This project evaluates the effectiveness of an evidence-based intervention (HEALTH-P2) to prevent excessive weight gain from pregnancy through 12 months postpartum when disseminated and implemented in real-world settings, through Parents as Teachers. To enhance the impact of HEALTH-P2, the study also evaluates implementation outcomes from the training curriculum (implementation strategy) and external validity when HEALTH-P2 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.
Women are exceptionally vulnerable during childbearing years to gain disproportionally large amounts of weight when compared to men or other life periods. Weight gained during pregnancy and retained after the postpartum period contributes to obesity development and progression. Evidence based lifestyle interventions addressing the trajectory of weight gain across the childbearing continuum can reverse these alarming trends of excessive weight among young women, but have had limited uptake due to time, expense, and parenting priorities. To address this gap, our research team developed the lifestyle intervention Healthy Eating, Activity Living, Taught at Home during Pregnancy and Postpartum (HEALTH-P2) in partnership with Parents as Teachers (PAT). This study will provide evidence for the dissemination and implementation (D\&I) of HEALTH-P2 across PAT's network of sites, promoting healthy weight on a national scale. The study builds on our previous work with a pragmatic cluster randomized controlled trial to evaluate D\&I of HEALTH-P2 across multiple levels to achieve widespread impact. First, we will determine weight outcomes (12-month postpartum weight; gestational weigh gain) among 336 overweight/obese women (N=168 HEALTH-P2; N=168 usual care) when parent educators (\~8/site) from PAT sites nationwide receive the HEALTH-P2 training through PAT National Center's existing training infrastructure and conduct HEALTH-P2 as part of routine practice. From a D\&I perspective, an evaluation guided by RE-AIM will measure implementation outcomes (acceptability, appropriateness, feasibility, fidelity, adaptation). Further, the Conceptual Framework for Implementation Research will guide an assessment of contextual factors that influence external validity at multiple levels (mother, parent educator, PAT site).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
784
The HEALTH-P2 curriculum includes evidence based lifestyle change strategies to prevent excess gestational weight gain and postpartum weight retention embedded within and delivered as part of home visits.
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.
Washington University in St. Louis
St Louis, Missouri, United States
RECRUITINGChange in weight
Mother's body weight
Time frame: 12 months postpartum
Fidelity of delivery to the intervention
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
Time frame: throughout intervention delivery, which can range from 2-4 years for parent educators depending on when their site is randomized
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