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

Hypertension Clinical Trial

— HH  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05379296
• Other study ID #: 21-0325
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: January 20, 2023

Study information

• Verified date: January 2023
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 20, 2023
• Est. primary completion date: January 20, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Gestational Weight Gain
• Hypertension
• Overweight
• Overweight or Obesity
• Prediabetic State
• Weight Gain

Intervention

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
• Diabetes Prevention Program (DPP)
CDC-approved DPP lifestyle program

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Systolic Blood Pressure at 6 months		Baseline, 6-months
Primary	Change from Baseline Systolic Blood Pressure at 12 months		Baseline, 12-months
Primary	Change from Baseline Diastolic Blood Pressure at 6 months		Baseline, 6-months
Primary	Change from Baseline Diastolic Blood Pressure at 12 months		Baseline, 12-months
Primary	Change from Baseline High-density lipoproteins at 6 months		Baseline, 6-months
Primary	Change from Baseline High-density lipoproteins at 12 months		Baseline, 12-months
Primary	Change from Baseline Low-density lipoproteins at 6 months		Baseline, 6-months
Primary	Change from Baseline Low-density lipoproteins at 12 months		Baseline, 12-months
Primary	Change from Baseline Triglycerides at 6 months		Baseline, 6-months
Primary	Change from Baseline Triglycerides at 12 months		Baseline, 12-months
Primary	Change from Baseline Total cholesterol at 6 months		Baseline, 6-months
Primary	Change from Baseline Total cholesterol at 12 months		Baseline, 12-months
Primary	Change from Baseline Hemoglobin a1c at 6 months		Baseline, 6-months
Primary	Change from Baseline Hemoglobin a1c at 12 months		Baseline, 12-months
Primary	Change from Baseline Weight at 6 months		Baseline, 6-months
Primary	Change from Baseline Weight at 12 months		Baseline, 12-months
Primary	Change from Baseline Body mass index at 6 months		Baseline, 6-months
Primary	Change from Baseline Body mass index at 12 months		Baseline, 12-months
Primary	Change from Baseline Fasting blood glucose at 6 months		Baseline, 6-months
Primary	Change from Baseline Fasting blood glucose at 12 months		Baseline, 12-months
Primary	Change from Baseline Serum insulin at 6 months		Baseline, 6-months
Primary	Change from Baseline Serum insulin at 12 months		Baseline, 12-months
Secondary	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
Secondary	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
Secondary	Change from Baseline Total portions of Fried Food Consumption at 6 months	Measured using the PreventT2 Diabetes Prevention Program questionnaire	Baseline, 6-months
Secondary	Change from Baseline Total portions of Fried Food Consumption at 12 months	Measured using the PreventT2 Diabetes Prevention Program questionnaire	Baseline, 12-months
Secondary	Change from Baseline Objective Total Weekly Physical activity minutes at 6 months	Measured using Fitbit Inspire 2	Baseline, 6-months
Secondary	Change from Baseline Objective Total Weekly Physical activity minutes at 12 months	Measured using Fitbit Inspire 2	Baseline, 12-months
Secondary	Change from Baseline Subjective Weekly Physical activity at 6 months	Stanford Brief Leisure-Time Activity Categorical Item (L-CAT 2.2)	Baseline, 6-months
Secondary	Change from Baseline Subjective Weekly Physical activity at 12 months	Stanford Brief Leisure-Time Activity Categorical Item (L-CAT 2.2)	Baseline, 12-months
Secondary	Change from Baseline Visceral adiposity tissue at 6 months	Measured using Dual energy X-ray absorptiometry	Baseline, 6-months
Secondary	Change from Baseline Visceral adiposity tissue at 12 months	Measured using Dual energy X-ray absorptiometry	Baseline, 12-months
Secondary	Change from Baseline C-reactive protein at 6 months		Baseline, 6-months
Secondary	Change from Baseline C-reactive protein at 12 months		Baseline, 12-months