Trial reportClinical trials (London, England)2012
Midcourse correction to a clinical trial when the event rate is underestimated: the Look AHEAD (Action for Health in Diabetes) Study.
Trial report in Clinical trials (London, England), 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed, 34 citations in OpenAlex.
- Type 2 Diabetes Subgroups, Risk for Complications, and Differential Effects Due to an Intensive Lifestyle Intervention.Diabetes care · 2021Trial
- The Effect of Intentional Weight Loss on Fracture Risk in Persons With Diabetes: Results From the Look AHEAD Randomized Clinical Trial.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2017Trial
- Implications of Look AHEAD for clinical trials and clinical practice.Diabetes, obesity & metabolism · 2014Trial
- Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes.The New England journal of medicine · 2013Trial
- Association of Lifestyle Intervention With Risk for Cardiovascular Events Differs by Level of Glycated Hemoglobin.The Journal of clinical endocrinology and metabolism · 2024Article
- Effects of Intensive Lifestyle Intervention on All-Cause Mortality in Older Adults With Type 2 Diabetes and Overweight/Obesity: Results From the Look AHEAD Study.Diabetes care · 2022Article
- Data Mining-Based Analysis of Modern Chinese Medicine for the Treatment of Stable Angina Pectoris in Coronary Heart Disease.Journal of healthcare engineering · 2022Article
- Evidence-Based Policy Making for Public Health Interventions in Cardiovascular Diseases: Formally Assessing the Feasibility of Clinical Trials.Circulation. Cardiovascular quality and outcomes · 2020Article
- History of Cardiovascular Disease, Intensive Lifestyle Intervention, and Cardiovascular Outcomes in the Look AHEAD Trial.Obesity (Silver Spring, Md.) · 2020Article
- Using the Bayesian credible subgroups method to identify populations benefiting from treatment: An application to the Look AHEAD trial.PloS one · 2020Article
- ISCHEMIA: Establishing the Primary End Point.Circulation. Cardiovascular quality and outcomes · 2018Article
- Changes in metformin use and other antihyperglycemic therapies after insulin initiation in patients with type 2 diabetes.Diabetes research and clinical practice · 2018Article
- Perspective: Randomized Controlled Trials Are Not a Panacea for Diet-Related Research.Advances in nutrition (Bethesda, Md.) · 2016Article
- The role of lifestyle change for prevention of cardiovascular disease in diabetes.Current atherosclerosis reports · 2014Review
- The Look AHEAD Trial: A Review and Discussion Of Its Outcomes.Current nutrition reports · 2014Article
- Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes.Current atherosclerosis reports · 2014Review
- Diabetes: Looking back at Look AHEAD--giving lifestyle a chance.Nature reviews. Cardiology · 2013Article
- The Look AHEAD Trial: Implications for Lifestyle Intervention in Type 2 Diabetes Mellitus.Progress in cardiovascular diseasesReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 8 institutions in 1 country.
Funding
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 continue with inadequate statistical power. Trialists sometimes need to modify endpoints after launch. This decision should be well justified and should be made by individuals who are fully masked to interim results that could introduce bias. This article describes this process in the Look AHEAD study and places it in the context of recent articles on endpoint modification and recent trials that reported endpoint modification.
Indexed as
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.