Investigating the Feasibility and Preliminary Effects of Yoga on Excessive Gestational Weight Gain

Arizona State University (ASU)

Status: Completed

Conditions: Weight Gain

Treatments: Behavioral: Pregnancy education; Behavioral: Prenatal yoga

Study type: Interventional

Funder types: Other

Identifiers

NCT03893708

FP00012624 (Other Grant/Funding Number)

STUDY00007808

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: Female

Ages: 18 to 46 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Prenatal yoga

Experimental group

Description:

Each class will be outlined as follows: 1) opening greeting/intention setting, 2) pranayama (i.e., breathing exercises), 3) warm-up/sun salutations (i.e., flowing sequence), 4) yoga sequence (e.g., combination of sun salutations, vinyasa, and standing, seated, and/or balancing poses), 5) cool-down 6) Savasana (i.e., final resting pose), and 7) class closing. Meditation and breath awareness (e.g., linking each movement with breath) will be emphasized throughout each class. All classes will focus on safety and alignment and be appropriate for women during pregnancy by incorporating modifications to poses/exercises as necessary (e.g., yoga block, strap). Certified yoga instructors with a bachelors degree in a health related field and experience teaching pregnant women will instruct all yoga classes. Participants will be provided with a 'yoga during pregnancy' safety packet that includes a list of prenatal yoga poses that women may do at their own leisure at home.

Treatment:

Behavioral: Prenatal yoga

Pregnancy education

Active Comparator group

Description:

Participants will be asked to attend a group-based pregnancy education group (similar to a birth education class). The class format will include a didactic portion followed by group discussion (N=12). The following evidence-based topics (based on the American College of Obstetrics and Gynecologists) to be discussed may include (but not limited to): financial management in preparation for baby, preparing for labor and delivery, transitioning into motherhood, sleep hygiene, and baby bonding. A labor and delivery nurse and certified Dula will instruct all classes.

Treatment:

Behavioral: Pregnancy education