Centering Pregnancy Care + Yoga for Diverse Pregnant Women

Study Overview
=================
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.

Official Title
-----------------
Centering Pregnancy Care + Yoga for Diverse Pregnant Women

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Behavioral: Centering Pregnancy Care plus Yoga (CPC+Y)


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga (CPC+Y)<br>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) | Behavioral: Centering Pregnancy Care plus Yoga (CPC+Y)<br>* Gentle prenatal yoga for 30 minutes at the end of the Centering Pregnancy Care session<br>|
| No Intervention: Comparison (CPC alone)<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Retention/ Adherence | Numbers of women who stayed in the study through their pregnancy and attended all intervention sessions | through study completion, an average of 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-efficacy for Physical Activity | 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. | baseline (early pregnancy), end of pregnancy (approx 10 months) | 
| Salivary Biomarkers (α-amylase) | 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. | baseline (early pregnancy), mid-pregnancy (approx 4-5 months), end of pregnancy (approx 10 months) | 
| Depressive Symptoms | 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. | baseline (early pregnancy), end of pregnancy (approx 10 months) | 
| Stress | 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. | baseline (early pregnancy), end of pregnancy (approx 10 months) | 
| Number of Subjects Participating in Focus Group | Women will volunteer to discuss their experiences (acceptability) with the intervention through focus groups conducted following the intervention period | at intervention completion, an average of 20 weeks | 
| Recruitment Feasibility | Numbers of women who agreed to participate in the study; | at intervention completion, an average of 20 weeks |