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

Phase 3

Active, not recruiting

• Conditions: Obesity
• Interventions: Behavioral: Healthy Eating & Active Living Taught at Home; Behavioral: Usual Care

• Registration Number: NCT03758638
• Lead Sponsor: Washington University School of Medicine

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.

Study Timeline

• Study First Submitted: 2018-11-26
• Study First Submitted QC: 2018-11-28
• Study First Posted: 2018-11-29
• Study Start: 2019-01-25
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 624

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Eating & Active Living Taught at Home	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.
Usual Care	Usual Care	Participants at usual care PAT sites will receive PAT as usual

Primary Outcome Measures

Name	Time	Method
Change in Weight	24-months	Mother's body weight assessed by data collector

Secondary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (1)

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States