AzTrials
AzTrials

Prediabetic StateHHNCT05379296

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

A study testing Diabetes Prevention Program Plus (DPP+) and Diabetes Prevention Program (DPP) in people with Prediabetic State and Gestational Weight Gain, run by The University of Texas Medical Branch, Galveston.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
What is being tested?
Diabetes Prevention Program Plus (DPP+) and Diabetes Prevention Program (DPP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Jan 2022to 20 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Pregnant and lactating women, participants planning to move out of Galveston County within the next year

About this study

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.

Being tested
Diabetes Prevention Program Plus (DPP+), Diabetes Prevention Program (DPP)
Keywords
Prediabetic State, Gestational Weight Gain, Hypertension, Overweight or Obesity, Women's Health, Cardiovascular disease
Medical subject headings
Prediabetic State, Gestational Weight Gain, Hypertension, Overweight, Obesity, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diabetes Prevention Program Plus (DPP+)Behavioural

    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)Behavioural

    CDC-approved DPP lifestyle program

Study groups in NCT05379296
Study groupRoleWhat they receive
Diabetes Prevention Program (DPP)Active comparatorCDC-approved 12-month DPP virtual lifestyle program
Receives: Behavioral: Diabetes Prevention Program (DPP)
Diabetes Prevention Program Plus (DPP+)ExperimentalCDC-approved 12-month DPP virtual lifestyle program expanded to include a CDC-approved module on hypertension prevention and treatment
Receives: Behavioral: Diabetes Prevention Program Plus (DPP+)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline Systolic Blood Pressure at 6 months

    Measured: Baseline, 6-months

  2. Change from Baseline Systolic Blood Pressure at 12 months

    Measured: Baseline, 12-months

  3. Change from Baseline Diastolic Blood Pressure at 6 months

    Measured: Baseline, 6-months

  4. Change from Baseline Diastolic Blood Pressure at 12 months

    Measured: Baseline, 12-months

  5. Change from Baseline High-density lipoproteins at 6 months

    Measured: Baseline, 6-months

  6. Change from Baseline High-density lipoproteins at 12 months

    Measured: Baseline, 12-months

  7. Change from Baseline Low-density lipoproteins at 6 months

    Measured: Baseline, 6-months

  8. Change from Baseline Low-density lipoproteins at 12 months

    Measured: Baseline, 12-months

  9. Change from Baseline Triglycerides at 6 months

    Measured: Baseline, 6-months

  10. Change from Baseline Triglycerides at 12 months

    Measured: Baseline, 12-months

  11. Change from Baseline Total cholesterol at 6 months

    Measured: Baseline, 6-months

  12. Change from Baseline Total cholesterol at 12 months

    Measured: Baseline, 12-months

  13. Change from Baseline Hemoglobin a1c at 6 months

    Measured: Baseline, 6-months

  14. Change from Baseline Hemoglobin a1c at 12 months

    Measured: Baseline, 12-months

  15. Change from Baseline Weight at 6 months

    Measured: Baseline, 6-months

  16. Change from Baseline Weight at 12 months

    Measured: Baseline, 12-months

  17. Change from Baseline Body mass index at 6 months

    Measured: Baseline, 6-months

  18. Change from Baseline Body mass index at 12 months

    Measured: Baseline, 12-months

  19. Change from Baseline Fasting blood glucose at 6 months

    Measured: Baseline, 6-months

  20. Change from Baseline Fasting blood glucose at 12 months

    Measured: Baseline, 12-months

  21. Change from Baseline Serum insulin at 6 months

    Measured: Baseline, 6-months

  22. Change from Baseline Serum insulin at 12 months

    Measured: Baseline, 12-months

Secondary outcomes (12)

  1. Change from Baseline Total portions of Combined Weekly Fruit and Vegetable Consumption at 6 months

    Measured using the PreventT2 Diabetes Prevention Program questionnaire

    Measured: Baseline, 6-months

  2. Change from Baseline Total portions of Combined Weekly Fruit and Vegetable Consumption at 12 months

    Measured using the PreventT2 Diabetes Prevention Program questionnaire

    Measured: Baseline, 12-months

  3. Change from Baseline Total portions of Fried Food Consumption at 6 months

    Measured using the PreventT2 Diabetes Prevention Program questionnaire

    Measured: Baseline, 6-months

  4. Change from Baseline Total portions of Fried Food Consumption at 12 months

    Measured using the PreventT2 Diabetes Prevention Program questionnaire

    Measured: Baseline, 12-months

  5. Change from Baseline Objective Total Weekly Physical activity minutes at 6 months

    Measured using Fitbit Inspire 2

    Measured: Baseline, 6-months

  6. Change from Baseline Objective Total Weekly Physical activity minutes at 12 months

    Measured using Fitbit Inspire 2

    Measured: Baseline, 12-months

  7. Change from Baseline Subjective Weekly Physical activity at 6 months

    Stanford Brief Leisure-Time Activity Categorical Item (L-CAT 2.2)

    Measured: Baseline, 6-months

  8. Change from Baseline Subjective Weekly Physical activity at 12 months

    Stanford Brief Leisure-Time Activity Categorical Item (L-CAT 2.2)

    Measured: Baseline, 12-months

  9. Change from Baseline Visceral adiposity tissue at 6 months

    Measured using Dual energy X-ray absorptiometry

    Measured: Baseline, 6-months

  10. Change from Baseline Visceral adiposity tissue at 12 months

    Measured using Dual energy X-ray absorptiometry

    Measured: Baseline, 12-months

  11. Change from Baseline C-reactive protein at 6 months

    Measured: Baseline, 6-months

  12. Change from Baseline C-reactive protein at 12 months

    Measured: Baseline, 12-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2022
  2. Study start1 Jan 2022
  3. Primary completion20 Jan 2023 (estimated)
  4. Study completion20 Jan 2023

Why it stopped: Inadequate resources to complete within the required timeline.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05379296
Sponsor's protocol ID
21-0325
Acronym
HH
Status last verified
Jan 2023
First submitted
2 May 2022
Last updated
27 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Diabetes Prevention Program Plus (DPP+) and Diabetes Prevention Program (DPP) in people with Prediabetic State and Gestational Weight Gain, run by The University of Texas Medical Branch, Galveston.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Systolic Blood Pressure at 6 months (time frame: Baseline, 6-months). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05379296.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in