Healthy Hearts: Leveraging the Diabetes Prevention Program to Decrease Health Disparities in Women of Reproductive Age

Study Overview
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Brief Summary
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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.

Official Title
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Healthy Hearts: Leveraging the Diabetes Prevention Program to Decrease Health Disparities in Women of Reproductive Age

Conditions
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Prediabetic State, Gestational Weight Gain, Hypertension, Overweight or Obesity

Intervention / Treatment
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* Behavioral: Diabetes Prevention Program Plus (DPP+)
* Behavioral: Diabetes Prevention Program (DPP)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diabetes Prevention Program (DPP)<br>CDC-approved 12-month DPP virtual lifestyle program | Behavioral: Diabetes Prevention Program (DPP)<br>* CDC-approved DPP lifestyle program<br>|
| Experimental: Diabetes Prevention Program Plus (DPP+)<br>CDC-approved 12-month DPP virtual lifestyle program expanded to include a CDC-approved module on hypertension prevention and treatment | Behavioral: Diabetes Prevention Program Plus (DPP+)<br>* The DPP+ includes the CDC-approved DPP lifestyle program expanded to include a CDC-approved module on hypertension prevention and treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Systolic Blood Pressure at 6 months |  | Baseline, 6-months | 
| Change from Baseline Systolic Blood Pressure at 12 months |  | Baseline, 12-months | 
| Change from Baseline Diastolic Blood Pressure at 6 months |  | Baseline, 6-months | 
| Change from Baseline Diastolic Blood Pressure at 12 months |  | Baseline, 12-months | 
| Change from Baseline High-density lipoproteins at 6 months |  | Baseline, 6-months | 
| Change from Baseline High-density lipoproteins at 12 months |  | Baseline, 12-months | 
| Change from Baseline Low-density lipoproteins at 6 months |  | Baseline, 6-months | 
| Change from Baseline Low-density lipoproteins at 12 months |  | Baseline, 12-months | 
| Change from Baseline Triglycerides at 6 months |  | Baseline, 6-months | 
| Change from Baseline Triglycerides at 12 months |  | Baseline, 12-months | 
| Change from Baseline Total cholesterol at 6 months |  | Baseline, 6-months | 
| Change from Baseline Total cholesterol at 12 months |  | Baseline, 12-months | 
| Change from Baseline Hemoglobin a1c at 6 months |  | Baseline, 6-months | 
| Change from Baseline Hemoglobin a1c at 12 months |  | Baseline, 12-months | 
| Change from Baseline Weight at 6 months |  | Baseline, 6-months | 
| Change from Baseline Weight at 12 months |  | Baseline, 12-months | 
| Change from Baseline Body mass index at 6 months |  | Baseline, 6-months | 
| Change from Baseline Body mass index at 12 months |  | Baseline, 12-months | 
| Change from Baseline Fasting blood glucose at 6 months |  | Baseline, 6-months | 
| Change from Baseline Fasting blood glucose at 12 months |  | Baseline, 12-months | 
| Change from Baseline Serum insulin at 6 months |  | Baseline, 6-months | 
| Change from Baseline Serum insulin at 12 months |  | Baseline, 12-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Total portions of Combined Weekly Fruit and Vegetable Consumption at 6 months | Measured using the PreventT2 Diabetes Prevention Program questionnaire | Baseline, 6-months | 
| Change from Baseline Total portions of Combined Weekly Fruit and Vegetable Consumption at 12 months | Measured using the PreventT2 Diabetes Prevention Program questionnaire | Baseline, 12-months | 
| Change from Baseline Total portions of Fried Food Consumption at 6 months | Measured using the PreventT2 Diabetes Prevention Program questionnaire | Baseline, 6-months | 
| Change from Baseline Total portions of Fried Food Consumption at 12 months | Measured using the PreventT2 Diabetes Prevention Program questionnaire | Baseline, 12-months | 
| Change from Baseline Objective Total Weekly Physical activity minutes at 6 months | Measured using Fitbit Inspire 2 | Baseline, 6-months | 
| Change from Baseline Objective Total Weekly Physical activity minutes at 12 months | Measured using Fitbit Inspire 2 | Baseline, 12-months | 
| Change from Baseline Subjective Weekly Physical activity at 6 months | Stanford Brief Leisure-Time Activity Categorical Item (L-CAT 2.2) | Baseline, 6-months | 
| Change from Baseline Subjective Weekly Physical activity at 12 months | Stanford Brief Leisure-Time Activity Categorical Item (L-CAT 2.2) | Baseline, 12-months | 
| Change from Baseline Visceral adiposity tissue at 6 months | Measured using Dual energy X-ray absorptiometry | Baseline, 6-months | 
| Change from Baseline Visceral adiposity tissue at 12 months | Measured using Dual energy X-ray absorptiometry | Baseline, 12-months | 
| Change from Baseline C-reactive protein at 6 months |  | Baseline, 6-months | 
| Change from Baseline C-reactive protein at 12 months |  | Baseline, 12-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prediabetic State, Gestational Weight Gain, Hypertension, Overweight or Obesity, Women's Health, Cardiovascular disease