CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 620 enrolled
Drug / intervention
Healthy Eating & Active Living Taught at Home +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03758638
NCT03758638Phase 3Completed

Disseminating and Implementing A Lifestyle Based Healthy Weight Program in a National Organization

Washington University School of Medicine·interventional·Posted Nov 29, 2018·Updated Nov 12, 2025

In Brief

A Phase 3 clinical trial evaluating Healthy Eating & Active Living Taught at Home and Usual Care for Obesity. Completed, enrolled 620 participants across 1 site.

Detailed Summary

This project evaluates the effectiveness of an evidence-based intervention (HEALTH) to prevent weight gain and promote weight loss when disseminated and implemented in real-world settings, through Parents as Teachers. To enhance the impact of HEALTH, the study also evaluates implementation outcomes from the training curriculum (implementation strategy) and external validity when HEALTH is implemented within this national home visiting organization. This partnership has potential for significant impact on obesity and chronic diseases such as cardiovascular disease and diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedNov 29, 2018
Enrollment StartJan 25, 2019
Primary CompletionJul 31, 2024
Study CompletionJun 30, 2025
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 7.6 years ago

Interventions

Healthy Eating & Active Living Taught at Homebehavioral

PAT National Center will train educators affiliated with PAT sites in HEALTH; among these, using the HEALTH training curriculum, which includes training materials, an \~8 hour training delivered through a synchronous web-based experience, and ongoing consultation. 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. In addition to the usual care PAT curriculum content, goal setting related to healthy weight, and the importance of parental modeling of healthy eating and physical activity are incorporated throughout the discussion and visit. HEALTH will be delivered over 24 months via a (1) core and (2) maintenance phase. The visits begin with greater frequency, and taper. Consistent with PAT practice, the frequency and number of visits are determined by the family's needs and preferences.

Usual Carebehavioral

The Foundational (usual care) curriculum uses a strength-based, solution-focused model to provide parents with child development knowledge and parenting support, empowering parents as their child's first and most influential teacher.