NCT04183907

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2021

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

8 months

First QC Date

November 29, 2019

Last Update Submit

September 20, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Health outcomes

    Weight loss

    3 to 6 months

  • Work outcomes

    lower absenteeism

    3 to 6 months

Study Arms (2)

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)

Behavioral: Transform

Interventions

TransformBEHAVIORAL

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

Transform

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fraser Health

Surrey, British Columbia, V3T OH1, Canada

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: There will be one group that participates in the intervention, and one control group that does not.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 29, 2019

First Posted

December 3, 2019

Study Start

February 1, 2021

Primary Completion

September 14, 2021

Study Completion

September 14, 2021

Last Updated

September 21, 2021

Record last verified: 2021-09

Locations