Clinical trial NCT03949725: A Mixed Methods Randomized Controlled Trial Evaluating the Hans Kai Program
Official title: Evaluating the Hans Kai Program for Canadian Adults Via an 18-month Mixed Methods Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Social Isolation
Loneliness
Health-Related Behavior
Keywords: Health Promotion
Peer-led
Mixed Methods RCT
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: NorWest Co-op Community Health
First posted: 2019-05-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention study model is a 2-arm randomized control trial with a 2:1 allocation of participants to the treatment condition (i.e., the Hans Kai program) or the control condition (i.e., usual care without the Hans Kai program). After 6 months in the control condition, participants in the control group will join the Hans Kai program.
Primary purpose: PREVENTION

Brief summary: The Hans Kai trial is a mixed methods randomized controlled trial evaluating the effectiveness of the peer-led health promotion Hans Kai program for Canadian adults with or without chronic health conditions. The Hans Kai trial also aims to identify the strengths and weaknesses of the Hans Kai program as well as the facilitators and barriers to its implementation from the perspectives of the program participants and facilitators. The intervention (Hans Kai program) consists of an 8-week health school that program participants attend to develop health knowledge and skills. Next, program participants form Hans Kai groups of 3 or more people, who meet on a monthly basis independently in a peer-led self-sustaining model. The trial will measure the impact of Hans Kai, compared to waitlist control, on program participants' mental health; social connections; health-related knowledge and empowerment (i.e., self-efficacy and self-determination); health-promoting behaviors (i.e., diet, alcohol consumption, tobacco use, physical activity, and sleep); and clinical measures of cardio-metabolic health.

Detailed description: The Hans Kai trial will follow a prospective mixed methods intervention design involving an RCT and an interpretative descriptive qualitative study. The mixed methods intervention design is a mixed methods approach to research in which the collection, analysis, and integration of both quantitative and qualitative data are embedded within an experimental quantitative research design. The objective of gathering qualitative data within an experiment, along with the quantitative data on the outcome measures, is to gain an understanding of the personal, contextual experiences of the study participants.

In this mixed methods intervention study design, quantitative data on the outcomes of interest will be collected along with qualitative data on the experiences of program participants and facilitators, and integrated within an intervention trial (i.e., RCT) to address the research objectives (see next section for details). The primary research design in this study will be a quantitative intervention trial or RCT that will follow a pragmatic randomized wait-list-control design with an 18-month follow-up. The RCT will involve the collection, analysis, and interpretation of quantitative data (self-reports and objective indicators) on primary, secondary, and tertiary outcomes that will be gathered to evaluate the effectiveness of the Hans Kai program in promoting the health and wellbeing of Canadian adults. To enrich the RCT results, the secondary qualitative strand of the study will be added during and after the intervention by embedding a combination of convergent and explanatory sequential designs into the RCT.

Eligibility criteria: Inclusion Criteria. Participants may enter the trial if all the following apply.

* Age 18 years or above.
* Any gender.
* Willingness and ability to give informed consent for participation in the trial.
* Ability to speak and read English at a grade 6 level.
* Motivation to make a lifestyle change as indicated on the research study consent form.
* Stable health status that allows participation in the group context, including performing light exercise, to be determined by the participant and study Hans Kai staff.
* Ability and willingness to comply with all trial requirements, to be determined by the research team.

Exclusion Criteria. Participants may not enter the trial if any of the following apply.

* Age under 18 years.
* Cognitive impairment that prevents the person from providing informed consent or participating in the program.
* Existing relationship with the research team, such as supervisory relationship (e.g., student or employee) or familial relationship (e.g., child or spouse).
* Frailty that prevents the person from participating in group activities or exercise.
* Participation in another research trial in the past 12 weeks.
* Unstable health or serious illness, for example, dementia, terminal illness, or recent significant medical diagnosis.
* Inability to attend the scheduled Hans Kai Health School and assessment sessions.

Primary outcomes:
measure: Mental Health
timeFrame: 6 months
Secondary outcomes:
measure: Social Connectivity
timeFrame: 6 months
measure: Health-related Knowledge and Empowerment
timeFrame: 6 months
measure: Diet, Alcohol Consumption, & Tobacco Use
timeFrame: 6 months
measure: Sleep Quality, Habits, and Patterns
timeFrame: 6 months
measure: Physical Activity: Moderate-to-Vigorous Physical Activity (MVPA)
timeFrame: 6 months
measure: Physical Activity: Step Count
timeFrame: 6 months
Other outcomes:
measure: Waist Circumference
timeFrame: 6 months
measure: Systolic Blood Pressure
timeFrame: 6 months
measure: Diastolic Blood Pressure
timeFrame: 6 months
measure: Fasting Blood Sugar
timeFrame: 6 months
measure: Heart Rate
timeFrame: 6 months
Locations:
city: Winnipeg
country: Canada
facility: NorWest Co-op Community Health
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Dylan Mackay, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: