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Completed

NCT Number: NCT05403983

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.

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Key information

Conditions

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of the Fraser Valley

Chilliwack, British Columbia, V2R0N3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yoga movement intervention

Behavioral

Mixture of yoga, tai chi, pilates. Will be delivered in person (experimental) and online (active comparator)

Other names: Les Mills BodyBalance, Les Mills BodyFlow

Education Booklet

Other

Recently published postpartum physical activity guidebook through the Sport Information Resource Center of Canada

Primary outcomes

  1. Heart rate variability

    Time frame: Baseline, 12 weeks

    Waking RMSDD heart rate variability (chest strap)

  2. Self compassion

    Time frame: Baseline, 12 weeks, 3 months

    Self-compassion scale, maximum score 125. Minimum score 25. Higher score is a better outcome.

Secondary outcomes

  1. Physical activity

    Time frame: Baseline, 12 weeks, 3 months

    Type, amount and frequency of planned exercise, and walking bouts

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Sponsors and collaborators

Lead sponsor

University of the Fraser Valley

Other

Collaborators

  • Les Mills International

Registry information

Official study title

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

Acronym: MOM-mi

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 3, 2022
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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