search
Back to results

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Withdrawn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
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 45 Years (Adult)FemaleDoes not accept 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

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

    First Posted
    May 2, 2022
    Last Updated
    January 25, 2023
    Sponsor
    The University of Texas Medical Branch, Galveston
    search

    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

    We'll reach out to this number within 24 hrs