Overview

This trial is active, not recruiting.

Condition pregnancy
Treatment centering pregnancy care plus yoga (cpc+y)
Sponsor Virginia Commonwealth University
Collaborator Sigma Theta Tau International- the Honor Society of Nursing
Start date July 2015
End date December 2016
Trial size 20 participants
Trial identifier NCT02873481, HM20005136

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Women in Centering Pregnancy Care (CPC) will receive the intervention which is a 30 minute yoga sessions during each of the 2-hour CPC meetings (CPC+Y)
centering pregnancy care plus yoga (cpc+y)
Gentle prenatal yoga for 30 minutes at the end of the Centering Pregnancy Care session
(No Intervention)
To strengthen our ability to examine causal relationships between the intervention and outcomes, we will use longitudinal comparison group data contributed from deidentified archival data from an existing IRB-approved study (PI: Masho) which includes pregnant women who participated in the CPC model of care alone (without the yoga component) and were followed throughout their pregnancies using numerous measures identical to those in the proposed study, including weight/BMI, depressive symptoms, anxiety, and stress.

Primary Outcomes

Measure
feasibility of retention/ adherence
time frame: through study completion, an average of 20 weeks

Secondary Outcomes

Measure
Self-efficacy for physical activity
time frame: baseline (early pregnancy), mid-pregnancy (approx 4-5 months), end of pregnancy (approx 10 months)
Salivary biomarkers (NGF and α-amylase)
time frame: baseline (early pregnancy), mid-pregnancy (approx 4-5 months), end of pregnancy (approx 10 months)
Depressive symptoms
time frame: baseline (early pregnancy), mid-pregnancy (approx 4-5 months), end of pregnancy (approx 10 months)
Stress
time frame: baseline (early pregnancy), mid-pregnancy (approx 4-5 months), end of pregnancy (approx 10 months)
Focus Group
time frame: at intervention completion, an average of 20 weeks
recruitment feasibility
time frame: at intervention completion, an average of 20 weeks

Eligibility Criteria

Female participants from 18 years up to 55 years old.

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)

Additional Information

Official title Centering Pregnancy Care + Yoga for Diverse Pregnant Women
Principal investigator Patricia Kinser, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Virginia Commonwealth University.