Midcourse correction to a clinical trial when the event rate is underestimated: the Look AHEAD (Action for Health in Diabetes) Study

Clinical Trials : Journal of the Society for Clinical Trials
Frederick BrancatiLook AHEAD Study Group

Abstract

The Look AHEAD (Action for Health in Diabetes) Study is a long-term clinical trial that aims to determine the cardiovascular disease (CVD) benefits of an intensive lifestyle intervention (ILI) in obese adults with type 2 diabetes. The study was designed to have 90% statistical power to detect an 18% reduction in the CVD event rate in the ILI Group compared to the Diabetes Support and Education (DSE) Group over 10.5 years of follow-up. The original power calculations were based on an expected CVD rate of 3.125% per year in the DSE group; however, a much lower-than-expected rate in the first 2 years of follow-up prompted the Data and Safety Monitoring Board (DSMB) to recommend that the Steering Committee undertake a formal blinded evaluation of these design considerations. The Steering Committee created an Endpoint Working Group (EPWG) that consisted of individuals masked to study data to examine relevant issues. The EPWG considered two primary options: (1) expanding the definition of the primary endpoint and (2) extending follow-up of participants. Ultimately, the EPWG recommended that the Look AHEAD Steering Committee approve both strategies. The DSMB accepted these modifications, rather than recommending that the trial continu...Continue Reading

Associated Clinical Trials

References

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Citations

Nov 5, 2014·Current Atherosclerosis Reports·Lisa R StaimezEdward W Gregg
Jan 7, 2014·Nutrition, Metabolism, and Cardiovascular Diseases : NMCD·G AnnuzziG Riccardi
Jun 26, 2013·The New England Journal of Medicine·Rena R WingSusan Z Yanovski
Mar 3, 2015·Current Nutrition Reports·Xavier Pi-Sunyer
May 21, 2014·Current Medical Research and Opinion·Richard KonesJordi Merino
Mar 28, 2013·The American Journal of the Medical Sciences·Scott Drab
May 24, 2014·Diabetes, Obesity & Metabolism·R R Wing, UNKNOWN Look AHEAD Research Group
May 6, 2015·Progress in Cardiovascular Diseases·Gareth R Dutton, Cora E Lewis
Mar 25, 2014·Journal of the Academy of Nutrition and Dietetics·Linda M Delahanty
Jul 6, 2017·Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research·Karen C JohnsonUNKNOWN Look AHEAD Study Group
May 18, 2016·Advances in Nutrition·James R HébertIra S Ockene
Feb 20, 2013·Nature Reviews. Cardiology·Jean-Pierre Després, Paul Poirier
Oct 8, 2014·Current Atherosclerosis Reports·Craig A JohnstonJohn P Foreyt
May 13, 2018·Circulation. Cardiovascular Quality and Outcomes·Sripal BangaloreJudith S Hochman
Mar 11, 2018·Diabetes Research and Clinical Practice·Scott J PillaHsin-Chieh Yeh

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Methods Mentioned

BETA
coronary
percutaneous
amputation

Clinical Trials Mentioned

NCT00017953

Software Mentioned

Look AHEAD
NAVIGATOR
PEACE
EUROPA
Look

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