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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03949725
Recruitment Status : Suspended (Covid 19 pandemic, will restart in the future)
First Posted : May 14, 2019
Last Update Posted : August 20, 2020
Sponsor:
Collaborator:
NorWest Co-op Community Health
Information provided by (Responsible Party):
Dylan MacKay. PhD, University of Manitoba

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
Mental Health Social Isolation Loneliness Behavioral: Hans Kai Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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
Estimated Study Start Date : June 10, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : January 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

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



Primary Outcome Measures :
  1. Mental Health [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 months ]
    Blood glucose will be measured in mmol/L by finger stick capillary blood sampling using a calibrated glucometer.

  5. Heart Rate [ Time Frame: 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 [ Time Frame: 6 months ]
    Daily average anti-sedentary time will be measured using pedometers worn for 1 week.

  7. Daily Steps Taken [ Time Frame: 6 months ]
    Daily average steps taken will be measured using a pedometers worn for 1 week.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949725


Locations
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Canada, Manitoba
NorWest Co-op Community Health
Winnipeg, Manitoba, Canada, R2X 3B9
Sponsors and Collaborators
University of Manitoba
NorWest Co-op Community Health
Investigators
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Principal Investigator: Dylan Mackay, PhD University of Manitoba
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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    Key Record Dates
Last Update Posted: August 20, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No