Preventing Risk for Metabolic Syndrome in Workaholics: An Intervention

PreDiabetes Clinical Trial

Official title:

Preventing Risk for Metabolic Syndrome in Workaholics: An Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04183907
• Other study ID #: H19-01533
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: September 14, 2021

Study information

• Verified date: September 2021
• Source: Simon Fraser University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: September 14, 2021
• Est. primary completion date: September 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• PreDiabetes

Intervention

Behavioral:
• Transform
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

Locations

Country	Name	City	State
Canada	Fraser Health	Surrey	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Simon Fraser University	Fraser Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health outcomes	Weight loss	3 to 6 months
Primary	Work outcomes	lower absenteeism	3 to 6 months