PregnancySLMMNCT07223112
Effectiveness of Interventions to Promote Physical Activity During Pregnancy
A study testing Sit Less, Move More (SLMM) for pregnant women in people with Pregnancy and Sedentary Behavior, run by University of Central Florida at 1 site in United States.
Trial summary
Pregnant women are more sedentary (sit, recline, lie down more) on average than non-pregnant women (more than 12 versus less than 8 waking sedentary hours/day). Sedentary behavior has been related to psychological distress, pregnancy weight gain, impaired sleep and very large size infants, while adequate physical… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy, Sedentary Behavior, Insufficient Physical Activity
- What is being tested?
- Sit Less, Move More (SLMM) for pregnant women
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2026to 31 Aug 2027
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Women with physical activity restrictions (e.g., placenta previa) that prevent them from completing ACOG recommended pregnancy physical activity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Carmen Giurgescu UCF College of Nursing ADR, PhD contact
United States1 site, 1 recruiting
- Recruiting
Orlando Health
Orlando, Florida, 32806
Stanislaw K Miaskowski, M.D., 877-793-0145, Stanislaw.Miaskowski@orlandohealth.com
Satnislaw K Miaskowski, M.D.
About this study
Pregnant women are more sedentary (sit, recline, lie down more) on average than non-pregnant women (more than 12 versus less than 8 waking sedentary hours/day). Sedentary behavior has been related to psychological distress, pregnancy weight gain, impaired sleep and very large size infants, while adequate physical activity has been found to improve mental health, decrease risk of high blood pressure in pregnancy and lower risk of preterm birth infants (less than 37 weeks gestation). Decreased sedentary behavior and increased physical activity may be crucial and neglected lifestyle behavior changes that can be promoted to reduce these and other maternal health and birth outcome problems among pregnant women.
Read the detailed description
Interventions that decrease sedentary behavior (SB) and improve physical activity (PA) provide a path to improve maternal health and infant outcomes. Sedentary behavior (sitting, reclining, or lying while awake; activity energy expenditure of 1.5 metabolic equivalent of task [MET]) during pregnancy is a modifiable factor associated with adverse maternal health (e.g., psychological distress, gestational weight gain, impaired sleep, impaired glucose regulation, hypertension) and infant (e.g., earlier gestational age at birth, macrosomia [>4,000 grams]) health outcomes. Pregnant women are more sedentary than the average U.S. reproductive age woman (>12 hours/day vs. <8 hours/day), placing pregnant women in the highest sedentary risk category. Most pregnant women do not meet pregnancy guideline recommendations for moderate-intensity PA of 150 minutes/week. Improved PA among pregnant women is crucial to improve maternal health outcomes.
Using a behavioral clinical trial design, 60 pregnant women with singleton pregnancy (e.g., no twins) will be recruited at 8-15 weeks, 6 days gestation (T1) from prenatal clinics. Participants will engage in the Sit Less, Move More (SLMM) intervention. At T1, participants complete questionnaires about SB and PA habits, weekly PA, and personal factors (e.g., demographics) and wear an ActiGraph PA tracker for 2 weeks. At Week 3, Fitbits and a SB and PA prescription will be given to participants with information on safe recommended pregnancy PA and health risks of SB while pregnant; have PA coaching (virtual 1:1 session, weekly texts); exercise with a partner at least 4 days/week; and receive Fitbit prompts for activity when SB ≥50 minutes while awake is detected. Participants also: 1) complete questionnaires at T2 (18-26 weeks) and T3 (28-36 weeks); and 2) wear a Fitbit throughout the study from Study Week 3 to 36 weeks gestation. We aim to: Aim 1) Determine the feasibility of recruitment, retention, adherence and acceptability of the SLMM intervention for pregnant women; and Aim 2) Obtain estimates of the efficacy of the SLMM intervention on daily SB, SB habit reversal, and weekly PA and PA habit for pregnant women.
The study will allow the investigators to modify SLMM, estimate its behavior change efficacy and lead to formal efficacy testing with an R01 submission to better understand pathways to improve SB and PA amongst pregnant women. This study fosters the NICHD mission to improve reproductive health and support enhanced maternal health and birth outcomes.
