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

NCT02738216 | Completed DMC

• 1 other identifier: R01HD081868
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

• Quick Inventory of Depression Symptoms - Clinician Rating

  Clinician-rated depression severity

  Baseline to 9-week end point

Secondary Outcomes (4)

• Edinburgh Postnatal Depression Screen

  Baseline to 9-week endpoint

• State-Trait Anxiety Inventory

  Baseline to 9-week endpoint

• Pittsburgh Sleep Quality Index

  Baseline to 9-week endpoint

• Maternal & Neonatal Outcomes Checklist (MNOC)

  30 days postpartum

Study Arms (2)

Prenatal Yoga

EXPERIMENTAL

A 9-week prenatal yoga program

Behavioral: Prenatal Yoga

Mother Baby Wellness Workshop

ACTIVE COMPARATOR

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

Behavioral: Mother Baby Wellness

Interventions

Prenatal Yoga 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.

Prenatal Yoga

Mother Baby Wellness 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.

Mother Baby Wellness Workshop

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• New or unstable depression treatment
• Currently a regular yoga practitioner
• Bipolar disorder, schizophrenia, psychotic depression, chronic psychosis
• Current hazardous drug or alcohol use
• Acute suicidality

Sponsors & Collaborators

• Butler Hospital: lead

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Study Officials

• Cynthia Battle, PhD

  Butler Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 14, 2016
• Study Start: March 1, 2016
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)