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

NCT ID: NCT03758638

Last Updated: 2025-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 620 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-25
• Study Completion Date: 2025-06-30

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.

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Healthy Eating & Active Living Taught at Home

Intervention Type: 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.

Usual Care

Participants at usual care PAT sites will receive PAT as usual

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Parents as Teachers

Eligibility Criteria

Inclusion Criteria

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

• 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

• At least 18 years of age

For Participants:

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel G Tabak, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University in St. Louis

St Louis, Missouri, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40211363 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38414886 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34909520 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31238955 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

201810157-1R01HL143360

Identifier Type: -

Identifier Source: org_study_id