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Background
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.
Purpose
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.