Feasibility and Implementation of a Healthy Lifestyles Program: A Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Health Behavior
- Sponsor
- McMaster University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Retention rates
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Elizabeth Alvarez
Assistant Professor
McMaster University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Retention rates
Time Frame: Baseline to 12 months
Number of participants recruited and number of participants completing the program
Secondary Outcomes
- 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)