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

Primary Purpose

Weight Gain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prenatal yoga
Pregnancy education
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Weight Gain focused on measuring pregnancy, prenatal yoga, excessive gestational weight gain

Eligibility Criteria

18 Years - 46 Years (Adult)FemaleAccepts 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)

Sites / Locations

  • Arizona Biomedical Collaborative (ASU)
  • Urban Wellness

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prenatal yoga

Pregnancy education

Arm 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.

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.

Outcomes

Primary Outcome Measures

Acceptability via satisfaction survey at post-intervention
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.
Demand (attendance/adherence) of yoga 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.

Secondary Outcome Measures

Number of participants with excessive GWG (total GWG from baseline to delivery)
Weight gain exceeding IOM recommendations
Mindfulness (mean change from baseline)
Self-report mindfulness scores via Mindful Attention Awareness Scale (MAAS); 15-item questionnaire with score ranges 1-6. Higher scores reflect higher levels of dispositional mindfulness.
Self-awareness (mean change from baseline)
Self-report self-awareness scores via Self-Awareness Outcomes Questionnaire (SAOQ); Consists of 38 items measuring 4 subscales (reflective self-development, acceptance, proactive at work, and emotional costs). Score ranges for each subscale are between 1-5. Higher scores represent a greater frequency of experienced outcomes.
Emotion Regulation (mean change from baseline)
Self-report emotion regulation scores via Emotional Regulation Questionnaire (ERQ); Consists of 10 items measuring 2 subscales (reappraisal items, suppression items). Score ranges for each subscale are between 1-7. The higher the scores, the greater the use of the emotional regulation strategy.
Sleep Quality (mean change from baseline)
Self-report sleep quality via Pittsburgh Sleep Quality Index (PSQI); Consists of 10-items. In scoring the PSQI, seven component scores are derived ranging from 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

Full Information

First Posted
March 19, 2019
Last Updated
January 5, 2021
Sponsor
Arizona State University
Collaborators
Kripalu Center for Yoga and Health
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1. Study Identification

Unique Protocol Identification Number
NCT03893708
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 12, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arizona State University
Collaborators
Kripalu Center for Yoga and Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain
Keywords
pregnancy, prenatal yoga, excessive gestational weight gain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prenatal yoga
Arm Type
Experimental
Arm 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.
Arm Title
Pregnancy education
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Prenatal yoga
Intervention Description
The prenatal yoga classes will be offered at Urban Wellness (2024 N. 7th St., Phoenix, AZ 85006). Classes will be offered Tuesdays's from 4:15-5:30 pm and Saturday's from 9:00-10:15 am. Participants will be able to attend both classes if they so choose but are only asked to attend 1/week. Participants will be asked to arrive to class at least 10 minutes early in order for the research team to collect their weight in a private room. Additionally, if participants have attended at least 70% of classes (1 per week for 8/12 weeks), participants will be able to attend sessions up until birth (beyond the 12-week intervention) if they so choose. If participants decide to attend classes beyond the 12-week intervention the investigators will continue to collect their weight at each session.
Intervention Type
Behavioral
Intervention Name(s)
Pregnancy education
Intervention Description
Pregnancy education classes will be offered at the Arizona Biomedical Collaborative Building on ASU Phoenix Campus. Classes will be offered on Tuesday's from 5:30-6:45 pm and Saturday's from 9:00-10:15 am. Participants will be able to attend both classes if they so choose but are only asked to attend 1/week. Participants will be asked to arrive to class at least 10 minutes early in order for the research team to collect their weight in a private room. Additionally, if participants have attended at least 70% of classes (1 per week for 8/12 weeks), participants will be able to attend sessions up until birth (beyond the 12-week intervention) if they so choose. If participants decide to attend classes beyond the 12-week intervention the investigators will continue to collect their weight at each session.
Primary Outcome Measure Information:
Title
Acceptability via satisfaction survey at post-intervention
Description
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.
Time Frame
post-intervention (12-weeks)
Title
Demand (attendance/adherence) of yoga intervention
Description
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.
Time Frame
Weekly (during 12-week intervention)
Secondary Outcome Measure Information:
Title
Number of participants with excessive GWG (total GWG from baseline to delivery)
Description
Weight gain exceeding IOM recommendations
Time Frame
Weekly (during 12-week intervention) and at delivery (up to 42 weeks gestation)
Title
Mindfulness (mean change from baseline)
Description
Self-report mindfulness scores via Mindful Attention Awareness Scale (MAAS); 15-item questionnaire with score ranges 1-6. Higher scores reflect higher levels of dispositional mindfulness.
Time Frame
Baseline, post-intervention (12-weeks)
Title
Self-awareness (mean change from baseline)
Description
Self-report self-awareness scores via Self-Awareness Outcomes Questionnaire (SAOQ); Consists of 38 items measuring 4 subscales (reflective self-development, acceptance, proactive at work, and emotional costs). Score ranges for each subscale are between 1-5. Higher scores represent a greater frequency of experienced outcomes.
Time Frame
Baseline, post-intervention (12-weeks)
Title
Emotion Regulation (mean change from baseline)
Description
Self-report emotion regulation scores via Emotional Regulation Questionnaire (ERQ); Consists of 10 items measuring 2 subscales (reappraisal items, suppression items). Score ranges for each subscale are between 1-7. The higher the scores, the greater the use of the emotional regulation strategy.
Time Frame
Baseline, post-intervention (12-weeks)
Title
Sleep Quality (mean change from baseline)
Description
Self-report sleep quality via Pittsburgh Sleep Quality Index (PSQI); Consists of 10-items. In scoring the PSQI, seven component scores are derived ranging from 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Time Frame
Baseline, post-intervention (12-weeks)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
46 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Huberty, PHD
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Biomedical Collaborative (ASU)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Urban Wellness
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Consent forms indicate that data will not be shared with anyone other than those listed on the study team.

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

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