Pregnancy RelatedMOM-miNCT05403983
Effectiveness of a 12-week Movement Intervention on Heart Rate Variability and Self-compassion Among New Mothers
A study testing Yoga movement intervention and Education booklet in people with Pregnancy Related, run by University of the Fraser Valley at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Yoga movement intervention and Education booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- 15 Aug 2022to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of the Fraser Valley
Chilliwack, British Columbia, V2R0N3
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy Related
- Being tested
- Yoga movement intervention, Education booklet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga movement interventionBehavioural
Also called Les Mills BodyBalance, Les Mills BodyFlow
Mixture of yoga, tai chi, pilates. Will be delivered in person (experimental) and online (active comparator)
Education bookletOther
Recently published postpartum physical activity guidebook through the Sport Information Resource Center of Canada
| Study group | Role | What they receive |
|---|---|---|
| In person movement intervention | Experimental | In person yoga movement intervention (Les Mills BodyBalance: mixture of yoga, tai chi, pilates) two times per week Receives: Behavioral: Yoga movement intervention |
| Online yoga movement intervention | Active comparator | Pre-recorded video of yoga movement intervention (Les Mills BodyBalance: mixture of yoga, tai chi, pilates) two times per week Receives: Behavioral: Yoga movement intervention |
| Education | Active comparator | Education control group using a recently published postpartum physical activity guidebook through the Sport Information Resource Center Receives: Other: Education booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
Waking RMSDD heart rate variability (chest strap)
Measured: Baseline, 12 weeks
Self compassion
Self-compassion scale, maximum score 125. Minimum score 25. Higher score is a better outcome.
Measured: Baseline, 12 weeks, 3 months
Secondary outcomes (11)
Physical activity
Type, amount and frequency of planned exercise, and walking bouts
Measured: Baseline, 12 weeks, 3 months
Self efficacy
Self-efficacy and barrier to exercise scale. Maximum score of 36. Minimum score of 9. Lower score is a better outcome.
Measured: Baseline, 12 weeks, 3 months
Fear of self-compassion
Fear of self-compassion scale. Maximum score of 60. Minimum score of 0. Lower score is a better outcome.
Measured: Baseline, 12 weeks, 3 months
Fatigue
Multidimensional fatigue inventory scale. Maximum score is 100. Minimum score is 20. Lower score is a better outcome.
Measured: Baseline, 12 weeks, 3 months
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.
Measured: Baseline, 12 weeks, 3 months
Perceived stress
Perceived stress scale. Maximum score of 40. Minimum score of 0. Lower score is a better outcome.
Measured: Baseline, 12 weeks, 3 months
Physical activity identify
Athlete identity measurement scale. Maximum score of 49. Minimum score is 7. Higher score is better outcome.
Measured: Baseline, 12 weeks, 3 months
Body image
Body dissatisfaction scale. Maximum score of 48. Minimum score of 8. Lower score is better outcome.
Measured: Baseline, 12 weeks, 3 months
Motivation for exercise
Psychological needs for exercise scale. Maximum score of 55. Minimum score of 11. Higher score is better outcome.
Measured: Baseline, 12 weeks, 3 months
Postpartum depression
Edinburgh postnatal depression scale. Maximum score is 30. Minimum score is 0. Lower score is better outcome.
Measured: Baseline, 12 weeks, 3 months
Anxiety
State-trait anxiety scale. Maximum score of 80. Minimum score of 20. Higher score is better outcome.
Measured: Baseline, 12 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start15 Aug 2022
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Fraser Valley
- Sponsor type
- University, hospital or other
- Collaborators
- Les Mills International
- Responsible party
- Principal investigator, Gillian Hatfield, University of the Fraser Valley
- Investigators
- Iris Lesser, PhD, Principal investigator, University of the Fraser ValleyGillian Hatfield, PhD, Principal investigator, University of the Fraser ValleyAmanda Wurz, PhD, Principal investigator, University of the Fraser Valley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403983
- Sponsor's protocol ID
- 101075
- Acronym
- MOM-mi
- Status last verified
- Dec 2023
- First submitted
- 31 May 2022
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOM-mi: Exploring the Effectiveness of a 12-week Movement Intervention on Heart Rate Variability and Self-compassion Among New Mothers
- ClinicalTrials.gov ID
- NCT05403983
- Acronym / sponsor ID
- MOM-mi / 101075
- Conditions
- Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of the Fraser ValleyUniversity, hospital or other
- Collaborators
- Les Mills International
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| In person movement intervention | Experimental | Behavioral: Yoga movement interventionIn person yoga movement intervention (Les Mills BodyBalance: mixture of yoga, tai chi, pilates) two times per week |
| Online yoga movement intervention | Active comparator | Behavioral: Yoga movement interventionPre-recorded video of yoga movement intervention (Les Mills BodyBalance: mixture of yoga, tai chi, pilates) two times per week |
| Education | Active comparator | Other: Education bookletEducation control group using a recently published postpartum physical activity guidebook through the Sport Information Resource Center |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga movement interventionAlso: Les Mills BodyBalance, Les Mills BodyFlowMixture of yoga, tai chi, pilates. Will be delivered in person (experimental) and online (active comparator) | Behavioural | In person movement intervention, Online yoga movement intervention |
| Education bookletRecently published postpartum physical activity guidebook through the Sport Information Resource Center of Canada | Other | Education |
Primary outcome
Heart rate variability
Time frame: Baseline, 12 weeks
Waking RMSDD heart rate variability (chest strap)
Self compassion
Time frame: Baseline, 12 weeks, 3 months
Self-compassion scale, maximum score 125. Minimum score 25. Higher score is a better outcome.
11 secondary outcomes
Physical activity
Time frame: Baseline, 12 weeks, 3 months
Self efficacy
Time frame: Baseline, 12 weeks, 3 months
Fear of self-compassion
Time frame: Baseline, 12 weeks, 3 months
Fatigue
Time frame: Baseline, 12 weeks, 3 months
Sleep quality
Time frame: Baseline, 12 weeks, 3 months
Perceived stress
Time frame: Baseline, 12 weeks, 3 months
Physical activity identify
Time frame: Baseline, 12 weeks, 3 months
Body image
Time frame: Baseline, 12 weeks, 3 months
Motivation for exercise
Time frame: Baseline, 12 weeks, 3 months
Postpartum depression
Time frame: Baseline, 12 weeks, 3 months
Anxiety
Time frame: Baseline, 12 weeks, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Pregnancy Related
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Not yet recruitingObservational study
Obesity-Related Indices and Albuminuria in Type 2 Diabetes
Obesity and Diabetes Mellitus, Type 2, Albuminuria
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Not yet recruiting
Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy
Methamphetamine Use Disorder, Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iris Lesser, PhD principal investigator
University of the Fraser Valley
Gillian Hatfield, PhD principal investigator
University of the Fraser Valley
Amanda Wurz, PhD principal investigator
University of the Fraser Valley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga movement intervention and Education booklet in people with Pregnancy Related, run by University of the Fraser Valley at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (time frame: Baseline, 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.