NCT05403983

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 15, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

10 months

First QC Date

May 31, 2022

Last Update Submit

December 2, 2023

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (2)

  • Heart rate variability

    Waking RMSDD heart rate variability (chest strap)

    Baseline, 12 weeks

  • Self compassion

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

    Baseline, 12 weeks, 3 months

Secondary Outcomes (11)

  • Physical activity

    Baseline, 12 weeks, 3 months

  • Self efficacy

    Baseline, 12 weeks, 3 months

  • Fear of self-compassion

    Baseline, 12 weeks, 3 months

  • Fatigue

    Baseline, 12 weeks, 3 months

  • Sleep quality

    Baseline, 12 weeks, 3 months

  • +6 more secondary outcomes

Study Arms (3)

In person movement intervention

EXPERIMENTAL

In person yoga movement intervention (Les Mills BodyBalance: mixture of yoga, tai chi, pilates) two times per week

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

Behavioral: Yoga movement intervention

Education

ACTIVE COMPARATOR

Education control group using a recently published postpartum physical activity guidebook through the Sport Information Resource Center

Other: Education booklet

Interventions

Yoga movement interventionBEHAVIORAL

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

Also known as: Les Mills BodyBalance, Les Mills BodyFlow
In person movement interventionOnline yoga movement intervention
Education bookletOTHER

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

Education

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of the Fraser Valley

Chilliwack, British Columbia, V2R0N3, Canada

Location

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 31, 2022

First Posted

June 3, 2022

Study Start

August 15, 2022

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

December 5, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)