CompletedNot Applicable

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

United States49 participantsStarted 2018-06-12

Plain-language 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.

Who can participate

Age range

18 Years – 46 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Acceptability via satisfaction survey at post-intervention

Timeframe: post-intervention (12-weeks)

Demand (attendance/adherence) of yoga intervention

Timeframe: Weekly (during 12-week intervention)

Trial details

NCT IDNCT03893708

SponsorArizona State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-01

View on ClinicalTrials.gov More Weight Gain trials