Centering Pregnancy Care + Yoga for Diverse Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility of Retention/ Adherence
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •pregnant women age 18 years or older
- •currently participating in CPC at the VCU Health System Nelson Clinic or Richmond Health District
排除标准
- •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)
研究组 & 干预措施
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)
干预措施: Centering Pregnancy Care plus Yoga (CPC+Y) (Behavioral)
Comparison (CPC alone)
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.
结局指标
主要结局
Feasibility of Retention/ Adherence
时间窗: through study completion, an average of 20 weeks
Numbers of women who stayed in the study through their pregnancy and attended all intervention sessions
次要结局
- Self-efficacy for Physical Activity(baseline (early pregnancy), end of pregnancy (approx 10 months))
- Salivary Biomarkers (α-amylase)(baseline (early pregnancy), mid-pregnancy (approx 4-5 months), end of pregnancy (approx 10 months))
- Depressive Symptoms(baseline (early pregnancy), end of pregnancy (approx 10 months))
- Stress(baseline (early pregnancy), end of pregnancy (approx 10 months))
- Number of Subjects Participating in Focus Group(at intervention completion, an average of 20 weeks)
- Recruitment Feasibility(at intervention completion, an average of 20 weeks)
研究者
Patricia Anne Kinser
Assistant Professor
Virginia Commonwealth University