Promoting Healthy Weight Across the Pregnancy and Postpartum Period

Obesity Clinical Trial

— HEALTH-P2  

Official title:

Promoting Healthy Weight Across the Pregnancy and Postpartum Period Through Dissemination of an Evidence Based Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04253977
• Other study ID #: 201909155
• Status: Recruiting
• Phase: Phase 2
• Start date: February 3, 2020
• Est. completion date: March 31, 2025

Study information

• Verified date: October 2023
• Source: Washington University School of Medicine
• Contact: Rachel Tabak, PhD, RD
• Phone: 314-935-0153
• Email: rtabak[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 784
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 the participants:

Inclusion Criteria:

• 18-45 years of age

• pregnant

• overweight or obese (BMI over 25 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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• HEALTH-P2
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.
• Usual Care
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.

Locations

Country	Name	City	State
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight	Mother's body weight	12 months postpartum
Secondary	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	throughout intervention delivery, which can range from 2-4 years for parent educators depending on when their site is randomized