NCT05755555

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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 4, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

February 1, 2023

Last Update Submit

March 30, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Fasting blood glucose (mmol/L)

    Type 2 Diabetes

    8 weeks

  • Glucose tolerance test (mmol/L)

    Type 2 Diabetes

    8 weeks

  • HbA1C(%)

    Pre-Diabetes

    8 weeks

Study Arms (3)

Diabetes specialist

EXPERIMENTAL

Message with a note from a diabetes specialist

Behavioral: Visit a doctor

Someone like you

EXPERIMENTAL

Message with a note from "a person like you"

Behavioral: Visit a doctor

Vitality doctor

EXPERIMENTAL

Message with a note from the Vitality doctor

Behavioral: Visit a doctor

Interventions

Visit a doctorBEHAVIORAL

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)

Diabetes specialistSomeone like youVitality doctor

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Discovery Vitality

Johannesburg, Gauteng, 2007, South Africa

Location

Related Publications (22)

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    PMID: 23034021BACKGROUND
  • 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.

    PMID: 34070714BACKGROUND
  • 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.

    PMID: 8432214BACKGROUND
  • 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.

    PMID: 8487827BACKGROUND
  • 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.

    PMID: 14693935BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 23264422BACKGROUND
  • Definitions and Diagnosis of Diabetes Mellitus and Intermediate Hyperglycemeia: Report of the WHO/IDF Consultation. Geneva: World Health Organisation, 2006

    BACKGROUND
  • 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.

    PMID: 17601626BACKGROUND
  • 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.

    PMID: 11832527BACKGROUND
  • 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.

    PMID: 11333990BACKGROUND
  • 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.

    PMID: 9096977BACKGROUND
  • 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.

    PMID: 18502303BACKGROUND
  • 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.

    PMID: 17098085BACKGROUND
  • 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.

    PMID: 23796131BACKGROUND
  • 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.

    PMID: 20876408BACKGROUND
  • 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.

    PMID: 21593294BACKGROUND
  • 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.

    PMID: 16855180BACKGROUND
  • 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.

    PMID: 17363746BACKGROUND
  • 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.

    PMID: 23288372BACKGROUND
  • 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.

    BACKGROUND
  • Samson, A. (Ed.)(2021). The Behavioral Economics Guide 2021 (with an Introduction by John List). https://www.behavioraleconomics.com/be-guide/.

    BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Glucose Intolerance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2023

First Posted

March 6, 2023

Study Start

August 4, 2022

Primary Completion

March 3, 2023

Study Completion

May 15, 2023

Last Updated

March 31, 2023

Record last verified: 2023-03

Locations