Hans Kai Trial: an Evaluation of a Peer-led Preventative Health Intervention
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|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
|Condition or disease||Intervention/treatment||Phase|
|Mental Health Social Isolation Loneliness||Behavioral: Hans Kai Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|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)|
|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|
|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|
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Anti-sedentary Time at 6 months [ Time Frame: 6 months ]Daily average anti-sedentary time will be measured using pedometers worn for 1 week.
- Daily Steps Taken [ Time Frame: 6 months ]Daily average steps taken will be measured using a pedometers worn for 1 week.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949725
|NorWest Co-op Community Health|
|Winnipeg, Manitoba, Canada, R2X 3B9|
|Principal Investigator:||Dylan Mackay, PhD||University of Manitoba|