Methods
DM, Fracture, fracture
The Look AHEAD randomized clinical trial involved 16 clinical sites across the US (Clinicaltrials.gov Identifier: NCT00017953). The methods and baseline characteristics of the study population have been published and the protocol is available (Intervention curricula for both ILI and DSE were developed centrally and have been described in detail [Look AHEAD was approved by local Institutional Review Boards and all participants provided informed consent. Look AHEAD complied with the World Medical Association Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects.Major eligibility criteria for Look AHEAD included the following: 45–76 years of age; type 2 DM; body mass index (BMI) of ≥ 25.0 kg/mRandomization occurred from August 2001 through April 2004 with an allocation ratio of 1:1 and stratification by clinical site. At baseline and annual clinic visits, weight and height were measured with a digital scale and a standard wall-mounted stadiometer respectively. BMI was calculated from the measured weights and heights. Questionnaires were used to collect demographic characteristics, medical history, smoking history, and alcohol use. Fracture data was collected as previously described in the Look AHEAD fracture paper [