Mindful Moms Randomized Control Trial

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

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2026-06-30

Brief Summary

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The purpose of this study is to test whether a program called "Mindful Moms" can be helpful for specific measures of mood and health in pregnant women with depressive symptoms, compared to group-based education workshops.

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Detailed Description

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The Mindful Moms Study is a randomized controlled trial, in which participants will be randomly assigned (like the flip of a coin) to either the "Mindful Moms" group (12 weeks of group-based prenatal yoga) or the "Prenatal Education Circle" group (12 weeks of group-based prenatal education). 200 pregnant women will participate over the course of the study.

Conditions

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Depression

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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Mindful Moms

Weekly "Mindful Moms" sessions

Group Type EXPERIMENTAL

Mindful Moms

Intervention Type BEHAVIORAL

Twelve 75 minutes weekly group sessions involving gentle yoga practices designed for pregnant women, led by experienced yoga teachers.

Prenatal Education

Weekly prenatal education sessions

Group Type ACTIVE_COMPARATOR

Prenatal Education

Intervention Type BEHAVIORAL

Twelve 75 minutes weekly group sessions involving prenatal education (for example, what to expect during your pregnancy, during labor and delivery, and after the delivery of your child).

Interventions

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Mindful Moms

Twelve 75 minutes weekly group sessions involving gentle yoga practices designed for pregnant women, led by experienced yoga teachers.

Intervention Type BEHAVIORAL

Prenatal Education

Twelve 75 minutes weekly group sessions involving prenatal education (for example, what to expect during your pregnancy, during labor and delivery, and after the delivery of your child).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. pregnant woman at 12-26 weeks gestation at baseline visit;
2. defined as minority (e.g., Black/ African American, Hispanic/ Latino, Native American, etc) and/or annual household income at qualification level for Women, Infants, \& Children \[WIC\] benefits in Virginia and/or educational attainment ≤high school education;
3. ≥age 18;
4. current depressive symptoms, as defined by a score ≥7 on the Edinburgh Postnatal Depression Scale (EPDS);
5. able to read, write, and understand English;
6. has not been told by a healthcare provider to avoid physical activity;
7. has not engaged in a consistent (once/week or more) yoga-based practice during the current pregnancy.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No