Enhanced DPP-GLB for Weight Loss Nonresponders

Recruiting at 20 trial locations

Overseen By Erika Karle

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lovoria Williams

Disqualifiers: Diabetes, Pregnancy, Serious medical condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

403 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the idea that Enhanced DPP-GLB for Weight Loss Nonresponders is an effective treatment?

The available research shows that the Enhanced DPP-GLB program is effective in helping people lose weight and improve their health. For example, in a study with older adults, those who started the program immediately lost more weight and improved their physical activity and health markers compared to those who started later. These improvements were maintained over time. This suggests that the program can be a good option for people at risk of diabetes and heart disease, especially in community settings. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment DPP-GLB Enhanced for weight loss nonresponders?

Research shows that the Group Lifestyle Balance (GLB) program, an adaptation of the Diabetes Prevention Program (DPP), is effective in promoting weight loss and improving health markers like blood sugar levels and waist size in various settings, including community centers and military facilities. This suggests that the DPP-GLB Enhanced treatment could be beneficial for weight loss nonresponders by building on these proven strategies. ^{1 2 3 4 5}

What safety data exists for the Enhanced DPP-GLB treatment?

The provided research does not specifically address safety data for the Enhanced DPP-GLB treatment. However, it discusses the effectiveness and feasibility of the Group Lifestyle Balance (GLB) program, an adaptation of the Diabetes Prevention Program (DPP), in various settings and formats. The studies focus on outcomes like weight loss, physical activity, and metabolic improvements, but do not explicitly mention safety concerns or adverse effects. ^{1 2 4 5 6}

Is the Group Lifestyle Balance program safe for humans?

The Group Lifestyle Balance (GLB) program, an adaptation of the Diabetes Prevention Program (DPP), has been evaluated in various settings and populations, including older adults and military personnel. While the studies focus on effectiveness, they do not report any significant safety concerns, suggesting it is generally safe for human participants. ^{1 2 4 5 6}

Is the treatment DPP-GLB Enhanced a promising treatment for weight loss?

Yes, the DPP-GLB Enhanced treatment is promising for weight loss. It is based on the Diabetes Prevention Program, which has been effective in preventing diabetes through lifestyle changes. The Group Lifestyle Balance (GLB) program, an adaptation of this, has shown success in various settings, including military and community centers, and has been effective in promoting weight loss and improving health markers like physical activity and waist circumference. ^{1 2 4 5 6}

How is the DPP-GLB Enhanced treatment different from other weight loss treatments?

The DPP-GLB Enhanced treatment is unique because it adapts the Diabetes Prevention Program into a group-based lifestyle intervention, focusing on diet and physical activity changes to promote weight loss. It is designed to be more cost-effective and easier to implement than individual sessions, making it accessible to a wider audience. ^{1 2 4 5 6}

Research Team

Lovoria Williams

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for Black individuals with a BMI of 25 or higher, at risk for diabetes but not yet diagnosed with Type 1 or Type 2 diabetes. Participants must live near the study sites and be able to engage in moderate physical activity. Pregnant individuals or those planning pregnancy during the study are excluded.

Inclusion Criteria

live within driving distance of participating church/site

I do not have diabetes.

You have a body mass index (BMI) of 25 or higher.

Exclusion Criteria

I have a health condition that makes weight loss unsafe for me.

You are unable to perform moderate physical activity.

I have been diagnosed with Type 1 or Type 2 diabetes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive the standard or enhanced Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) intervention

12 weeks

Regular telephone contacts and access to additional resources

Extended Treatment

Continued intervention with focus on identifying and enhancing treatment for nonresponders

6 months

Ongoing monitoring and support

Follow-up

Participants are monitored for changes in weight, physical activity, dietary intake, and quality of life

6 months

Treatment Details

Interventions

• DPP-GLB Enhanced
• DPP-GLB Standard

Trial Overview The trial tests an enhanced Diabetes Prevention Program (DPP-GLB Enhanced) against a standard version (DPP-GLB Standard). It aims to see if providing extra support through phone calls and resources helps those who initially don't lose weight in community-based settings.

Participant Groups

Group I: DPP-GLB Standard Experimental Treatment 1 Intervention

Participants in this group will receive the standard Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.

Group II: DPP-GLB Enhanced Experimental Treatment 1 Intervention

Participants in this group will receive the enhanced Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.

DPP-GLB Enhanced is already approved in United States for the following indications:

Approved in United States as DPP-GLB for:

• Type 2 diabetes prevention
• Weight loss

Who Is Running the Clinical Trial?

