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NCT05379296: HH
Healthy Hearts: Leveraging the Diabetes Prevention Program to Decrease Health Disparities in Women of Reproductive Age
NA trial testing Diabetes Prevention Program Plus (DPP+) in Prediabetic State. Withdrawn.
20 January 2023
Quick facts
| Lead sponsor | The University of Texas Medical Branch, Galveston |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Start date | 1 January 2022 |
| Primary completion | 20 January 2023 |
| Estimated completion | 20 January 2023 |
Drugs / interventions tested
- Diabetes Prevention Program Plus (DPP+)
- Diabetes Prevention Program (DPP)
Conditions studied
- Prediabetic State — all drugs for Prediabetic State →
- Gestational Weight Gain — all drugs for Gestational Weight Gain →
- Hypertension — all drugs for Hypertension →
- Overweight or Obesity — all drugs for Overweight or Obesity →
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.
Verify or expand the search:
- PubMed search for NCT05379296
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05379296 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston
- Last refreshed: 27 January 2023
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