- Being tested
- Sit Less, Move More (SLMM) for pregnant women
- Keywords
- Sit Less, Move More effectiveness for pregnant women, physical activity habit formation, sedentary behavior habit reversal, sedentary time disruption, wearable device, nudging, health coach, social support, behavior change
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sit Less, Move More (SLMM) for pregnant womenBehavioural
Health Coach sessions and SMS texts ramp up to goal ACOG opinion 804 pregnancy physical activity; wearable device activity tracker (Fitbit) for monitoring and self-regulation, exercise with a partner for support and accountability most days of the week.
| Study group | Role | What they receive |
|---|---|---|
| Sit Less, Move More (SLMM) program intervention | Experimental | Health Coaching sessions and text messages; Fitbit sedentary time disruption, monitoring, self-regulation, exercise with a partner most days of the week to ACOG opinion 804 recommended physical activity Receives: Behavioral: Sit Less, Move More (SLMM) for pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from first two weeks (baseline) ActiGraph device measured weekly moderate-intensity physical activity in minutes/week and time spent in sedentary behavior in hours per day
Change from first two weeks moderate-intensity physical activity in minutes per week and sedentary time measures in hours per day, baseline measure by participant blinded ActiGraph at 8 to 15 weeks, 6 days gestation, prior to the intervention beginning with goal of pregnancy recommended moderate-intensity physical activity using CDC talk test of 150 minutes/week measured by Fitbit and sedentary time 8 hours/day or less. The intervention begins at 10 to 18 weeks gestation. ActiGraph device measured change from 8 to 15 weeks, 6 days baseline physical activity and sedentary time as described above is measured again at 20 to 26 weeks gestation, and 30 to 36 weeks gestation in minutes of moderate-intensity physical activity per week and hours of sedentary time per day.
Measured: Intervention begins at 10-15 weeks, 6 days gestation; 18-26 weeks gestation ActiGraph measured weekly PA & ST; 28 -36 weeks gestation ActiGraph measured weekly PA & ST; Fitbit measured weekly PA & daily ST measured 10-14 to 28-36 weeks gestation
Secondary outcomes (4)
Feasibility of recruitment for the study
The following metrics are used to measure this outcome:
- Over 12 months the research team will recruit 60 participants.
Measured: 12 months (February 2026 through February 2027)
Feasibility of retention in the SLMM intervention
The following metric is used to measure this outcome: ≥70% of participants in SLMM will be retained through 28 to 36 weeks gestation
Measured: 10 to 18 weeks gestation start of SLMM per participant through 28 to 36 weeks gestation
Feasibility of adherence to the SLMM intervention
≥70% of participants in SLMM will adhere by achieving moderate-intensity physical activity ≥4 days/week as measured by Fitbit; using the Fitbit ≥10 hours/day for ≥4 days/week as measured by Fitbit; responding to ≥50% of Fitbit prompts of haptic vibration and text to move ≥4 days/week as measured by Fitbit; achieving decreased sedentary behavior by Fitbit measure by endpoint of 28 to 32 weeks gestation compared to first week of Fitbit use at 10-14 weeks gestation; complete ≥2 of 3 coach sessions as documented on coach session checklist at 10-14 weeks gestation, 18 to 19 weeks gestation and 28 to 29 weeks gestation; and receive weekly coach texts with receipt recorded in UCF text message software from 10 to 14 weeks gestation through 28 to 32 weeks gestation
Measured: 10-14 weeks gestation through 28 to 32 weeks gestation
Acceptability of the SLMM Intervention to participants
≥80% of participants in SLMM will indicate high program acceptance of all components of the intervention--coaching Fitbit use and exercise with a partner, through satisfaction items on surveys item "How satisfied are you with the SLMM program?" and open-ended question response to "How satisfied are you with the SLMM program?" following coaching sessions as recorded on coach session checklist
Measured: 20 to 28 weeks gestation and 30 to 36 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2025
- Study start1 Feb 2026
- Primary completionAug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Hybrid Model, Behavioral intervention clinical trial for effect on behavior change and implementation adaption for scale
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Jean Davis, University of Central Florida
- Investigators
- Jean W Davis, PhD, DNP, EdD, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223112
- Sponsor's protocol ID
- 529953 clinicaltrials.gov
- Other IDs
- R03HD117025
- Acronym
- SLMM
- Status last verified
- Aug 2026
- First submitted
- 15 Oct 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: DATA MANAGEMENT AND SHARING PLAN below and through OpenICPSR according to its terms and conditions. Following the study and initial publications, data will be shared per NIH - NICHD requirements. The de-identified data will be housed indefinitely in the OpenICPSR databank administered by the University of Michigan. Access occurs by open access to researchers of member organizations such as UCF and otherwise through approved requests for research purposes. All de-identified participant data will be stored. No PHI or identifiable participant data from this study is stored in OpenICPSR. Users are required to apply for access to restricted data. Additionally, non-members will be charged $825 to access the data (this includes the administrative fee to access data in the virtual data enclave) plus a $349 administrative fee for secure download." https://www.openicpsr.org/openicpsr/faqs Further details are available here: https://www.openicpsr.org/openicpsr/accessRD;jses
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Interventions to Promote Physical Activity During Pregnancy
- ClinicalTrials.gov ID
- NCT07223112
- Acronym / sponsor ID
- SLMM / 529953 clinicaltrials.gov
- Keywords
- Sit Less, Move More effectiveness for pregnant women, physical activity habit formation, sedentary behavior habit reversal, sedentary time disruption, wearable device, nudging, health coach, social support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 31 Oct 2025 (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.
