Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT03758638 |
Other study ID # |
201810157-1R01HL143360 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
Phase 3
|
First received |
|
Last updated |
|
Start date |
January 25, 2019 |
Est. completion date |
September 2024 |
Study information
Verified date |
April 2024 |
Source |
Washington University School of Medicine |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.