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

NCT03758638 | Completed Phase 3 Results DMC

• 1 other identifier: 201810157-1R01HL143360
• Study Type: interventional
• Target: 620
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Change in Weight

  Mother's body weight assessed by data collector

  24-months

Secondary Outcomes (1)

• Fidelity of Delivery to the Intervention

  throughout intervention delivery, which can range from 2-4 years for parent educators depending on when their site is randomized

Study Arms (2)

Healthy Eating & Active Living Taught at Home

EXPERIMENTAL

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.

Behavioral: Healthy Eating & Active Living Taught at Home

Usual Care

ACTIVE COMPARATOR

Participants at usual care PAT sites will receive PAT as usual

Behavioral: Usual Care

Interventions

Healthy Eating & Active Living Taught at Home BEHAVIORAL

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.

Healthy Eating & Active Living Taught at Home

Usual Care BEHAVIORAL

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.

Also known as: Parents as Teachers

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: For the participants (i.e., not the parent educators), only women will be included: Including only female participants is scientifically justified, as the study focus is addressing the dramatic weight gain women experience in early adulthood, which is not experienced to the same extent among men. Further, HEALTH was tested and demonstrated effectiveness only in mothers, and the very small number of fathers who participate in PAT will not provide an adequate sample to evaluate HEALTH in this population.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Deliver PAT at a site participating in the study
• Provide informed consent

You may not qualify if:

• At least 18 years of age
• For Participants:
• 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
• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63130, United States

Location

Related Publications (5)

• Gilbert A, Martinez A, Farabi S, Cortez A, Baumann AA, Haire-Joshu D, Brownson RC, Morshed AB, Tabak RG. Social determinants of health influence maternal health behaviors and engagement in an obesity prevention intervention. Transl Behav Med. 2026 Jan 7;16(1):ibaf088. doi: 10.1093/tbm/ibaf088.

  PMID: 41498407 DERIVED

• Tabak RG, Schwarz CD, Kemner A, Haire-Joshu D. 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. Int J Behav Nutr Phys Act. 2025 Apr 10;22(1):42. doi: 10.1186/s12966-025-01736-5.

  PMID: 40211363 DERIVED

• Farabi SS, Schwarz C, Persaud A, Gilbert A, Haire-Joshu D, Tabak RG. Sleep, Stress, and Cardiometabolic Health in Women of Childbearing Age with Overweight and Obesity. Womens Health Rep (New Rochelle). 2024 Feb 21;5(1):143-151. doi: 10.1089/whr.2023.0138. eCollection 2024.

  PMID: 38414886 DERIVED

• Tabak RG, Schwarz CD, Kemner A, Johnston S, Aramburu A, Haire-Joshu D. Social Determinants of Health Discussed with Mothers During Personal Visits Before and During the COVID-19 Pandemic. Health Equity. 2021 Sep 3;5(1):536-544. doi: 10.1089/heq.2020.0140. eCollection 2021.

  PMID: 34909520 DERIVED

• Tabak RG, Schwarz CD, Kemner A, Schechtman KB, Steger-May K, Byrth V, Haire-Joshu D. Disseminating and implementing a lifestyle-based healthy weight program for mothers in a national organization: a study protocol for a cluster randomized trial. Implement Sci. 2019 Jun 25;14(1):68. doi: 10.1186/s13012-019-0916-0.

  PMID: 31238955 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Diet, Healthy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: Rachel Tabak
• Organization: Washington University in St. Louis

rtabak@wustl.edu

3149350153

Study Officials

• Rachel G Tabak, PhD, RD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Healthy Eating \& Active Living Taught at Home (HEALTH) embeds content related to healthy eating and activity within Parents as Teachers (PAT)'s existing home visits.

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 29, 2018
• Study Start: January 25, 2019
• Primary Completion: July 31, 2024
• Study Completion: June 30, 2025
• Last Updated: November 12, 2025
• Results First Posted: November 12, 2025

Record last verified: 2025-10

Locations

US (1)