An interventional study of Exercise in Pregnancy in Pregnancy Related, sponsored by Arkansas Children's Hospital Research Institute. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-02.
Sponsored by Arkansas Children's Hospital Research Institute · Not applicable, Interventional, and Prevention
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.
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).
Arkansas Children's Hospital Research Institute is the lead sponsor of 118 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The Expecting intervention at the ACNC includes three 30-45 minute, in-person exercise sessions per week. The sessions are gradually increased in length over the first weeks of participation, and are comprised of 15-30 minutes of moderate aerobic activity (recumbent bike, walking on a treadmill or on an elliptical machine) as well as 5-10 minutes of resistance training using hydraulic exercise equipment. The sessions conclude with stretching exercises. Throughout the session, a personal trainer assesses the rating of perceived exertion using the 6 to 20 point Borg scale of exhaustion.41 Between sessions, participants are asked to monitor their daily step count with a target of 10,000 steps per day using a pedometer provided to the participant. This number is reported to or downloaded by the personal trainer at each in-person session. These elements will be adapted to provide a similar exercise experience that is accessible to women in their local community.
Behavioral: Exercise in Pregnancy
Participants will receive guidance on exercise from their physician as usual.
Women in this group will participate in psychical activity 3 times per week in their community setting.
Feasibility of Intervention Measure:38 weeks
Attitudinal Implementation Outcome on a 1 to 5 scale
Time frame: 38 weeks
Acceptability of Intervention Measure: 38 weeks
Attitudinal Implementation Outcome on a 1 to 5 scale
Time frame: 38 weeks
Number of intervention sessions completed
Measured with attendance records
Time frame: 15 weeks through 38 weeks
Number of minutes of physical activity
Measured with Actical
Time frame: Change from Baseline to Delivery and 6 Months Post Delivery
Body Mass Index
Collected from Medical Record, weight and height will be combined to report BMI in kg/m\^2
Time frame: Change from Baseline to Delivery and 6 Months Post Delivery
Blood Pressure
Collected from Medical Record
Time frame: Change from Baseline to Delivery and 6 Months Post Delivery
Total Cholesterol from Lipid Panel
Collected from Medical Record
Time frame: Change from Baseline to Delivery and 6 Months Post Delivery
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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Arkansas Children's Hospital Research Institute