NCT03758638: HEALTH D&I

Healthy Eating and Active Living Taught at Home (HEALTH) Dissemination & Implementation (D&I)

Completed Phase 3 Results posted Last updated 12 November 2025

What this trial tests

Phase 3 trial testing Healthy Eating & Active Living Taught at Home in Obesity in 620 participants. Completed in 30 June 2025.

Timeline

25 January 2019

Primary endpoint
31 July 2024

30 June 2025

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	620
Start date	25 January 2019
Primary completion	31 July 2024
Estimated completion	30 June 2025
Sites	1 location across United States

Drugs / interventions tested

• Healthy Eating & Active Living Taught at Home
• Usual Care

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Weight Primary · 24-months

Mother's body weight assessed by data collector

Group	Value	95% CI
Healthy Eating & Active Living Taught at Home	-0.24	± 9.75
Usual Care	0.49	± 11.87

Fidelity of Delivery to the Intervention Secondary · throughout intervention delivery, which can range from 2-4 years for parent educators depending on when their site is randomized

Parent educators' fidelity to the intervention will all be assessed using a coding document (developed for the current study), which will be applied to audio-recordings of study visits, and will document the following components: adherence, quality of delivery, exposure to the intervention, and participant responsiveness or involvement, all of which share a common unit of measure

Group	Value	95% CI
Healthy Eating & Active Living Taught at Home	67
Healthy Eating & Active Living Taught at Home	12
Healthy Eating & Active Living Taught at Home	9

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Disseminating and implementing a lifestyle-based healthy weight program for mothers in a national organization: a study protocol for a cluster randomized trial.
   Tabak RG, Schwarz CD, Kemner A, Schechtman KB, et al · · 2019 · cited 12× · PMID 31238955 · DOI 10.1186/s13012-019-0916-0
2. Social Determinants of Health Discussed with Mothers During Personal Visits Before and During the COVID-19 Pandemic.
   Tabak RG, Schwarz CD, Kemner A, Johnston S, et al · · 2021 · cited 3× · PMID 34909520 · DOI 10.1089/heq.2020.0140
3. Sleep, Stress, and Cardiometabolic Health in Women of Childbearing Age with Overweight and Obesity.
   Farabi SS, Schwarz C, Persaud A, Gilbert A, et al · · 2024 · cited 1× · PMID 38414886 · DOI 10.1089/whr.2023.0138
4. Accessibility, acceptability, and usage during COVID-19 of the evidence-based intervention Healthy Eating and Active Living Taught at Home (HEALTH): implications for implementation strategies.
   Gilbert A, Haire-Joshu D, Morshed AB, Schwarz CD, et al · · 2026 · PMID 41731558 · DOI 10.1186/s12966-026-01896-y
5. Social determinants of health influence maternal health behaviors and engagement in an obesity prevention intervention.
   Gilbert A, Martinez A, Farabi S, Cortez A, et al · · 2026 · PMID 41498407 · DOI 10.1093/tbm/ibaf088
6. Cross-Sectional associations between inner setting determinants of self-efficacy and intent to deliver a healthy eating and activity curriculum embedded in a community setting.
   Tabak RG, Schwarz CD, Kemner A, Haire-Joshu D. · · 2025 · PMID 40211363 · DOI 10.1186/s12966-025-01736-5