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Clinical Trials/NCT05755555
NCT05755555
Active, Not Recruiting
N/A

Testing the Effectiveness of Different Messaging Approaches to Increase Doctor Visits to Confirm or Exclude a Diagnosis of Prediabetes or Diabetes Amongst Individuals With Risk Factors for Diabetes: A Randomised, Controlled Trial

Wits Health Consortium (Pty) Ltd1 site in 1 country5,000 target enrollmentAugust 4, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
Wits Health Consortium (Pty) Ltd
Enrollment
5000
Locations
1
Primary Endpoint
Fasting blood glucose (mmol/L)
Status
Active, Not Recruiting
Last Updated
3 years ago

Overview

Brief Summary

The purpose of the research is to test the effectiveness of different messaging approaches to nudge members of Vitality and Discovery Health, with risk factors for diabetes (based on data from the Vitality Health Check and Vitality Age assessment), to visit a doctor and test for diabetes. The messages are based on concepts from behavioural economics that aim to make information on screening more salient by using the concept of social proof (person like you) and an authoritative source (a diabetes specialist and the Vitality doctor).

Detailed Description

Members of Vitality who are also members of the Discovery Health medical plan and who have risk factors for diabetes but who have not previously been diagnosed with diabetes will be eligible for the study. Subjects will be identified based on the Vitality Age assessment and the Vitality Health Check done in the previous year. The risk factors identified by these assessments and which are important for eligibility are age ≥45years, overweight and obesity, family history of diabetes, hypertension or raised high blood pressure, low levels of physical activity, cardiovascular disease, and dyslipidemia. It is estimated that approximately 5000 Vitality members will be eligible for the study. Only the actuarial team assigned to the study will have access to the data. Participants will de-identified and randomly allocated to the control and four intervention arms. Messages will be sent via email to them which addresses their specific health risks and measures they can take to address those risk. The messages will be in an encrypted PDF sent by email. In compliance with the POPIA Act, as a first step, participants will be asked to provide consent, by confirming their ID number, to share their individual risks information with them. Messages sent via email will have the same basic structure. All three of the experimental arm messages will include the following: * The same subject line * A description of their risk factors for diabetes * A description of the benefits of visiting a doctor and getting screened for diabetes

Registry
clinicaltrials.gov
Start Date
August 4, 2022
End Date
May 15, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Members of Vitality who are also members of the Discovery Health medical plan and who have risk factors for diabetes but who have not previously been diagnosed with diabetes
  • Risk factors are age ≥45years, overweight and obesity, family history of diabetes, hypertension or raised high blood pressure, low levels of physical activity, cardiovascular disease, and dyslipidemia.

Exclusion Criteria

  • \< 18 years \>= 65 years
  • Diagnosed with diabetes

Outcomes

Primary Outcomes

Fasting blood glucose (mmol/L)

Time Frame: 8 weeks

Type 2 Diabetes

Glucose tolerance test (mmol/L)

Time Frame: 8 weeks

Type 2 Diabetes

HbA1C(%)

Time Frame: 8 weeks

Pre-Diabetes

Study Sites (1)

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