Clinical trial NCT04402710: Is Teaching People to be Self-compassionate Feasible and Acceptable for People Who Are Pre-diabetic
Official title: Examining the Feasibility and Acceptability of a Self-compassion Intervention on Physical Activity Behaviour Among People With Prediabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Keywords: self-compassion
physical activity
self-regulation
randomized controlled trial
emotions
feasibility
acceptability
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2020-05-27
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either a control group or the intervention group. Both sessions will run concurrently.
Primary purpose: PREVENTION

Brief summary: The investigators plan to examine the feasibility and acceptability of an online, two arm intervention (\[self-compassion intervention + ideal care\] versus \[health information + ideal care\]) designed to increase physical activity among individuals at risk of type two diabetes. The aim of the self-compassion intervention is to teach people at risk of type two diabetes how to use self-compassion (orientation to care for oneself during difficult situations) in order to help them self-manage and increase their physical activity. In a group, online format people at risk for type 2 diabetes will learn about their type 2 diabetes risk and strategies to increase their physical activity, which represents the recommended information that people at risk for type two diabetes should receive (i.e. ideal care). In addition to this, some participants, but not all, will be taught to be self-compassionate in relation to their type two diabetes risk and their efforts to increase their physical activity (i.e. intervention group). The other participants (i.e. control group) will instead receive general health information in addition to ideal care. Feasibility outcomes will be assessed using Thabane and colleagues (2010) model including the study's process, resources, management and scientific outcomes. In addition, qualitative exit-interviews with participants and research personnel will be conducted to assess the acceptability and feasibility of the intervention. Lastly, investigators will explore whether the intervention leads to changes from pre- to post-intervention in the secondary outcomes. This study is important as it will help inform and ensure the larger efficacy trial is of high quality.

Detailed description: The primary research objective of this study is to test the feasibility and acceptability of an online, two arm (\[self-compassion intervention + ideal care\] versus \[health information + ideal care\]) intervention designed to increase physical activity among individuals at risk for type 2 diabetes.

Primary research question: Is an online, two-arm intervention (\[self-compassion intervention + ideal care\] versus \[health information + ideal care\]) focused on increasing physical activity levels among individuals at risk of type two diabetes feasible using Thabane and colleagues model of feasibility (2010)?

Secondary research question: Is an online, two-arm intervention (\[self-compassion intervention + ideal care\] versus \[health information + ideal care\]) focused on increasing physical activity levels among individuals at risk of type two diabetes acceptable to both participants and research personnel?

The secondary research objective is to explore whether an online, two-arm intervention (\[self-compassion intervention + ideal care\] versus \[health information + ideal care\]) focused on increasing physical activity levels among individuals at risk of type two diabetes leads to changes from pre- to post-intervention in self-compassion, physical activity levels, nutrition, self-regulatory skill use, experience of exercise barriers, personal growth initiative, negative affect, and engagement in other health behaviours (e.g. stress management).

This pilot and feasibility study is a single centre, randomized, active controlled, six week intervention with baseline and follow-up assessment at intervention-end, 6- and 12-weeks post-intervention. It follows a quantitative-dominant, mixed-methods design. They will supplement this trial with interviews after follow-up testing with participants and study personnel. These interviews will provide feasibility and acceptability information.

Eligibility criteria: Inclusion Criteria:

* Medium to high type 2 diabetes risk (assessed with the CANRISK tool)
* Age 40 - 74
* No current medical treatment for type 2 diabetes
* Safe to engage in physical activity
* No non-study self-reported current type 2 diabetes/behaviour change education that may interfere with the intervention
* Available for all sessions and testing
* Insufficient physical activity relative to guidelines of 150 minutes of moderate to vigorous physical activity per week.
* Below the mean on the self-compassion scale

Exclusion Criteria:

* Be under 40 years old, or over the age of 74
* Have a medical condition which would not allow them to participate safely in physical activity
* Already are part of a different behavioural change/ type 2 diabetes education group
* Already engage in over 150 minutes of moderate to vigorous physical activity per week
* Already have high levels of self-compassion (over the mean)
* Could not commit to the intervention/control sessions

Primary outcomes:
measure: Recruitment Rate
timeFrame: During the recruitment phase of the study
measure: Most successful Recruitment Strategy
timeFrame: During the recruitment phase of the study
measure: Retention Rates
timeFrame: Week 1 (baseline) to Week 18 (follow-up)
measure: Compliance
timeFrame: Week 1 (baseline) to Week 18 (follow-up)
measure: Instructor Fidelity
timeFrame: Week 1 (baseline) to Week 6 (end of intervention)
measure: Capacity
timeFrame: Week 1 (baseline) to Week 18 (follow-up)
measure: Process Time
timeFrame: During the recruitment phase of the study
measure: Study Personnel Challenges and Insights
timeFrame: 6 weeks (end of intervention)
measure: Participant safety will be assessed by asking participants to explain their thoughts and feelings about whether the study impacted their physical and psychological safety through a semi-structured exit interview.
timeFrame: 6-weeks (end of intervention)
measure: Acceptability as assessed by semi-structured exit interviews with participants which will include questions related to their thoughts and feelings about the study and whether they believed the study was acceptable (e.g. content, timing).
timeFrame: 6 weeks (end of intervention)
Secondary outcomes:
measure: Change in Moderate to Vigorous Physical Activity from baseline to 6 weeks (intervention end)
timeFrame: baseline to 6 weeks (intervention end)
measure: Change in self-report Moderate to Vigorous Physical Activity from baseline to 6 weeks (intervention end)
timeFrame: baseline to 6 weeks (intervention end)
measure: Change in Self-Compassion from baseline to 6 weeks (intervention end)
timeFrame: baseline to 6 weeks
measure: Change in Mild Physical Activity from baseline to 6 weeks (intervention end)
timeFrame: baseline to 6 weeks (intervention end)
measure: Change in Sporadic Physical Activity from baseline to 6 weeks (intervention end)
timeFrame: baseline to 6 weeks (intervention end)
measure: Change in Negative Affect Related to Diabetes Risk from baseline to 6 weeks (intervention end)
timeFrame: baseline to 6-weeks (intervention end)
measure: Change in Negative Affect Related to Low Physical Activity Levels from baseline to 6 weeks (intervention end)
timeFrame: 6-weeks (intervention end)
measure: Change in Health Promoting Behaviors from baseline to 6 weeks (intervention end)
timeFrame: baseline to 6 weeks (intervention end)
measure: Change in Fear of Self-Compassion from baseline to 6 weeks (intervention end)
timeFrame: baseline week 1
measure: Change in Exercise barriers from baseline to 6 weeks (intervention end)
timeFrame: baseline to 6 weeks (intervention end).
measure: Change in Cognitive Emotion Regulation strategies from baseline to 6 weeks (intervention end)
timeFrame: baseline to 6 weeks (intervention end)
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
References:
citation: Signore AK, Jung ME, Semenchuk B, Kullman SM, Tefft O, Webber S, Ferguson LJ, Kowalski K, Fortier M, McGavock J, Ahmed R, Orr M, Strachan S. A pilot and feasibility study of a randomized clinical trial testing a self-compassion intervention aimed to increase physical activity behaviour among people with prediabetes. Pilot Feasibility Stud. 2022 May 27;8(1):111. doi: 10.1186/s40814-022-01072-6.