Diabetes Prevention Program Plus (DPP+) for Gestational Weight Gain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Texas Medical Branch, Galveston, TX
Gestational Weight Gain+5 More
Diabetes Prevention Program Plus (DPP+) - Behavioral
Eligibility
18 - 65
Female
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Study Summary

Nearly half of women have obesity and/or hypertension (HTN). Specific to women, pregnancy creates a vulnerable window for excess gestational weight gain (GWG), exacerbating intergenerational risks for obesity, HTN, type 2 diabetes (T2D), and cardiovascular disease (CVD) across the lifespan. Healthy lifestyles are the first-line recommendations for prevention and treatment of overweight/obesity, HTN, T2D, and CVD. The Diabetes Prevention Program (DPP) is a well-established, Centers for Disease Control and Prevention (CDC)-led public health program focusing on healthy lifestyle changes and is effective at reducing 5-7% of body weight, lowering risks for T2D. Interestingly, research investigating the DPP as a lifestyle intervention for other chronic conditions (i.e., overweight/obesity and HTN) is lacking, demonstrating a missed opportunity. The aim of this study is to determine the initial effects of the first 6-months and after receiving the full 12-months of the virtual DPP compared to the DPP expanded with a CDC-approved HTN prevention component (DPP+) on physical activity, diet, weight, and CVD risk factors in 30 prediabetic women (18-45 years old) with a history of excess GWG, overweight/obesity, and HTN. Participants will be recruited through University of Texas Medical Branch (UTMB) community-based clinics using Epic. The Participants will be randomized into 2 groups (DPP and DPP+) and guided through the 12-month virtual DPP or DPP+ program using UTMB DPP personnel.

Eligible Conditions

  • Gestational Weight Gain
  • Prediabetic State
  • Hypertension
  • Overweight or Obesity

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

22 Primary · 12 Secondary · Reporting Duration: Baseline, 12-months

Baseline, 12-months
Change from Baseline Body mass index at 12 months
Change from Baseline C-reactive protein at 12 months
Change from Baseline Diastolic Blood Pressure at 12 months
Change from Baseline Fasting blood glucose at 12 months
Change from Baseline Hemoglobin a1c at 12 months
Change from Baseline High-density lipoproteins at 12 months
Change from Baseline Low-density lipoproteins at 12 months
Change from Baseline Objective Total Weekly Physical activity minutes at 12 months
Change from Baseline Serum insulin at 12 months
Change from Baseline Subjective Weekly Physical activity at 12 months
Change from Baseline Systolic Blood Pressure at 12 months
Change from Baseline Total cholesterol at 12 months
Change from Baseline Total portions of Combined Weekly Fruit and Vegetable Consumption at 12 months
Change from Baseline Total portions of Fried Food Consumption at 12 months
Change from Baseline Triglycerides at 12 months
Change from Baseline Visceral adiposity tissue at 12 months
Change from Baseline Weight at 12 months
Baseline, 6-months
Change from Baseline Body mass index at 6 months
Change from Baseline C-reactive protein at 6 months
Change from Baseline Diastolic Blood Pressure at 6 months
Change from Baseline Fasting blood glucose at 6 months
Change from Baseline Hemoglobin a1c at 6 months
Change from Baseline High-density lipoproteins at 6 months
Change from Baseline Low-density lipoproteins at 6 months
Change from Baseline Objective Total Weekly Physical activity minutes at 6 months
Change from Baseline Serum insulin at 6 months
Change from Baseline Subjective Weekly Physical activity at 6 months
Change from Baseline Systolic Blood Pressure at 6 months
Change from Baseline Total cholesterol at 6 months
Change from Baseline Total portions of Combined Weekly Fruit and Vegetable Consumption at 6 months
Change from Baseline Total portions of Fried Food Consumption at 6 months
Change from Baseline Triglycerides at 6 months
Change from Baseline Visceral adiposity tissue at 6 months
Change from Baseline Weight at 6 months

Trial Safety

Trial Design

2 Treatment Groups

Diabetes Prevention Program (DPP)
1 of 2
Diabetes Prevention Program Plus (DPP+)
1 of 2
Active Control
Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: Diabetes Prevention Program Plus (DPP+) · No Placebo Group · N/A

Diabetes Prevention Program Plus (DPP+)
Behavioral
Experimental Group · 1 Intervention: Diabetes Prevention Program Plus (DPP+) · Intervention Types: Behavioral
Diabetes Prevention Program (DPP)
Behavioral
ActiveComparator Group · 1 Intervention: Diabetes Prevention Program (DPP) · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 12-months
Closest Location: University of Texas Medical Branch · Galveston, TX
2011First Recorded Clinical Trial
2 TrialsResearching Gestational Weight Gain
323 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · Female Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.