Feasibility and Implementation of a Healthy Lifestyles Program

NCT03258138 | Completed

• 1 other identifier: Healthy lifestyles pilot
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Pragmatic; Pilot study; Mixed methods; Randomized controlled trial; Implementation research; Person-centered care; Multidisciplinary; Ecological approach

Outcome Measures

Primary Outcomes (1)

• Retention rates

  Number of participants recruited and number of participants completing the program

  Baseline to 12 months

Secondary Outcomes (14)

• 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 - 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 - Goal achievement over time

  Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 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 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

Study Arms (2)

More Intensive Program (MIP)

EXPERIMENTAL

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.

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

Less Intensive Program (LIP)

EXPERIMENTAL

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.

Behavioral: Health goal development; Behavioral: Physical activity and nutrition journals

Interventions

Health and wellness learning sessions BEHAVIORAL

The health and wellness learning sessions provide a platform for concepts from a variety of health behaviour theories and CBT to be combined with evidence- and practice-based recommendations for healthy lifestyles. They provide the basis for participants' development of an individualized action plan. The sessions will last one hour and participants will receive them in a group setting, 18 times throughout the duration of the program. Specifically, the sessions will be delivered during weeks: 1-8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48.

More Intensive Program (MIP)

Brainstorming group sessions BEHAVIORAL

The brainstorming group sessions allow for facilitated discussions where individuals explore barriers and facilitators to achieving their goals and provide an interpersonal component to the program through the building of social interactions. Participants will also receive help in finding community programs to support healthy lifestyles. These sessions will last one hour and participants will receive them in a group setting, 30 times throughout the duration of the program. Specifically, these sessions will be delivered during weeks: 9-11, 13-15, 17-19, 21-23, 25-27, 29-31, 33-35, 37-39, 41-43, 45-47.

More Intensive Program (MIP)

Individual sessions with a multidisciplinary health team BEHAVIORAL

Monthly individual sessions with a family physician trained in medical CBT, a dietician and a physical therapist help individuals tailor their action plans and recommendations to their particular circumstances and provide supports based on their needs. The initial session will last 3 hours and occur at baseline. The follow-up sessions will last 1 hour.

More Intensive Program (MIP)

Health goal development BEHAVIORAL

Participants in both arms will develop health goals. Several components of these goals will be measured throughout the study, including the stage of change, self-efficacy and actual goal achievement. In the more intensive program arm, participants will develop health goals and learn about how to meet those goals through the group and individual sessions. In the less intensive program arm, participants will receive support in developing health goals from a research assistant trained in theories of health behaviour and in goal setting at baseline, 3 months, 6 months, 9 months and 12 months. The initial goal setting session will be provided within a time period of 2 hours, and the follow-up sessions will be provided within one hour time periods.

Less Intensive Program (LIP); More Intensive Program (MIP)

Physical activity and nutrition journals BEHAVIORAL

Participants in both arm will be asked to maintain a physical activity journal and a nutrition journal for a week each every three months. These journals help participants reflect on current behaviours and areas for change.

Less Intensive Program (LIP); More Intensive Program (MIP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking
• years of age or older
• English-speaking
• years of age or older
• related to participants in randomized controlled trial
• Provide services within the more intensive program
• Provide health care outside of the healthy lifestyles program for participants in randomized controlled trial

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

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Related Links

• Obesity and overweight
• Obesity in Canada
• Obesity Puts Young Kids at Risk of Social Isolation
• Socializing key to "successful aging"
• Ontario youth wait a year or more for mental health care: report
• Taking patient-centred health care from rhetoric to reality
• Maslow's Hierarchy of Needs
• Prochaska and diclemente's stages of change model - Google Search
• Mixed methods embedded design in medical education, mental health and health services research: A methodological analysis
• Chapter 4: Screening for Type 1 and Type 2 Diabetes
• HUI Update
• Measuring and Valuing Health
• Patient Healthcare Questionnaire
• Validation of the Insomnia Severity Index as an outcome measure for insomnia research

MeSH Terms

Conditions

Health Behavior; Chronic Disease

Interventions

Health; Exercise

Condition Hierarchy (Ancestors)

Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Population Characteristics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Elizabeth Alvarez, MD, MPH, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The amount of exposure to the programs will be known to participants and providers.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 23, 2017
• Study Start: February 15, 2018
• Primary Completion: October 30, 2019
• Study Completion: September 22, 2021
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)