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

NCT ID: NCT02738216

Last Updated: 2022-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2022-11-30

Brief Summary

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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

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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

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Prenatal Yoga

A 9-week prenatal yoga program

Group Type EXPERIMENTAL

Prenatal Yoga

Intervention Type BEHAVIORAL

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.

Mother Baby Wellness Workshop

A 9-week workshop on mother and baby wellness in the first postpartum year

Group Type ACTIVE_COMPARATOR

Mother Baby Wellness

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Healthy singleton pregnancy, 12-27 weeks gestation
2. Medically cleared for moderate exercise
3. Depression symptoms in moderate range. Participants must have an Quick Inventory of Depressive Symptoms (QIDS; \[119\]) score between 8-20
4. English-speaking
5. Aged 18 or older

Exclusion Criteria

1. New or unstable depression treatment
2. Currently a regular yoga practitioner
3. Bipolar disorder, schizophrenia, psychotic depression, chronic psychosis
4. Current hazardous drug or alcohol use
5. Acute suicidality
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Butler Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cynthia Battle, PhD

Role: PRINCIPAL_INVESTIGATOR

Butler Hospital

Locations

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Butler Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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R01HD081868

Identifier Type: NIH

Identifier Source: org_study_id

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