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HEALTH-P2 Intervention for Preventing Obesity During and After Pregnancy (HEALTH-P2 Trial)

Phase 2
Recruiting
Led By Rachel G Tabak, PhD, RD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18-45 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout intervention delivery, which can range from 2-4 years for parent educators depending on when their site is randomized
Awards & highlights

HEALTH-P2 Trial Summary

This trial is testing whether an evidence-based intervention can help prevent excessive weight gain during and after pregnancy, when delivered through a national home visiting organization. If successful, the intervention could have a significant impact on obesity and related chronic diseases.

Who is the study for?
This trial is for pregnant women aged 18-45 who are overweight or obese, speak English or Spanish, and are willing to participate in a program called Parents as Teachers (PAT) until their baby turns one. They must not plan another pregnancy before their current baby's first birthday and should be able to engage in walking.Check my eligibility
What is being tested?
The study tests the HEALTH-P2 intervention aimed at preventing excessive weight gain during pregnancy through the first year postpartum. It compares this with usual care and assesses how well it works when applied by PAT, focusing on outcomes like obesity prevention and chronic disease impact.See study design
What are the potential side effects?
Since this trial involves lifestyle interventions rather than medications, side effects may include typical exercise-related issues such as muscle soreness or fatigue but will vary based on individual health conditions.

HEALTH-P2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 45 years old.

HEALTH-P2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout intervention delivery, which can range from 2-4 years for parent educators depending on when their site is randomized
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout intervention delivery, which can range from 2-4 years for parent educators depending on when their site is randomized for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in weight
Secondary outcome measures
Fidelity of delivery to the intervention

HEALTH-P2 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: HEALTH-P2Experimental Treatment1 Intervention
Along with PAT National Center, parent educators affiliated with PAT sites in HEALTH-P2; with be trained to use the HEALTH-P2 training curriculum (implementation strategy).
Group II: Usual CareActive Control1 Intervention
Participants at usual care PAT sites will receive PAT as usual.

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,936 Previous Clinical Trials
2,298,906 Total Patients Enrolled
77 Trials studying Obesity
13,033 Patients Enrolled for Obesity
Rachel G Tabak, PhD, RDPrincipal InvestigatorWashington University School of Medicine
2 Previous Clinical Trials
642 Total Patients Enrolled
1 Trials studying Obesity
624 Patients Enrolled for Obesity
Debra Haire-Joshu, PhDPrincipal InvestigatorWashington University School of Medicine
2 Previous Clinical Trials
1,343 Total Patients Enrolled
1 Trials studying Obesity
1,325 Patients Enrolled for Obesity

Media Library

HEALTH-P2 Clinical Trial Eligibility Overview. Trial Name: NCT04253977 — Phase 2
Obesity Research Study Groups: HEALTH-P2, Usual Care
Obesity Clinical Trial 2023: HEALTH-P2 Highlights & Side Effects. Trial Name: NCT04253977 — Phase 2
HEALTH-P2 2023 Treatment Timeline for Medical Study. Trial Name: NCT04253977 — Phase 2
Obesity Patient Testimony for trial: Trial Name: NCT04253977 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for this clinical study?

"Affirmative. According to information posted on clinicaltrials.gov, the trial is currently recruiting participants and was initially listed on February 3rd 2020 with its last update taking place on October 28th 2022. This research endeavour requires 784 patients across a single site."

Answered by AI

How many individuals have signed up to partake in this experiment?

"Affirmative. According to clinicaltrials.gov, this clinical trial is actively seeking participants and has been since February 3rd 2020. The listing was last updated on October 28th 2022 and 784 people across a single site are required for enrolment purposes."

Answered by AI

What potential risks do patients face when using HEALTH-P2?

"Although preliminary evidence exists of HEALTH-P2's safety, efficacy has yet to be substantiated. Therefore, our team at Power rated the drug a 2 on their 1-3 scale."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
What site did they apply to?
Washington University in St. Louis
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I had never been on weight loss drugs. I have gone fron 216 to 195 in the past year and i am interested in checking out thr trial.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Promoting Healthy Weight Across the Pregnancy and Postpartum Period
2020. "Promoting Healthy Weight Across the Pregnancy and Postpartum Period". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04253977.
All > Pregnancy
~141 spots leftby Mar 2025
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