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The development and description of the comparison group in the Look AHEAD trial.

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.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.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.

SUBMITTER: Wesche-Thobaben JA

PROVIDER: S-EPMC3198118 | biostudies-literature | 2011 Jun

REPOSITORIES: biostudies-literature

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The development and description of the comparison group in the Look AHEAD trial.

Wesche-Thobaben Jacqueline Ann JA

Clinical trials (London, England) 20110601 3

<h4>Background</h4>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 increas ...[more]

PMID: 21730080

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Project description:BACKGROUND:Little has been reported regarding food and nutrient intake in individuals diagnosed with type 2 diabetes, and most reports have been based on findings in select groups or individuals who self-reported having diabetes. OBJECTIVE:To describe the baseline food and nutrient intake of the Look AHEAD (Action for Health in Diabetes) trial participants, compare participant intake to national guidelines, and describe demographic and health characteristics associated with food group consumption. METHODS:The Look AHEAD trial is evaluating the effects of a lifestyle intervention (calorie control and increased physical activity for weight loss) compared with diabetes support and education on long-term cardiovascular and other health outcomes. Participants are 45 to 75 years old, overweight or obese (body mass index [BMI] > or = 25), and have type 2 diabetes. In this cross-sectional analysis, baseline food consumption was assessed by food frequency questionnaire from 2,757 participants between September 2000 and December 2003. STATISTICAL ANALYSIS:Descriptive statistics were used to summarize intake by demographic characteristics. Kruskal-Wallis tests assessed univariate effects of characteristics on consumption. Multiple linear regression models assessed factors predictive of intake. Least square estimates were based on final models, and logistic regression determined factors predictive of recommended intake. RESULTS:Ninety-three percent of the participants exceeded the recommended percentage of calories from fat, 85% exceeded the saturated fat recommendation, and 92% consumed too much sodium. Also, fewer than half met the minimum recommended servings of fruit, vegetables, dairy, and grains. CONCLUSIONS:These participants with pre-existing diabetes did not meet recommended food and nutrition guidelines. These overweight adults diagnosed with diabetes are exceeding recommended intake of fat, saturated fats, and sodium, which may contribute to increasing their risk of cardiovascular disease and other chronic diseases.

Dataset Information

The development and description of the comparison group in the Look AHEAD trial.

Publications

The development and description of the comparison group in the Look AHEAD trial.

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