Is Teaching People to be Self-compassionate Feasible and Acceptable for People Who Are Pre-diabetic

NCT04402710 | Completed

• 1 other identifier: E2020:006
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

PreDiabetes

Keywords

self-compassion; physical activity; self-regulation; randomized controlled trial; emotions; feasibility; acceptability

Outcome Measures

Primary Outcomes (10)

• Recruitment Rate

  Number of participants screened/showed interest in partaking in the study during the recruitment period and how many of these individuals get successfully recruited into the study.

  During the recruitment phase of the study

• Most successful Recruitment Strategy

  Participants will be asked to state how they heard about the study

  During the recruitment phase of the study

• Retention Rates

  The number of people who begin the study relative to the number of people who drop out at any point during the study.

  Week 1 (baseline) to Week 18 (follow-up)

• Compliance

  This will consist of online class attendance and through participant responses using a text messaging system (e.g. responding 'yes' or 'no' to whether they completed their at home practice), and will be determined by the number of individuals who wear their accelerometer for the recommended 4 days, 10 hours per day.

  Week 1 (baseline) to Week 18 (follow-up)

• Instructor Fidelity

  How well facilitators conduct class sessions and activities compared to the set protocol. This will be determined by a checklist with a protocol for each session where facilitators will identify what components they did/did not complete and whether they followed the session protocol accordingly. With participant approval, facilitators will video record 15% of all sessions and the principal investigator will assess the adherence to the planned intervention, presentation skills, and will assess the adherence to the planned intervention, presentation skills, and will rate communication skills. The principal investigator will rate each component on a 5-point Likert scale.

  Week 1 (baseline) to Week 6 (end of intervention)

• Capacity

  This will be determined by evaluating whether the number of hours it takes study personnel to complete study tasks stays under the total cost that was budgeted for personnel hours for this study.

  Week 1 (baseline) to Week 18 (follow-up)

• Process Time

  How much time it takes to send out the initial eligibility email questionnaire, determine the participant's eligibility, and contact the eligible participant for the next steps of the study.

  During the recruitment phase of the study

• Study Personnel Challenges and Insights

  Through a semi-structured exit-interview study personnel will be asked whether they encountered any challenges throughout the study or have any reccomendations.

  6 weeks (end of intervention)

• 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.

  To determine whether participants felt safe while participating in this study, they will be asked to explain their thoughts and feelings through a semi-structured exit-interview. A sample question is, "Did you feel safe physically and psychologically during each session"

  6-weeks (end of intervention)

• 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).

  To assess participant satisfaction and their experience with the study, they will be asked a variety of questions to understand their thoughts and feelings during the semi-structured exit-interview. An example question participants will be asked is, "what components of the intervention did you like/dislike?"

  6 weeks (end of intervention)

Secondary Outcomes (11)

• Change in Moderate to Vigorous Physical Activity from baseline to 6 weeks (intervention end)

  baseline to 6 weeks (intervention end)

• Change in self-report Moderate to Vigorous Physical Activity from baseline to 6 weeks (intervention end)

  baseline to 6 weeks (intervention end)

• Change in Self-Compassion from baseline to 6 weeks (intervention end)

  baseline to 6 weeks

• Change in Mild Physical Activity from baseline to 6 weeks (intervention end)

  baseline to 6 weeks (intervention end)

• Change in Sporadic Physical Activity from baseline to 6 weeks (intervention end)

  baseline to 6 weeks (intervention end)

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Session 1: Participants will meet individually with a research assistant to discuss their type 2 risk and discuss benefits of engaging in 150 minutes of moderate-to-vigorous physical activity per week. Ideal Care will involve: Session 2: Introductions and Goal setting/planning. Session 3: Action-Coping Planning and Monitoring Physical Activity Session 4: Goal re-visitation and adjustment and building self-efficacy. Session 5: Physical Activity Enjoyment and Barriers/Solutions. Session 6: Relapse prevention and commitment to exercise. The last 30 minutes of sessions 2-6, control participants will receive 30-minutes of non-self-compassion or physical activity related health education (i.e., sleep, screen time, antibiotic use, oral health, osteoporosis and vitamin D).

Behavioral: Control Group

Intervention Group

EXPERIMENTAL

Session 1: Participants will meet individually with a research assistant to discuss their type 2 risk and discuss benefits of engaging in 150 minutes of moderate-to-vigorous physical activity per week. First 30 minutes of each subsequent session will be ideal care (as described above in the control group). Last 30 minutes of sessions 2-6, self-compassion condition participants will learn to apply self-compassion to their prediabetes experience and physical activity. Session 2: Learn about fear of self-compassion and the benefits of self-compassion. Session 3: Yin and Yang of self-compassion. Session 4: Mindfulness. Session 5: Dealing with difficult emotions, loving Kindness and Self-Compassionate motivation. Session 6: Living deeply, self-appreciation and stages of progress.

Behavioral: Self-compassion

Interventions

Self-compassion BEHAVIORAL

Six week behavioural change program plus a self-compassion intervention aimed to increase physical activity among individuals with prediabetes

Intervention Group

Control Group BEHAVIORAL

Six week behavioural change program aimed to increase physical activity plus information on general health topics.

Control Group

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3T 2N2, Canada

Location

Related Publications (1)

• 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.

  PMID: 35624519 DERIVED

MeSH Terms

Conditions

Prediabetic State; Motor Activity; Self-Control

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior; Social Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The research assistant who is in charge of conducting the statistical analyses will not be involved in the randomization process or running the intervention or control groups. Research assistants who will be conducting in-person eligibility and/or follow-up visits (e.g. handing out accelerometers) will be blinded to participant group assignment. Participants will also be blinded to which group they are randomized into. The investigators will present the study as examining different education interventions to increase physical activity and will not let the participants know whether they are in the intervention or control condition.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to either a control group or the intervention group. Both sessions will run concurrently.

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: May 27, 2020
• Study Start: September 1, 2020
• Primary Completion: November 10, 2020
• Study Completion: February 2, 2021
• Last Updated: April 26, 2021

Record last verified: 2020-03

Locations

CA (1)