Wellness for 2: Understanding How to Foster Well Being for Mom and Her Baby (WF2)
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ClinicalTrials.gov Identifier: NCT02738216 |
Recruitment Status :
Completed
First Posted : April 14, 2016
Last Update Posted : December 21, 2022
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Condition or disease | Intervention/treatment | Phase |
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Pregnancy | Behavioral: Prenatal Yoga Behavioral: Mother Baby Wellness | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 178 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Efficacy of a Prenatal Yoga Intervention for Antenatal Depression |
Actual Study Start Date : | March 2016 |
Actual Primary Completion Date : | November 2022 |
Actual Study Completion Date : | November 2022 |

Arm | Intervention/treatment |
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Experimental: Prenatal Yoga
A 9-week prenatal yoga program
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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. |
Active Comparator: Mother Baby Wellness Workshop
A 9-week workshop on mother and baby wellness in the first postpartum year
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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. |
- Quick Inventory of Depression Symptoms - Clinician Rating [ Time Frame: Baseline to 9-week end point ]Clinician-rated depression severity
- Edinburgh Postnatal Depression Screen [ Time Frame: Baseline to 9-week endpoint ]Self-reported depression severity
- State-Trait Anxiety Inventory [ Time Frame: Baseline to 9-week endpoint ]Anxiety level
- Pittsburgh Sleep Quality Index [ Time Frame: Baseline to 9-week endpoint ]Sleep disturbance
- Maternal & Neonatal Outcomes Checklist (MNOC) [ Time Frame: 30 days postpartum ]rates of preterm birth

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738216
United States, Rhode Island | |
Butler Hospital | |
Providence, Rhode Island, United States, 02906 |
Principal Investigator: | Cynthia Battle, PhD | Butler Hospital |
Responsible Party: | Butler Hospital |
ClinicalTrials.gov Identifier: | NCT02738216 |
Other Study ID Numbers: |
R01HD081868 ( U.S. NIH Grant/Contract ) |
First Posted: | April 14, 2016 Key Record Dates |
Last Update Posted: | December 21, 2022 |
Last Verified: | December 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |