Enhanced DPP-GLB for Weight Loss Nonresponders

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist individuals struggling to lose weight despite participating in a standard weight loss program. It tests whether adding personalized support, such as phone coaching and extra resources, can benefit those who have not achieved results with the usual program. The trial targets Black individuals who are not diabetic but have a high risk of developing diabetes and live near a participating site. Participants will be divided into two groups: one will follow the standard program (DPP-GLB Standard), while the other will receive additional support (DPP-GLB Enhanced). The study will also evaluate the cost-effectiveness of this enhanced approach. As an unphased trial, this study provides a unique opportunity to explore innovative support methods that could significantly improve weight loss outcomes.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the enhanced Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) is generally easy to follow. Studies have found that this program helps people lose weight and become more active, especially if other treatments have not been successful. For instance, one study showed that participants in the enhanced program lost weight and improved their overall health. While this does not mean there are no side effects, no serious problems have been reported in connection with the program. This suggests it is a safe choice for those wanting to improve their health and manage their weight. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DPP-GLB Enhanced treatment because it takes the standard Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) and adds new strategies to address weight loss nonresponders. Unlike typical lifestyle interventions that might not work for everyone, this enhanced version aims to personalize and intensify the approach, potentially leading to better outcomes for those who haven't succeeded with standard methods. By focusing on tailored support and possibly integrating new behavioral techniques, the enhanced treatment has the potential to offer a fresh solution for individuals struggling to lose weight.

What evidence suggests that this trial's treatments could be effective for weight loss?

Research has shown that the improved Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) helps people lose weight and become more active. In past studies, participants lost an average of 7.4 pounds, or about 3.65% of their body weight. The program also improves other health aspects, such as lowering blood pressure and encouraging healthier eating habits. This trial will compare the standard DPP-GLB with an enhanced version designed for those who don't respond well to standard treatments, offering more personalized support. Previous research demonstrated that this enhanced approach effectively assists people who have difficulty losing weight. ^{1 2 3 6 7}

Who Is on the Research Team?

Lovoria Williams

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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 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]

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]

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