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Healthy Eating & Active Living Program for Obesity (HEALTH D&I Trial)

Phase 3
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
participating or willing to participate in PAT at a participating PAT site for 2 years
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 D&I Trial Summary

This trial is testing an obesity prevention intervention called HEALTH, to see if it is effective when delivered through the Parents as Teachers program. The study will also evaluate how well the intervention is implemented, and how well it works in the real world.

Who is the study for?
This trial is for individuals aged 18-45 who are overweight or obese, with a BMI of 25-45 kg/m2. They must be English or Spanish speakers participating in the Parents as Teachers program at a study site and willing to do so for two years. Pregnant individuals or those planning pregnancy within the next 24 months cannot join.Check my eligibility
What is being tested?
The HEALTH intervention, which aims to prevent weight gain and promote weight loss through home-based education on healthy eating and active living, is being tested against usual care. The study also examines how well this program works when taught by trained instructors in real-world settings.See study design
What are the potential side effects?
Since this trial involves lifestyle changes rather than medication, side effects may include typical exercise-related issues such as muscle soreness or fatigue from increased activity levels, and potential dietary adjustment discomforts.

HEALTH D&I Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 45 years old.
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I am willing to join a therapy program at a specific site for 2 years.
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I speak English or Spanish.

HEALTH D&I 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 D&I Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Healthy Eating & Active Living Taught at HomeExperimental Treatment1 Intervention
PAT National Center will train educators affiliated with PAT sites in HEALTH; among these, using the HEALTH training curriculum (implementation strategy). Participants at HEALTH sites receive usual care PAT+evidence-based life-style change strategies to prevent weight gain and promote weight loss embedded within and delivered as part of home visits.
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
1,928 Previous Clinical Trials
2,296,339 Total Patients Enrolled
77 Trials studying Obesity
13,193 Patients Enrolled for Obesity
Rachel G Tabak, PhD, RDPrincipal InvestigatorWashington University School of Medicine
2 Previous Clinical Trials
799 Total Patients Enrolled
1 Trials studying Obesity
784 Patients Enrolled for Obesity

Media Library

Healthy Eating & Active Living Taught at Home Clinical Trial Eligibility Overview. Trial Name: NCT03758638 — Phase 3
Obesity Research Study Groups: Healthy Eating & Active Living Taught at Home, Usual Care
Obesity Clinical Trial 2023: Healthy Eating & Active Living Taught at Home Highlights & Side Effects. Trial Name: NCT03758638 — Phase 3
Healthy Eating & Active Living Taught at Home 2023 Treatment Timeline for Medical Study. Trial Name: NCT03758638 — Phase 3
Obesity Patient Testimony for trial: Trial Name: NCT03758638 — Phase 3

Frequently Asked Questions

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

Are new patients still being enrolled in this experiment?

"That is correct. The clinical trial was initially posted on 1/25/2019 and was most recently edited on 3/10/2022. The trial is looking for 624 participants at 1 locations."

Answered by AI

What is the likelihood of experiencing negative side effects from Healthy Eating & Active Living Taught at Home?

"This Healthy Eating & Active Living Taught at Home intervention has received a score of 3 for safety. This is because it is a Phase 3 trial, which signifies that there is both efficacy and safety data from multiple rounds of testing."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
How old are they?
65+
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
1
3+

Why did patients apply to this trial?

need help achieving a more healthy weight. I am trying the GOLO plan advertised on TV.
PatientReceived no prior treatments
Help to maintain weight loss and additional weight loss.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
~47 spots leftby Sep 2024