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

University of Manitoba

Status: Completed

Conditions: PreDiabetes

Treatments: Behavioral: Self-compassion; Behavioral: Control Group

Study type: Interventional

Funder types: Other

Identifiers

NCT04402710

E2020:006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 40 to 74 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 2 patient groups

Control Group

Active Comparator group

Description:

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).

Treatment:

Behavioral: Control Group

Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Self-compassion