Clinical trial NCT03758638: Healthy Eating and Active Living Taught at Home (HEALTH) Dissemination & Implementation (D&I)
Official title: Disseminating and Implementing A Lifestyle Based Healthy Weight Program in a National Organization
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 624
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Weight
timeFrame: 24-months
Secondary outcomes:
measure: Fidelity of delivery to the intervention
timeFrame: throughout intervention delivery, which can range from 2-4 years for parent educators depending on when their site is randomized
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Rachel G Tabak, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.