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

NCT05379296 | Withdrawn

• 1 other identifier: 21-0325
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (22)

• 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 Outcomes (12)

• Change from Baseline Total portions of Combined Weekly Fruit and Vegetable Consumption at 6 months

  Baseline, 6-months

• Change from Baseline Total portions of Combined Weekly Fruit and Vegetable Consumption at 12 months

  Baseline, 12-months

• Change from Baseline Total portions of Fried Food Consumption at 6 months

  Baseline, 6-months

• Change from Baseline Total portions of Fried Food Consumption at 12 months

  Baseline, 12-months

• Change from Baseline Objective Total Weekly Physical activity minutes at 6 months

  Baseline, 6-months

Study Arms (2)

Diabetes Prevention Program (DPP)

ACTIVE COMPARATOR

CDC-approved 12-month DPP virtual lifestyle program

Behavioral: Diabetes Prevention Program (DPP)

Diabetes Prevention Program Plus (DPP+)

EXPERIMENTAL

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+)

Interventions

Diabetes Prevention Program Plus (DPP+) BEHAVIORAL

The DPP+ includes the CDC-approved DPP lifestyle program expanded to include a CDC-approved module on hypertension prevention and treatment

Diabetes Prevention Program Plus (DPP+)

Diabetes Prevention Program (DPP) BEHAVIORAL

CDC-approved DPP lifestyle program

Diabetes Prevention Program (DPP)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

MeSH Terms

Conditions

Prediabetic State; Gestational Weight Gain; Hypertension; Overweight; Obesity; Cardiovascular Diseases

Interventions

dentin sialophosphoprotein

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Overnutrition; Nutrition Disorders

Study Officials

• Crystal Clark Douglas, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 18, 2022
• Study Start: January 1, 2022
• Primary Completion: January 20, 2023
• Study Completion: January 20, 2023
• Last Updated: January 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share