Clinical trial NCT05379296: Healthy Hearts: Leveraging the Diabetes Prevention Program to Decrease Health Disparities in Women of Reproductive Age
Official title: Healthy Hearts: Leveraging the Diabetes Prevention Program to Decrease Health Disparities in Women of Reproductive Age
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prediabetic State
Gestational Weight Gain
Hypertension
Overweight or Obesity
Keywords: Prediabetic State
Gestational Weight Gain
Hypertension
Overweight or Obesity
Women's Health
Cardiovascular disease
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Women with prediabetes and eligible for the DPP, overweight/obesity, HTN (diagnosed or 3 successive high blood pressure readings), and history of excess gestational weight gain during most recent pregnancy

Exclusion Criteria:

* Pregnant and lactating women, participants planning to move out of Galveston County within the next year

Primary outcomes:
measure: Change from Baseline Systolic Blood Pressure at 6 months
timeFrame: Baseline, 6-months
measure: Change from Baseline Systolic Blood Pressure at 12 months
timeFrame: Baseline, 12-months
measure: Change from Baseline Diastolic Blood Pressure at 6 months
timeFrame: Baseline, 6-months
measure: Change from Baseline Diastolic Blood Pressure at 12 months
timeFrame: Baseline, 12-months
measure: Change from Baseline High-density lipoproteins at 6 months
timeFrame: Baseline, 6-months
measure: Change from Baseline High-density lipoproteins at 12 months
timeFrame: Baseline, 12-months
measure: Change from Baseline Low-density lipoproteins at 6 months
timeFrame: Baseline, 6-months
measure: Change from Baseline Low-density lipoproteins at 12 months
timeFrame: Baseline, 12-months
measure: Change from Baseline Triglycerides at 6 months
timeFrame: Baseline, 6-months
measure: Change from Baseline Triglycerides at 12 months
timeFrame: Baseline, 12-months
measure: Change from Baseline Total cholesterol at 6 months
timeFrame: Baseline, 6-months
measure: Change from Baseline Total cholesterol at 12 months
timeFrame: Baseline, 12-months
measure: Change from Baseline Hemoglobin a1c at 6 months
timeFrame: Baseline, 6-months
measure: Change from Baseline Hemoglobin a1c at 12 months
timeFrame: Baseline, 12-months
measure: Change from Baseline Weight at 6 months
timeFrame: Baseline, 6-months
measure: Change from Baseline Weight at 12 months
timeFrame: Baseline, 12-months
measure: Change from Baseline Body mass index at 6 months
timeFrame: Baseline, 6-months
measure: Change from Baseline Body mass index at 12 months
timeFrame: Baseline, 12-months
measure: Change from Baseline Fasting blood glucose at 6 months
timeFrame: Baseline, 6-months
measure: Change from Baseline Fasting blood glucose at 12 months
timeFrame: Baseline, 12-months
measure: Change from Baseline Serum insulin at 6 months
timeFrame: Baseline, 6-months
measure: Change from Baseline Serum insulin at 12 months
timeFrame: Baseline, 12-months
Secondary outcomes:
measure: Change from Baseline Total portions of Combined Weekly Fruit and Vegetable Consumption at 6 months
timeFrame: Baseline, 6-months
measure: Change from Baseline Total portions of Combined Weekly Fruit and Vegetable Consumption at 12 months
timeFrame: Baseline, 12-months
measure: Change from Baseline Total portions of Fried Food Consumption at 6 months
timeFrame: Baseline, 6-months
measure: Change from Baseline Total portions of Fried Food Consumption at 12 months
timeFrame: Baseline, 12-months
measure: Change from Baseline Objective Total Weekly Physical activity minutes at 6 months
timeFrame: Baseline, 6-months
measure: Change from Baseline Objective Total Weekly Physical activity minutes at 12 months
timeFrame: Baseline, 12-months
measure: Change from Baseline Subjective Weekly Physical activity at 6 months
timeFrame: Baseline, 6-months
measure: Change from Baseline Subjective Weekly Physical activity at 12 months
timeFrame: Baseline, 12-months
measure: Change from Baseline Visceral adiposity tissue at 6 months
timeFrame: Baseline, 6-months
measure: Change from Baseline Visceral adiposity tissue at 12 months
timeFrame: Baseline, 12-months
measure: Change from Baseline C-reactive protein at 6 months
timeFrame: Baseline, 6-months
measure: Change from Baseline C-reactive protein at 12 months
timeFrame: Baseline, 12-months
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas
name: Crystal Clark Douglas, PhD
role: PRINCIPAL_INVESTIGATOR
References: