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

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.

Study Overview

• Status: Withdrawn
• Conditions: Hypertension; Prediabetic State; Overweight or Obesity; Gestational Weight Gain
• Intervention / Treatment: Behavioral: Diabetes Prevention Program (DPP); Behavioral: Diabetes Prevention Program Plus (DPP+)

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Crystal Clark Douglas, PhD, University of Texas

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): January 20, 2023
• Study Completion (Actual): January 20, 2023

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Hypertension; Women's Health; Gestational Weight Gain; Prediabetic State; Overweight or Obesity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Body Weight; Body Weight Changes; Hypertension; Prediabetic State; Overweight; Weight Gain; Gestational Weight Gain
• Other Study ID Numbers: 21-0325

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No