ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 37 of 206 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

Hans Kai: Impact of a Peer Lead Community Health Program on Behavior Change, Mental Health, Health Efficacy and Social Support Comparative Control Study

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03450382
Recruitment Status : Not yet recruiting
First Posted : March 1, 2018
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Mike Sadlowski, NorWest Co-op Community Health

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

Condition or disease Intervention/treatment Phase
Health Behavior Other: Hans Kai Education Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Open label, quasi-experimental clinical trial comparative study.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Hans Kai: Impact of a Peer Lead Community Health Program on Behavior Change, Mental Health, Health Efficacy and Social Support Comparative Control Study
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Hans Kai Participant
Participants receiving Hans Kai intervention
Other: Hans Kai Education
9 weeks of health education classes preceding social group formation into Hans Kai. Peer led support focused on behavioural change.
No Intervention: Control
Participants not enrolled in Hans Kai



Primary Outcome Measures :
  1. Behaviour Change [ Time Frame: 1 year ]
    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.

  2. Self-health Efficacy [ Time Frame: 1 year ]
    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.

  3. Social Support [ Time Frame: 1 year ]
    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.

  4. Mental Health [ Time Frame: 1 year ]
    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.



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.


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

Inclusion Criteria: Participants must be committed to making a lifestyle change

Exclusion Criteria:

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

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): NCT03450382


Contacts
Contact: Mike L Sadlowski, MSc 204-770-1010 msadlowski@norwestcoop.ca
Contact: Michelle Kirkbride, BA 204-938-5996 mkirkbride@norwestcoop.ca

Locations
Canada, Manitoba
Access NorWest Not yet recruiting
Winnipeg, Manitoba, Canada, R2X 3B9
Contact: Michelle Gobiel    204.938.5903    mgobiel@norwestcoop.ca   
Sub-Investigator: Raphael Nepomuceno, PHD         
Sponsors and Collaborators
NorWest Co-op Community Health
Investigators
Study Director: Leanne LeClair, PHD University of Manitoba

Responsible Party: Mike Sadlowski, Health Promoter, NorWest Co-op Community Health
ClinicalTrials.gov Identifier: NCT03450382     History of Changes
Other Study ID Numbers: 02222018
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers.

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

Keywords provided by Mike Sadlowski, NorWest Co-op Community Health:
community health
mental health
behavior change
social support
health promotion