- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05403983
Effectiveness of a 12-week Movement Intervention on Heart Rate Variability and Self-compassion Among New Mothers (MOM-mi)
MOM-mi: Exploring the Effectiveness of a 12-week Movement Intervention on Heart Rate Variability and Self-compassion Among New Mothers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a mixed-methods randomized controlled trial assessing the effects of an online and in person 12-week movement intervention compared to an education only control group on heart rate variability, self-compassion, psychological well-being, fatigue, exercise self-efficacy, physical activity identity, and body image in postpartum women.
Participants will be randomized into one of three groups: 1) in person yoga movement intervention, 2) online yoga movement intervention, 3) education group. Heart rate variability will be measured using a chest strap at the beginning and end of the 12 week intervention. At the beginning and end of the 12 week intervention, and at 3-months post-intervention, questionnaires will be completed online to assess self-compassion, psychological well-being, fatigue, exercise self-efficacy, physical activity identity, and body image.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
-
Chilliwack, British Columbia, Canada, V2R0N3
- University of the Fraser Valley
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women who have given birth to a child within the past 6 months and who are cleared for physical activity by their health care provider.
Exclusion Criteria:
- Participants who have a medical condition that precludes them passing the Get Active questionnaire
- Women not clear for physical activity by a health care provider
- Participants who are not able to attend classes at pre-specified times
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: In person movement intervention
In person yoga movement intervention (Les Mills BodyBalance: mixture of yoga, tai chi, pilates) two times per week
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Mixture of yoga, tai chi, pilates.
Will be delivered in person (experimental) and online (active comparator)
Other Names:
|
|
Active Comparator: Online yoga movement intervention
Pre-recorded video of yoga movement intervention (Les Mills BodyBalance: mixture of yoga, tai chi, pilates) two times per week
|
Mixture of yoga, tai chi, pilates.
Will be delivered in person (experimental) and online (active comparator)
Other Names:
|
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Active Comparator: Education
Education control group using a recently published postpartum physical activity guidebook through the Sport Information Resource Center
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Recently published postpartum physical activity guidebook through the Sport Information Resource Center of Canada
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate variability
Time Frame: Baseline, 12 weeks
|
Waking RMSDD heart rate variability (chest strap)
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Baseline, 12 weeks
|
|
Self compassion
Time Frame: Baseline, 12 weeks, 3 months
|
Self-compassion scale, maximum score 125.
Minimum score 25.
Higher score is a better outcome.
|
Baseline, 12 weeks, 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity
Time Frame: Baseline, 12 weeks, 3 months
|
Type, amount and frequency of planned exercise, and walking bouts
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Baseline, 12 weeks, 3 months
|
|
Self efficacy
Time Frame: Baseline, 12 weeks, 3 months
|
Self-efficacy and barrier to exercise scale.
Maximum score of 36.
Minimum score of 9. Lower score is a better outcome.
|
Baseline, 12 weeks, 3 months
|
|
Fear of self-compassion
Time Frame: Baseline, 12 weeks, 3 months
|
Fear of self-compassion scale.
Maximum score of 60.
Minimum score of 0. Lower score is a better outcome.
|
Baseline, 12 weeks, 3 months
|
|
Fatigue
Time Frame: Baseline, 12 weeks, 3 months
|
Multidimensional fatigue inventory scale.
Maximum score is 100.
Minimum score is 20.
Lower score is a better outcome.
|
Baseline, 12 weeks, 3 months
|
|
Sleep quality
Time Frame: Baseline, 12 weeks, 3 months
|
Patient Reported Outcomes Measurement Information System (PROMIS) sleep questionnaire.
Maximum score of 40.
Minimum score of 8. Lower score is a better outcome.
|
Baseline, 12 weeks, 3 months
|
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Perceived stress
Time Frame: Baseline, 12 weeks, 3 months
|
Perceived stress scale.
Maximum score of 40.
Minimum score of 0. Lower score is a better outcome.
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Baseline, 12 weeks, 3 months
|
|
Physical activity identify
Time Frame: Baseline, 12 weeks, 3 months
|
Athlete identity measurement scale.
Maximum score of 49.
Minimum score is 7. Higher score is better outcome.
|
Baseline, 12 weeks, 3 months
|
|
Body image
Time Frame: Baseline, 12 weeks, 3 months
|
Body dissatisfaction scale.
Maximum score of 48.
Minimum score of 8. Lower score is better outcome.
|
Baseline, 12 weeks, 3 months
|
|
Motivation for exercise
Time Frame: Baseline, 12 weeks, 3 months
|
Psychological needs for exercise scale.
Maximum score of 55.
Minimum score of 11.
Higher score is better outcome.
|
Baseline, 12 weeks, 3 months
|
|
Postpartum depression
Time Frame: Baseline, 12 weeks, 3 months
|
Edinburgh postnatal depression scale.
Maximum score is 30.
Minimum score is 0. Lower score is better outcome.
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Baseline, 12 weeks, 3 months
|
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Anxiety
Time Frame: Baseline, 12 weeks, 3 months
|
State-trait anxiety scale.
Maximum score of 80. Minimum score of 20.
Higher score is better outcome.
|
Baseline, 12 weeks, 3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Iris Lesser, PhD, University of the Fraser Valley
- Principal Investigator: Gillian Hatfield, PhD, University of the Fraser Valley
- Principal Investigator: Amanda Wurz, PhD, University of the Fraser Valley
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 101075
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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