N/A
N=51
Sedentary Behavior Reduction in Pregnancy Intervention Study
Pregnancy Complications · Sedentary Behavior
Bottom Line
View on ClinicalTrials.gov: NCT05093842 ↗Enrolled (actual)
51
Serious AEs
2.0%
Results posted
Jan 2025
Primary outcome: Primary: Sedentary Time — 10.42; 10.52; 9.62; 10.38 total hours/day — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sedentary Behavior Reduction (Behavioral); Information on Physical Activity Recommendations during Pregnancy (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Pittsburgh
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sedentary Time |
10.42; 10.52; 9.62; 10.38 | <0.05 sig |
| PRIMARY Standing |
2.79; 2.74; 3.81; 2.81 | <0.05 sig |
| PRIMARY Steps Per Day |
5224; 6268; 6777; 6479 | <0.05 sig |
| SECONDARY Recruitment |
69; 38; 27; 6 | — |
| SECONDARY Retention |
30; 16; 27; 15 | — |
| SECONDARY Intervention Adherence to Behavioral Coaching Contacts |
85.5 | — |
| SECONDARY Outcome Assessment Rates |
30; 16; 27; 15 | — |
Summary
This pilot and feasibility study will enroll newly pregnant women at risk for high sedentary behavior (SED) and elevated APO risk (n=53) and will randomize them to either a SED reduction intervention or control. Research aims include to: 1) demonstrate our ability to decrease SED and increase standing and light activity in pregnant women; 2) evaluate feasibility; and 3) gather preliminary effects on clinical outcomes including APOs, cardiometabolic risk factors, well-being, and fetal outcomes.
Eligibility Criteria
Inclusion Criteria
- <13 w 0 d pregnant
- at risk for high levels of sedentary behavior: i) work at a desk job ≥ 30 hrs per week; ii) work at a desk job <30 hrs per week and report sitting on non-work days 1/2 the time or more; iii) do not work but report sitting 3/4 of the time or more; iv) self-reports <6000 steps per day
- ≥1 risk factor for APO: nulliparity, history of APO, prepregnancy BMI ≥ 30 kg/m2, or age ≥35 yr
- plan to deliver at UPMC facility or willing to provide medical record release for prenatal care and birth records
Exclusion Criteria
- chronic hypertension (resting blood pressure ≥140/90 mmHg or antihypertensive medication use)
- pre-gestational diabetes
- self-report of inability to walk 2 blocks or climb a flight of stairs
- other serious medical condition in pregnancy for which exercise is contraindicated (e.g., underlying cardiac disease, severe anemia, chronic bronchitis, or poorly controlled hyperthyroidism or seizure disorder)
- unable to provide physician's consent to participate
- participating in another health-related intervention study that could affect study outcomes
Data sourced from ClinicalTrials.gov (NCT05093842). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.