Hans Kai Trial: an Evaluation of a Peer-led Preventative Health Intervention

Sponsor
University of Manitoba (Other)
Overall Status
Suspended
CT.gov ID
NCT03949725
Collaborator
NorWest Co-op Community Health (Other)
72
1
2
18.7
3.9

Study Details

Study Description

Brief Summary

The Hans Kai trial is a randomized wait-list controlled trial looking at the impact of the Hans Kai program, a peer-led, self-sustaining preventative health program that empower participants to take control of their health with social support. The interventions consists of a health school to develop health knowledge and skills, then participants form Hans Kai groups of 3 or more people, who meet on a monthly basis independently in a self-sustaining model. The trial will look at the impact of the 6 months of the Hans Kai program, compared to wait list control, on mental health, loneliness, health behavior changes and clinical measures of cardio-metabolic health.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Hans Kai Program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The study model is a randomized control trial with a 2 to 1 allocation of participants to treatment, the Hans Kai Program, or control, usual care without the Hans Kai Program. After 6 months in the control, participants will then join the Hans Kai program.The study model is a randomized control trial with a 2 to 1 allocation of participants to treatment, the Hans Kai Program, or control, usual care without the Hans Kai Program. After 6 months in the control, participants will then join the Hans Kai program.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Evaluating the Effectiveness of Hans Kai in the General Population: A Randomized Wait-list Controlled Trial of a Community Developed, Peer-led Program That Empowers People to Take Control of Their Own Health
Anticipated Study Start Date :
Jul 10, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jan 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hans Kai program

Behavioral: Hans Kai Program
Participants in the Hans Kai program attend a health school to enhance their health knowledge and skills. Once complete, the participants form Hans Kai groups of 3 or more people, who meet on a monthly basis independently in a self-sustaining model, each meeting includes a group exercise activity, a group cooking activity, a group learning and discussion activity, and group monitoring of health biomarkers, such as blood pressure, waits circumference, and/or blood glucose.

No Intervention: Wait list control

Outcome Measures

Primary Outcome Measures

  1. Mental Health [6 months]

    Mental health will be measured using the Mental Health Continuum Short Form (MHC-SF). MHC-SF measures emotional, social and psychological well-being by assessing the regularity with which respondents experience symptoms of positive mental health. The MHC-SF contains 14 items: 3 items for emotional well-being, 5 items for social well-being, and 6 items for psychological well-being. Each item is assessed with a 6-point Likert (0-5) scale. Items are summed, yielding a total score ranging from 0 to 70. Higher scores indicate greater levels of positive well-being.

  2. Friendship and Social Connectivity [6 months]

    Feelings of loneliness as well as feelings of social isolation will be measured by the UCLA loneliness scale. The UCLA Loneliness Scale is a 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item on a scale from 1 (Never) to 4 (Often), yielding a total score ranging from 20 to 80, with lower scores indicating greater loneliness and/or social isolation.

Secondary Outcome Measures

  1. Health Knowledge and Self-Efficacy [6 months]

    Health knowledge and self-efficacy will be measured using the perceived health competence scale (PHCS). The eight-item PHCS is a measure of general health management self-efficacy beliefs scored on a 5-point Likert scale designed to measure an individual's self-perceived ability to accomplish things that are undertaken or that are important to the individual.

  2. Moderate to Vigorous Physical Activity [6 months]

    Moderate to vigorous physical activity (MVPA) in minutes per week days will be measured using pedometers worn for 1 week.

  3. Sleep Behavior [6 months]

    Sleep will be measured subjectively by the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over the previous month.

  4. Nutritional Behavior [6 months]

    Nutritional behavior will be measured by the Nutrition Quality of Life (NQoL) survey. The NQoL survey asks about how eating habits have affected aspects of quality of life. The NQoL survey contains 50 questions which are answered on a 5-point Likert scale.

Other Outcome Measures

  1. Waist Circumference [6 months]

    Waist circumference in cm will be measured in triplicate, to the nearest 0.1 cm at the umbilicus, between the last rib and the iliac crest using a fibreglass tape measure by a registered nurse.

  2. Systolic Blood Pressure [6 months]

    Systolic blood pressure in mmHg is measured in triplicate, on the non-dominant arm in a sitting position by a registered nurse using a validated oscillometric blood pressure monitor.

  3. Diastolic Blood Pressure [6 months]

    Diastolic blood pressure in mmHg is measured in triplicate, on the non-dominant arm in a sitting position by a registered nurse using a validated oscillometric blood pressure monitor.

  4. Fasting Blood Sugar [6 months]

    Blood glucose will be measured in mmol/L by finger stick capillary blood sampling using a calibrated glucometer.

  5. Heart Rate [6 months]

    Heart Rate in beats per minute is measured in triplicate, on the non-dominant arm in a sitting position by a registered nurse using a validated oscillometric blood pressure monitor.

  6. Anti-sedentary Time at 6 months [6 months]

    Daily average anti-sedentary time will be measured using pedometers worn for 1 week.

  7. Daily Steps Taken [6 months]

    Daily average steps taken will be measured using a pedometers worn for 1 week.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Participant is willing and able to give informed consent for participation in the trial.

  • Participant has the ability to speak and read English

  • Any gender.

  • Aged 18 years or above.

  • Participants must be wanting to making a lifestyle change as indicated on the research study consent form.

  • Participant healthy enough to participate in the group context, including perform light exercise, to be determined by the participant and study staff.

  • In the Investigator's opinion, participant is able and willing to comply with all trial requirements.

  • Participant willing to allow their primary care provider, to be notified of participation in the trial, if appropriate.

Exclusion Criteria:
  • • The participant is cognitively impaired and cannot give consent or participate in the group program

  • The participant is under 18 years of age.

  • The participant has an existing relationship with the research team, such as supervisory relationship (student, employee) or familial relationship (child, spouse, etc)

  • The participant is frail and cannot participate in group activities or even light and/or modified exercise.

  • Participants who have participated in another research trial in the past 12 weeks.

  • Participants with unstable or serious illness, for example, dementia, terminal illness, or recent significant medical diagnosis will also be excluded.

  • Participants who indicate that they would be unable to attend the scheduled HK school and assessment schedule will also be excluded.

Contacts and Locations

Locations

Site City State Country Postal Code
1 NorWest Co-op Community Health Winnipeg Manitoba Canada R2X 3B9

Sponsors and Collaborators

  • University of Manitoba
  • NorWest Co-op Community Health

Investigators

  • Principal Investigator: Dylan Mackay, PhD, University of Manitoba

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dylan MacKay. PhD, Assistant Professor, University of Manitoba
ClinicalTrials.gov Identifier:
NCT03949725
Other Study ID Numbers:
  • HS21887 (H2018:241)
First Posted:
May 14, 2019
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 18, 2022