Examining the Feasibility and Acceptability of a Self-compassion Intervention on Physical Activity Behaviour Among People With Prediabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control Group
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).
干预措施: Control Group (Behavioral)
Intervention Group
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.
干预措施: Self-compassion (Behavioral)
结局指标
主要结局
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.
时间窗: 6-weeks (end of intervention)
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"
Recruitment Rate
时间窗: During the recruitment phase of the study
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.
Most successful Recruitment Strategy
时间窗: During the recruitment phase of the study
Participants will be asked to state how they heard about the study
Study Personnel Challenges and Insights
时间窗: 6 weeks (end of intervention)
Through a semi-structured exit-interview study personnel will be asked whether they encountered any challenges throughout the study or have any reccomendations.
Compliance
时间窗: Week 1 (baseline) to Week 18 (follow-up)
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.
Retention Rates
时间窗: Week 1 (baseline) to Week 18 (follow-up)
The number of people who begin the study relative to the number of people who drop out at any point during the study.
Capacity
时间窗: Week 1 (baseline) to Week 18 (follow-up)
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.
Instructor Fidelity
时间窗: Week 1 (baseline) to Week 6 (end of intervention)
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.
Process Time
时间窗: During the recruitment phase of the study
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.
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).
时间窗: 6 weeks (end of intervention)
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?"
次要结局
- Change in Self-Compassion from baseline to 6 weeks (intervention end)(baseline to 6 weeks)
- Change in Fear of Self-Compassion from baseline to 6 weeks (intervention end)(baseline week 1)
- 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 Cognitive Emotion Regulation strategies 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))
- Change in Mild Physical Activity from baseline to 6 weeks (intervention end)(baseline to 6 weeks (intervention end))
- Change in Negative Affect Related to Diabetes Risk from baseline to 6 weeks (intervention end)(baseline to 6-weeks (intervention end))
- Change in Exercise barriers from baseline to 6 weeks (intervention end)(baseline to 6 weeks (intervention end).)
- Change in Negative Affect Related to Low Physical Activity Levels from baseline to 6 weeks (intervention end)(6-weeks (intervention end))
- Change in Health Promoting Behaviors from baseline to 6 weeks (intervention end)(baseline to 6 weeks (intervention end))