weekly phone calls using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Links to relevant videos may also be provided.
|
|---|---|---|
|
Overall Study
STARTED
|
203 10
|
200 10
|
|
Overall Study
COMPLETED
|
186 10
|
182 10
|
|
Overall Study
NOT COMPLETED
|
17 0
|
18 0
|
Reasons for withdrawal
| Measure |
DPP-GLB Standard
Participants in this group will receive the standard Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
DPP-GLB Standard: The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer.
|
DPP-GLB Enhanced
Participants in this group will receive the enhanced Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
DPP-GLB Enhanced: The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer. Intervention week 4, weight loss non-responders defined as weight loss less than 1% receive weekly telephone intervention, using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Additionally, this intervention includes weekly phone calls using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Links to relevant videos may also be provided.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
17
|
18
|
Baseline Characteristics
The number analyzed in the row differs from the overall due to some participants consenting and enrolling, but withdrawing before the first data collection.
Baseline characteristics by cohort
| Measure |
DPP-GLB Standard
n=203 Participants
Participants in this group will receive the standard Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
DPP-GLB Standard: The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer.
|
DPP-GLB Enhanced
n=200 Participants
Participants in this group will receive the enhanced Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
DPP-GLB Enhanced: The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer. Intervention week 4, weight loss non-responders defined as weight loss less than 1% receive weekly telephone intervention, using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Additionally, this intervention includes weekly phone calls using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Links to relevant videos may also be provided.
|
Total
n=403 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.9 years
STANDARD_DEVIATION 12.2 • n=186 Participants • The number analyzed in the row differs from the overall due to some participants consenting and enrolling, but withdrawing before the first data collection.
|
53.2 years
STANDARD_DEVIATION 12.1 • n=182 Participants • The number analyzed in the row differs from the overall due to some participants consenting and enrolling, but withdrawing before the first data collection.
|
54.56 years
STANDARD_DEVIATION 12.15 • n=368 Participants • The number analyzed in the row differs from the overall due to some participants consenting and enrolling, but withdrawing before the first data collection.
|
|
Sex: Female, Male
Female
|
158 Participants
n=186 Participants • The number analyzed in the row differs from the overall due to some participants consenting and enrolling, but withdrawing before the first data collection.
|
163 Participants
n=182 Participants • The number analyzed in the row differs from the overall due to some participants consenting and enrolling, but withdrawing before the first data collection.
|
321 Participants
n=368 Participants • The number analyzed in the row differs from the overall due to some participants consenting and enrolling, but withdrawing before the first data collection.
|
|
Sex: Female, Male
Male
|
28 Participants
n=186 Participants • The number analyzed in the row differs from the overall due to some participants consenting and enrolling, but withdrawing before the first data collection.
|
19 Participants
n=182 Participants • The number analyzed in the row differs from the overall due to some participants consenting and enrolling, but withdrawing before the first data collection.
|
47 Participants
n=368 Participants • The number analyzed in the row differs from the overall due to some participants consenting and enrolling, but withdrawing before the first data collection.
|
|
Race/Ethnicity, Customized
African American / Black
|
203 Participants
n=203 Participants
|
200 Participants
n=200 Participants
|
403 Participants
n=403 Participants
|
|
Region of Enrollment
United States
|
203 participants
n=203 Participants
|
200 participants
n=200 Participants
|
403 participants
n=403 Participants
|
|
Married/partnered
|
87 Participants
n=203 Participants
|
86 Participants
n=200 Participants
|
173 Participants
n=403 Participants
|
|
College or graduate degree
|
109 Participants
n=203 Participants
|
106 Participants
n=200 Participants
|
215 Participants
n=403 Participants
|
|
Private Insurance
|
120 Participants
n=203 Participants
|
120 Participants
n=200 Participants
|
240 Participants
n=403 Participants
|
|
Income > $50,000 annually
|
93 Participants
n=203 Participants
|
95 Participants
n=200 Participants
|
188 Participants
n=403 Participants
|
PRIMARY outcome
Timeframe: 12 weeks (at baseline and12 weeks)Population: Participants who completed the 12-week data collection.
Weight will be measured in pounds using a cellular scale at baseline and at 12 weeks.
