Enhanced DPP-GLB to Promote Weight Loss Among Nonresponders in a Community-Based Lifestyle Intervention.

Study Overview
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Brief Summary
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This study seeks to establish the efficacy of identifying weight loss nonresponders early in a Diabetes Prevention Program (DPP) intervention in 20 community settings (primarily churches and community centers) and providing them with individual-level, enhanced treatment through telephone contacts and access to additional resources. Additionally, potential mediators and moderators of the relationship between intervention status and weight loss response at 6 months in both nonresponders and responders will be examined and a cost-effectiveness analysis to evaluate the cost of the intervention will be conducted. This study addresses key gaps in the literature about the weight loss effects of identifying nonresponders early and characterizing individuals who need more intense personalized strategies. The investigators hypothesize that changes between baseline and 3 months will be more pronounced among the nonresponders in the intervention group compared to the nonresponders in the active control group.

Official Title
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Enhancing the Diabetes Prevention Program to Promote Weight Loss Among Nonresponders in a Community-Based Lifestyle Intervention.

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: DPP-GLB Standard
* Behavioral: DPP-GLB Enhanced


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: self-described as Black non-diabetic body mass index (BMI) equal to or greater than 25 CDC diabetes risk assessment greater than or equal to 5 or diabetes pre-diagnosis or history of gestational diabetes live within driving distance of participating church/site Exclusion Criteria: diagnosed Type 1 or 2 diabetes pregnant or planning to become pregnant during study period contraindications to moderate physical activity serious medical condition that contradicts weight loss not Black or African American

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DPP-GLB Standard<br>Participants in this group will receive the standard Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program. | Behavioral: DPP-GLB Standard<br>* 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.<br>|
| Experimental: DPP-GLB Enhanced<br>Participants in this group will receive the enhanced Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program. | Behavioral: DPP-GLB Enhanced<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight at 12 Weeks | Weight will be measured in pounds using a cellular scale at baseline and at 12 weeks. | 12 weeks (at baseline and12 weeks) | 
| Change in Weight at 6 Months | Weight will be measured in pounds using a cellular scale at baseline and at 6 months. | 6 months (at baseline and 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Blood Pressure at 12 Weeks | Blood pressure will be measured with calibrated automated blood pressure monitor at baseline and at 12 weeks. | 12 weeks (at baseline and 12 weeks) | 
| Change in Blood Pressure at 6 Months | Blood pressure will be measured with calibrated automated blood pressure monitor at baseline and at 6 months. | 6 months (at baseline and 6 months) | 
| Change in Physical Activity at 12 Weeks | Change in Physical Activity will be measured at baseline and 12 weeks using the Modifiable Activity Questionnaire (MAQ), which assesses activity frequency and duration. Scoring is open-ended; higher scores indicate increased activity. | 12 weeks (at baseline and 12 weeks) | 
| Change in Physical Activity at 6 Months | Change in Physical Activity will be measured at baseline and 6 months using the Modifiable Activity Questionnaire (MAQ), which assesses activity frequency and duration. Scoring is open-ended; higher scores indicate increased activity. | 6 months (at baseline and 6 months) | 
| Change in Dietary Intake at 12 Weeks | 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. | 12 weeks (at baseline and 12 weeks) | 
| Change in Dietary Intake at 6 Months | 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. | 6 months (at baseline, 12 weeks, 6 months) | 
| Cost Analysis | 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. | 6 months | 
| Impact of Weight on Quality of Life | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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faith based, prevention, weight loss, community, personalized, telephone, resources, lifestyle intervention, racial ethnic minorities / African American, non-responders, cancer, adults, obesity