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

January 25, 2023 updated by: The University of Texas Medical Branch, Galveston
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Diabetes Prevention Program (DPP)
CDC-approved 12-month DPP virtual lifestyle program
Behavioral: Diabetes Prevention Program (DPP)
CDC-approved DPP lifestyle program
Experimental: Diabetes Prevention Program Plus (DPP+)
CDC-approved 12-month DPP virtual lifestyle program expanded to include a CDC-approved module on hypertension prevention and treatment
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from Baseline Systolic Blood Pressure at 6 months
Time Frame: Baseline, 6-months
Baseline, 6-months
Change from Baseline Systolic Blood Pressure at 12 months
Time Frame: Baseline, 12-months
Baseline, 12-months
Change from Baseline Diastolic Blood Pressure at 6 months
Time Frame: Baseline, 6-months
Baseline, 6-months
Change from Baseline Diastolic Blood Pressure at 12 months
Time Frame: Baseline, 12-months
Baseline, 12-months
Change from Baseline High-density lipoproteins at 6 months
Time Frame: Baseline, 6-months
Baseline, 6-months
Change from Baseline High-density lipoproteins at 12 months
Time Frame: Baseline, 12-months
Baseline, 12-months
Change from Baseline Low-density lipoproteins at 6 months
Time Frame: Baseline, 6-months
Baseline, 6-months
Change from Baseline Low-density lipoproteins at 12 months
Time Frame: Baseline, 12-months
Baseline, 12-months
Change from Baseline Triglycerides at 6 months
Time Frame: Baseline, 6-months
Baseline, 6-months
Change from Baseline Triglycerides at 12 months
Time Frame: Baseline, 12-months
Baseline, 12-months
Change from Baseline Total cholesterol at 6 months
Time Frame: Baseline, 6-months
Baseline, 6-months
Change from Baseline Total cholesterol at 12 months
Time Frame: Baseline, 12-months
Baseline, 12-months
Change from Baseline Hemoglobin a1c at 6 months
Time Frame: Baseline, 6-months
Baseline, 6-months
Change from Baseline Hemoglobin a1c at 12 months
Time Frame: Baseline, 12-months
Baseline, 12-months
Change from Baseline Weight at 6 months
Time Frame: Baseline, 6-months
Baseline, 6-months
Change from Baseline Weight at 12 months
Time Frame: Baseline, 12-months
Baseline, 12-months
Change from Baseline Body mass index at 6 months
Time Frame: Baseline, 6-months
Baseline, 6-months
Change from Baseline Body mass index at 12 months
Time Frame: Baseline, 12-months
Baseline, 12-months
Change from Baseline Fasting blood glucose at 6 months
Time Frame: Baseline, 6-months
Baseline, 6-months
Change from Baseline Fasting blood glucose at 12 months
Time Frame: Baseline, 12-months
Baseline, 12-months
Change from Baseline Serum insulin at 6 months
Time Frame: Baseline, 6-months
Baseline, 6-months
Change from Baseline Serum insulin at 12 months
Time Frame: Baseline, 12-months
Baseline, 12-months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline Total portions of Combined Weekly Fruit and Vegetable Consumption at 6 months
Time Frame: Baseline, 6-months
Measured using the PreventT2 Diabetes Prevention Program questionnaire
Baseline, 6-months
Change from Baseline Total portions of Combined Weekly Fruit and Vegetable Consumption at 12 months
Time Frame: Baseline, 12-months
Measured using the PreventT2 Diabetes Prevention Program questionnaire
Baseline, 12-months
Change from Baseline Total portions of Fried Food Consumption at 6 months
Time Frame: Baseline, 6-months
Measured using the PreventT2 Diabetes Prevention Program questionnaire
Baseline, 6-months
Change from Baseline Total portions of Fried Food Consumption at 12 months
Time Frame: Baseline, 12-months
Measured using the PreventT2 Diabetes Prevention Program questionnaire
Baseline, 12-months
Change from Baseline Objective Total Weekly Physical activity minutes at 6 months
Time Frame: Baseline, 6-months
Measured using Fitbit Inspire 2
Baseline, 6-months
Change from Baseline Objective Total Weekly Physical activity minutes at 12 months
Time Frame: Baseline, 12-months
Measured using Fitbit Inspire 2
Baseline, 12-months
Change from Baseline Subjective Weekly Physical activity at 6 months
Time Frame: Baseline, 6-months
Stanford Brief Leisure-Time Activity Categorical Item (L-CAT 2.2)
Baseline, 6-months
Change from Baseline Subjective Weekly Physical activity at 12 months
Time Frame: Baseline, 12-months
Stanford Brief Leisure-Time Activity Categorical Item (L-CAT 2.2)
Baseline, 12-months
Change from Baseline Visceral adiposity tissue at 6 months
Time Frame: Baseline, 6-months
Measured using Dual energy X-ray absorptiometry
Baseline, 6-months
Change from Baseline Visceral adiposity tissue at 12 months
Time Frame: Baseline, 12-months
Measured using Dual energy X-ray absorptiometry
Baseline, 12-months
Change from Baseline C-reactive protein at 6 months
Time Frame: Baseline, 6-months
Baseline, 6-months
Change from Baseline C-reactive protein at 12 months
Time Frame: Baseline, 12-months
Baseline, 12-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Medical Branch, Galveston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Crystal Clark Douglas, PhD, University of Texas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21-0325

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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