CClinicalTrials.gg
Status unknownNCT05755555Updated Mar 31, 2023

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

An interventional study of Visit a doctor in Type 2 Diabetes and Pre-diabetes, sponsored by Wits Health Consortium (Pty) Ltd. Status unknown at 1 site in South Africa. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-31.

Sponsored by Wits Health Consortium (Pty) Ltd · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Aug 2022, registered Feb 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
5,000
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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).

Read the 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
02

Conditions studied

  • Type 2 Diabetes
  • Pre-diabetes
03

In context

Diabetes Mellitus

10,926 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 5,000 is above the median of 80 across 8,368 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Wits Health Consortium (Pty) Ltd is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • \< 18 years >= 65 years
  • Diagnosed with diabetes
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
5,000 participants (actual)

Study arms

  • Experimental
    Diabetes specialist

    Message with a note from a diabetes specialist

    Behavioral: Visit a doctor

  • Experimental
    Someone like you

    Message with a note from "a person like you"

    Behavioral: Visit a doctor

  • Experimental
    Vitality doctor

    Message with a note from the Vitality doctor

    Behavioral: Visit a doctor

Interventions

  • BehavioralVisit 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)

06

What researchers measure

Primary outcomes

  1. Fasting blood glucose (mmol/L)

    Type 2 Diabetes

    Time frame: 8 weeks

  2. Glucose tolerance test (mmol/L)

    Type 2 Diabetes

    Time frame: 8 weeks

  3. HbA1C(%)

    Pre-Diabetes

    Time frame: 8 weeks

07

Study locations

1 site
  • Discovery Vitality
    Johannesburg, Gauteng 2007, South Africa
08

References and documents

Publications

  • Polonsky KS. The past 200 years in diabetes. N Engl J Med. 2012 Oct 4;367(14):1332-40. doi: 10.1056/NEJMra1110560. No abstract available. PubMed 23034021 ↗
  • Pheiffer C, Pillay-van Wyk V, Turawa E, Levitt N, Kengne AP, Bradshaw D. Prevalence of Type 2 Diabetes in South Africa: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 May 30;18(11):5868. doi: 10.3390/ijerph18115868. PubMed 34070714 ↗
  • Stamler J, Vaccaro O, Neaton JD, Wentworth D. Diabetes, other risk factors, and 12-yr cardiovascular mortality for men screened in the Multiple Risk Factor Intervention Trial. Diabetes Care. 1993 Feb;16(2):434-44. doi: 10.2337/diacare.16.2.434. PubMed 8432214 ↗
  • Nathan DM. Long-term complications of diabetes mellitus. N Engl J Med. 1993 Jun 10;328(23):1676-85. doi: 10.1056/NEJM199306103282306. No abstract available. PubMed 8487827 ↗
  • Fong DS, Aiello L, Gardner TW, King GL, Blankenship G, Cavallerano JD, Ferris FL 3rd, Klein R; American Diabetes Association. Retinopathy in diabetes. Diabetes Care. 2004 Jan;27 Suppl 1:S84-7. doi: 10.2337/diacare.27.2007.s84. No abstract available. PubMed 14693935 ↗
  • The Society for Endocrinology, Metabolism and Diabetes of South Africa Type 2 Diabetes Guidelines Expert Committee. Chapter 3: Screening and diagnosis of type 2 diabetes and intermediate hyperglycaemia "Chapter Title" in 2017 SEMDSA Guideline for the Management of Type 2 Diabetes Guideline Committee. JEMDSA 2017; 21(1)(Supplement 1): S1-S196.
  • American Diabetes Association. Standards of medical care in diabetes--2013. Diabetes Care. 2013 Jan;36 Suppl 1(Suppl 1):S11-66. doi: 10.2337/dc13-S011. No abstract available. PubMed 23264422 ↗
  • Definitions and Diagnosis of Diabetes Mellitus and Intermediate Hyperglycemeia: Report of the WHO/IDF Consultation. Geneva: World Health Organisation, 2006
  • Gerstein HC, Santaguida P, Raina P, Morrison KM, Balion C, Hunt D, Yazdi H, Booker L. Annual incidence and relative risk of diabetes in people with various categories of dysglycemia: a systematic overview and meta-analysis of prospective studies. Diabetes Res Clin Pract. 2007 Dec;78(3):305-12. doi: 10.1016/j.diabres.2007.05.004. Epub 2007 Jun 29. PubMed 17601626 ↗
  • Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512. PubMed 11832527 ↗
  • Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50. doi: 10.1056/NEJM200105033441801. PubMed 11333990 ↗
  • Pan XR, Li GW, Hu YH, Wang JX, Yang WY, An ZX, Hu ZX, Lin J, Xiao JZ, Cao HB, Liu PA, Jiang XG, Jiang YY, Wang JP, Zheng H, Zhang H, Bennett PH, Howard BV. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study. Diabetes Care. 1997 Apr;20(4):537-44. doi: 10.2337/diacare.20.4.537. PubMed 9096977 ↗
