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Behavioral Intervention

Enhanced DPP-GLB for Weight Loss Nonresponders

N/A
Recruiting
Research Sponsored by Lovoria Williams
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
non-diabetic
Be older than 18 years old
Must not have
serious medical condition that contradicts weight loss
diagnosed Type 1 or 2 diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months (at baseline, 12 weeks, 6 months)
Awards & highlights
No Placebo-Only Group

Summary

This trial will help to establish the efficacy of identifying weight loss nonresponders early and providing them with more intense personalized strategies.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this intervention involves lifestyle changes rather than medication, side effects may include typical responses to diet change and increased physical activity such as muscle soreness, fatigue, or digestive adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I do not have diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a health condition that makes weight loss unsafe for me.
Select...
I have been diagnosed with Type 1 or Type 2 diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months (at baseline, 12 weeks, 6 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months (at baseline, 12 weeks, 6 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Weight at 12 Weeks
Change in Weight at 6 Months
Secondary study objectives
Change in Blood Pressure at 12 Weeks
Change in Blood Pressure at 6 Months
Change in Dietary Intake at 12 Weeks
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: DPP-GLB StandardExperimental Treatment1 Intervention
Participants in this group will receive the standard Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
Group II: DPP-GLB EnhancedExperimental Treatment1 Intervention
Participants in this group will receive the enhanced Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.

Find a Location

Who is running the clinical trial?

Lovoria WilliamsLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,448 Previous Clinical Trials
4,331,919 Total Patients Enrolled
108 Trials studying Diabetes
138,177 Patients Enrolled for Diabetes
~21 spots leftby Jan 2025
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