Healthy Hearts: Leveraging the Diabetes Prevention Program to Decrease Health Disparities in Women of Reproductive Age (HH)
Primary Purpose
Prediabetic State, Gestational Weight Gain, Hypertension
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Diabetes Prevention Program Plus (DPP+)
Diabetes Prevention Program (DPP)
Sponsored by
About this trial
This is an interventional treatment trial for Prediabetic State focused on measuring Prediabetic State, Gestational Weight Gain, Hypertension, Overweight or Obesity, Women's Health, Cardiovascular disease
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Diabetes Prevention Program (DPP)
Diabetes Prevention Program Plus (DPP+)
Arm Description
CDC-approved 12-month DPP virtual lifestyle program
CDC-approved 12-month DPP virtual lifestyle program expanded to include a CDC-approved module on hypertension prevention and treatment
Outcomes
Primary Outcome Measures
Change from Baseline Systolic Blood Pressure at 6 months
Change from Baseline Systolic Blood Pressure at 12 months
Change from Baseline Diastolic Blood Pressure at 6 months
Change from Baseline Diastolic Blood Pressure at 12 months
Change from Baseline High-density lipoproteins at 6 months
Change from Baseline High-density lipoproteins at 12 months
Change from Baseline Low-density lipoproteins at 6 months
Change from Baseline Low-density lipoproteins at 12 months
Change from Baseline Triglycerides at 6 months
Change from Baseline Triglycerides at 12 months
Change from Baseline Total cholesterol at 6 months
Change from Baseline Total cholesterol at 12 months
Change from Baseline Hemoglobin a1c at 6 months
Change from Baseline Hemoglobin a1c at 12 months
Change from Baseline Weight at 6 months
Change from Baseline Weight at 12 months
Change from Baseline Body mass index at 6 months
Change from Baseline Body mass index at 12 months
Change from Baseline Fasting blood glucose at 6 months
Change from Baseline Fasting blood glucose at 12 months
Change from Baseline Serum insulin at 6 months
Change from Baseline Serum insulin at 12 months
Secondary Outcome Measures
Change from Baseline Total portions of Combined Weekly Fruit and Vegetable Consumption at 6 months
Measured using the PreventT2 Diabetes Prevention Program questionnaire
Change from Baseline Total portions of Combined Weekly Fruit and Vegetable Consumption at 12 months
Measured using the PreventT2 Diabetes Prevention Program questionnaire
Change from Baseline Total portions of Fried Food Consumption at 6 months
Measured using the PreventT2 Diabetes Prevention Program questionnaire
Change from Baseline Total portions of Fried Food Consumption at 12 months
Measured using the PreventT2 Diabetes Prevention Program questionnaire
Change from Baseline Objective Total Weekly Physical activity minutes at 6 months
Measured using Fitbit Inspire 2
Change from Baseline Objective Total Weekly Physical activity minutes at 12 months
Measured using Fitbit Inspire 2
Change from Baseline Subjective Weekly Physical activity at 6 months
Stanford Brief Leisure-Time Activity Categorical Item (L-CAT 2.2)
Change from Baseline Subjective Weekly Physical activity at 12 months
Stanford Brief Leisure-Time Activity Categorical Item (L-CAT 2.2)
Change from Baseline Visceral adiposity tissue at 6 months
Measured using Dual energy X-ray absorptiometry
Change from Baseline Visceral adiposity tissue at 12 months
Measured using Dual energy X-ray absorptiometry
Change from Baseline C-reactive protein at 6 months
Change from Baseline C-reactive protein at 12 months
Full Information
NCT ID
NCT05379296
First Posted
May 2, 2022
Last Updated
January 25, 2023
Sponsor
The University of Texas Medical Branch, Galveston
1. Study Identification
Unique Protocol Identification Number
NCT05379296
Brief Title
Healthy Hearts: Leveraging the Diabetes Prevention Program to Decrease Health Disparities in Women of Reproductive Age
Acronym
HH
Official Title
Healthy Hearts: Leveraging the Diabetes Prevention Program to Decrease Health Disparities in Women of Reproductive Age
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Inadequate resources to complete within the required timeline.
