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NCT05379296: HH

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

Withdrawn NA Last updated 27 January 2023
What this trial tests

NA trial testing Diabetes Prevention Program Plus (DPP+) in Prediabetic State. Withdrawn.

Timeline
1 January 2022
Primary endpoint
20 January 2023
20 January 2023

Quick facts

Lead sponsorThe University of Texas Medical Branch, Galveston
PhaseNA
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Start date1 January 2022
Primary completion20 January 2023
Estimated completion20 January 2023

Drugs / interventions tested

Conditions studied

Sponsor

The University of Texas Medical Branch, Galveston

Who can join

Adults 18 to 45, female only, with Prediabetic State or Gestational Weight Gain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Prediabetic State

Currently open trials in the same condition.

Other The University of Texas Medical Branch, Galveston trials

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05379296.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing