Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2019

Open Access 01-12-2019 | Study protocol

TRIal to slow the Progression Of Diabetes (TRIPOD): study protocol for a randomized controlled trial using wireless technology and incentives

Authors: Robyn Su May Lim, Daphne Su Lyn Gardner, Yong Mong Bee, Yin Bun Cheung, Joann Bairavi, Mihir Gandhi, Su-Yen Goh, Emily Tse Lin Ho, Xinyi Lin, Ngiap Chuan Tan, Tunn Lin Tay, Eric Andrew Finkelstein

Published in: Trials | Issue 1/2019

Login to get access

Abstract

Background

The outcomes for those with type 2 diabetes mellitus (T2DM) in Singapore are poor. In this TRIal to slow the Progression Of Diabetes (TRIPOD), we will evaluate the effectiveness and cost-effectiveness of a comprehensive diabetes management package (DMP), with or without a financial incentives program, M-POWER Rewards, in efforts to improve HbA1c levels for individuals with T2DM.

Methods/design

TRIPOD is a randomized, open-label, controlled, multi-center, superiority trial with three parallel arms: (1) usual care only, (2) usual care with DMP, and (3) usual care with DMP plus M-POWER Rewards. A total of 339 adults with sub-optimally controlled T2DM (self-reported HbA1c 7.5–11.0%) will be block randomized according to a 1:1:1 allocation ratio to the three arms. The primary outcome is mean change in HbA1c level at Month 12 from baseline. Secondary outcomes include mean change in HbA1c level at Months 6, 18, and 24; mean changes at Months 6, 12, 18, and 24 in weight, blood pressure, and self-reported physical activity, weight monitoring, blood glucose monitoring, medication adherence, diabetes self-management, sleep quality, work productivity and daily activity impairment, and health utility index; and proportion of participants initiating insulin treatment by Months 6, 12, 18, and 24. Incremental cost-effectiveness ratios will be computed based on costs per improvement in HbA1c at Month 12 and converted to cost per quality-adjusted life year gained.

Discussion

The TRIPOD study will present insights about the long-term cost-effectiveness and financial viability of the interventions and the potential for integrating within usual care.

Trial registration

ClinicalTrials.gov, NCT03800680. Registered on 11 January 2019.
Appendix
Available only for authorised users
Literature
1.
NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in diabetes since 1980: a pooled analysis of 751 population-based studies with 4.4 million participants. Lancet. 2016;387(10027):1513–30.CrossRef
2.
3.
Phan TP, Alkema L, Tai ES, Tan KH, Yang Q, Lim WY, et al. Forecasting the burden of type 2 diabetes in Singapore using a demographic epidemiological model of Singapore. BMJ Open Diabetes Res Care. 2014;2(1):e000012.PubMedPubMedCentralCrossRef
4.
Png ME, Yoong J, Phan TP, Wee HL. Current and future economic burden of diabetes among working-age adults in Asia: conservative estimates for Singapore from 2010-2050. BMC Public Health. 2016;16(1):153.PubMedPubMedCentralCrossRef
5.
Stratton IM, Adler AI, Neil HAW, Matthews DR, Manley SE, Cull CA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000;321(7258):405–12.PubMedPubMedCentralCrossRef
6.
Wing RR, Lang W, Wadden TA, Safford M, Knowler WC, Bertoni AG, et al. Benefits of modest weight loss in improving cardiovascular risk factors in overweight and obese individuals with type 2 diabetes. Diabetes Care. 2011;34(7):1481–6.PubMedPubMedCentralCrossRef
7.
Pillay J, Armstrong MJ, Butalia S, Donovan LE, Sigal RJ, Vandermeer B, et al. Behavioral programs for type 2 diabetes mellitus: a systematic review and network meta-analysis. Ann Intern Med. 2015;163(11):848–60.CrossRef
8.
Chrvala CA, Sherr D, Lipman RD. Diabetes self-management education for adults with type 2 diabetes mellitus: a systematic review of the effect on glycemic control. Patient Educ Couns. 2016;99(6):926–43.PubMedCrossRef
9.
Avery L, Flynn D, van Wersch A, Sniehotta FF, Trenell MI. Changing physical activity behavior in type 2 diabetes: a systematic review and meta-analysis of behavioral interventions. Diabetes Care. 2012;35(12):2681–9.PubMedPubMedCentralCrossRef
10.
11.
McIntosh B, Yu C, Lal A, Chelak K, Cameron C, Singh SR, et al. Efficacy of self-monitoring of blood glucose in patients with type 2 diabetes mellitus managed without insulin: a systematic review and meta-analysis. Open Med. 2010;4(2):e102–13.PubMedPubMedCentral
12.
Sapkota S, Brien JA, Greenfield J, Aslani P. A systematic review of interventions addressing adherence to anti-diabetic medications in patients with type 2 diabetes–impact on adherence. PLOS One. 2015;10(2):e0118296.PubMedPubMedCentralCrossRef
13.
Pirbaglou M, Katz J, Motamed M, Pludwinski S, Walker K, Ritvo P. Personal health coaching as a type 2 diabetes mellitus self-management strategy: a systematic review and meta-analysis of randomized controlled trials. Am J Health Promot. 2018;32(7):1613–26.PubMedCrossRef
14.
Koot D, Goh PSC, Lim RSM, Tian Y, Yau TY, Tan NC, et al. A mobile lifestyle management program (GlycoLeap) for people with type 2 diabetes: single-arm feasibility study. JMIR Mhealth Uhealth. 2019;7(5):e12965.PubMedPubMedCentralCrossRef
15.
Gummesson A, Nyman E, Knutsson M, Karpefors M. Effect of weight reduction on glycated haemoglobin in weight loss trials in patients with type 2 diabetes. Diabetes Obes Metab. 2017;19(9):1295–305.CrossRef
16.
Dempsey RC, McAlaney J, Bewick BM. A critical appraisal of the social norms approach as an interventional strategy for health-related behavior and attitude change. Front Psychol. 2018;9:2180.PubMedPubMedCentralCrossRef
17.
Robinson E, Fleming A, Higgs S. Prompting healthier eating: testing the use of health and social norm based messages. Health Psychol. 2014;33(9):1057–64.PubMedCrossRef
18.
Mollen S, Rimal RN, Ruiter RA, Kok G. Healthy and unhealthy social norms and food selection. Findings from a field-experiment. Appetite. 2013;65:83–9.PubMedCrossRef
19.
Stok FM, de Ridder DT, de Vet E, de Wit JB. Don’t tell me what I should do, but what others do: the influence of descriptive and injunctive peer norms on fruit consumption in adolescents. Br J Health Psychol. 2014;19(1):52–64.PubMedCrossRef
20.
Tversky A, Kahneman D. Loss aversion in riskless choice: a reference-dependent model. Q J Econ. 1991;106(4):1039–61.CrossRef
21.
22.
23.
Adams R. Revised physical activity readiness questionnaire. Can Fam Physician. 1999;45(992):995,1004–5.
24.
Mazar N, Amir O, Ariely D. The dishonesty of honest people: a theory of self-concept maintenance. J Mark Res. 2008;45(6):633–44.CrossRef
25.
Tricco AC, Ivers NM, Grimshaw JM, Moher D, Turner L, Galipeau J, et al. Effectiveness of quality improvement strategies on the management of diabetes: a systematic review and meta-analysis. Lancet. 2012;379(9833):2252–61.PubMedCrossRef
26.
Armstrong T, Bull F. Development of the World Health Organization Global Physical Activity Questionnaire (GPAQ). J Public Health. 2006;14(2):66–70.CrossRef
