NCT04298125

Community Translation of the Expecting Study

Antenatal Factors Impacting Obesity and Metabolism in Children: Sub-objective 2D

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Arkansas Children's Hospital Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Expecting intervention as delivered in prior studies in a clinical setting is described in a previous approved IRB submission (Protocol 202954). The current project will seek to engage community stakeholders to translate Expecting to a community-delivered intervention and to test its acceptability, feasibility, and fidelity in a proof of principle study with 60 expecting mothers.

Detailed description

The aim of this study is to adapt and determine acceptability, feasibility and fidelity of the research- clinic-based Expecting intervention with pregnant women with obesity in community settings. Specifically, the investigators will show effective application of the Replicating Effective Programs (REP) framework (e.g., fidelity, feasibility, acceptability) to translate the research clinic-based intervention to community settings. REP provides a four-phase process for implementing evidence-based interventions and has demonstrated effective application to translate clinical interventions to community settings. Built into the REP framework is the collection of feedback from community stakeholders, iterative piloting of the intervention in the community, and a process for standardizing the intervention across community settings. Following adaptation, the updated intervention will be piloted. The pilot study will include 60 expecting women. The investigators will randomize half to receive the community-adapted Expecting intervention (Intervention, N=30) and half to receive standard of care (Control, N=30).

Conditions

• Pregnancy Related

Interventions

Type	Name	Description
BEHAVIORAL	Exercise in Pregnancy	Women in this group will participate in psychical activity 3 times per week in their community setting.

Timeline

• Start date: 2021-07-16
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2020-03-06
• Last updated: 2025-10-02

Locations

1 site across 1 country: United States