Feasibility and Implementation of a Healthy Lifestyles Program
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Disease
- Health Behavior
- Health Promotion
- Mental Health Wellness 1
- Quality of Life
- Stress
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Enrolled participants will be allocated to one of the two intervention groups for the duration of the study. One group will be assigned to the more intensive program (MIP= usual care plus healthy lifestyles program) and the other group will be assigned to the less intensive program (LIP= usual care plus health goal development).Masking: None (Open Label)Masking Description: The amount of exposure to the programs will be known to participants and providers.Primary Purpose: Health Services Research
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 inten...
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.
Tracking Information
- NCT #
- NCT03258138
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Elizabeth Alvarez, MD, MPH, PhD McMaster University
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