Physical ActivitiesNCT07343700
Community Expecting: Exercise During Pregnancy
A study testing Community Expecting in people with Physical Activities, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Physical Activities
- What is being tested?
- Community Expecting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2025to 1 Jul 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Arkansas Children's Research Institute
Little Rock, Arkansas, 72202
Taren Swindle, 8702360997, tswindle@uams.edu
About this study
Official title: Community Expecting: Exercise During Pregnancy for Sedentary Women With Obesity
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.
Read more
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.
Read the detailed description
In the COMMUNITY EXPECTING intervention, 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 COMMUNITY EXPECTING 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. Participants will be provided with postpartum support, and incentive schedule that will promote scalability and sustainability.
Additional details of the program include the following:
- Participants will be asked to complete at least 2 live, in-person (i.e., synchronous) training sessions per week; the third session can be via a Docebo workout. Docebo may also be used in inclement weather. Participants in the exercise group can access recorded workouts on the Docebo learning platform for participants (https://www.communityexpecting.com/learn). Docebo is a secure and HIPPA compliant platform where participants can use multiple video platforms (e.g., zoom, Teams) to have live training sessions with a trainer and access recorded training sessions. Participants in the exercise group will receive training in the use of Docebo and have support from the research team to navigate all components. We may also house content on UAMS web pages as needed.
- Participants can elect to have one person join them for the workout sessions. Each person participating in the workouts that is not a study participant will sign and return the "Workout "Buddy" Release and Waiver of Liability Form," approved by ACH legal representatives.
- All trainers will receive a 3-hour training in the protocol and receive 80% or higher on a knowledge assessment post-training before being certified to provide training for the study. We will train the certified personal trainers to deliver the sessions with fidelity to the intended format using body weight exercise and minimal equipment (e.g., resistance band). Trainers will be required to submit videos of sessions or agree to live observations for fidelity scoring to the research team.
- The workouts will include 3 major components: (1) Aerobics, (2) Resistance Training, and (3) Stretching. Aerobic activities will be done primarily without equipment; examples include walking, marching in place, low impact jumping jacks (side step with overhead jack). If participants have access to equipment (e.g., treadmill, swimming pool), only low-impact activities will be included. Resistance activities are designed to strengthen major muscle groups except for the abdominals. Target muscle groups include arms, chest, back, hips/glutes, and legs. These activities will use bodyweight and/or resistance bands (e.g., upper body rows, seated leg curls). Stretching activities are aimed to increase flexibility and mobility of the whole body (e.g., calf stretches, gentle neck stretches). Table 1 details the duration of each activity across the weeks of the intervention. Workouts will occur 3 times per week until delivery or a contraindication for exercise (e.g., doctor's request). The goal is for the aerobic and resistance training to be of moderate intensity. The trainer will monitor the intensity of the workout by asking the participant to rate their perceived exertion during the workouts and using the "talk test" to ensure the participants can speak short sentences without difficulty. Perceived exertion is rated using an established measure - the Rate of Perceived Exertion (RPE) scale, which is rated on a scale of 6 -20. The target for participants for aerobic and resistance components is 12-14. The trainers will suggest modifications to ensure moderate intensity (e.g., slowing/increasing pace, adding/decreasing resistance). There is no intensity target for the stretching portion of the sessions. Following each workout, participants will complete a short survey acknowledging their attendance at the workout, average heart rate during the workout, and their RPE following the session. Surveys are completed and data stored using REDCap.
- After delivery and clearance for exercise from their doctor, mothers will have the option to continue with the program for up to 12 months. If participants elect to receive post-partum support, they could be in the study up to 18 months. This post-partum program will support mothers' re-entry into exercise when/if desired.
- "The study was registered once the requirement for registration in an ICMJE-accepted registry was identified. No changes were made to study procedures or participant activities as a result of this timing
- Conditions
- Physical Activities
- Being tested
- Community Expecting
- Keywords
- Pregnancy, Prenatal Exercise, Prenatal fitness, Community, Implementation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community ExpectingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Community Expecting |
| Control | No intervention | Women receive standard care and encouraged to follow doctor's recommendations for physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weekly from enrollment (baseline) through delivery, assessed throughout pregnancy (up to ~40 weeks gestation).
Secondary outcomes (3)
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.
Measured: 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
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.
Measured: At enrollment (pre-third trimester), during the third trimester, at 6 weeks postpartum, and at 1 year postpartum.
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.
