Bringing the Expecting program into community settings for pregnant people with obesity.
Antenatal Factors Impacting Obesity and Metabolism in Children: Sub-objective 2D
This pilot will test whether a community-delivered version of the Expecting exercise program works well and is easy to use for pregnant people with obesity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Arkansas Children's Hospital Research Institute Academic / other |
| Locations | 1 site (Little Rock, Arkansas) |
| Trial ID | NCT04298125 on ClinicalTrials.gov |
What this trial studies
The team will adapt the clinic-based Expecting exercise program for community delivery using the Replicating Effective Programs (REP) framework, incorporating feedback from community stakeholders and iterative piloting. After adaptation, 60 pregnant participants with BMI > 30 enrolled at 11–15 weeks' gestation will be randomized 1:1 to the community-adapted intervention (N=30) or to standard care (N=30). The study will measure acceptability, feasibility, and fidelity of the community-delivered program and collect implementation feedback. Findings will guide standardization and potential scale-up of the intervention across community settings.
Who should consider this trial
Good fit: Ideal candidates are pregnant people carrying a single fetus with BMI over 30, enrolled at 11–15 weeks, doing less than 150 minutes of activity per week, and cleared by their physician to exercise.
Not a fit: People with medical contraindications to exercise (for example placenta previa, preeclampsia), multiple gestation, current illicit drug use, or those already meeting activity guidelines may not benefit from this program.
Why it matters
Potential benefit: If successful, community delivery could help more pregnant people with obesity safely increase physical activity and improve access to supportive programming.
How similar studies have performed: The Expecting intervention has been delivered in clinic settings previously and REP has been used successfully to translate clinical programs to community settings, but community-delivered Expecting is being piloted and is not yet proven.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Little Rock, Arkansas
- Arkansas Children's Nutrition Center — Little Rock, Arkansas, United States (Recruiting)
Study contacts
- Study coordinator: Taren Swindle, PhD
- Email: tswindle@uams.edu
- Phone: 501-526-7058
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.