Pregnant women are more sedentary (sit, recline, lie down more) on average than non-pregnant women (more than 12 versus less than 8 waking sedentary hours/day). Sedentary behavior has been related to psychological distress, pregnancy weight gain, impaired sleep and very large size infants, while adequate physical activity has been found to improve mental health, decrease risk of high blood pressure in pregnancy and lower risk of preterm birth infants (less than 37 weeks gestation). Decreased sedentary behavior and increased physical activity may be crucial and neglected lifestyle behavior changes that can be promoted to reduce these and other maternal health and birth outcome problems among pregnant women.
Detailed description
Interventions that decrease sedentary behavior (SB) and improve physical activity (PA) provide a path to improve maternal health and infant outcomes. Sedentary behavior (sitting, reclining, or lying while awake; activity energy expenditure of 1.5 metabolic equivalent of task [MET]) during pregnancy is a modifiable factor associated with adverse maternal health (e.g., psychological distress, gestational weight gain, impaired sleep, impaired glucose regulation, hypertension) and infant (e.g., earlier gestational age at birth, macrosomia [>4,000 grams]) health outcomes. Pregnant women are more sedentary than the average U.S. reproductive age woman (>12 hours/day vs. <8 hours/day), placing pregnant women in the highest sedentary risk category. Most pregnant women do not meet pregnancy guideline recommendations for moderate-intensity PA of 150 minutes/week. Improved PA among pregnant women is crucial to improve maternal health outcomes.
Using a behavioral clinical trial design, 60 pregnant women with singleton pregnancy (e.g., no twins) will be recruited at 8-15 weeks, 6 days gestation (T1) from prenatal clinics. Participants will engage in the Sit Less, Move More (SLMM) intervention. At T1, participants complete questionnaires about SB and PA habits, weekly PA, and personal factors (e.g., demographics) and wear an ActiGraph PA tracker for 2 weeks. At Week 3, Fitbits and a SB and PA prescription will be given to participants with information on safe recommended pregnancy PA and health risks of SB while pregnant; have PA coaching (virtual 1:1 session, weekly texts); exercise with a partner at least 4 days/week; and receive Fitbit prompts for activity when SB ≥50 minutes while awake is detected. Participants also: 1) complete questionnaires at T2 (18-26 weeks) and T3 (28-36 weeks); and 2) wear a Fitbit throughout the study from Study Week 3 to 36 weeks gestation. We aim to: Aim 1) Determine the feasibility of recruitment, retention, adherence and acceptability of the SLMM intervention for pregnant women; and Aim 2) Obtain estimates of the efficacy of the SLMM intervention on daily SB, SB habit reversal, and weekly PA and PA habit for pregnant women.
