Promoting Healthy Weight Across the Pregnancy and Postpartum Period

  • STATUS
    Recruiting
  • participants needed
    784
  • sponsor
    Washington University School of Medicine
Updated on 19 February 2024
diabetes
cardiovascular disease
chronic disease

Summary

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.

Description

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 468 overweight/obese women (N=234 HEALTH-P2; N=234 usual care) when parent educators (~8/site) from 36 PAT sites nationwide (18 HEALTH-P2, 18 usual care) 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).

Details
Condition Obesity, Obesity
Age 18-100 years
Treatment Usual care, HEALTH-P2
Clinical Study IdentifierNCT04253977
SponsorWashington University School of Medicine
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

-45 years of age
pregnant but before 20 weeks gestation
overweight or obese (BMI 25-45 kg/m2) before becoming pregnant
English or Spanish speaking
participating or willing to participate in PAT at a participating PAT site until baby turns 1
able to give informed consent for participation

Exclusion Criteria

planning to become pregnant again before their baby turns 1
unable to engage in a walking program
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