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Feasibility and Implementation of a Healthy Lifestyles Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03258138
Recruitment Status : Active, not recruiting
First Posted : August 23, 2017
Last Update Posted : March 20, 2020
Sponsor:
Information provided by (Responsible Party):
Elizabeth Alvarez, 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.


Condition or disease Intervention/treatment Phase
Health Behavior Quality of Life Chronic Disease Health Promotion Stress Mental Health Wellness 1 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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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).
Masking: None (Open Label)
Masking Description: The amount of exposure to the programs will be known to participants and providers.
Primary Purpose: Health Services Research
Official Title: Feasibility and Implementation of a Healthy Lifestyles Program: A Pilot Study
Actual Study Start Date : February 15, 2018
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Living

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.




Primary Outcome Measures :
  1. Retention rates [ Time Frame: Baseline to 12 months ]
    Number of participants recruited and number of participants completing the program


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258138


Locations
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Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8S 4K1
Sponsors and Collaborators
McMaster University
Investigators
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Principal Investigator: Elizabeth Alvarez, MD, MPH, PhD McMaster University
  Study Documents (Full-Text)

Documents provided by Elizabeth Alvarez, McMaster University:
Informed Consent Form: Participants  [PDF] October 21, 2017
Informed Consent Form: Program staff  [PDF] October 21, 2017
Informed Consent Form: Family members  [PDF] October 21, 2017

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Elizabeth Alvarez, Assistant Professor, McMaster University
ClinicalTrials.gov Identifier: NCT03258138    
Other Study ID Numbers: Healthy lifestyles pilot
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elizabeth Alvarez, McMaster University:
Pragmatic
Pilot study
Mixed methods
Randomized controlled trial
Implementation research
Person-centered care
Multidisciplinary
Ecological approach
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes