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

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

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 Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Usual Care; Behavioral: Healthy Eating & Active Living Taught at Home

Detailed Description

Excessive weight gain among young adult women age 18-35 years is an alarming and overlooked trend that must be addressed to reverse the epidemics of obesity and chronic disease. During this vulnerable period women tend to gain disproportionally large amounts of weight compared to men and other life periods. A lifestyle modification intervention (HEALTH) that prevented weight gain, promoted sustained weight loss, and reduced waist circumference was developed in partnership with Parents as Teachers (PAT), a national home visiting, community based organization with significant reach in this population. PAT provides parent-child education and services free-of-charge to nearly 170,000 families through up to 25 free home visits per year until the child enters kindergarten. This study will extend these findings with a pragmatic cluster randomized controlled trial to evaluate dissemination and implementation of HEALTH across three levels (mother, parent educator, PAT site) to achieve widespread impact. The pragmatic cluster randomized controlled trial will evaluate HEALTH and the HEALTH training curriculum (implementation strategy) on weight among mothers with overweight and obesity across the US (N= 200 HEALTH; N= 200 usual care). Parent educators from 40 existing PAT sites (20 HEALTH, 20 usual care) will receive the HEALTH training curriculum through the PAT National Center, using PAT's existing training infrastructure, as a continuing education opportunity. An extensive evaluation, guided by RE-AIM (Reach, Efficacy, Adoption, Implementation, and Maintenance) will determine implementation outcomes (acceptability, adoption, appropriateness, feasibility, fidelity, and adaptation) at the parent educator level. The Conceptual Framework for Implementation research will characterize determinants that influence HEALTH dissemination and implementation at three levels: mother, parent educator, PAT site to enhance external validity (reach and maintenance) and population level impact. The findings from this innovative study will have significant potential to help reverse the trend of excessive weight gain among young adult women, a critical priority target in battling the epidemics of obesity and chronic disease, by reaching women with an evidence-based intervention nation-wide.

• Study Type: Interventional
• Enrollment (Actual): 620
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63130
      • Washington University in St. Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Eating & Active Living Taught at Home; 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; 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.
Active Comparator: Usual Care; Participants at usual care PAT sites will receive PAT as usual	Behavioral: Usual Care; 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.; Other Names: Parents as Teachers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Weight	Mother's body weight assessed by data collector	24-months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Rachel G Tabak, PhD, RD, Washington University School of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2019
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: November 26, 2018
• First Submitted That Met QC Criteria: November 28, 2018
• First Posted (Actual): November 29, 2018

Study Record Updates

• Last Update Posted (Actual): November 12, 2025
• Last Update Submitted That Met QC Criteria: October 25, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet; Diet, Healthy
• Other Study ID Numbers: 201810157-1R01HL143360

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Only data with identifiers removed will be shared publicly.; Any identified data to be shared will only be done so in coordination with the Human Research Protection Office at Washington University in St. Louis and the Institutional Review Board (IRB) at the requesting investigator's institution.; Datasets with identifiers will only be accessible to study team members with appropriate Human Subjects training.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No