The Power of Yoga: Investigating the Feasibility and Preliminary Effects of Yoga on Excessive Gestational Weight Gain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 4
- 主要终点
- Demand (attendance/adherence) of yoga intervention
研究概览
简要总结
This study will test the feasibility (i.e., acceptability, demand) of a 12-week prenatal yoga intervention on excessive gestational weight gain (GWG) in pregnant women in the second trimester (enrolled at 12-24 weeks). Participants will be randomized into the prenatal yoga intervention or a pregnancy education (e.g., information on preparing for motherhood, labor and delivery etc.) control group. Participants in both groups will be asked to attend one 75 minute class per week.
The investigators hypothesize that prenatal yoga intervention will be feasible for pregnant women.
The study aims are as follows:
Primary Aim: Determine the feasibility (i.e., acceptability, demand) of a 12-week prenatal yoga intervention in pregnant women. In a randomized controlled pilot study comparing prenatal yoga to a pregnancy education control condition, the investigators will assess 1) acceptability (defined as satisfaction, intent to continue use, perceived appropriateness) and 2) demand (defined as attendance/adherence).
Exploratory Aim 1: Ascertain the preliminary effects of prenatal yoga on excessive GWG [i.e., weight gain exceeding Institute of Medicine (IOM) recommendations]. The investigators will compare weight change between intervention and control groups.
Exploratory Aim 2: Explore the potential mediators (i.e., mindfulness, self-regulation) on the effect of prenatal yoga on excessive GWG.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 46 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women 18-46 years of age (childbearing age)
- •Primiparous (women giving birth for the first time)
- •12-24 weeks gestation at onset of intervention
- •Reside in the Phoenix Metropolitan area
- •Singleton pregnancy
- •English speaking
- •Not planning on moving before giving birth
- •Can attend at least one session per week
排除标准
- •Current alcohol or substance abuse
- •Engage in ≥150 min of physical activity
- •Participation in ≥30 minutes/week of yoga or contemplative practice (i.e., meditation, qigong) for the previous six months
- •Pre-pregnancy BMI ≥40 or <18.5
- •Denial of physical activity participation from a physician (PARmed-X for pregnancy)
结局指标
主要结局
Demand (attendance/adherence) of yoga intervention
时间窗: Weekly (during 12-week intervention)
Demand was measured using attendance/adherence to the yoga intervention. Attendance was tracked by a researcher who was present at each yoga session. Benchmarks for demand include ≥60% of participants in each group will attend one class per week.
Acceptability via satisfaction survey at post-intervention
时间窗: post-intervention (12-weeks)
Acceptability (defined as satisfaction, intent to continue use, perceived appropriateness); Benchmarks for acceptability include ≥70% of the sample will report the yoga intervention to be a satisfactory, useful, and appropriate modality to prevent excessive GWG.
次要结局
- Mindfulness (mean change from baseline)(Baseline, post-intervention (12-weeks))
- Number of participants with excessive GWG (total GWG from baseline to delivery)(Weekly (during 12-week intervention) and at delivery (up to 42 weeks gestation))
- Emotion Regulation (mean change from baseline)(Baseline, post-intervention (12-weeks))
- Sleep Quality (mean change from baseline)(Baseline, post-intervention (12-weeks))
- Self-awareness (mean change from baseline)(Baseline, post-intervention (12-weeks))
研究者
Jennifer Huberty
Associate Professor
Arizona State University