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Completed

NCT Number: NCT03758638

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Washington University in St. Louis

St Louis, Missouri, 63130, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Other names: Parents as Teachers

Primary outcomes

  1. Change in Weight

    Time frame: 24-months

    Mother's body weight assessed by data collector

Secondary outcomes

  1. Fidelity of Delivery to the Intervention

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

    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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Acronym: HEALTH D&I

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Nov 29, 2018
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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