HEALTH-P2 for Obesity

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Washington University in St. Louis, Saint Louis, MOObesityHEALTH-P2 - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Treatment Effectiveness

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: throughout intervention delivery, which can range from 2-4 years for parent educators depending on when their site is randomized

12 months postpartum
Change in weight
Year 4
Fidelity of delivery to the intervention

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Usual Care
1 of 2
HEALTH-P2
1 of 2

Active Control

Experimental Treatment

784 Total Participants · 2 Treatment Groups

Primary Treatment: HEALTH-P2 · No Placebo Group · Phase 2

HEALTH-P2
Behavioral
Experimental Group · 1 Intervention: HEALTH-P2 · Intervention Types: Behavioral
Usual Care
Behavioral
ActiveComparator Group · 1 Intervention: Usual Care · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: throughout intervention delivery, which can range from 2-4 years for parent educators depending on when their site is randomized

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,823 Previous Clinical Trials
2,283,329 Total Patients Enrolled
71 Trials studying Obesity
12,648 Patients Enrolled for Obesity
Debra Haire-Joshu, PhDPrincipal InvestigatorWashington University School of Medicine
2 Previous Clinical Trials
1,340 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
639 Total Patients Enrolled
1 Trials studying Obesity
624 Patients Enrolled for Obesity

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are currently pregnant.

Who else is applying?

What state do they live in?
Missouri100.0%
What site did they apply to?
Washington University in St. Louis100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
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"
How many prior treatments have patients received?
0100.0%

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.