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Effectiveness of Interventions to Promote Physical Activity During Pregnancy

NCT ID: NCT07223112

Last Updated: 2025-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-08-31

Brief Summary

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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

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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 8-12 weeks 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 (18-22 weeks) and T3 (28-32 weeks); and 2) wear a Fitbit throughout the study from Study Week 3 to 32 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.

Conditions

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Pregnancy Sedentary Behavior Insufficient Physical Activity

Keywords

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Hybrid Model, Behavioral intervention clinical trial for effect on behavior change and implementation adaption for scale
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Participant baseline physical activity is masked to the participant

Study Groups

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Sit Less, Move More (SLMM) program intervention

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

Group Type EXPERIMENTAL

Sit Less, Move More (SLMM) for pregnant women

Intervention Type BEHAVIORAL

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.

Interventions

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Sit Less, Move More (SLMM) for pregnant women

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Exclusion Criteria

• Women with physical activity restrictions (e.g., placenta previa) that prevent them from completing ACOG recommended pregnancy physical activity
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of Central Florida

OTHER

Sponsor Role lead

Responsible Party

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Jean Davis

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean W Davis, PhD, DNP, EdD

Role: PRINCIPAL_INVESTIGATOR

University of Central Florida

Central Contacts

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Jean W Davis, PhD,DNP,EdD

Role: CONTACT

Phone: 1-800-208-4545

Email: [email protected]

Carmen Giurgescu UCF College of Nursing ADR, PhD

Role: CONTACT

Phone: 800-208-4545

Email: [email protected]

Other Identifiers

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R03HD117025

Identifier Type: NIH

Identifier Source: secondary_id

View Link

529953 clinicaltrials.gov

Identifier Type: -

Identifier Source: org_study_id