Community Translation of the Expecting Study

Not Applicable

• Conditions: Pregnancy Related

• Registration Number: NCT04298125
• Lead Sponsor: Arkansas Children's Hospital Research Institute

Brief 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).

Study Timeline

• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-03-05
• Study First Posted: 2020-03-06
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-30
• Last Update Posted: 2021-08-06
• Study Start: 2021-09-01
• Primary Completion: 2024-01
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• (a) Body Mass Index > 30,
• (b) singleton pregnancy,
• (c) between 11-15 weeks of pregnancy (at enrollment),
• (d) sedentary (do not engage in purposeful physical activity plus have sedentary work)
• (e) cleared by physician

Exclusion Criteria

• (a) contraindications for exercise (preeclampsia-eclampsia, premature rupture of the membranes, antepartum hemorrhage, placenta previa, multiple gestation and other defined conditions)
• (b) illicit drug use.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Acceptability of Intervention Measure: 38 weeks	38 weeks	Attitudinal Implementation Outcome on a 1 to 5 scale
Feasibility of Intervention Measure:38 weeks	38 weeks	Attitudinal Implementation Outcome on a 1 to 5 scale

Secondary Outcome Measures

Name	Time	Method
Body Mass Index	Change from Baseline to Delivery and 6 Months Post Delivery	Collected from Medical Record, weight and height will be combined to report BMI in kg/m\^2
Total Cholesterol from Lipid Panel	Change from Baseline to Delivery and 6 Months Post Delivery	Collected from Medical Record
Number of intervention sessions completed	15 weeks through 38 weeks	Measured with attendance records
Blood Pressure	Change from Baseline to Delivery and 6 Months Post Delivery	Collected from Medical Record
Number of minutes of physical activity	Change from Baseline to Delivery and 6 Months Post Delivery	Measured with Actical

Trial Locations

Locations (1)

Arkansas Children's Nutrition Center; 🇺🇸 Little Rock, Arkansas, United States