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Completed

NCT Number: NCT04183907

Preventing Risk for Metabolic Syndrome in Workaholics: An Intervention

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.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fraser Health

Surrey, British Columbia, V3T OH1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transform

Behavioral

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 outcomes

  1. Health outcomes

    Time frame: 3 to 6 months

    Weight loss

  2. Work outcomes

    Time frame: 3 to 6 months

    lower absenteeism

Sponsors and collaborators

Lead sponsor

Simon Fraser University

Other

Collaborators

  • Fraser Health

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 3, 2019
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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