Feasibility and Implementation of a Healthy Lifestyles Program

Not Applicable

Completed

• Conditions: Health Behavior; Stress; Quality of Life; Chronic Disease; Health Promotion; Mental Health Wellness 1
• Interventions: Behavioral: Health and wellness learning sessions; Behavioral: Health goal development; Behavioral: Physical activity and nutrition journals; Behavioral: Brainstorming group sessions; Behavioral: Individual sessions with a multidisciplinary health team

• Registration Number: NCT03258138
• Lead Sponsor: McMaster University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-17
• Study First Submitted QC: 2017-08-21
• Study First Posted: 2017-08-23
• Study Start: 2018-02-15
• Primary Completion: 2019-10-30
• Study Completion: 2021-09-22
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-12
• Last Update Posted: 2022-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

• NA

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
More Intensive Program (MIP)	Health and wellness learning sessions	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.
Less Intensive Program (LIP)	Physical activity and nutrition journals	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.
Less Intensive Program (LIP)	Health goal development	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.
More Intensive Program (MIP)	Brainstorming group sessions	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.
More Intensive Program (MIP)	Individual sessions with a multidisciplinary health team	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.
More Intensive Program (MIP)	Health goal development	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.
More Intensive Program (MIP)	Physical activity and nutrition journals	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.

Primary Outcome Measures

Name	Time	Method
Retention rates	Baseline to 12 months	Number of participants recruited and number of participants completing the program

Secondary Outcome Measures

Name	Time	Method
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	Using a validated scale, signs and symptoms of insomnia will be measured over time. Comparisons will be made with baseline but also with other time points.
Changes in the Perceived Stress Scale	Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months	Using a validated scale, signs and symptoms of perceived stress will be measured over time. Comparisons will be made with baseline but also with other time points.
Changes in waist:hip ratio	Baseline and 12 months, 24 months, 36 months	Measured around waist and hips with a tape measure in inches
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	For each health goal, self-efficacy will be determined with a 7-point Likert scale. Comparisons will be made with baseline but also with other time points.
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	For each health goal, stage of change will be determined with a 7-point Likert scale. Comparisons will be made with baseline but also with other time points.
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	For each health goal, goal achievement will be determined with a 7-point Likert scale. Comparisons will be made with baseline but also with other time points.
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	Using a validated scale, emotional and social loneliness will be measured over time. Comparisons will be made with baseline but also with other time points.
Changes in weight	Baseline and 12 months, 24 months, 36 months	Weight will be measured in kilograms
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	Using a validated scale, health-related quality of life will be measured over time. Comparisons will be made with baseline but also with other time points.
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	Using a validated scale, five common mental health conditions (depression, anxiety, alcohol misuse, somatoform disorder and bulimia) will be measured over time. Comparisons will be made with baseline but also with other time points.
Changes in blood pressure	Baseline and 12 months, 24 months, 36 months	Both systolic and diastolic blood pressure will be measured
Changes in body mass index (BMI)	Baseline and 12 months, 24 months, 36 months	Weight and height will be combined to report BMI in kg/m\^2
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	Using a validated scale, health-related quality of life will be measured over time. Comparisons will be made with baseline but also with other time points.
Changes in waist circumference	Baseline and 12 months, 24 months, 36 months	Measured around waist with a tape measure in inches

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada