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Completed

NCT Number: NCT04757519

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Corinthian Baptist Church, Frankfort, Kentucky, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DPP-GLB Standard

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Change in Weight at 12 Weeks

    Time frame: 12 weeks (at baseline and12 weeks)

    Weight will be measured in pounds using a cellular scale at baseline and at 12 weeks.

  2. Change in Weight at 6 Months

    Time frame: 6 months (at baseline and 6 months)

    Weight will be measured in pounds using a cellular scale at baseline and at 6 months.

Secondary outcomes

  1. Change in Blood Pressure at 12 Weeks

    Time frame: 12 weeks (at baseline and 12 weeks)

    Blood pressure will be measured with calibrated automated blood pressure monitor at baseline and at 12 weeks.

  2. Change in Blood Pressure at 6 Months

    Time frame: 6 months (at baseline and 6 months)

    Blood pressure will be measured with calibrated automated blood pressure monitor at baseline and at 6 months.

  3. Change in Physical Activity at 12 Weeks

    Time frame: 12 weeks (at baseline and 12 weeks)

    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.

  4. Change in Physical Activity at 6 Months

    Time frame: 6 months (at baseline and 6 months)

    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.

  5. Change in Dietary Intake at 12 Weeks

    Time frame: 12 weeks (at baseline and 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. The total score is the sum of the scores on all items, divided by the total maximum score possible, and then multiplied by 100.

  6. Change in Dietary Intake at 6 Months

    Time frame: 6 months (at baseline, 12 weeks, 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.The total score is the sum of the scores on all items, divided by the total maximum score possible, and then multiplied by 100.

  7. Cost Analysis

    Time frame: 6 months

    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.

  8. Impact of Weight on Quality of Life

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Lovoria Williams

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Feb 17, 2021
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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