Effectiveness of Interventions to Promote Physical Activity During Pregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of Central Florida
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 to 45 years old
speak English
8 to 15 weeks, 6 days pregnant (gestation)
singleton pregnancy (no twins or more)
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Sit Less, Move More (SLMM) for pregnant women
BehavioralHealth 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Sit Less, Move More (SLMM) program interventionExperimental treatment 1 intervention
Trial outcomes
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 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.
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 gestationSecondary outcomes
1
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.
Time frame
12 months (February 2026 through February 2027)2
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
Time frame
10 to 18 weeks gestation start of SLMM per participant through 28 to 36 weeks gestation3
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
Time frame
10-14 weeks gestation through 28 to 32 weeks gestation4
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
Time frame
20 to 28 weeks gestation and 30 to 36 weeks gestationSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Central Florida
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov