Feasibility and Implementation of a Healthy Lifestyles Program

October 12, 2022 updated by: Elizabeth Alvarez, McMaster University

Feasibility and Implementation of a Healthy Lifestyles Program: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4K1
        • McMaster University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: More Intensive Program (MIP)
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
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.
Behavioral: Brainstorming group sessions
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.
Behavioral: Individual sessions with a multidisciplinary health team
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.
Behavioral: Health goal development
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.
Behavioral: Physical activity and nutrition journals
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.
Experimental: Less Intensive Program (LIP)
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
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.
Behavioral: Physical activity and nutrition journals
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention rates
Time Frame: Baseline to 12 months
Number of participants recruited and number of participants completing the program
Baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in health goals - Stage of change over time
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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)
Time Frame: 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.
Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months
Changes in the Insomnia Severity Index (ISI)
Time Frame: 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.
Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months
Changes in the Perceived Stress Scale
Time Frame: 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.
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
Time Frame: 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.
Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months
Changes in blood pressure
Time Frame: Baseline and 12 months, 24 months, 36 months
Both systolic and diastolic blood pressure will be measured
Baseline and 12 months, 24 months, 36 months
Changes in weight
Time Frame: Baseline and 12 months, 24 months, 36 months
Weight will be measured in kilograms
Baseline and 12 months, 24 months, 36 months
Changes in body mass index (BMI)
Time Frame: Baseline and 12 months, 24 months, 36 months
Weight and height will be combined to report BMI in kg/m^2
Baseline and 12 months, 24 months, 36 months
Changes in waist circumference
Time Frame: Baseline and 12 months, 24 months, 36 months
Measured around waist with a tape measure in inches
Baseline and 12 months, 24 months, 36 months
Changes in waist:hip ratio
Time Frame: Baseline and 12 months, 24 months, 36 months
Measured around waist and hips with a tape measure in inches
Baseline and 12 months, 24 months, 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Investigators

  • Principal Investigator: Elizabeth Alvarez, MD, MPH, PhD, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2018

Primary Completion (Actual)

October 30, 2019

Study Completion (Actual)

September 22, 2021

Study Registration Dates

First Submitted

August 17, 2017

First Submitted That Met QC Criteria

August 21, 2017

First Posted (Actual)

August 23, 2017

Study Record Updates

Last Update Posted (Actual)

October 14, 2022

Last Update Submitted That Met QC Criteria

October 12, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Healthy lifestyles pilot

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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