The study will allow the investigators to modify SLMM, estimate its behavior change efficacy and lead to formal efficacy testing with an R01 submission to better understand pathways to improve SB and PA amongst pregnant women. This study fosters the NICHD mission to improve reproductive health and support enhanced maternal health and birth outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Hybrid Model, Behavioral intervention clinical trial for effect on behavior change and implementation adaption for scale
| Arm | Type | Receives |
|---|---|---|
| Sit Less, Move More (SLMM) program intervention | Experimental | Behavioral: Sit Less, Move More (SLMM) for pregnant womenHealth Coaching sessions and text messages; Fitbit sedentary time disruption, monitoring, self-regulation, exercise with a partner most days of the week to ACOG opinion 804 recommended physical activity |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Women with physical activity restrictions (e.g., placenta previa) that prevent them from completing ACOG recommended pregnancy physical activity
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 |
|---|---|---|
| Sit Less, Move More (SLMM) for pregnant womenHealth Coach sessions and SMS texts ramp up to goal ACOG opinion 804 pregnancy physical activity; wearable device activity tracker (Fitbit) for monitoring and self-regulation, exercise with a partner for support and accountability most days of the week. | Behavioural | Sit Less, Move More (SLMM) program intervention |
Primary outcome
Change from first two weeks (baseline) ActiGraph device measured weekly moderate-intensity physical activity in minutes/week and time spent in sedentary behavior in hours per day
Time frame: Intervention begins at 10-15 weeks, 6 days gestation; 18-26 weeks gestation ActiGraph measured weekly PA & ST; 28 -36 weeks gestation ActiGraph measured weekly PA & ST; Fitbit measured weekly PA & daily ST measured 10-14 to 28-36 weeks gestation
Change from first two weeks moderate-intensity physical activity in minutes per week and sedentary time measures in hours per day, baseline measure by participant blinded ActiGraph at 8 to 15 weeks, 6 days gestation, prior to the intervention beginning with goal of pregnancy recommended moderate-intensity physical activity using CDC talk test of 150 minutes/week measured by Fitbit and sedentary time 8 hours/day or less. The intervention begins at 10 to 18 weeks gestation. ActiGraph device measured change from 8 to 15 weeks, 6 days baseline physical activity and sedentary time as described above is measured again at 20 to 26 weeks gestation, and 30 to 36 weeks gestation in minutes of moderate-intensity physical activity per week and hours of sedentary time per day.
4 secondary outcomes
Feasibility of recruitment for the study
Time frame: 12 months (February 2026 through February 2027)
Feasibility of retention in the SLMM intervention
Time frame: 10 to 18 weeks gestation start of SLMM per participant through 28 to 36 weeks gestation
Feasibility of adherence to the SLMM intervention
Time frame: 10-14 weeks gestation through 28 to 32 weeks gestation
Acceptability of the SLMM Intervention to participants
Time frame: 20 to 28 weeks gestation and 30 to 36 weeks gestation
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 25 Aug 2026.
- Individual participant dataSharing planned: Yes. DATA MANAGEMENT AND SHARING PLAN below and through OpenICPSR according to its terms and conditions. Following the study and initial publications, data will be shared per NIH - NICHD requirements. The de-identified data will be housed indefinitely in the OpenICPSR databank administered by the University of Michigan. Access occurs by open access to researchers of member organizations such as UCF and otherwise through approved requests for research purposes. All de-identified participant data will be stored. No PHI or identifiable participant data from this study is stored in OpenICPSR. Users are required to apply for access to restricted data. Additionally, non-members will be charged $825 to access the data (this includes the administrative fee to access data in the virtual data enclave) plus a $349 administrative fee for secure download." https://www.openicpsr.org/openicpsr/faqs Further details are available here: https://www.openicpsr.org/openicpsr/accessRD;jses
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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.
Carmen Giurgescu UCF College of Nursing ADR, PhD contact
Jean W Davis, PhD, DNP, EdD principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sit Less, Move More (SLMM) for pregnant women in people with Pregnancy and Sedentary Behavior, run by University of Central Florida 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 0 inclusion and 1 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 25 Aug 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 Jean W Davis, PhD,DNP,EdD (1-800-208-4545 ext. 1-407-823-2609, jean.davis@ucf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from first two weeks (baseline) ActiGraph device measured weekly moderate-intensity physical activity in minutes/week and time spent in sedentary behavior in hours per day (time frame: Intervention begins at 10-15 weeks, 6 days gestation; 18-26 weeks gestation ActiGraph measured weekly PA & ST; 28 -36 weeks gestation ActiGraph measured weekly PA & ST; Fitbit measured weekly PA & daily ST measured 10-14 to 28-36 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 25 Aug 2026.