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

The University of Texas System (UT)

Status: Withdrawn

Conditions: Hypertension; Overweight or Obesity; Prediabetic State; Gestational Weight Gain

Treatments: Behavioral: Diabetes Prevention Program Plus (DPP+); Behavioral: Diabetes Prevention Program (DPP)

Study type: Interventional

Funder types: Other

Identifiers

NCT05379296

21-0325

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Diabetes Prevention Program (DPP)

Active Comparator group

Description:

CDC-approved 12-month DPP virtual lifestyle program

Treatment:

Behavioral: Diabetes Prevention Program (DPP)

Diabetes Prevention Program Plus (DPP+)

Experimental group

Description:

CDC-approved 12-month DPP virtual lifestyle program expanded to include a CDC-approved module on hypertension prevention and treatment

Treatment:

Behavioral: Diabetes Prevention Program Plus (DPP+)