NCT03450382

Brief Summary

To study the difference between participants interested in a lifestyle change when enrolled in Hans Kai or not when comparing behaviour change, social support, self health efficacy and mental health. Hans Kai is a community based, peer led program that is low cost and self sustaining, which places participants through a 9 week health school to learn skills related to improving health such as nutrition, exercise, sleep, stress management etc. Once completed, participants form a Hans Kai group and continue meeting independently of health care providers

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

August 28, 2019

Status Verified

February 1, 2018

Enrollment Period

2.2 years

First QC Date

February 22, 2018

Last Update Submit

August 27, 2019

Conditions

Keywords

community healthmental healthbehavior changesocial supporthealth promotion

Outcome Measures

Primary Outcomes (4)

  • Behaviour Change

    To determine the power difference between Hans Kai participants and control group with respect to behavior change. Readiness to Change, Confidence to Change Questionnaire: Gillespie \& Lenz (2011) will be used to measure this outcome.

    1 year

  • Self-health Efficacy

    To determine the power difference between Hans Kai participants and control group with respect to self-health efficacy. Health Self-Efficacy Questionnaire: Lee, Hwang, Hawkins \& Pingree (2008) will be used to measure this outcome.

    1 year

  • Social Support

    To determine the power difference between Hans Kai participants and control group with respect to Social Support. A Social Connectedness Questionnaire developed by researchers will be used to measure this outcome.

    1 year

  • Mental Health

    To determine the power difference between Hans Kai participants and control group with respect to mental health. Mental Health Questionnaire: Keyes, C.L.M. (2009) will be used to measure this outcome.

    1 year

Study Arms (2)

Hans Kai Participant

EXPERIMENTAL

Participants receiving Hans Kai intervention

Other: Hans Kai Education

Control

NO INTERVENTION

Participants not enrolled in Hans Kai

Interventions

9 weeks of health education classes preceding social group formation into Hans Kai. Peer led support focused on behavioural change.

Hans Kai Participant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • cognitively impaired
  • Under 18
  • students of children of Research team
  • clients in emergency/life threatening conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Access NorWest

Winnipeg, Manitoba, R2X 3B9, Canada

Location

MeSH Terms

Conditions

Health BehaviorPsychological Well-Being

Condition Hierarchy (Ancestors)

BehaviorPersonal Satisfaction

Study Officials

  • Leanne LeClair, PHD

    University of Manitoba

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Open label, quasi-experimental clinical trial comparative study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Health Promoter

Study Record Dates

First Submitted

February 22, 2018

First Posted

March 1, 2018

Study Start

April 1, 2018

Primary Completion

June 1, 2020

Study Completion

June 30, 2020

Last Updated

August 28, 2019

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

IPD will not be shared with other researchers.

Locations