Clinical trial NCT03258138: Feasibility and Implementation of a Healthy Lifestyles Program
Official title: Feasibility and Implementation of a Healthy Lifestyles Program: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Quality of Life
Chronic Disease
Health Promotion
Stress
Mental Health Wellness 1
Keywords: Pragmatic
Pilot study
Mixed methods
Randomized controlled trial
Implementation research
Person-centered care
Multidisciplinary
Ecological approach
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2017-08-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Retention rates
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Changes in health goals - Stage of change over time
timeFrame: Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months
measure: Changes in health goals - Self-efficacy over time
timeFrame: Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months
measure: Changes in health goals - Goal achievement over time
timeFrame: Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months
measure: Changes in health-related quality of life on the SF-36
timeFrame: Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months
measure: Changes in health-related quality of life on the Health Utilities Index (HUI) 2/3
timeFrame: Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months
measure: Changes in the Patient Health Questionnaire (PHQ)
timeFrame: Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months
measure: Changes in the Insomnia Severity Index (ISI)
timeFrame: Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months
measure: Changes in the Perceived Stress Scale
timeFrame: Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months
measure: Changes in the DeJong Gierveld 6-item Loneliness Scale
timeFrame: Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months
measure: Changes in blood pressure
timeFrame: Baseline and 12 months, 24 months, 36 months
measure: Changes in weight
timeFrame: Baseline and 12 months, 24 months, 36 months
measure: Changes in body mass index (BMI)
timeFrame: Baseline and 12 months, 24 months, 36 months
measure: Changes in waist circumference
timeFrame: Baseline and 12 months, 24 months, 36 months
measure: Changes in waist:hip ratio
timeFrame: Baseline and 12 months, 24 months, 36 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Elizabeth Alvarez, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
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