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

Pregnancy Related Clinical Trial

— MOM-mi  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05403983
• Other study ID #: 101075
• Status: Completed
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: December 2023
• Source: University of the Fraser Valley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Behavioral:
• Yoga movement intervention
Mixture of yoga, tai chi, pilates. Will be delivered in person (experimental) and online (active comparator)

Other:
• Education booklet
Recently published postpartum physical activity guidebook through the Sport Information Resource Center of Canada

Locations

Country	Name	City	State
Canada	University of the Fraser Valley	Chilliwack	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of the Fraser Valley	Les Mills International

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability	Waking RMSDD heart rate variability (chest strap)	Baseline, 12 weeks
Primary	Self compassion	Self-compassion scale, maximum score 125. Minimum score 25. Higher score is a better outcome.	Baseline, 12 weeks, 3 months
Secondary	Physical activity	Type, amount and frequency of planned exercise, and walking bouts	Baseline, 12 weeks, 3 months
Secondary	Self efficacy	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
Secondary	Fear of self-compassion	Fear of self-compassion scale. Maximum score of 60. Minimum score of 0. Lower score is a better outcome.	Baseline, 12 weeks, 3 months
Secondary	Fatigue	Multidimensional fatigue inventory scale. Maximum score is 100. Minimum score is 20. Lower score is a better outcome.	Baseline, 12 weeks, 3 months
Secondary	Sleep quality	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
Secondary	Perceived stress	Perceived stress scale. Maximum score of 40. Minimum score of 0. Lower score is a better outcome.	Baseline, 12 weeks, 3 months
Secondary	Physical activity identify	Athlete identity measurement scale. Maximum score of 49. Minimum score is 7. Higher score is better outcome.	Baseline, 12 weeks, 3 months
Secondary	Body image	Body dissatisfaction scale. Maximum score of 48. Minimum score of 8. Lower score is better outcome.	Baseline, 12 weeks, 3 months
Secondary	Motivation for exercise	Psychological needs for exercise scale. Maximum score of 55. Minimum score of 11. Higher score is better outcome.	Baseline, 12 weeks, 3 months
Secondary	Postpartum depression	Edinburgh postnatal depression scale. Maximum score is 30. Minimum score is 0. Lower score is better outcome.	Baseline, 12 weeks, 3 months
Secondary	Anxiety	State-trait anxiety scale. Maximum score of 80. Minimum score of 20. Higher score is better outcome.	Baseline, 12 weeks, 3 months