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

Weight Gain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03893708
• Other study ID #: STUDY00007808
• Secondary ID: FP00012624
• Status: Completed
• Phase: N/A
• Start date: June 12, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: January 2021
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 46 Years

Eligibility

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)

Related Conditions & MeSH terms

• Body Weight
• Gestational Weight Gain
• Weight Gain

Intervention

Behavioral:
• Prenatal yoga
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.
• Pregnancy education
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.

Locations

Country	Name	City	State
United States	Arizona Biomedical Collaborative (ASU)	Phoenix	Arizona
United States	Urban Wellness	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Arizona State University	Kripalu Center for Yoga and Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	post-intervention (12-weeks)
Primary	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.	Weekly (during 12-week intervention)
Secondary	Number of participants with excessive GWG (total GWG from baseline to delivery)	Weight gain exceeding IOM recommendations	Weekly (during 12-week intervention) and at delivery (up to 42 weeks gestation)
Secondary	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.	Baseline, post-intervention (12-weeks)
Secondary	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.	Baseline, post-intervention (12-weeks)
Secondary	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.	Baseline, post-intervention (12-weeks)
Secondary	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.	Baseline, post-intervention (12-weeks)