Community Translation of the Expecting Study

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04298125
• Other study ID #: 260132
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: June 2024

Study information

• Verified date: July 2021
• Source: Arkansas Children's Hospital Research Institute
• Contact: Taren Swindle, PhD
• Phone: 501-526-7058
• Email: tswindle[@]uams.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Behavioral:
• Exercise in Pregnancy
Women in this group will participate in psychical activity 3 times per week in their community setting.

Locations

Country	Name	City	State
United States	Arkansas Children's Nutrition Center	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Intervention Measure:38 weeks	Attitudinal Implementation Outcome on a 1 to 5 scale	38 weeks
Primary	Acceptability of Intervention Measure: 38 weeks	Attitudinal Implementation Outcome on a 1 to 5 scale	38 weeks
Secondary	Number of intervention sessions completed	Measured with attendance records	15 weeks through 38 weeks
Secondary	Number of minutes of physical activity	Measured with Actical	Change from Baseline to Delivery and 6 Months Post Delivery
Secondary	Body Mass Index	Collected from Medical Record, weight and height will be combined to report BMI in kg/m^2	Change from Baseline to Delivery and 6 Months Post Delivery
Secondary	Blood Pressure	Collected from Medical Record	Change from Baseline to Delivery and 6 Months Post Delivery
Secondary	Total Cholesterol from Lipid Panel	Collected from Medical Record	Change from Baseline to Delivery and 6 Months Post Delivery