Feasibility and Implementation of a Healthy Lifestyles Program
- Conditions
- Health BehaviorStressQuality of LifeChronic DiseaseHealth PromotionMental Health Wellness 1
- Registration Number
- NCT03258138
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
- NA
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Retention rates Baseline to 12 months Number of participants recruited and number of participants completing the program
- Secondary Outcome Measures
Name Time Method 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 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.
Changes in the Insomnia Severity Index (ISI) 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.
Changes in the Perceived Stress Scale 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.
Changes in waist:hip ratio Baseline and 12 months, 24 months, 36 months Measured around waist and hips with a tape measure in inches
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 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.
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 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.
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 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.
Changes in the DeJong Gierveld 6-item Loneliness Scale 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.
Changes in weight Baseline and 12 months, 24 months, 36 months Weight will be measured in kilograms
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 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.
Changes in the Patient Health Questionnaire (PHQ) 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.
Changes in blood pressure Baseline and 12 months, 24 months, 36 months Both systolic and diastolic blood pressure will be measured
Changes in body mass index (BMI) Baseline and 12 months, 24 months, 36 months Weight and height will be combined to report BMI in kg/m\^2
Changes in waist circumference Baseline and 12 months, 24 months, 36 months Measured around waist with a tape measure in inches
Trial Locations
- Locations (1)
McMaster University
🇨🇦Hamilton, Ontario, Canada
McMaster University🇨🇦Hamilton, Ontario, Canada