Testing the Effectiveness of Different Messaging Approaches to Increase Doctor Visits Amongst Individuals With Risk Factors for Diabetes

March 30, 2023 updated by: Wits Health Consortium (Pty) Ltd

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

5000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2007
        • Discovery Vitality

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diabetes specialist
Message with a note from a diabetes specialist
Behavioral: Visit a doctor
Test messages 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)
Experimental: Someone like you
Message with a note from "a person like you"
Behavioral: Visit a doctor
Test messages 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)
Experimental: Vitality doctor
Message with a note from the Vitality doctor
Behavioral: Visit a doctor
Test messages 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting blood glucose (mmol/L)
Time Frame: 8 weeks
Type 2 Diabetes
8 weeks
Glucose tolerance test (mmol/L)
Time Frame: 8 weeks
Type 2 Diabetes
8 weeks
HbA1C(%)
Time Frame: 8 weeks
Pre-Diabetes
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wits Health Consortium (Pty) Ltd

Collaborators

Discovery Vitality

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2022

Primary Completion (Actual)

March 3, 2023

Study Completion (Anticipated)

May 15, 2023

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

March 3, 2023

First Posted (Actual)

March 6, 2023

Study Record Updates

Last Update Posted (Actual)

March 31, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M220715

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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