Centering Pregnancy Care + Yoga for Diverse Pregnant Women

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Behavioral: Centering Pregnancy Care plus Yoga (CPC+Y)

• Registration Number: NCT02873481
• Lead Sponsor: Virginia Commonwealth University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-08-16
• Study First Posted: 2016-08-19
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Results First Submitted: 2017-05-02
• Status Verified: 2018-06
• Results First Submitted QC: 2018-06-04
• Last Update Submitted: 2018-06-04
• Results First Posted: 2018-06-06
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• pregnant women age 18 years or older
• currently participating in CPC at the VCU Health System Nelson Clinic or Richmond Health District

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yoga (CPC+Y)	Centering Pregnancy Care plus Yoga (CPC+Y)	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)

Primary Outcome Measures

Name	Time	Method
Feasibility of Retention/ Adherence	through study completion, an average of 20 weeks	Numbers of women who stayed in the study through their pregnancy and attended all intervention sessions

Secondary Outcome Measures

Name	Time	Method
Self-efficacy for Physical Activity	baseline (early pregnancy), end of pregnancy (approx 10 months)	Physical Activity Self-Efficacy Scale (PASES): The Physical Activity Self-Efficacy Scale (PASES) is an 8 question scale which contains items about SM of physical activities and social support regarding PA. This psychometrically sound scale was selected because of its specific focus on SM of PA. Originally designed for adolescents, the wording has been slightly adapted for an adult sample. A higher score indicates higher levels of self-efficacy. Lowest possible score is 8; highest possible score is 40. Only participants in the intervention arm receive this particular instrument.
Salivary Biomarkers (α-amylase)	baseline (early pregnancy), mid-pregnancy (approx 4-5 months), end of pregnancy (approx 10 months)	salivary biomaker measure. This is an exploratory measure related to acute stress, yet it does not currently have known clinical associations with certain numeric levels of this measure (i.e., there is no identified "high" or "low" level of alpha-amylase). Only collected in the intervention group.
Depressive Symptoms	baseline (early pregnancy), end of pregnancy (approx 10 months)	Patient Health Questionnaire-9 (PHQ9): The PHQ-9 includes self-report items regarding depressive symptoms over the past two weeks. Total scores range from 0-27, where 0-4 indicates minimal depression, 5-9 mild depressive symptoms, 10-14 moderate depressive symptoms, 15-19 moderately severe depressive symptoms, and ≥20 severe depressive symptoms.
Stress	baseline (early pregnancy), end of pregnancy (approx 10 months)	Perceived Stress Scale (PSS): The Perceived Stress Scale-10 (PSS-10), a widely used, psychometrically sound instrument, will assess the degree to which a participant perceives stress in her life during the past month. The PSS-10 asks respondents to report about feelings such as unpredictability, uncontrollability, and overloading of stress in their lives; scores range from 0-40; higher scores correspond to a higher perceived stress level.
Number of Subjects Participating in Focus Group	at intervention completion, an average of 20 weeks	Women will volunteer to discuss their experiences (acceptability) with the intervention through focus groups conducted following the intervention period
Recruitment Feasibility	at intervention completion, an average of 20 weeks	Numbers of women who agreed to participate in the study;

Trial Locations

Locations (1)

Virginia Commonwealth University School of Nursing; 🇺🇸 Richmond, Virginia, United States