27.
Schmitt A, Gahr A, Hermanns N, Kulzer B, Huber J, Haak T. The Diabetes Self-Management Questionnaire (DSMQ): development and evaluation of an instrument to assess diabetes self-care activities associated with glycaemic control. Health Qual Life Outcomes. 2013;11(1):138.PubMedPubMedCentralCrossRef
28.
Buysse DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28(2):193–213.PubMedCrossRef
29.
Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993;4(5):353–65.PubMedCrossRef
30.
EuroQol. EuroQol - a new facility for the measurement of health-related quality of life. Health Policy. 1990;16(3):199–208.CrossRef
31.
Bilger M, Shah M, Tan NC, Howard KL, Xu HY, Lamoureux EL, et al. Trial to Incentivise Adherence for Diabetes (TRIAD): study protocol for a randomised controlled trial. Trials. 2017;18(1):551.PubMedPubMedCentralCrossRef
32.
Marcus R, Peritz E, Gabriel KR. On closed testing procedures with special reference to ordered analysis of variance. Biometrika. 1976;63(3):655–60.CrossRef
33.
34.
Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006;60(6):631–7.PubMedCrossRef
35.
Broadbent E, Wilkes C, Koschwanez H, Weinman J, Norton S, Petrie KJ. A systematic review and meta-analysis of the Brief Illness Perception Questionnaire. Psychol Health. 2015;30:1–74.CrossRef
36.
Finkelstein EA, Troped PJ, Will JC, Palombo R. Cost-effectiveness of a cardiovascular disease risk reduction program aimed at financially vulnerable women: the Massachusetts WISEWOMAN project. J Womens Health Gend Based Med. 2002;11(6):519–26.PubMedCrossRef
37.
Finkelstein E, Khavjou O, Will J. Cost-effectiveness of WISEWOMAN, a program aimed at reducing heart disease risk among low-income women. J Women's Health. 2006;15:379–89.CrossRef
38.
Jakicic JM, Tate DF, Lang W, Davis KK, Polzien K, Rickman AD, et al. Effect of a stepped-care intervention approach on weight loss in adults: a randomized clinical trial. JAMA. 2012;307(24):2617–26.PubMedPubMedCentralCrossRef
39.
Finkelstein EA, Haaland BA, Bilger M, Sahasranaman A, Sloan RA, Nang EEK, et al. Effectiveness of activity trackers with and without incentives to increase physical activity (TRIPPA): a randomised controlled trial. Lancet Diabetes Endocrinol. 2016;4(12):983–95.PubMedCrossRef
40.
Bilger M, Wong TT, Howard KL, Lee JY, Toh AN, John G, et al. Study on Incentives for Glaucoma Medication Adherence (SIGMA): study protocol for a randomized controlled trial to increase glaucoma medication adherence using value pricing. Trials. 2016;17(1):316.PubMedPubMedCentralCrossRef
41.
Long JA, Jahnle EC, Richardson DM, Loewenstein G, Volpp KG. Peer mentoring and financial incentives to improve glucose control in African American veterans: a randomized trial. Ann Intern Med. 2012;156(6):416–24.PubMedPubMedCentralCrossRef
42.
Sen AP, Sewell TB, Riley EB, Stearman B, Bellamy SL, Hu MF, et al. Financial incentives for home-based health monitoring: a randomized controlled trial. J Gen Intern Med. 2014;29(5):770–7.PubMedPubMedCentralCrossRef
43.
International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals. N Engl J Med. 1997;336(4):309–15.CrossRef
Metadata
Title
TRIal to slow the Progression Of Diabetes (TRIPOD): study protocol for a randomized controlled trial using wireless technology and incentives
Authors
Robyn Su May Lim
Daphne Su Lyn Gardner
Yong Mong Bee
Yin Bun Cheung
Joann Bairavi
Mihir Gandhi
Su-Yen Goh
Emily Tse Lin Ho
Xinyi Lin
Ngiap Chuan Tan
Tunn Lin Tay
Eric Andrew Finkelstein
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3749-x

Other articles of this Issue 1/2019

Trials 1/2019 Go to the issue

Study protocol

Protocol for a phase III wait-listed cluster randomised controlled trial of an intervention for mental well-being through enhancing mental health literacy and improving work friendliness in Hong Kong

Study protocol

A double-blinded, randomized placebo-controlled trial on the effect of traditional Chinese medicine formula Wuzi Yanzong pill on improving semen qualities in men with suboptimal parameters

Study protocol

Efficacy of post-procedural oral hydration volume on risk of contrast-induced acute kidney injury following primary percutaneous coronary intervention: study protocol for a randomized controlled trial

Methodology

Sample size estimation for randomised controlled trials with repeated assessment of patient-reported outcomes: what correlation between baseline and follow-up outcomes should we assume?

Study protocol

MultiTex RCT – a multifaceted intervention package for protection against cotton dust exposure among textile workers – a cluster randomized controlled trial in Pakistan: study protocol

Methodology

Expert panel process to optimise the design of a randomised controlled trial in chronic rhinosinusitis (the MACRO programme)