Clinical trial NCT04183907: Preventing Risk for Metabolic Syndrome in Workaholics: An Intervention
Official title: Preventing Risk for Metabolic Syndrome in Workaholics: An Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Lead sponsor: Simon Fraser University
Sponsor class: OTHER
Collaborators: name: Fraser Health
First posted: 2019-12-03
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be one group that participates in the intervention, and one control group that does not.
Primary purpose: PREVENTION

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:

1. A screening and eligibility survey (3 min) that determines a participant's risk for type 2 diabetes.
2. Participants receive an email informing them of their relative risk (above average or below average).

   1. 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.
   2. 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).
3. The information session will take place for eligible participants assigned to the Transform group. Attending this session is voluntary.
4. Both groups (Transform and Control) complete Monitor Survey 1 including questions on health behaviours, workaholism and work outcomes.
5. 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.
6. 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.
7. 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.

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

Primary outcomes:
measure: Health outcomes
timeFrame: 3 to 6 months
measure: Work outcomes
timeFrame: 3 to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Surrey
country: Canada
facility: Fraser Health
state: British Columbia
Study officials:
References: