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Mental HealthNCT03949725

A Mixed Methods Randomized Controlled Trial Evaluating the Hans Kai Program

A study testing Hans Kai Program in people with Mental Health and Social Isolation, run by University of Manitoba at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Mental Health, Social Isolation, Loneliness
What is being tested?
Hans Kai Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteCanada
Study dates
24 Jan 2023to 6 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • NorWest Co-op Community Health

    Winnipeg, Manitoba, R2X 3B9

Other trials in Canada

About this study

Official title: Evaluating the Hans Kai Program for Canadian Adults Via an 18-month Mixed Methods Randomized Controlled Trial

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.

Read the 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.

Being tested
Hans Kai Program
Keywords
Health Promotion, Peer-led, Mixed Methods RCT
Medical subject headings
Psychological Well-Being, Social Isolation, Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hans Kai ProgramBehavioural

    In Hans Kai, first, participants attend a 2-month Health School to develop the skills necessary to improve their health and wellbeing. The Health School includes sessions on health indicators; nutrition, grocery shopping and meal planning; physical activity; stress, coping, and health (sleep); and primary care through the years. After participants complete the Health School, they form Hans Kai groups (of 3 or more adults) and begin to meet regularly (at least once a month) independently of facilitators, in a self-sustaining model.

Study groups in NCT03949725
Study groupRoleWhat they receive
Hans Kai programExperimentalThe Hans Kai program is a peer-led, preventative, self-sustaining, community-based health promotion program for adults of all ages, genders, and socioeconomic circumstances who wish to maintain or improve their health. Hans Kai empowers individuals to take control of their own health and provides a unique opportunity for participants to have an active role in improving or maintaining their health and wellbeing.
Receives: Behavioral: Hans Kai Program
Wait list controlNo interventionParticipants in the waitlist control group will remain as close to a 'typical' community member as possible as they will be able to receive any health programming normally available to them in Winnipeg, except the Hans Kai program. Standard of care is made available to all members of the control group as related to the healthcare rights of Canadians and Manitobans holding a Manitoba health card. NorWest staff will provide support to the community members without a Manitoba health card in obtaining one. The only deviation from standard care in the waitlist control group will be the pre- and post-intervention visits during which the control participants will fill out self-report questionnaires and undergo physical assessments.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mental Health

    Mental health will be measured using the Mental Health Continuum Short Form (MHC-SF). The MHC-SF is a standardized self-report questionnaire that measures emotional, social, and psychological well-being by assessing the regularity with which respondents experience symptoms of positive mental health. The questionnaire includes 14 items asking respondents to indicate on a 6-point Likert scale (ranging from 0 = never to 5 = everyday) how often in the previous month they experienced symptoms of emotional, social, and psychological wellbeing. Item responses are summed, yielding a total score ranging from 0 to 70, with higher scores indicating more positive wellbeing.

    Measured: 6 months

Secondary outcomes (6)

  1. Social Connectivity

    Feelings of loneliness and social isolation will be measured using the revised UCLA Loneliness Scale. This is a standardized 20-item scale designed to measure one's subjective feelings of loneliness and social isolation by asking respondents to rate each item on a scale from 1 (Never) to 4 (Often). Single-item scores are summed to obtain a total score ranging from 20 to 80, with lower scores indicating greater loneliness and/or social isolation.

    Measured: 6 months

  2. Health-related Knowledge and Empowerment

    Health-related knowledge and empowerment in the form of self-efficacy and self-determination will be measured using the Perceived Health Competence Scale (PHCS). This is a standardized measure of general health management self-efficacy beliefs designed to assess respondents' self-perceived ability to accomplish health-related goals and manage their health positively. The 8 items ask respondents to rate on a 5-point Likert scale ranging from 1 = strongly disagree to 5 = strongly agree the degree to which they feel capable of effectively managing their health outcomes. Single item scores are summed to create an overall score ranging from 8 to 40, with higher scores indicating a higher self-perceived health competence.

    Measured: 6 months

  3. Diet, Alcohol Consumption, & Tobacco Use

    Changes in nutritional behavior (diet), alcohol consumption, and tobacco use will be measured using a modified version of the Healthy Eating Assessment. The adapted self-report scale includes a total of 22 items divided into two main sections: (1) a first section that includes 18 items evaluating respondents' eating habits, and (2) a second section including four items that assess respondents' alcohol consumption and tobacco use.

    Measured: 6 months

  4. Sleep Quality, Habits, and Patterns

    The standardized self-report questionnaire Pittsburgh Sleep Quality Index (PSQI) will be used to subjectively measure sleep quality, habits, and patterns. This scale includes nine items that assess seven aspects of sleep: (1) subjective sleep quality; (2) sleep latency; (3) sleep duration; (4) habitual sleep efficiency; (5) sleep disturbances; (6) use of sleeping medications; and (7) daytime dysfunction over the last month. Scoring varies across items; however, an overall score can be calculated by summing the seven component scores, yielding a Global PSQI score ranging from 0 to 45, with higher scores indicating poorer sleep quality. Sleep quality and patterns will also be measured objectively using data provided by the Fitbits that participants will wear for a week at each assessment point. The average of these seven measurements will be used as an indicator of sleep patterns and quality

    Measured: 6 months

  5. Physical Activity: Moderate-to-Vigorous Physical Activity (MVPA)

    Physical activity levels will be measured by recording the minutes of moderate-to-vigorous physical activity (MVPA) study participants engage in each day over a 7-day period using a Fitbit that study participants will wear for 1 week. The average of these seven measurements will be used as an indicator of participants' level of physical activity.

    Measured: 6 months

  6. Physical Activity: Step Count

    At each assessment point, a daily step count will be recorded over a 7-day period. The average of these seven measurements will be used as an indicator of participants' level of physical activity at that timepoint of data collection.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2019
  2. Study start24 Jan 2023
  3. Primary completion6 Feb 2025
  4. Study completion6 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03949725
Sponsor's protocol ID
HS21887 (H2018:241)
Status last verified
Mar 2025
First submitted
8 May 2019
Last updated
17 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Following deidentification, all of the individual participant data (IPD) collected during the trial will be shared.

Publications

  • Cameranesi M, Mollard R, Balshaw R, MacKay D. The Hans Kai trial: study protocol of a mixed methods randomized controlled trial evaluating a peer-led health promotion program for adults with or without noncommunicable diseases. Trials. 2023 Oct 24;24(1):689. doi: 10.1186/s13063-023-07708-z.

    PubMed 37875962

Questions about this trial

What is this clinical trial studying?

A study testing Hans Kai Program in people with Mental Health and Social Isolation, run by University of Manitoba at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mental Health (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03949725, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.

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Clinical Trial NCT03949725 | AzTrials