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Phase 3 Completed N=620 Randomized Prevention

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

Source: ClinicalTrials.gov NCT03758638 ↗
Enrolled (actual)
620
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcomePrimary: Change in Weight — -0.24; 0.49 Kg
◆ Published Evidence
Emerging
15citations · ~2 / year
Disseminating and implementing a lifestyle-based healthy weight program for mothers in a national organization: a study protocol for a cluster randomized trial.
Implementation science : IS · 2019 · Open access · Likely link

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.

Linked Publications (5)

  • Disseminating and implementing a lifestyle-based healthy weight program for mothers in a national organization: a study protocol for a cluster randomized trial.
    Implementation science : IS · 2019 · 15 citations · Open access · Likely link
  • Social Determinants of Health Discussed with Mothers During Personal Visits Before and During the COVID-19 Pandemic.
    Health equity · 2021 · 2 citations · Open access · Likely link
  • Social determinants of health influence maternal health behaviors and engagement in an obesity prevention intervention.
    Translational behavioral medicine · 2026 · 1 citation · Open access · Likely link
  • Sleep, Stress, and Cardiometabolic Health in Women of Childbearing Age with Overweight and Obesity.
    Women's health reports (New Rochelle, N.Y.) · 2024 · 1 citation · Open access · Likely link
  • 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.
    The international journal of behavioral nutrition and physical activity · 2025 · 0 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Weight
-0.24; 0.49
SECONDARY
Fidelity of Delivery to the Intervention
67; 12; 9

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03758638) and the linked publication. 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. Informational only — not medical advice.

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