Feasibility and Implementation of a Healthy Lifestyles Program

McMaster University

Status: Completed

Conditions: Chronic Disease; Health Promotion; Mental Health Wellness 1; Quality of Life; Health Behavior; Stress

Treatments: Behavioral: Physical activity and nutrition journals; Behavioral: Brainstorming group sessions; Behavioral: Health goal development; Behavioral: Individual sessions with a multidisciplinary health team; Behavioral: Health and wellness learning sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT03258138

Healthy lifestyles pilot

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria 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

Exclusion Criteria:

• NA

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

More Intensive Program (MIP)

Experimental group

Description:

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.

Treatment:

Behavioral: Brainstorming group sessions

Behavioral: Individual sessions with a multidisciplinary health team

Behavioral: Health and wellness learning sessions

Behavioral: Physical activity and nutrition journals

Behavioral: Health goal development

Less Intensive Program (LIP)

Experimental group

Description:

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.

Treatment:

Behavioral: Physical activity and nutrition journals

Behavioral: Health goal development