Effectiveness of Interventions to Promote Physical Activity During Pregnancy

Part of paid clinical trials in Orlando, Florida.

Sponsor
University of Central Florida
Study ID
NCT07223112
Status
Recruiting

Conditions

  • Insufficient Physical Activity
  • Pregnancy
  • Sedentary Behavior

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Feb 1, 2026
Status verified
Mar 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: 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

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 10-14 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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Orlando HealthOrlandoFlorida32806
Stanislaw K Miaskowski, M.D.
877-793-0145
Satnislaw K Miaskowski, M.D. (PRINCIPAL_INVESTIGATOR)

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