Outcome measures
| Measure |
DPP-GLB Standard
n=176 Participants
Participants in this group will receive the standard Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
DPP-GLB Standard: The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer.
|
DPP-GLB Enhanced
n=168 Participants
Participants in this group will receive the enhanced Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
DPP-GLB Enhanced: The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer. Intervention week 4, weight loss non-responders defined as weight loss less than 1% receive weekly telephone intervention, using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Additionally, this intervention includes weekly phone calls using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Links to relevant videos may also be provided.
|
|---|---|---|
|
Change in Weight at 12 Weeks
Baseline
|
230.48 pounds (lbs)
Standard Deviation 52.22
|
225.94 pounds (lbs)
Standard Deviation 46.24
|
|
Change in Weight at 12 Weeks
12-Week
|
224.71 pounds (lbs)
Standard Deviation 51.3
|
219.30 pounds (lbs)
Standard Deviation 44.51
|
PRIMARY outcome
Timeframe: 6 months (at baseline and 6 months)Population: Participants who completed the 6-month data collection.
Weight will be measured in pounds using a cellular scale at baseline and at 6 months.
Outcome measures
| Measure |
DPP-GLB Standard
n=167 Participants
Participants in this group will receive the standard Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
DPP-GLB Standard: The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer.
|
DPP-GLB Enhanced
n=165 Participants
Participants in this group will receive the enhanced Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
DPP-GLB Enhanced: The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer. Intervention week 4, weight loss non-responders defined as weight loss less than 1% receive weekly telephone intervention, using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Additionally, this intervention includes weekly phone calls using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Links to relevant videos may also be provided.
|
|---|---|---|
|
Change in Weight at 6 Months
Baseline
|
230.48 pounds (lbs)
Standard Deviation 52.22
|
225.94 pounds (lbs)
Standard Deviation 46.24
|
|
Change in Weight at 6 Months
6-Month
|
223.16 pounds (lbs)
Standard Deviation 51.8
|
216.44 pounds (lbs)
Standard Deviation 44.31
|
SECONDARY outcome
Timeframe: 12 weeks (at baseline and 12 weeks)Population: Participants who completed the 12-week data collection.
Blood pressure will be measured with calibrated automated blood pressure monitor at baseline and at 12 weeks.
Outcome measures
| Measure |
DPP-GLB Standard
n=173 Participants
Participants in this group will receive the standard Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
DPP-GLB Standard: The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer.
|
DPP-GLB Enhanced
n=165 Participants
Participants in this group will receive the enhanced Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
DPP-GLB Enhanced: The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer. Intervention week 4, weight loss non-responders defined as weight loss less than 1% receive weekly telephone intervention, using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Additionally, this intervention includes weekly phone calls using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Links to relevant videos may also be provided.
|
|---|---|---|
|
Change in Blood Pressure at 12 Weeks
Baseline Systolic
|
138 Millimeters of mercury (mm Hg)
Standard Deviation 16
|
138 Millimeters of mercury (mm Hg)
Standard Deviation 17
|
|
Change in Blood Pressure at 12 Weeks
Baseline Diastolic
|
78 Millimeters of mercury (mm Hg)
Standard Deviation 10
|
80 Millimeters of mercury (mm Hg)
Standard Deviation 11
|
|
Change in Blood Pressure at 12 Weeks
12 Weeks Systolic
|
133 Millimeters of mercury (mm Hg)
Standard Deviation 14
|
136 Millimeters of mercury (mm Hg)
Standard Deviation 15
|
|
Change in Blood Pressure at 12 Weeks
12 Weeks Diastolic
|
77 Millimeters of mercury (mm Hg)
Standard Deviation 10
|
79 Millimeters of mercury (mm Hg)
Standard Deviation 11
|
SECONDARY outcome
Timeframe: 6 months (at baseline and 6 months)Population: Those who participated in 6-month data collection.
Blood pressure will be measured with calibrated automated blood pressure monitor at baseline and at 6 months.
Outcome measures
| Measure |
DPP-GLB Standard
n=167 Participants
Participants in this group will receive the standard Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
DPP-GLB Standard: The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer.
|
DPP-GLB Enhanced
n=161 Participants
Participants in this group will receive the enhanced Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
DPP-GLB Enhanced: The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer. Intervention week 4, weight loss non-responders defined as weight loss less than 1% receive weekly telephone intervention, using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Additionally, this intervention includes weekly phone calls using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Links to relevant videos may also be provided.
|
|---|---|---|
|
Change in Blood Pressure at 6 Months
Baseline Systolic
|
138 Millimeters of mercury (mm Hg)
Standard Deviation 16
|
138 Millimeters of mercury (mm Hg)
Standard Deviation 17
|
|
Change in Blood Pressure at 6 Months
Baseline Diastolic
|
78 Millimeters of mercury (mm Hg)
Standard Deviation 10
|
80 Millimeters of mercury (mm Hg)
Standard Deviation 11
|
|
Change in Blood Pressure at 6 Months
6 Month Systolic
|
135 Millimeters of mercury (mm Hg)
Standard Deviation 17
|
134 Millimeters of mercury (mm Hg)
Standard Deviation 15
|
|
Change in Blood Pressure at 6 Months
6 Month Diastolic
|
78 Millimeters of mercury (mm Hg)
Standard Deviation 12
|
78 Millimeters of mercury (mm Hg)
Standard Deviation 11
|
SECONDARY outcome
Timeframe: 12 weeks (at baseline and 12 weeks)Population: Participants who completed 12-week data collection and said yes to performing any form of physical activity listed on the MAQ
Change in Physical Activity will be measured at baseline and 12-week using the Modifiable Activity Questionnaire (MAQ), which assesses activity frequency and duration across the leisure and occupational components. Responses were converted to metabolic equivalent hours per week (MET-hrs/week) using standard scoring procedures, where higher MET-hrs/week indicates greater physical activity.
Outcome measures
| Measure |
DPP-GLB Standard
n=158 Participants
Participants in this group will receive the standard Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
DPP-GLB Standard: The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer.
|
DPP-GLB Enhanced
n=151 Participants
Participants in this group will receive the enhanced Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
DPP-GLB Enhanced: The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer. Intervention week 4, weight loss non-responders defined as weight loss less than 1% receive weekly telephone intervention, using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Additionally, this intervention includes weekly phone calls using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Links to relevant videos may also be provided.
|
|---|---|---|
|
Change in Physical Activity at 12 Weeks
Baseline
|
9.2 MET-hrs/week
Standard Deviation 10
|
6.5 MET-hrs/week
Standard Deviation 7.4
|
|
Change in Physical Activity at 12 Weeks
12 Weeks
|
13.8 MET-hrs/week
Standard Deviation 12.8
|
12.2 MET-hrs/week
Standard Deviation 13.6
|
SECONDARY outcome
Timeframe: 6 months (at baseline and 6 months)Population: Participants who completed 6-month data collection and said Yes to performing a form of activity on MAQ.
Change in Physical Activity will be measured at baseline and 6-month using the Modifiable Activity Questionnaire (MAQ), which assesses activity frequency and duration across the leisure and occupational components. Responses were converted to metabolic equivalent hours per week (MET-hrs/week) using standard scoring procedures, where higher MET-hrs/week indicates greater physical activity.
Outcome measures
| Measure |
DPP-GLB Standard
n=144 Participants
Participants in this group will receive the standard Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
DPP-GLB Standard: The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer.
|
DPP-GLB Enhanced
n=123 Participants
Participants in this group will receive the enhanced Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
DPP-GLB Enhanced: The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer. Intervention week 4, weight loss non-responders defined as weight loss less than 1% receive weekly telephone intervention, using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Additionally, this intervention includes weekly phone calls using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Links to relevant videos may also be provided.
|
|---|---|---|
|
Change in Physical Activity at 6 Months
6 Months
|
14.47 MET-hrs/week
Standard Deviation 13.02
|
10.49 MET-hrs/week
Standard Deviation 9.69
|
|
Change in Physical Activity at 6 Months
Baseline
|
9.2 MET-hrs/week
Standard Deviation 10
|
6.5 MET-hrs/week
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: 12 weeks (at baseline and 12 weeks)Population: Participants who completed the 12-week data collection.
Change in Dietary Intake will be measured using the validated, Dana Farber eating habits tool and the Dietary screener questionnaire which assesses the frequency of consumption of selected foods and drinks. The scoring range of the survey is Never or less than once per month, 1-3 per month, 1 per week, 2-4 per week, 5-6 per week, 1 per day, 2-3 per day, 4-5 per day, 6 or more per day, Prefer not to answer. Higher scores indicated increased dietary intake. The total score is the sum of the scores on all items, divided by the total maximum score possible, and then multiplied by 100.
