Community Expecting: Exercise During Pregnancy
ConditionPhysical Activities
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorArkansas Children's Hospital Research Institute
About this trial
Regular physical activity during pregnancy is safe and offers many health benefits for both mothers and their babies. Research over the past decade shows that exercise can help pregnant women gain a healthy amount of weight, lower their risk of gestational diabetes and high blood pressure, and reduce stress, anxiety, and symptoms of postpartum depression. Babies also benefit when their mothers are active, with lower risks of preterm birth, unhealthy birth size, and childhood obesity.
Despite this strong evidence, very few exercise programs for pregnant women have been tested in real-world community settings, such as fitness centers, community health programs, or local organizations. Even fewer studies explain how these programs were delivered or what helped them succeed. Without this information, it is difficult for communities and health programs to offer exercise support that is both effective and practical for pregnant women.
To address this gap, the research team adapted an evidence-based program called EXPECTING so it could be delivered by community organizations. Previous participants and community advisors helped to understand what changes were needed to make the program easier to offer while still keeping it safe and effective. The core parts of the program, including the type, amount, and intensity of aerobic and strength-building exercises, remained the same and are based on established pregnancy exercise guidelines.
The adapted program, called COMMUNITY EXPECTING, includes both aerobic exercise and resistance training. The research team also developed specific supports to help community instructors deliver the program consistently and with confidence. All program components have already been tested in community settings and shown to be realistic, acceptable, and delivered as planned.
This study will examine whether offering a structured exercise program in community settings helps pregnant women be more physically active than usual prenatal care alone. We will also assess whether the program can be delivered successfully and in a way that works for both participants and community providers. The results will help determine whether COMMUNITY EXPECTING is a practical approach for supporting healthy pregnancies in real-world settings.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or older
Having a BMI ≥ 30
Not currently meeting guidelines for 150 min of moderate physical activity per week.
All children born to mother participants will be included and eligible.
Disqualifiers
Non-English speaking individuals.
Contraindications for exercise (preeclampsia-eclampsia, premature rupture of the membranes, antepartum hemorrhage, placenta previa, or multiple gestation),) as determined by the investigators to affect the outcomes of interest
Using recreational drugs, tobacco, or alcohol during their pregnancy.
< 11 or > 16 weeks gestation
Trial design
Design model
Parallel
Treatments tested in this trial
Community Expecting
Behavioralour team adapted EXPECTING for community delivery through extensive input from prior participants and community advisors using an implementation science framework. In our prior project plan, the EXPECTING intervention was successfully adapted to community settings and tested for its acceptability, feasibility and fidelity using the Replicating Effective Programs (REP) strategy8 with input from diverse community partners. This process resulted in 4 key adaptations to define the COMMUNITY EXPECTING Intervention and 3 implementation strategies to support its uptake in the community. Dose, frequency, type, and targeted exertion during exercise were retained as core components from the original EXPECTING study. All intervention components have been tested in the community.
Treatment groups
228 Participants
are divided into 2 treatment groupsGroup A: ExerciseExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Step Logs
All "expecting mother" participants in both groups will receive a FitBit arm bracelet to self-monitor activity levels and for the research team to monitor their physical activity levels. They will also submit their step counts on a weekly basis and/or give permission for us to access their step count data from the Fitbit records. Weekly step count logs are sent to the participant through REDCap via email or text message. The message contains a "survey link" produced by REDCap, where the participant reports step count data or answers survey questions. Upon completion, the data is automatically upload to REDCap for later analysis.
Time frame
Weekly from enrollment (baseline) through delivery, assessed throughout pregnancy (up to ~40 weeks gestation).Secondary outcomes
1
Maternal Health Assessment
To obtain both mother anthropometrics and vital signs, we will use the Health Assessment forms via healthcare providers and provide our community workout locations with equipment to collect height, weight, and blood pressure of mothers if there are barriers to collecting this information from the healthcare provider. Health assessments will be collected from expecting mother participants in both groups.
Time frame
Assessed at baseline (post-consent), during the third trimester of pregnancy, 6 -12 weeks postpartum, and 1 year postpartum (as close as possible but can exceed).2
Beck Depression Inventory
Expecting mother participants in both groups will complete this measure. Maternal signs and symptoms of depression will be evaluated using the Beck Depression Inventory-II (BDI-II) The BDI-II is a 21-item self-report questionnaire, rated on a four-point scale, which has been validated for use in pregnancy (37). Each item consists of four statements, scored 0-3, and total scores can range from 0 to 63. The BDI-II will be analyzed to determine if there is any evidence of changes in depression signs and symptoms during pregnancy and postpartum and determine if any relationship exists with changes in physical activity. The BDI-II will be sent to the participant via a survey link through REDCap via email or text and they will fill out the questionnaire, which will be saved in REDCap. This information is being collected because mental health may be an important moderator of the intervention's effects.
Time frame
At enrollment (pre-third trimester), during the third trimester, at 6 weeks postpartum, and at 1 year postpartum.3
Trainer fidelity
Study team members will monitor fidelity to implementation of delivery. This will be completed in-person or via video recorded submissions from community sites. The fidelity assessment by a study team member of the community-based trainer will be completed in person or virtually. Feedback will be shared in a timely fashion with trainers as needed to correct any deviations from the protocol.
Time frame
Weekly at site or cohort launch, followed by monthly fidelity assessments during the intervention period (up to ~12 months).Sponsors and contacts
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Source ClinicalTrials.gov