Phase 3
N=620
Healthy Eating and Active Living Taught at Home (HEALTH) Dissemination & Implementation (D&I)
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03758638 ↗Enrolled (actual)
620
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Change in Weight — -0.24; 0.49 Kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Healthy Eating & Active Living Taught at Home (Behavioral); Usual Care (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Weight |
-0.24; 0.49 | — |
| SECONDARY Fidelity of Delivery to the Intervention |
67; 12; 9 | — |
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.
Eligibility Criteria
For Parent educators:
Inclusion Criteria
- Deliver PAT at a site participating in the study
- Provide informed consent
Exclusion Criteria
- At least 18 years of age
For Participants:
Inclusion Criteria
- 18-45 years of age
- overweight or obese (BMI 25-45 kg/m2)
- English or Spanish speaking
- participating or willing to participate in PAT at a participating PAT site for 2 years
- able to give informed consent for participation
Exclusion Criteria
- currently pregnant or planning to become pregnant in the next 24 months
- unable to speak English or Spanish
- unable to engage in a walking program
Data sourced from ClinicalTrials.gov (NCT03758638). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.