Outcome measures
| Measure |
DPP-GLB Standard
n=167 Participants
Participants in this group will receive the standard Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
DPP-GLB Standard: The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer.
|
DPP-GLB Enhanced
n=152 Participants
Participants in this group will receive the enhanced Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
DPP-GLB Enhanced: The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer. Intervention week 4, weight loss non-responders defined as weight loss less than 1% receive weekly telephone intervention, using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Additionally, this intervention includes weekly phone calls using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Links to relevant videos may also be provided.
|
|---|---|---|
|
Change in Dietary Intake at 12 Weeks
Baseline
|
69.86 score on a scale
Standard Deviation 14.22
|
68.13 score on a scale
Standard Deviation 14.22
|
|
Change in Dietary Intake at 12 Weeks
12 Weeks
|
72.22 score on a scale
Standard Deviation 13.22
|
71.52 score on a scale
Standard Deviation 13.15
|
SECONDARY outcome
Timeframe: 6 months (at baseline, 12 weeks, 6 months)Population: Those who participated in 6-month data collection.
Change in Dietary Intake will be measured using the validated, Dana Farber eating habits tool and the Dietary screener questionnaire which assesses the frequency of consumption of selected foods and drinks. The scoring range of the survey is Never or less than once per month, 1-3 per month, 1 per week, 2-4 per week, 5-6 per week, 1 per day, 2-3 per day, 4-5 per day, 6 or more per day, Prefer not to answer. Higher scores indicated increased dietary intake.The total score is the sum of the scores on all items, divided by the total maximum score possible, and then multiplied by 100.
Outcome measures
| Measure |
DPP-GLB Standard
n=160 Participants
Participants in this group will receive the standard Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
DPP-GLB Standard: The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer.
|
DPP-GLB Enhanced
n=156 Participants
Participants in this group will receive the enhanced Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
DPP-GLB Enhanced: The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer. Intervention week 4, weight loss non-responders defined as weight loss less than 1% receive weekly telephone intervention, using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Additionally, this intervention includes weekly phone calls using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Links to relevant videos may also be provided.
|
|---|---|---|
|
Change in Dietary Intake at 6 Months
Baseline
|
69.86 score on a scale
Standard Deviation 14.22
|
68.13 score on a scale
Standard Deviation 14.22
|
|
Change in Dietary Intake at 6 Months
6 Month
|
71.11 score on a scale
Standard Deviation 15.0
|
70.08 score on a scale
Standard Deviation 13.15
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants who completed the 6-month data collection.
Investigator-developed instrument. At 6 months, conduct a cost-effectiveness analysis to evaluate the cost of the intervention arm by comparing the incremental cost and weight loss with the active control arm. The generated final output is the cost per participant in dollars.
Outcome measures
| Measure |
DPP-GLB Standard
n=186 Participants
Participants in this group will receive the standard Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
DPP-GLB Standard: The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer.
|
DPP-GLB Enhanced
n=182 Participants
Participants in this group will receive the enhanced Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
DPP-GLB Enhanced: The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer. Intervention week 4, weight loss non-responders defined as weight loss less than 1% receive weekly telephone intervention, using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Additionally, this intervention includes weekly phone calls using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Links to relevant videos may also be provided.
|
|---|---|---|
|
Cost Analysis
|
471.49 dollar
Standard Deviation 75.25
|
461.06 dollar
Standard Deviation 39.87
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants who completed the 6-month data collection.
Quality of life will be measured using Impact of Weight on Quality of Life Questionnaire (IWQOL-Lite). This is a 31-item self-report scale. Scores range from 0-100; higher scores indicate greater quality of life.
Outcome measures
| Measure |
DPP-GLB Standard
n=141 Participants
Participants in this group will receive the standard Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
DPP-GLB Standard: The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer.
|
DPP-GLB Enhanced
n=148 Participants
Participants in this group will receive the enhanced Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
DPP-GLB Enhanced: The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer. Intervention week 4, weight loss non-responders defined as weight loss less than 1% receive weekly telephone intervention, using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Additionally, this intervention includes weekly phone calls using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Links to relevant videos may also be provided.
|
|---|---|---|
|
Impact of Weight on Quality of Life
|
44.75 score on a scale
Standard Deviation 16.66
|
47.10 score on a scale
Standard Deviation 18.15
|
Adverse Events
DPP-GLB Standard
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DPP-GLB Enhanced
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Lovoria Williams
University of Kentucky College of Nursing
Phone: 859 323-5579
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place