Testing the Effectiveness of Different Messaging Approaches to Increase Doctor Visits Amongst Individuals With Risk Factors for Diabetes
Primary Purpose
Type 2 Diabetes, Pre-diabetes
Status
Active
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Visit a doctor
Sponsored by
About this trial
This is an interventional screening trial for Type 2 Diabetes
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
Sites / Locations
- Discovery Vitality
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Diabetes specialist
Someone like you
Vitality doctor
Arm Description
Message with a note from a diabetes specialist
Message with a note from "a person like you"
Message with a note from the Vitality doctor
Outcomes
Primary Outcome Measures
Fasting blood glucose (mmol/L)
Type 2 Diabetes
Glucose tolerance test (mmol/L)
Type 2 Diabetes
HbA1C(%)
Pre-Diabetes
Secondary Outcome Measures
Full Information
NCT ID
NCT05755555
First Posted
February 1, 2023
Last Updated
March 30, 2023
Sponsor
Wits Health Consortium (Pty) Ltd
Collaborators
Discovery Vitality
1. Study Identification
Unique Protocol Identification Number
NCT05755555
Brief Title
Testing the Effectiveness of Different Messaging Approaches to Increase Doctor Visits Amongst Individuals With Risk Factors for Diabetes
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 4, 2022 (Actual)
Primary Completion Date
March 3, 2023 (Actual)
Study Completion Date
May 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wits Health Consortium (Pty) Ltd
Collaborators
Discovery Vitality
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Pre-diabetes
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
5000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diabetes specialist
Arm Type
Experimental
Arm Description
Message with a note from a diabetes specialist
Arm Title
Someone like you
Arm Type
Experimental
Arm Description
Message with a note from "a person like you"
Arm Title
Vitality doctor
Arm Type
Experimental
Arm Description
Message with a note from the Vitality doctor
Intervention Type
Behavioral
Intervention Name(s)
Visit a doctor
Intervention Description
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)
Primary Outcome Measure Information:
Title
Fasting blood glucose (mmol/L)
Description
Type 2 Diabetes
Time Frame
8 weeks
Title
Glucose tolerance test (mmol/L)
Description
Type 2 Diabetes
Time Frame
8 weeks
Title
HbA1C(%)
Description
Pre-Diabetes
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Discovery Vitality
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2007
Country
South Africa
12. IPD Sharing Statement
Citations:
PubMed Identifier
23034021
Citation
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.
Results Reference
background
PubMed Identifier
34070714
Citation
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.
Results Reference
background
PubMed Identifier
8432214
Citation
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.
Results Reference
background
PubMed Identifier
8487827
Citation
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.
Results Reference
background
PubMed Identifier
14693935
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
23264422
Citation
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.
Results Reference
background
Citation
Definitions and Diagnosis of Diabetes Mellitus and Intermediate Hyperglycemeia: Report of the WHO/IDF Consultation. Geneva: World Health Organisation, 2006
Results Reference
background
PubMed Identifier
17601626
Citation
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.
Results Reference
background
PubMed Identifier
11832527
Citation
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.
Results Reference
background
PubMed Identifier
11333990
Citation
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.
Results Reference
background
PubMed Identifier
9096977
Citation
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.
Results Reference
background
PubMed Identifier
18502303
Citation
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.
Results Reference
background
PubMed Identifier
17098085
Citation
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.
Results Reference
background
PubMed Identifier
23796131
Citation
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.
Results Reference
background
PubMed Identifier
20876408
Citation
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.
Results Reference
background
PubMed Identifier
21593294
Citation
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.
Results Reference
background
PubMed Identifier
16855180
Citation
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.
Results Reference
background
PubMed Identifier
17363746
Citation
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.
Results Reference
background
PubMed Identifier
23288372
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
Samson, A. (Ed.)(2021). The Behavioral Economics Guide 2021 (with an Introduction by John List). https://www.behavioraleconomics.com/be-guide/.
Results Reference
background
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Testing the Effectiveness of Different Messaging Approaches to Increase Doctor Visits Amongst Individuals With Risk Factors for Diabetes
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