ClinicalTrials.gg
WithdrawnNCT03450382Updated Aug 28, 2019

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

An interventional study of Hans Kai Education in Health Behavior, sponsored by NorWest Co-op Community Health. Withdrawn at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-28.

Sponsored by NorWest Co-op Community Health · Not applicable, Interventional, and Health services research

Why this study was withdrawn
New Principal Investigator
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 42 studies in Health Behavior with a site in Canada — 3 open to participants now, 5 under way, none of them phase 3. Health Behavior · Canada.

Enrollment
34th of 35
0 · median 100
Started
2018
with 6 others
No phase
34 of 42
2 open now
Registered
16th of 42
by date

Among the 42 studies in Health Behavior with a site in Canada, this one is the 34th largest by enrollment of the 35 interventional ones that give a count, is one of 7 that started in 2018, is one of 34 with no phase, and was the 16th registered.

Health Behavior

968 studies on the registry are indexed under Health Behavior; 166 are open to participants now.

Browse Health Behavior studies →

Open to participants now

3 of the 42 studies in Health Behavior with a site in Canada are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 93 Health Behavior studies recruiting now, 39 (42%) set no upper age limit and 37 (40%) stop at 75 or younger; 25 take children under 18; 58 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 42 studies in Health Behavior with a site in Canada, or all of them as a file.
02

Study 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

Read the 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.

03

Conditions studied

  • Health Behavior

Keywords

  • community health
  • mental health
  • behavior change
  • social support
  • health promotion
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility 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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Hans Kai Participant

    Participants receiving Hans Kai intervention

    Other: Hans Kai Education

  • No intervention
    Control

    Participants not enrolled in Hans Kai

Interventions

  • OtherHans Kai Education

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

  2. 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.

    Time frame: 1 year

  3. 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.

    Time frame: 1 year

  4. 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.

    Time frame: 1 year

07

Study locations

1 site
  • Access NorWest
    Winnipeg, Manitoba R2X 3B9, Canada
08

References and documents

Individual participant data

Plan to share: No — IPD will not be shared with other researchers.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Apr 2018; primary completion for Jun 2020, 26 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 22, 2018
First posted
Mar 1, 2018
StartEst.
Apr 1, 2018
Primary completionEst.
Jun 1, 2020
CompletionEst.
Jun 30, 2020
Last update
Aug 28, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03450382
Lead sponsor
NorWest Co-op Community Health
Responsible party
Mike Sadlowski (Health Promoter, NorWest Co-op Community Health) — Principal investigator
First posted
Mar 1, 2018
Start date
Apr 1, 2018 (estimated)
Primary completion
Jun 1, 2020 (estimated)
Completion
Jun 30, 2020 (estimated)
Last update
Aug 28, 2019

Study contacts

Leanne LeClair, PHD
study director · University of Manitoba

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion