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Preventing Risk for Metabolic Syndrome in Workaholics: An Intervention

Primary Purpose

PreDiabetes

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Transform
Sponsored by
Simon Fraser University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PreDiabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- Employees who work 24 hours (3 days) per week or more.

Exclusion Criteria:

  • Pre-existing diabetes (I and II)
  • Pregnancy
  • End stage Renal disease

Sites / Locations

  • Fraser Health

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Transform

Arm Description

The control group completes three questionnaires in months 1, 3 and 6, including questions on health behaviours, workaholism and work outcomes.

Intervention (see next page)

Outcomes

Primary Outcome Measures

Health outcomes
Weight loss
Work outcomes
lower absenteeism

Secondary Outcome Measures

Full Information

First Posted
November 29, 2019
Last Updated
September 20, 2021
Sponsor
Simon Fraser University
Collaborators
Fraser Health
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1. Study Identification

Unique Protocol Identification Number
NCT04183907
Brief Title
Preventing Risk for Metabolic Syndrome in Workaholics: An Intervention
Official Title
Preventing Risk for Metabolic Syndrome in Workaholics: An Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
September 14, 2021 (Actual)
Study Completion Date
September 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Simon Fraser University
Collaborators
Fraser Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Given the serious nature of the health risks workaholics face, it is important to understand how the health risks of workaholics can be mitigated. Blue Mesa Health (BMH), partner in this research, has developed a digital lifestyle intervention program, Transform, that aims to prevent or delay the onset of type 2 diabetes through incremental changes to health behaviours. The program's participants work to improve their diet and physical activity levels with the guidance of a smartphone app and a remote health coach. The researchers designed a study to examine if Transform is particularly effective for workaholics as compared to non-workaholics. The goal of this study is to test the effectiveness of Transform in improving workaholics' and non-workaholics' health and work outcomes.
Detailed Description
The study that BMH and SFU will coordinate together consists of the following steps: A screening and eligibility survey (3 min) that determines a participant's risk for type 2 diabetes. Participants receive an email informing them of their relative risk (above average or below average). Above average risk: Participants are invited to participate in the study. Of the interested participants 100 will be randomly assigned to the Transform group or the Control group (n = 50 in each group). They have the option of deferring study enrollment until after an onsite information session. Below average risk: Participants are informed that they do not qualify to participate in Transform but they are welcome to participate in the Control group. There are 50 spots for below risk participants in the Control Group (total in control group = 100). The information session will take place for eligible participants assigned to the Transform group. Attending this session is voluntary. Both groups (Transform and Control) complete Monitor Survey 1 including questions on health behaviours, workaholism and work outcomes. The Transform intervention delivers weekly learning sessions and health coaching via the Transform mobile app to initiate and sustain changes to health behaviors. Participants receive a wireless scale at the start of Transform, and a wearable activity tracker (Fitbit) after 4 weeks provided that they meet the minimum engagement criteria . Both devices synchronize with the Transform app to transmit and automatically track activity and weight data. The program runs for six months; 4 months of core programing and 2 months of maintenance programing. At month 3, the Transform group and Control group are invited to complete Monitor Survey 2 (15-minutes) to report their health, well-being and work outcomes. This survey is meant to capture Transform's short-term effectiveness. At month 6, when the Transform maintenance program ends, Monitor Survey 3 is sent to the Transform and Control group participants to capture Transform's longer-term effectiveness on participants' health, well-being and work outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There will be one group that participates in the intervention, and one control group that does not.
Masking
None (Open Label)
Masking Description
Interested employees working at Fraser Health can sign up to our study. They will fill in a prediabetes check list. By filling out this check list (online survey) participants' the Blue Mesa Health portal assigns a participant number to each participant. The names of participants are stored on the portal. Participants scoring as 'risk for prediabetes' are invited to participate in the study. Of the interested participants 100 will be randomly assigned to the Transform group or the Control group (n = 50 in each group). Participants will know whether they participate in the lifestyle intervention (Transform program) or not. The researchers do not know (it is an online program) although they could in theory look up in the data which person is in the control vs treatment group.
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group completes three questionnaires in months 1, 3 and 6, including questions on health behaviours, workaholism and work outcomes.
Arm Title
Transform
Arm Type
Experimental
Arm Description
Intervention (see next page)
Intervention Type
Behavioral
Intervention Name(s)
Transform
Intervention Description
The Partner, Blue Mesa Health, has developed a lifestyle intervention program for pre-diabetics that aims to prevent or delay the onset of type 2 diabetes through incremental changes to health behaviours. Transform is based on the CDC's National Diabetes Prevention Program (DPP). Blue Mesa Health adapted the National DPP into a digital experience by combining the use of technology- an app, wearable activity trackers (Fitbit) and digital scales- with the professional guidance of remote health coaches. It is a 6-month intervention that helps individuals establish healthier lifestyle habits. Each participant strives to achieve 2 primary goals: Attaining 5 to 7 percent weight loss from their starting bodyweight Engaging in at least 150 minutes of weekly physical activity
Primary Outcome Measure Information:
Title
Health outcomes
Description
Weight loss
Time Frame
3 to 6 months
Title
Work outcomes
Description
lower absenteeism
Time Frame
3 to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Employees who work 24 hours (3 days) per week or more. Exclusion Criteria: Pre-existing diabetes (I and II) Pregnancy End stage Renal disease
Facility Information:
Facility Name
Fraser Health
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3T OH1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Electronic data collected in this study will be uploaded to the data repository of an academic journal, ONLY if the journal requires this. Some journals in health sciences and psychology require authors to share their data so that other researchers can re-analyze results or have statisticians check the analyses before publication. The de-identified data that will be uploaded to an online repository will not contain information that could identify participants (e.g., no names, email addresses, date of birth) and hence, does not increase the participants' risk or re-identification. Once data is shared with a journal, participants will be unable to withdraw their data. Participants can decide up to two months after completing the study, to withdraw their data.

Learn more about this trial

Preventing Risk for Metabolic Syndrome in Workaholics: An Intervention

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