A Mixed Methods Randomized Controlled Trial Evaluating the Hans Kai Program

NCT03949725 | Completed

• 1 other identifier: HS21887 (H2018:241)
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health; Social Isolation; Loneliness; Health-Related Behavior

Keywords

Health Promotion; Peer-led; Mixed Methods RCT

Outcome Measures

Primary Outcomes (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.

  6 months

Secondary Outcomes (6)

• Social Connectivity

  6 months

• Health-related Knowledge and Empowerment

  6 months

• Diet, Alcohol Consumption, & Tobacco Use

  6 months

• Sleep Quality, Habits, and Patterns

  6 months

• Physical Activity: Moderate-to-Vigorous Physical Activity (MVPA)

  6 months

Other Outcomes (5)

• Waist Circumference

  6 months

• Systolic Blood Pressure

  6 months

• Diastolic Blood Pressure

  6 months

Study Arms (2)

Hans Kai program

EXPERIMENTAL

The 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.

Behavioral: Hans Kai Program

Wait list control

NO INTERVENTION

Participants 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.

Interventions

Hans Kai Program BEHAVIORAL

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.

Hans Kai program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead
• NorWest Co-op Community Health: collaborator

Study Sites (1)

NorWest Co-op Community Health

Winnipeg, Manitoba, R2X 3B9, Canada

Location

Related Publications (1)

• 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.

  PMID: 37875962 DERIVED

MeSH Terms

Conditions

Psychological Well-Being; Social Isolation; Health Behavior

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Social Behavior

Study Officials

• Dylan Mackay, Ph.D.

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 14, 2019
• Study Start: January 24, 2023
• Primary Completion: February 6, 2025
• Study Completion: February 6, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The IPD will be available beginning immediately following publication and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by the trial PI.

Locations

CA (1)