Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
NCT ID:
NCT07223112
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.
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 8-12 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.
Study:
NCT07223112
Study Brief:
Protocol Section:
NCT07223112