Effectiveness of a 12-week Movement Intervention on Heart Rate Variability and Self-compassion Among New Mothers (MOM-mi)

December 2, 2023 updated by: Gillian Hatfield, University of the Fraser Valley

MOM-mi: Exploring the Effectiveness of a 12-week Movement Intervention on Heart Rate Variability and Self-compassion Among New Mothers

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.

Study Overview

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

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • British Columbia
      • Chilliwack, British Columbia, Canada, V2R0N3
        • University of the Fraser Valley

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Mixture of yoga, tai chi, pilates. Will be delivered in person (experimental) and online (active comparator)
Other Names:
  • Les Mills BodyBalance
  • Les Mills BodyFlow
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:
  • Les Mills BodyBalance
  • Les Mills BodyFlow
Active Comparator: Education
Education control group using a recently published postpartum physical activity guidebook through the Sport Information Resource Center
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)
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
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
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.
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.
Baseline, 12 weeks, 3 months
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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2022

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

May 31, 2022

First Submitted That Met QC Criteria

May 31, 2022

First Posted (Actual)

June 3, 2022

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 2, 2023

Last Verified

December 1, 2023

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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