← Back to Search

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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout intervention delivery, which can range from 2-4 years for parent educators depending on when their site is randomized

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 3Eligibility criteria met