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

Phase 2
Recruiting
Led By Debra Haire-Joshu, PhD
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
Must not have
At least 18 years of age
unable to engage in a walking program
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

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am 18 years old or older.
Select...
I cannot participate in a walking program.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in weight
Secondary study objectives
Fidelity of delivery to the intervention

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
1,970 Previous Clinical Trials
2,307,839 Total Patients Enrolled
81 Trials studying Obesity
13,369 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
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

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
~77 spots leftby Mar 2025
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