Measured: Weekly at site or cohort launch, followed by monthly fidelity assessments during the intervention period (up to ~12 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start30 May 2025
- Primary completion1 Jul 2030 (estimated)
- Study completion1 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taren Swindle, Arkansas Children's Hospital Research Institute
- Investigators
- Taren Swindle, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343700
- Sponsor's protocol ID
- 297995
- Status last verified
- Jan 2026
- First submitted
- 4 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Expecting: Exercise During Pregnancy for Sedentary Women With Obesity
- ClinicalTrials.gov ID
- NCT07343700
- Acronym / sponsor ID
- 297995
- Conditions
- Physical Activities
- Keywords
- Pregnancy, Prenatal Exercise, Prenatal fitness, Community, Implementation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 1 Jul 2031 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the COMMUNITY EXPECTING intervention, 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 COMMUNITY EXPECTING 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. Participants will be provided with postpartum support, and incentive schedule that will promote scalability and sustainability.
Additional details of the program include the following:
- Participants will be asked to complete at least 2 live, in-person (i.e., synchronous) training sessions per week; the third session can be via a Docebo workout. Docebo may also be used in inclement weather. Participants in the exercise group can access recorded workouts on the Docebo learning platform for participants (https://www.communityexpecting.com/learn). Docebo is a secure and HIPPA compliant platform where participants can use multiple video platforms (e.g., zoom, Teams) to have live training sessions with a trainer and access recorded training sessions. Participants in the exercise group will receive training in the use of Docebo and have support from the research team to navigate all components. We may also house content on UAMS web pages as needed.
- Participants can elect to have one person join them for the workout sessions. Each person participating in the workouts that is not a study participant will sign and return the "Workout "Buddy" Release and Waiver of Liability Form," approved by ACH legal representatives.
- All trainers will receive a 3-hour training in the protocol and receive 80% or higher on a knowledge assessment post-training before being certified to provide training for the study. We will train the certified personal trainers to deliver the sessions with fidelity to the intended format using body weight exercise and minimal equipment (e.g., resistance band). Trainers will be required to submit videos of sessions or agree to live observations for fidelity scoring to the research team.
- The workouts will include 3 major components: (1) Aerobics, (2) Resistance Training, and (3) Stretching. Aerobic activities will be done primarily without equipment; examples include walking, marching in place, low impact jumping jacks (side step with overhead jack). If participants have access to equipment (e.g., treadmill, swimming pool), only low-impact activities will be included. Resistance activities are designed to strengthen major muscle groups except for the abdominals. Target muscle groups include arms, chest, back, hips/glutes, and legs. These activities will use bodyweight and/or resistance bands (e.g., upper body rows, seated leg curls). Stretching activities are aimed to increase flexibility and mobility of the whole body (e.g., calf stretches, gentle neck stretches). Table 1 details the duration of each activity across the weeks of the intervention. Workouts will occur 3 times per week until delivery or a contraindication for exercise (e.g., doctor's request). The goal is for the aerobic and resistance training to be of moderate intensity. The trainer will monitor the intensity of the workout by asking the participant to rate their perceived exertion during the workouts and using the "talk test" to ensure the participants can speak short sentences without difficulty. Perceived exertion is rated using an established measure - the Rate of Perceived Exertion (RPE) scale, which is rated on a scale of 6 -20. The target for participants for aerobic and resistance components is 12-14. The trainers will suggest modifications to ensure moderate intensity (e.g., slowing/increasing pace, adding/decreasing resistance). There is no intensity target for the stretching portion of the sessions. Following each workout, participants will complete a short survey acknowledging their attendance at the workout, average heart rate during the workout, and their RPE following the session. Surveys are completed and data stored using REDCap.
- After delivery and clearance for exercise from their doctor, mothers will have the option to continue with the program for up to 12 months. If participants elect to receive post-partum support, they could be in the study up to 18 months. This post-partum program will support mothers' re-entry into exercise when/if desired.
- "The study was registered once the requirement for registration in an ICMJE-accepted registry was identified. No changes were made to study procedures or participant activities as a result of this timing
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Community ExpectingIn 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. |
| Control | No intervention | –Women receive standard care and encouraged to follow doctor's recommendations for physical activity |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Expectingour 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. | Behavioural | Exercise |
Primary outcome
Step Logs
Time frame: Weekly from enrollment (baseline) through delivery, assessed throughout pregnancy (up to ~40 weeks gestation).
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.
3 secondary outcomes
Maternal Health Assessment
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).
Beck Depression Inventory
Time frame: At enrollment (pre-third trimester), during the third trimester, at 6 weeks postpartum, and at 1 year postpartum.
Trainer fidelity
Time frame: Weekly at site or cohort launch, followed by monthly fidelity assessments during the intervention period (up to ~12 months).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Taren Swindle principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Expecting in people with Physical Activities, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taren Swindle (18702360997, tswindle@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step Logs (time frame: Weekly from enrollment (baseline) through delivery, assessed throughout pregnancy (up to ~40 weeks gestation).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.