Clinical trial NCT03893708: Investigating the Feasibility and Preliminary Effects of Yoga on Excessive Gestational Weight Gain
Official title: The Power of Yoga: Investigating the Feasibility and Preliminary Effects of Yoga on Excessive Gestational Weight Gain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Gain
Keywords: pregnancy
prenatal yoga
excessive gestational weight gain
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: Kripalu Center for Yoga and Health
First posted: 2019-03-28
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Acceptability via satisfaction survey at post-intervention
timeFrame: post-intervention (12-weeks)
measure: Demand (attendance/adherence) of yoga intervention
timeFrame: Weekly (during 12-week intervention)
Secondary outcomes:
measure: Number of participants with excessive GWG (total GWG from baseline to delivery)
timeFrame: Weekly (during 12-week intervention) and at delivery (up to 42 weeks gestation)
measure: Mindfulness (mean change from baseline)
timeFrame: Baseline, post-intervention (12-weeks)
measure: Self-awareness (mean change from baseline)
timeFrame: Baseline, post-intervention (12-weeks)
measure: Emotion Regulation (mean change from baseline)
timeFrame: Baseline, post-intervention (12-weeks)
measure: Sleep Quality (mean change from baseline)
timeFrame: Baseline, post-intervention (12-weeks)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Biomedical Collaborative (ASU)
state: Arizona
city: Phoenix
country: United States
facility: Urban Wellness
state: Arizona
Study officials:
affiliation: Arizona State University
name: Jennifer Huberty, PHD
role: PRINCIPAL_INVESTIGATOR
References: