N/A
N=32
Centering Pregnancy Care + Yoga for Diverse Pregnant Women
Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT02873481 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: Feasibility of Retention/ Adherence — 15; 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Centering Pregnancy Care plus Yoga (CPC+Y) (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Retention/ Adherence |
15; 17 | — |
| SECONDARY Self-efficacy for Physical Activity |
25.8; 25 | — |
| SECONDARY Salivary Biomarkers (α-amylase) |
112.4145; 99.59; 127.045 | — |
| SECONDARY Depressive Symptoms |
5.2; 6.9; 6.3; 12 | — |
| SECONDARY Stress |
1.8; 1.3; 0.33; 1.3 | — |
| SECONDARY Number of Subjects Participating in Focus Group |
8 | — |
| SECONDARY Recruitment Feasibility |
15; 17 | — |
Summary
This is a pilot longitudinal mixed-methods study of pregnant women (n=20) who participate in CPC+Y at the VCU Health System Nelson Clinic or the Virginia Department of Health Richmond Health District's prenatal clinic (RHD) during their pregnancies. This pilot project will provide the necessary preliminary data to fuel an appropriately powered randomized controlled trial to evaluate the effects of CPC+Y in controlling weight gain, enhancing stress resilience, and improving maternal-child outcomes among overweight/obese diverse women. Because increasing physical activity has been found to have important mental health effects and maternal-child outcomes, it stands to reason that this innovative intervention has the potential to impact the way prenatal care is delivered in high risk populations.
Eligibility Criteria
Inclusion Criteria
- pregnant women age 18 years or older
- currently participating in CPC at the VCU Health System Nelson Clinic or Richmond Health District
Exclusion Criteria
- current physical conditions preventing participation in physical activity (ACOG guidelines: restrictive lung disease, hemodynamically significant heart disease, incompetent cervix, multiple gestation at risk of premature labor, persistent 2nd or 3rd trimester bleeding, placenta previa after 26 weeks gestation, premature labor, ruptured membranes, preeclampsia, severe anemia)
Data sourced from ClinicalTrials.gov (NCT02873481). 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.