PregnancyWF2NCT02738216
Wellness for 2: Understanding How to Foster Well Being for Mom and Her Baby
A study testing Prenatal Yoga and Mother Baby Wellness in people with Pregnancy, run by Butler Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Prenatal Yoga and Mother Baby Wellness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Prenatal Yoga Intervention for Antenatal Depression
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.
Read the 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
- Being tested
- Prenatal Yoga, Mother Baby Wellness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prenatal YogaBehavioural
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 WellnessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Prenatal Yoga | Experimental | A 9-week prenatal yoga program Receives: Behavioral: Prenatal Yoga |
| Mother Baby Wellness Workshop | Active comparator | A 9-week workshop on mother and baby wellness in the first postpartum year Receives: Behavioral: Mother Baby Wellness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick Inventory of Depression Symptoms - Clinician Rating
Clinician-rated depression severity
Measured: Baseline to 9-week end point
Secondary outcomes (4)
Edinburgh Postnatal Depression Screen
Self-reported depression severity
Measured: Baseline to 9-week endpoint
State-Trait Anxiety Inventory
Anxiety level
Measured: Baseline to 9-week endpoint
Pittsburgh Sleep Quality Index
Sleep disturbance
Measured: Baseline to 9-week endpoint
Maternal & Neonatal Outcomes Checklist (MNOC)
rates of preterm birth
Measured: 30 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionNov 2022
- Study completionNov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia Battle, PhD, Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02738216
- Sponsor's protocol ID
- R01HD081868
- Acronym
- WF2
- Status last verified
- Dec 2022
- First submitted
- 11 Apr 2016
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Prenatal Yoga Intervention for Antenatal Depression
- ClinicalTrials.gov ID
- NCT02738216
- Acronym / sponsor ID
- WF2 / R01HD081868
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Nov 2022 (actual)
- Study completion
- Nov 2022 (actual)
- First posted
- 14 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prenatal Yoga | Experimental | Behavioral: Prenatal YogaA 9-week prenatal yoga program |
| Mother Baby Wellness Workshop | Active comparator | Behavioral: Mother Baby WellnessA 9-week workshop on mother and baby wellness in the first postpartum year |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prenatal YogaAs 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. | Behavioural | Prenatal Yoga |
| Mother Baby WellnessThis 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. | Behavioural | Mother Baby Wellness Workshop |
Primary outcome
Quick Inventory of Depression Symptoms - Clinician Rating
Time frame: Baseline to 9-week end point
Clinician-rated depression severity
4 secondary outcomes
Edinburgh Postnatal Depression Screen
Time frame: Baseline to 9-week endpoint
State-Trait Anxiety Inventory
Time frame: Baseline to 9-week endpoint
Pittsburgh Sleep Quality Index
Time frame: Baseline to 9-week endpoint
Maternal & Neonatal Outcomes Checklist (MNOC)
Time frame: 30 days postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Battle, PhD principal investigator
Butler Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prenatal Yoga and Mother Baby Wellness in people with Pregnancy, run by Butler Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quick Inventory of Depression Symptoms - Clinician Rating (time frame: Baseline to 9-week end point). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.