  • Li G, Zhang P, Wang J, Gregg EW, Yang W, Gong Q, Li H, Li H, Jiang Y, An Y, Shuai Y, Zhang B, Zhang J, Thompson TJ, Gerzoff RB, Roglic G, Hu Y, Bennett PH. The long-term effect of lifestyle interventions to prevent diabetes in the China Da Qing Diabetes Prevention Study: a 20-year follow-up study. Lancet. 2008 May 24;371(9626):1783-9. doi: 10.1016/S0140-6736(08)60766-7. PubMed 18502303 ↗
  • Lindstrom J, Ilanne-Parikka P, Peltonen M, Aunola S, Eriksson JG, Hemio K, Hamalainen H, Harkonen P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Mannelin M, Paturi M, Sundvall J, Valle TT, Uusitupa M, Tuomilehto J; Finnish Diabetes Prevention Study Group. Sustained reduction in the incidence of type 2 diabetes by lifestyle intervention: follow-up of the Finnish Diabetes Prevention Study. Lancet. 2006 Nov 11;368(9548):1673-9. doi: 10.1016/S0140-6736(06)69701-8. PubMed 17098085 ↗
  • Look AHEAD Research Group; Wing RR, Bolin P, Brancati FL, Bray GA, Clark JM, Coday M, Crow RS, Curtis JM, Egan CM, Espeland MA, Evans M, Foreyt JP, Ghazarian S, Gregg EW, Harrison B, Hazuda HP, Hill JO, Horton ES, Hubbard VS, Jakicic JM, Jeffery RW, Johnson KC, Kahn SE, Kitabchi AE, Knowler WC, Lewis CE, Maschak-Carey BJ, Montez MG, Murillo A, Nathan DM, Patricio J, Peters A, Pi-Sunyer X, Pownall H, Reboussin D, Regensteiner JG, Rickman AD, Ryan DH, Safford M, Wadden TA, Wagenknecht LE, West DS, Williamson DF, Yanovski SZ. Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes. N Engl J Med. 2013 Jul 11;369(2):145-54. doi: 10.1056/NEJMoa1212914. Epub 2013 Jun 24. Erratum In: N Engl J Med. 2014 May 8;370(19):1866. PubMed 23796131 ↗
  • Look AHEAD Research Group; Wing RR. Long-term effects of a lifestyle intervention on weight and cardiovascular risk factors in individuals with type 2 diabetes mellitus: four-year results of the Look AHEAD trial. Arch Intern Med. 2010 Sep 27;170(17):1566-75. doi: 10.1001/archinternmed.2010.334. PubMed 20876408 ↗
  • Wing RR, Lang W, Wadden TA, Safford M, Knowler WC, Bertoni AG, Hill JO, Brancati FL, Peters A, Wagenknecht L; Look AHEAD Research Group. Benefits of modest weight loss in improving cardiovascular risk factors in overweight and obese individuals with type 2 diabetes. Diabetes Care. 2011 Jul;34(7):1481-6. doi: 10.2337/dc10-2415. Epub 2011 May 18. PubMed 21593294 ↗
  • Look AHEAD Research Group; Wadden TA, West DS, Delahanty L, Jakicic J, Rejeski J, Williamson D, Berkowitz RI, Kelley DE, Tomchee C, Hill JO, Kumanyika S. The Look AHEAD study: a description of the lifestyle intervention and the evidence supporting it. Obesity (Silver Spring). 2006 May;14(5):737-52. doi: 10.1038/oby.2006.84. Erratum In: Obesity (Silver Spring). 2007 May;15(5):1339. Wadden, Thomas A [added]; West, Delia Smith [added]; Delahanty, Linda [added]; Jakicic, John [added]; Rejeski, Jack [added]; Williamson, Don [added]; Berkowitz, Robert I [added]; Kelley, David E [added]; Tomchee, Christine [added]; Hill, James O [added]; K. PubMed 16855180 ↗
  • Look AHEAD Research Group; Pi-Sunyer X, Blackburn G, Brancati FL, Bray GA, Bright R, Clark JM, Curtis JM, Espeland MA, Foreyt JP, Graves K, Haffner SM, Harrison B, Hill JO, Horton ES, Jakicic J, Jeffery RW, Johnson KC, Kahn S, Kelley DE, Kitabchi AE, Knowler WC, Lewis CE, Maschak-Carey BJ, Montgomery B, Nathan DM, Patricio J, Peters A, Redmon JB, Reeves RS, Ryan DH, Safford M, Van Dorsten B, Wadden TA, Wagenknecht L, Wesche-Thobaben J, Wing RR, Yanovski SZ. Reduction in weight and cardiovascular disease risk factors in individuals with type 2 diabetes: one-year results of the look AHEAD trial. Diabetes Care. 2007 Jun;30(6):1374-83. doi: 10.2337/dc07-0048. Epub 2007 Mar 15. PubMed 17363746 ↗
  • Gregg EW, Chen H, Wagenknecht LE, Clark JM, Delahanty LM, Bantle J, Pownall HJ, Johnson KC, Safford MM, Kitabchi AE, Pi-Sunyer FX, Wing RR, Bertoni AG; Look AHEAD Research Group. Association of an intensive lifestyle intervention with remission of type 2 diabetes. JAMA. 2012 Dec 19;308(23):2489-96. doi: 10.1001/jama.2012.67929. PubMed 23288372 ↗
  • Camerer C. Challenges for Behavioral Economics - Cumulating and Distilling What We Know. In A. Samson (Ed.), The Behavioral Economics Guide 2020 (with an Introduction by Colin Camerer)(VI - XV). Retrieved from https://www.behavioraleconomics.com.
  • Samson, A. (Ed.)(2021). The Behavioral Economics Guide 2021 (with an Introduction by John List). https://www.behavioraleconomics.com/be-guide/.
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05755555
Lead sponsor
Wits Health Consortium (Pty) Ltd
Collaborators
Discovery Vitality
Responsible party
Sponsor
First posted
Mar 6, 2023
Start date
Aug 4, 2022
Primary completion
Mar 3, 2023
Completion
May 15, 2023 (estimated)
Last update
Mar 31, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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