PreDiabetesNCT04183907
Preventing Risk for Metabolic Syndrome in Workaholics: An Intervention
A study testing Transform in people with PreDiabetes, run by Simon Fraser University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Transform
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2021to 14 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employees who work 24 hours (3 days) per week or more.
Who cannot join
- Pre-existing diabetes (I and II)
- Pregnancy
- End stage Renal disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- PreDiabetes
- Being tested
- Transform
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TransformBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group completes three questionnaires in months 1, 3 and 6, including questions on health behaviours, workaholism and work outcomes. |
| Transform | Experimental | Intervention (see next page) Receives: Behavioral: Transform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health outcomes
Weight loss
Measured: 3 to 6 months
Work outcomes
lower absenteeism
Measured: 3 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start1 Feb 2021
- Primary completion14 Sep 2021
- Study completion14 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be one group that participates in the intervention, and one control group that does not.
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simon Fraser University
- Sponsor type
- University, hospital or other
- Collaborators
- Fraser Health
- Responsible party
- Principal investigator, Lieke ten Brummelhuis, Simon Fraser University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183907
- Sponsor's protocol ID
- H19-01533
- Status last verified
- Sep 2021
- First submitted
- 29 Nov 2019
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Risk for Metabolic Syndrome in Workaholics: An Intervention
- ClinicalTrials.gov ID
- NCT04183907
- Acronym / sponsor ID
- H19-01533
- Conditions
- PreDiabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Simon Fraser UniversityUniversity, hospital or other
- Collaborators
- Fraser Health
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 14 Sep 2021 (actual)
- Study completion
- 14 Sep 2021 (actual)
- First posted
- 3 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There will be one group that participates in the intervention, and one control group that does not.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group completes three questionnaires in months 1, 3 and 6, including questions on health behaviours, workaholism and work outcomes. |
| Transform | Experimental | Behavioral: TransformIntervention (see next page) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Employees who work 24 hours (3 days) per week or more.
Key exclusion criteria (3 listed)
- Pre-existing diabetes (I and II)
- Pregnancy
- End stage Renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TransformThe 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 | Behavioural | Transform |
Primary outcome
Health outcomes
Time frame: 3 to 6 months
Weight loss
Work outcomes
Time frame: 3 to 6 months
lower absenteeism
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transform in people with PreDiabetes, run by Simon Fraser University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health outcomes (time frame: 3 to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.