Feasibility and Implementation of a Healthy Lifestyles Program: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Retention rates
研究概览
简要总结
Chronic conditions, such as obesity and diabetes, are increasing worldwide. Lifestyle changes (e.g., physical activity, healthy diet, sufficient sleep, managing stress, smoking cessation) are often recommended to prevent or manage these conditions, but changing habits is difficult. Mental health can play a role in the ability to seek out and follow through on the changes necessary to achieve or maintain a healthy lifestyle, yet this aspect is rarely addressed, and access to mental health services is often limited. Furthermore, individuals are influenced by factors at the individual, interpersonal, community and policy levels (e.g., lack of socialization, unsafe neighborhoods). These factors can act as barriers and need to be addressed in order for individuals to make sustainable lifestyle changes.
A new year-long person-centered healthy lifestyles program is proposed to address the "how to" gap in making lifestyle changes through a combination of individual and group sessions. The feasibility and implementation of this new program will be evaluated through a pilot study looking at the full healthy lifestyles program compared to a less intensive version of the program. The study's hypothesis is that the full program will be feasible, acceptable and more effective for helping participants move across stages of change and for meeting their goals than the less intensive program.
详细描述
A pragmatic mixed methods design including a randomized controlled trial and qualitative components will be used for this pilot study. The randomized controlled trial will include a 1:1 allocation comparing a more intensive program (MIP - usual care plus healthy lifestyles program) with a less intensive program (LIP - usual care plus development of health goals).
The qualitative components include semi-structured interviews of participants (exit interviews at 12 months), MIP staff and participants' healthcare providers (at 6 months and 12 months). In addition, focus groups will be conducted with family members of MIP participants at 9 months. These elements will provide perspectives from multiple stakeholders for improving the healthy lifestyles program and on their roles in creating and maintaining healthy lifestyles.
The primary aim of this study is to assess the feasibility and implementation of the healthy lifestyles program. Impact on participant experiences and outcomes will also be measured. Findings from this study will help inform a larger randomized trial to further look at effectiveness of the program and to determine health system implications. A 2-year extension was approved in order to determine sustainability of findings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
The amount of exposure to the programs will be known to participants and providers.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for randomized controlled trial:
- •English-speaking
- •18 years of age or older
- •Inclusion criteria for qualitative components (family focus groups):
- •English-speaking
- •16 years of age or older
- •related to participants in randomized controlled trial
- •Inclusion criteria for qualitative components (program staff):
- •Provide services within the more intensive program
- •Inclusion criteria for qualitative components (healthcare providers):
- •Provide health care outside of the healthy lifestyles program for participants in randomized controlled trial
排除标准
- 未提供
研究组 & 干预措施
More Intensive Program (MIP)
Participants will receive the more intensive program, which combines usual care with the full version of the healthy lifestyles program. Participants in this arm will meet weekly for group health and wellness learning sessions or brainstorming group sessions. In addition, they will meet monthly for individual sessions with a multidisciplinary health team, including a family physician, physical therapist and dietician to tailor their health goal development and action plans to their particular needs and situations. They will be asked to maintain physical activity and nutrition journals for a week each every three months.
干预措施: Health and wellness learning sessions (Behavioral)
More Intensive Program (MIP)
Participants will receive the more intensive program, which combines usual care with the full version of the healthy lifestyles program. Participants in this arm will meet weekly for group health and wellness learning sessions or brainstorming group sessions. In addition, they will meet monthly for individual sessions with a multidisciplinary health team, including a family physician, physical therapist and dietician to tailor their health goal development and action plans to their particular needs and situations. They will be asked to maintain physical activity and nutrition journals for a week each every three months.
干预措施: Brainstorming group sessions (Behavioral)
More Intensive Program (MIP)
Participants will receive the more intensive program, which combines usual care with the full version of the healthy lifestyles program. Participants in this arm will meet weekly for group health and wellness learning sessions or brainstorming group sessions. In addition, they will meet monthly for individual sessions with a multidisciplinary health team, including a family physician, physical therapist and dietician to tailor their health goal development and action plans to their particular needs and situations. They will be asked to maintain physical activity and nutrition journals for a week each every three months.
干预措施: Individual sessions with a multidisciplinary health team (Behavioral)
More Intensive Program (MIP)
Participants will receive the more intensive program, which combines usual care with the full version of the healthy lifestyles program. Participants in this arm will meet weekly for group health and wellness learning sessions or brainstorming group sessions. In addition, they will meet monthly for individual sessions with a multidisciplinary health team, including a family physician, physical therapist and dietician to tailor their health goal development and action plans to their particular needs and situations. They will be asked to maintain physical activity and nutrition journals for a week each every three months.
干预措施: Health goal development (Behavioral)
More Intensive Program (MIP)
Participants will receive the more intensive program, which combines usual care with the full version of the healthy lifestyles program. Participants in this arm will meet weekly for group health and wellness learning sessions or brainstorming group sessions. In addition, they will meet monthly for individual sessions with a multidisciplinary health team, including a family physician, physical therapist and dietician to tailor their health goal development and action plans to their particular needs and situations. They will be asked to maintain physical activity and nutrition journals for a week each every three months.
干预措施: Physical activity and nutrition journals (Behavioral)
Less Intensive Program (LIP)
Participants will receive the less intensive program, which combines usual care along with health goal development. Participants in this arm will meet at baseline to set health goals with the support of a research assistant trained in theories of health behaviour and goal setting. They will also meet every three months to measure progress in achieving their goals. They will be asked to maintain physical activity and nutrition journals for a week each every three months.
干预措施: Health goal development (Behavioral)
Less Intensive Program (LIP)
Participants will receive the less intensive program, which combines usual care along with health goal development. Participants in this arm will meet at baseline to set health goals with the support of a research assistant trained in theories of health behaviour and goal setting. They will also meet every three months to measure progress in achieving their goals. They will be asked to maintain physical activity and nutrition journals for a week each every three months.
干预措施: Physical activity and nutrition journals (Behavioral)
结局指标
主要结局
Retention rates
时间窗: Baseline to 12 months
Number of participants recruited and number of participants completing the program
次要结局
- Changes in the Insomnia Severity Index (ISI)(Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months)
- Changes in the Perceived Stress Scale(Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months)
- Changes in waist:hip ratio(Baseline and 12 months, 24 months, 36 months)
- Changes in health goals - Self-efficacy over time(Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months)
- Changes in health goals - Stage of change over time(Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months)
- Changes in health goals - Goal achievement over time(Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months)
- Changes in the DeJong Gierveld 6-item Loneliness Scale(Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months)
- Changes in weight(Baseline and 12 months, 24 months, 36 months)
- Changes in health-related quality of life on the SF-36(Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months)
- Changes in the Patient Health Questionnaire (PHQ)(Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months)
- Changes in blood pressure(Baseline and 12 months, 24 months, 36 months)
- Changes in body mass index (BMI)(Baseline and 12 months, 24 months, 36 months)
- Changes in health-related quality of life on the Health Utilities Index (HUI) 2/3(Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months)
- Changes in waist circumference(Baseline and 12 months, 24 months, 36 months)
研究者
Elizabeth Alvarez
Assistant Professor
McMaster University