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

NCT03893708 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2021-01-07

No results posted yet for this study

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.

Conditions

  • Weight Gain

Interventions

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • Kripalu Center for Yoga and Health

    collaborator OTHER
  • Arizona State University

    lead OTHER

Principal Investigators

  • Jennifer Huberty, PHD · Arizona State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
46 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-12
Primary Completion
2019-12-01
Completion
2019-12-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03893708 on ClinicalTrials.gov