Effectiveness of Interventions to Promote Physical Activity During Pregnancy

NCT07223112 | Recruiting DMC

• 2 other identifiers: 529953 clinicaltrials.govR03HD117025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Pregnancy; Sedentary Behavior; Insufficient Physical Activity

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

Outcome Measures

Primary Outcomes (1)

• 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 12 weeks 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 14 weeks gestation. ActiGraph device measured change from 8 to 12 week baseline physical activity and sedentary time as described above is measured again at 18 to 22 weeks gestation, and 28 to 32 weeks gestation in minutes of moderate-intensity physical activity per week and hours of sedentary time per day.

  Intervention begins at 10-14 weeks gestation; 18-22 weeks gestation ActiGraph measured weekly PA & ST; 28 -32 weeks gestation ActiGraph measured weekly PA & ST; Fitbit measured weekly PA & daily ST measured 10-14 to 28-32 weeks gestation

Secondary Outcomes (4)

• Feasibility of recruitment for the study

  6 months (January 2026 through June 2026)

• Feasibility of retention in the SLMM intervention

  10 to 14 weeks gestation start of SLMM per participant through 28 to 32 weeks gestation

• Feasibility of adherence to the SLMM intervention

  10-14 weeks gestation through 28 to 32 weeks gestation

• Acceptability of the SLMM Intervention to participants

  18 to 22 weeks gestation and 28 to 32 weeks gestation

Study Arms (1)

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

Behavioral: Sit Less, Move More (SLMM) for pregnant women

Interventions

Sit Less, Move More (SLMM) for pregnant women 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.

Sit Less, Move More (SLMM) program intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant Females
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

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

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of Central Florida: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Orlando Health

Orlando, Florida, 32806, United States

RECRUITING

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jean W Davis, PhD, DNP, EdD

  University of Central Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean W Davis, PhD,DNP,EdD

CONTACT

1-800-208-4545; jean.davis@ucf.edu

Carmen Giurgescu UCF College of Nursing ADR, PhD

CONTACT

800-208-4545; carmen.giurgescu@ucf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participant baseline physical activity is masked to the participant
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Hybrid Model, Behavioral intervention clinical trial for effect on behavior change and implementation adaption for scale

Study Record Dates

• First Submitted: October 15, 2025
• First Posted: October 31, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be shared after publications and initial presentations, anticipated to be 1 year following the final data analysis 1/1/2029
• Access Criteria: 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

Locations

US (1)