Feasibility and Implementation of a Healthy Lifestyles Program

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03258138
• Other study ID #: Healthy lifestyles pilot
• Status: Completed
• Phase: N/A
• Start date: February 15, 2018
• Est. completion date: September 22, 2021

Study information

• Verified date: October 2022
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 22, 2021
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention rates	Number of participants recruited and number of participants completing the program	Baseline to 12 months
Secondary	Changes in health goals - Stage of change over time	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
Secondary	Changes in health goals - Self-efficacy over time	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
Secondary	Changes in health goals - Goal achievement over time	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
Secondary	Changes in health-related quality of life on the SF-36	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
Secondary	Changes in health-related quality of life on the Health Utilities Index (HUI) 2/3	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
Secondary	Changes in the Patient Health Questionnaire (PHQ)	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
Secondary	Changes in the Insomnia Severity Index (ISI)	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
Secondary	Changes in the Perceived Stress Scale	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
Secondary	Changes in the DeJong Gierveld 6-item Loneliness Scale	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
Secondary	Changes in blood pressure	Both systolic and diastolic blood pressure will be measured	Baseline and 12 months, 24 months, 36 months
Secondary	Changes in weight	Weight will be measured in kilograms	Baseline and 12 months, 24 months, 36 months
Secondary	Changes in body mass index (BMI)	Weight and height will be combined to report BMI in kg/m^2	Baseline and 12 months, 24 months, 36 months
Secondary	Changes in waist circumference	Measured around waist with a tape measure in inches	Baseline and 12 months, 24 months, 36 months
Secondary	Changes in waist:hip ratio	Measured around waist and hips with a tape measure in inches	Baseline and 12 months, 24 months, 36 months

External Links

•   36-Item Short Form Survey (SF-36)
•   Chapter 4: Screening for Type 1 and Type 2 Diabetes
•   HUI Update
•   Maslow's Hierarchy of Needs
•   Measuring and Valuing Health
•   Mental health wait times a serious problem across Ontario, say advocates
•   Mixed methods embedded design in medical education, mental health and health services research: A methodological analysis
•   Obesity and overweight
•   Obesity in Canada
•   Obesity Puts Young Kids at Risk of Social Isolation
•   Ontario youth wait a year or more for mental health care: report
•   Patient Healthcare Questionnaire
•   Prochaska and diclemente's stages of change model - Google Search
•   Socializing key to "successful aging"
•   Taking patient-centred health care from rhetoric to reality
•   The Patients First Act - Frequently Asked Questions
•   Validation of the Insomnia Severity Index as an outcome measure for insomnia research