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

August 27, 2019 updated by: Mike Sadlowski, NorWest Co-op Community Health
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Research Question Does Hans Kai have a greater influence on healthy behavior change, mental health status, social connectedness, and self-health efficacy outcomes compared to community healthcare clients with access to health education programming.

Hypothesis - Hans Kai members will experience higher mental health improvement scores compared to control group.

Hans Kai members will experience greater social connectedness compared to control group.

Hans Kai members will experience greater self-health efficacy compared to control group.

Hans Kai members will adopt more behavior changes compared to control group.

Null Hypothesis - There is no significant difference between Hans Kai members and control group in terms of mental health improvement scores.

There is no significant difference between Hans Kai members and control group in terms of social connectedness scores.

There is no significant difference between Hans Kai members and control group in terms of self-health efficacy scores.

There is no significant difference between Hans Kai members and control group in terms of adopted behavior change numbers.

In order to meet the demand for health programming in and reduce the prevalence of chronic disease NorWest developed the HANS KAI Project. Hans Kai is a self-sustaining, participant led health program for individuals wanting to maintain or improve their health. Hans Kai groups consist of 8-40 people per group in communities or workplaces. Hans Kai empowers individuals to take control of their own health and provides a unique opportunity for participants to have an active role in improving or maintaining their own health and well-being and that of their community.

HANS Kai Focuses on a number of factors relating to health including:

Healthy eating, physical activity, managing sleep and stress, mental health, physical health indicators, leadership and social supports. The program is participant led which enables members to have an active role in their health and the health of their families and communities.

Currently NorWest has trained 37 people in 5 provinces across Canada to deliver HANS KAI in their community and demand is growing. NorWest has developed a Teen and Family HANS KAI to address health across the ages.

HANS KAI's initial research phase assessed roughly 60 participants over 2 years to determine the impact of Hans Kai on strategic health indictors and influences. Our research and evaluation showed statistically significant improvements in:

Mental Health (prior to HANS Kai 33% had Flourishing Mental Health at 12 months 69% had Flourishing Mental Health) Physical Activity Knowledge of Health Connection to Resources Increased Social Connections, and Upward trends in nutrition. As the program continued to evolve, community members and participants were involved in every phase, giving community feedback on important health related topics they wanted discussed and to be given more information on. This lead the researchers toward the second phase of research which now focuses heavily on behavior change. Putting into practice the information that participants learn was the highest feedback received, and this echoes trends in health promotion interventions, as preventative healthcare and integrated service becomes the pinnacle to healthy communities. Empowering people and building their resilience is dependent on needs and perceived value of different lifestyle influences. For instance, an economically disadvantaged family may struggle on a low income, but may find value in the Hans Kai nutrition classes on how to feed their family healthy options and recipes on a fixed budget. Addressing a change from eating take-out to home cooking helps to move this family towards better health and become economically stronger through education and application. Building on this scenario, Hans Kai also serves to bolster social engagement, drawing out isolated individuals to engage in their communities, increasing their mental health and well-being. The researchers strive to prove that this support carries over into the overall lifestyle, increasing the likelihood and motivation to improve physical activity levels with other group members interested in the same. This increase in self-efficacy promotes community and family leadership, as others see positive life choices, they are likely to join in, seeing family walks become routine and volunteering in community engagement on the rise.

The researchers are wanting to prove that community led health programs lead to health behaviour changes in healthy lifestyle choices with social support and self-efficacy.

After completing our first phase of research, the researchers were able to determine challenges and how to improve them as research heads into the second phase. Creating group champions to help collect interval research data and modifying our research to determine a power difference between a control and Hans Kai member was of the utmost importance. The research objectives will be looking to discover the differences between non Hans Kai community members and Hans Kai members in the areas of: self-efficacy, behavior change, physical activity, nutrition, mental health and community connectedness. Data comparisons from initial baselines without the Hans Kai intervention, followed by a 9 week survey after Hans Kai participants have completed the health school, followed by a 6 month and one year survey will be assessed. The purpose in completing these objectives is to determine whether the Hans Kai model produces better results in each of the mentioned areas for participants interested in a lifestyle change compared to those participants not introduced to the Hans Kai concept of education. If successful, the Hans Kai model will be further studied and promoted to more community health clinics as a low cost method to produce positive healthy behaviours to communities.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2X 3B9
        • Access NorWest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 year
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.
1 year
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.
1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NorWest Co-op Community Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Leanne LeClair, PHD, University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 02222018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IPD will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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