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DiabetesNCT04757519

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

A study testing DPP-GLB Standard and DPP-GLB Enhanced in people with Diabetes, run by Lovoria Williams at 21 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetes
What is being tested?
DPP-GLB Standard and DPP-GLB Enhanced
Could I receive a placebo?
No, everyone receives an active treatment
How many people
403 participants
Where
21 sitesUnited States
Study dates
18 Feb 2021to 17 Apr 2026
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

United States21 sites

  • First Corinthian Baptist Church

    Frankfort, Kentucky, 40601

  • Heavenly Outpour

    Frankfort, Kentucky, 40601

  • Consolidated Baptist Church

    Lexington, Kentucky, 40505

  • Historic St. Paul AME Church

    Lexington, Kentucky, 40507

  • First African Baptist Church

    Lexington, Kentucky, 40508

  • Pilgrim Baptist Church

    Lexington, Kentucky, 40508

  • Shiloh Baptist Church

    Lexington, Kentucky, 40508

  • Redeemed Christian Church of God

    Lexington, Kentucky, 40509

  • First Baptist Church Brackstown

    Lexington, Kentucky, 40511

  • Lima Drive Seventh Day Adventist Church

    Lexington, Kentucky, 40511

  • Kingdom Fellowship

    Louisville, Kentucky, 40202

  • Bates Memorial Baptist Church

    Louisville, Kentucky, 40203

  • St. Stephen Baptist Church

    Louisville, Kentucky, 40210

  • Greater Gaililee CDC

    Louisville, Kentucky, 40211

  • Historic Calvary MBC

    Louisville, Kentucky, 40211

  • Spirit Filled New Life Church

    Louisville, Kentucky, 40214

  • Forest Baptist Church

    Louisville, Kentucky, 40218

  • Burnett Ave BC

    Louisville, Kentucky, 40291

  • Marnel C. Moorman Family Life Center

    Shelbyville, Kentucky, 40065

  • New Mt. Zion Baptist Church

    Shelbyville, Kentucky, 40065

  • First Baptist Winchester

    Winchester, Kentucky, 40391

Other trials in United States

About this study

Official title: Enhancing the Diabetes Prevention Program 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.

Conditions
Diabetes
Being tested
DPP-GLB Standard, DPP-GLB Enhanced
Keywords
prevention, weight loss, community, personalized, telephone, resources, lifestyle intervention, racial ethnic minorities / African American, faith based, obesity, non-responders, adults, cancer
Medical subject headings
Diabetes Mellitus, Weight Loss, Obesity, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DPP-GLB StandardBehavioural

    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 EnhancedBehavioural

    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.

Study groups in NCT04757519
Study groupRoleWhat they receive
DPP-GLB StandardExperimentalParticipants in this group will receive the standard Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
Receives: Behavioral: DPP-GLB Standard
DPP-GLB EnhancedExperimentalParticipants in this group will receive the enhanced Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
Receives: Behavioral: DPP-GLB Enhanced

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Weight at 12 Weeks

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

    Measured: 12 weeks (at baseline and12 weeks)

  2. Change in Weight at 6 Months

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

    Measured: 6 months (at baseline and 6 months)

Secondary outcomes (8)

  1. Change in Blood Pressure at 12 Weeks

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

    Measured: 12 weeks (at baseline and 12 weeks)

  2. Change in Blood Pressure at 6 Months

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

    Measured: 6 months (at baseline and 6 months)

  3. Change in Physical Activity at 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.

    Measured: 12 weeks (at baseline and 12 weeks)

  4. Change in Physical Activity at 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.

    Measured: 6 months (at baseline and 6 months)

  5. 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. The total score is the sum of the scores on all items, divided by the total maximum score possible, and then multiplied by 100.

    Measured: 12 weeks (at baseline and 12 weeks)

  6. 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.The total score is the sum of the scores on all items, divided by the total maximum score possible, and then multiplied by 100.

    Measured: 6 months (at baseline, 12 weeks, 6 months)

  7. 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. The generated final output is the cost per participant in dollars.

    Measured: 6 months

  8. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2021
  2. Study start18 Feb 2021
  3. Primary completion4 Dec 2024
  4. Study completion17 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
403 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04757519
Sponsor's protocol ID
58766
Other IDs
1R01DK125801-01
Status last verified
May 2026
First submitted
28 Jan 2021
Last updated
24 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Williams LB, Moser DK, Gustafson A, Waters TM, Rayens MK, Karle ER, Kriska AM. Reaching high-risk Black adults for diabetes prevention programming during a pandemic: The design of Fit & Faithful a randomized controlled community trial. Contemp Clin Trials. 2022 Dec;123:106973. doi: 10.1016/j.cct.2022.106973. Epub 2022 Nov 5.

    PubMed 36334705

Questions about this trial

What is this clinical trial studying?

A study testing DPP-GLB Standard and DPP-GLB Enhanced in people with Diabetes, run by Lovoria Williams at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Weight at 12 Weeks (time frame: 12 weeks (at baseline and12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04757519, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.

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