Lovoria Williams

Lead Sponsor

Trials

1

Recruited

400+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

The Group Lifestyle Balance (GLB) program, based on the Diabetes Prevention Program, effectively reduced the prevalence of prediabetes by 2.0%, obesity by 8.7%, and metabolic syndrome by 6.8% among participants who completed the 12-week intervention.

Despite a high initial attendance of 704 patients, only 52% completed the program, with significant dropouts occurring within the first four weeks, particularly among active duty military members, highlighting the need for strategies to improve retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Group Lifestyle Balance Program in a Military Setting: An Investment Worth Expanding. Wardian, JL., True, MW., Sauerwein, TJ., et al.[2019]

The adapted Diabetes Prevention Program (DPP) Group Lifestyle Balance (GLB) was effective in promoting weight loss and improving physical activity and diabetes risk factors among 134 older adults with prediabetes, showing significant benefits at 6 months compared to a delayed control group.

Both immediate and delayed groups maintained similar health improvements at 18 months, highlighting the program's long-term effectiveness and supporting the need for coverage of such prevention programs for older adults at risk for diabetes and cardiovascular disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Diabetes Prevention Program Lifestyle Intervention in Older Adults: A Randomized Controlled Study in Three Senior/Community Centers of Varying Socioeconomic Status. Kramer, MK., Vanderwood, KK., Arena, VC., et al.[2022]

The study involved 33 interviews with lifestyle coaches across 20 clinic sites, identifying six key factors that influence the successful implementation of the Diabetes Prevention Program (DPP) in large healthcare systems.

These factors include broader and institutional contexts, program provision, recruitment processes, characteristics of lifestyle coaches, and group dynamics, all of which are interconnected and can either facilitate or hinder the program's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and Facilitators to Real-world Implementation of the Diabetes Prevention Program in Large Healthcare Systems: Lifestyle Coach Perspectives. Halley, MC., Petersen, J., Nasrallah, C., et al.[2021]

The Group Lifestyle Balance program (GLB), adapted from the Diabetes Prevention Program (DPP), was evaluated in a pilot project using a DVD format with remote support.

Results indicate that the GLB-DVD with remote support could be an effective alternative method for delivering lifestyle intervention programs, potentially improving accessibility for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel approach to diabetes prevention: evaluation of the Group Lifestyle Balance program delivered via DVD. Kramer, MK., Kriska, AM., Venditti, EM., et al.[2022]

The study aims to enhance the effectiveness of the Group Lifestyle Balance (GLB) program for weight loss by integrating habit formation techniques, specifically if-then plans, in a randomized controlled trial with 154 overweight or obese participants.

The primary outcome is weight loss measured at 3, 12, and 24 months, with secondary outcomes including physical activity levels and weight-related health risk factors, providing a comprehensive evaluation of the enriched GLB program's impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing the effectiveness of the Diabetes Prevention Program through if-then plans: study protocol for the randomized controlled trial of the McGill CHIP Healthy Weight Program. Knäuper, B., Ivanova, E., Xu, Z., et al.[2021]

The enriched Group Lifestyle Balance (GLB) program, which incorporated habit formation tools, did not lead to greater long-term weight loss maintenance compared to the standard GLB, with both groups experiencing an average weight regain of 7.85 lbs after 24 months.

Despite some weight regain, participants in both groups maintained a significant portion of their weight loss, remaining 12.51 lbs (6.13%) lighter than their baseline weight at the 24-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of if-then plans on weight loss: results of the 24-month follow-up of the McGill CHIP Healthy Weight Program randomized controlled trial. Knäuper, B., Shireen, H., Carrière, K., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Evaluation of the Group Lifestyle Balance Program in a Military Setting: An Investment Worth Expanding. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Diabetes Prevention Program Lifestyle Intervention in Older Adults: A Randomized Controlled Study in Three Senior/Community Centers of Varying Socioeconomic Status. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Barriers and Facilitators to Real-world Implementation of the Diabetes Prevention Program in Large Healthcare Systems: Lifestyle Coach Perspectives. [2021]

4. Ireland pubmed.ncbi.nlm.nih.gov

A novel approach to diabetes prevention: evaluation of the Group Lifestyle Balance program delivered via DVD. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Increasing the effectiveness of the Diabetes Prevention Program through if-then plans: study protocol for the randomized controlled trial of the McGill CHIP Healthy Weight Program. [2021]

6. England pubmed.ncbi.nlm.nih.gov

The effects of if-then plans on weight loss: results of the 24-month follow-up of the McGill CHIP Healthy Weight Program randomized controlled trial. [2020]