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Optimizing a Self-compassion Intervention Designed to Improve Physical Activity Among Women at Risk for Heart Disease

NCT05209373 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2022-01-26

No results posted yet for this study

Summary

The investigators aim to optimize an intervention which teaches women at risk for cardiovascular disease (CVD) to cope with this risk using self-compassion (an attitude of kindness towards oneself) in order to adopt a physically active lifestyle.

The investigators previously conducted a one-on-one self-compassion intervention for 11 women with CVD risk that successfully increased physical activity. However, meeting one-on-one with each participant was time and resource intensive.

The primary purpose of the present study is to determine if group self-compassion intervention delivery is comparably effective to one-on-one delivery for increasing physical activity among women at risk for CVD. The investigators hypothesize that group delivery should be at least as effective as individual delivery at increasing physical activity.

Furthermore, only women low in self-compassion were included in the previous study. The secondary purpose of the present study is to determine if women higher in self-compassion can also benefit from the intervention. The investigators hypothesize that participants at all levels of self-compassion should benefit similarly from the intervention.

Finally, the tertiary purpose is to determine if delivery mode and self-compassion interact such that one method of delivery (group or one-on-one) is better suited to women at low, moderate, or high self-compassion. This outcome is exploratory only and the researchers present no hypothesis.

The present study follows the methods of a randomized optimization trial. Women at risk for CVD will be randomly assigned to receive four sessions of combined physical activity behaviour change and self-compassion training in groups of six to nine or through one-on-one delivery. The intervention will provide one session to discuss participants' CVD risk and physical activity goals, and then three sessions of self-compassion training.

Outcome measures will be assessed pre- and post-intervention. The effectiveness of the one-on-one and group conditions for improving the study outcomes will be examined. The present research will determine how best to deliver an intervention which teaches women to cope with their CVD risk using self-compassion in order to become more physically active. The results of the present study will inform an eventual efficacy trial.

Conditions

Interventions

BEHAVIORAL

Intervention Condition

4-week intervention combining behaviour change and self-compassion education to promote coping with CVD risk and increased engagement in physical activity.

BEHAVIORAL

Positive Control Condition

4-week intervention combining behaviour change and self-compassion education to promote coping with CVD risk and increased engagement in physical activity.

Sponsors & Collaborators

  • University of Manitoba

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-09
Primary Completion
2023-07-31
Completion
2023-08-31

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05209373 on ClinicalTrials.gov