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OpenTrials
Completed

NCT Number: NCT03258138

Feasibility and Implementation of a Healthy Lifestyles Program

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.

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Key information

Conditions

Health Behavior Behavior Chronic Disease Disease Attributes Health Promotion Mental Health Wellness 1 Pathologic Processes Pathological Conditions, Signs and Symptoms Quality of Life Stress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

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.

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.

Primary outcomes

  1. Retention rates

    Time frame: Baseline to 12 months

    Number of participants recruited and number of participants completing the program

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Changes in blood pressure

    Time frame: Baseline and 12 months, 24 months, 36 months

    Both systolic and diastolic blood pressure will be measured

  11. Changes in weight

    Time frame: Baseline and 12 months, 24 months, 36 months

    Weight will be measured in kilograms

  12. 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

  13. Changes in waist circumference

    Time frame: Baseline and 12 months, 24 months, 36 months

    Measured around waist with a tape measure in inches

  14. 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

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Aug 23, 2017
Registry last updated
Oct 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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