Antenatal Factors Impacting Obesity and Metabolism in Children: Sub-objective 2D
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pregnancy Related
- Sponsor
- Arkansas Children's Hospital Research Institute
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Acceptability of Intervention Measure: 38 weeks
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •(a) Body Mass Index \> 30,
- •(b) singleton pregnancy,
- •(c) between 11-15 weeks of pregnancy (at enrollment),
- •(d) Do not currently meet recommended guidelines of 150 min of activity per week
- •(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.
Outcomes
Primary Outcomes
Acceptability of Intervention Measure: 38 weeks
Time Frame: 38 weeks
Attitudinal Implementation Outcome on a 1 to 5 scale
Feasibility of Intervention Measure:38 weeks
Time Frame: 38 weeks
Attitudinal Implementation Outcome on a 1 to 5 scale
Secondary Outcomes
- Body Mass Index(Change from Baseline to Delivery and 6 Months Post Delivery)
- Total Cholesterol from Lipid Panel(Change from Baseline to Delivery and 6 Months Post Delivery)
- Number of intervention sessions completed(15 weeks through 38 weeks)
- Blood Pressure(Change from Baseline to Delivery and 6 Months Post Delivery)
- Number of minutes of physical activity(Change from Baseline to Delivery and 6 Months Post Delivery)