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
January 20, 2023 (Anticipated)
Study Completion Date
January 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetic State, Gestational Weight Gain, Hypertension, Overweight or Obesity
Keywords
Prediabetic State, Gestational Weight Gain, Hypertension, Overweight or Obesity, Women's Health, Cardiovascular disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diabetes Prevention Program (DPP)
Arm Type
Active Comparator
Arm Description
CDC-approved 12-month DPP virtual lifestyle program
Arm Title
Diabetes Prevention Program Plus (DPP+)
Arm Type
Experimental
Arm Description
CDC-approved 12-month DPP virtual lifestyle program expanded to include a CDC-approved module on hypertension prevention and treatment
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Prevention Program Plus (DPP+)
Intervention Description
The DPP+ includes the CDC-approved DPP lifestyle program expanded to include a CDC-approved module on hypertension prevention and treatment
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Prevention Program (DPP)
Intervention Description
CDC-approved DPP lifestyle program
Primary Outcome Measure Information:
Title
Change from Baseline Systolic Blood Pressure at 6 months
Time Frame
Baseline, 6-months
Title
Change from Baseline Systolic Blood Pressure at 12 months
Time Frame
Baseline, 12-months
Title
Change from Baseline Diastolic Blood Pressure at 6 months
Time Frame
Baseline, 6-months
Title
Change from Baseline Diastolic Blood Pressure at 12 months
Time Frame
Baseline, 12-months
Title
Change from Baseline High-density lipoproteins at 6 months
Time Frame
Baseline, 6-months
Title
Change from Baseline High-density lipoproteins at 12 months
Time Frame
Baseline, 12-months
Title
Change from Baseline Low-density lipoproteins at 6 months
Time Frame
Baseline, 6-months
Title
Change from Baseline Low-density lipoproteins at 12 months
Time Frame
Baseline, 12-months
Title
Change from Baseline Triglycerides at 6 months
Time Frame
Baseline, 6-months
Title
Change from Baseline Triglycerides at 12 months
Time Frame
Baseline, 12-months
Title
Change from Baseline Total cholesterol at 6 months
Time Frame
Baseline, 6-months
Title
Change from Baseline Total cholesterol at 12 months
Time Frame
Baseline, 12-months
Title
Change from Baseline Hemoglobin a1c at 6 months
Time Frame
Baseline, 6-months
Title
Change from Baseline Hemoglobin a1c at 12 months
Time Frame
Baseline, 12-months
Title
Change from Baseline Weight at 6 months
Time Frame
Baseline, 6-months
Title
Change from Baseline Weight at 12 months
Time Frame
Baseline, 12-months
Title
Change from Baseline Body mass index at 6 months
Time Frame
Baseline, 6-months
Title
Change from Baseline Body mass index at 12 months
Time Frame
Baseline, 12-months
Title
Change from Baseline Fasting blood glucose at 6 months
Time Frame
Baseline, 6-months
Title
Change from Baseline Fasting blood glucose at 12 months
Time Frame
Baseline, 12-months
Title
Change from Baseline Serum insulin at 6 months
Time Frame
Baseline, 6-months
Title
Change from Baseline Serum insulin at 12 months
Time Frame
Baseline, 12-months
Secondary Outcome Measure Information:
Title
Change from Baseline Total portions of Combined Weekly Fruit and Vegetable Consumption at 6 months
Description
Measured using the PreventT2 Diabetes Prevention Program questionnaire
Time Frame
Baseline, 6-months
Title
Change from Baseline Total portions of Combined Weekly Fruit and Vegetable Consumption at 12 months
Description
Measured using the PreventT2 Diabetes Prevention Program questionnaire
Time Frame
Baseline, 12-months
Title
Change from Baseline Total portions of Fried Food Consumption at 6 months
Description
Measured using the PreventT2 Diabetes Prevention Program questionnaire
Time Frame
Baseline, 6-months
Title
Change from Baseline Total portions of Fried Food Consumption at 12 months
Description
Measured using the PreventT2 Diabetes Prevention Program questionnaire
Time Frame
Baseline, 12-months
Title
Change from Baseline Objective Total Weekly Physical activity minutes at 6 months
Description
Measured using Fitbit Inspire 2
Time Frame
Baseline, 6-months
Title
Change from Baseline Objective Total Weekly Physical activity minutes at 12 months
Description
Measured using Fitbit Inspire 2
Time Frame
Baseline, 12-months
Title
Change from Baseline Subjective Weekly Physical activity at 6 months
Description
Stanford Brief Leisure-Time Activity Categorical Item (L-CAT 2.2)
Time Frame
Baseline, 6-months
Title
Change from Baseline Subjective Weekly Physical activity at 12 months
Description
Stanford Brief Leisure-Time Activity Categorical Item (L-CAT 2.2)
Time Frame
Baseline, 12-months
Title
Change from Baseline Visceral adiposity tissue at 6 months
Description
Measured using Dual energy X-ray absorptiometry
Time Frame
Baseline, 6-months
Title
Change from Baseline Visceral adiposity tissue at 12 months
Description
Measured using Dual energy X-ray absorptiometry
Time Frame
Baseline, 12-months
Title
Change from Baseline C-reactive protein at 6 months
Time Frame
Baseline, 6-months
Title
Change from Baseline C-reactive protein at 12 months
Time Frame
Baseline, 12-months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Crystal Clark Douglas, PhD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Healthy Hearts: Leveraging the Diabetes Prevention Program to Decrease Health Disparities in Women of Reproductive Age
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