NCT02738216

Wellness for 2: Understanding How to Foster Well Being for Mom and Her Baby

Efficacy of a Prenatal Yoga Intervention for Antenatal Depression

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 178 (estimated)
• Sponsor: Butler Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This NICHD-funded RCT will enroll up to 178 depressed pregnant women, randomly assigning them to one of 2 intervention conditions: (1) a gentle prenatal yoga program (PYP), or (2) a series of educational workshops focused on perinatal health, the Mom and Baby Wellness Workshop (MBWW), each condition lasting 9 weeks. The investigators will clinically monitor all participants in the study for safety and clinical deterioration, and measure a variety of symptom outcomes over the course of the intervention period during pregnancy, as well as at a postpartum follow-up.

Detailed description

In this randomized controlled trial, eligible women will be randomly assigned to either a 9-week Prenatal Yoga Program (PYP) vs. a 9-week health education control group, the Mother-Baby Wellness Workshop (MBWW). Follow up assessments will take place at multiple points during the study. The primary study outcome will be severity of prenatal depression assessed by a blind interviewer. The investigators will examine relevant secondary outcomes (self-reported depression, anxiety, functioning, \& pain; pre-term birth) and potential mediators (inflammation, mindfulness/non-judgment).

Conditions

• Pregnancy

Interventions

Type	Name	Description
BEHAVIORAL	Prenatal Yoga	As part of the yoga program, participants will be asked to go to one 75-minute prenatal yoga class each week for 9 weeks. The yoga classes will be designed to be safe for pregnant women. In addition to classes, the yoga teacher will ask them to practice yoga at home during the program. Each participant will be given a yoga mat and a prenatal yoga DVD to take home.
BEHAVIORAL	Mother Baby Wellness	This workshop is aimed at promoting moms' and babies' good health and will involve attending one 75-minute class each week for 9 weeks. Classes will cover topics such as: child development in the first year, child eating and sleeping in the first year, maintaining good health as a mom of an infant, and recent advances in women's healthcare. In addition to classes, participants will be given materials to review/ read at home.

Timeline

• Start date: 2016-03-01
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2016-04-14
• Last updated: 2022-12-21

Locations

1 site across 1 country: United States