NCT07343700

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
63mo left

Started May 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
May 2025Jul 2031

Study Start

First participant enrolled

May 30, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2031

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

5.1 years

First QC Date

December 4, 2025

Last Update Submit

January 8, 2026

Conditions

Keywords

PregnancyPrenatal ExercisePrenatal fitnessCommunityImplementation

Outcome Measures

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.

    Weekly from enrollment (baseline) through delivery, assessed throughout pregnancy (up to ~40 weeks gestation).

Secondary Outcomes (3)

  • Maternal Health Assessment

    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).

  • Beck Depression Inventory

    At enrollment (pre-third trimester), during the third trimester, at 6 weeks postpartum, and at 1 year postpartum.

  • Trainer fidelity

    Weekly at site or cohort launch, followed by monthly fidelity assessments during the intervention period (up to ~12 months).

Study Arms (2)

Exercise

EXPERIMENTAL

In the intervention group, women exercise in small groups with a certified personal trainer who has passed a certification process related to the research and exercise protocol. Specifically, women in the intervention are asked to work out three times per week, progressing to 45 minutes each session within the first 6 weeks. Participant workouts are focused primarily on body weight exercises although participants also receive resistance bands for use in the workouts. Participants can choose to watch a recorded workout rather than attend a live session for 1 of their 3 workouts for the week.

Behavioral: Community Expecting

Control

NO INTERVENTION

Women receive standard care and encouraged to follow doctor's recommendations for physical activity

Interventions

our 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.

Exercise

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Research Institute

Little Rock, Arkansas, 72202, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Taren Swindle

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Taren Swindle

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 4, 2025

First Posted

January 15, 2026

Study Start

May 30, 2025

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

July 1, 2031

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations