Submitted to: Clinical Trials
Publication Type: Review Article
Publication Acceptance Date: April 25, 2011
Publication Date: July 25, 2011
Citation: Raatz, S.K. 2011. The development and description of the comparison group in the Look AHEAD trial. Clinical Trials. 8:320-329. Interpretive Summary: Although there are many lifestyle intervention trials, little is published regarding how to establish an appropriate control group. This paper describes the comparison group intervention called the Diabetes Support and Education Intervention (DSE) of the Action for HEAlth in Diabetes (Look AHEAD trial). This trial is a randomized, controlled, multicenter trial designed to determine whether intensive lifestyle intervention to reduce body weight and increase physical activity is associated with reduced cardiovascular morbidity and mortality. The DSE was designed to be standard delivered across the 16 clinics and to contain sessions on basic diabetes education, nutrition and physical activity in sessions over 4 years. The design of the DSE resulted in excellent retention of participants throughout the first 4 years of the trial.
Technical Abstract: Despite more lifestyle intervention trials, there is little published information on the development of the comparison group intervention. This article describes the comparison group intervention, termed Diabetes Support and Education Intervention and its development for the Action for HEAlth in Diabetes (Look AHEAD) trial. Look AHEAD, a randomized, controlled, multicenter trial, was designed to determine whether an Intensive Lifestyle Intervention to reduce weight and increase physical activity reduces cardiovascular morbidity and mortality in overweight volunteers with type 2 diabetes compared to the Diabetes Support and Education Intervention. The Diabetes Support and Education Committee was charged with developing the Diabetes Support and Education Intervention with the primary aim of participant retention. The objectives were to design the Diabetes Support and Education. Intervention sessions, standardize delivery across the 16 clinics, review quality and protocol adherence and advise on staffing and funding. Methods Following a mandatory session on basic diabetes education, three optional sessions were offered on nutrition, physical activity, and support yearly for 4 years. For each session, guidelines, objectives, activities, and a resource list were created. Conclusions Participant evaluations were very positive with hands on experiences being the most valuable. Retention so far at years 1 and 4 has been excellent and only slightly lower in the Diabetes Support and Education Intervention arm. The comparison group plays an important role in the success of a clinical trial. Understanding the effort needed to develop and implement the comparison group intervention will facilitate its implementation in future lifestyle intervention trials, particularly multicenter trials. Retention rates may improve by developing the comparison intervention simultaneously with the lifestyle intervention.