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

Wesche-Thobaben JA - Clin Trials (2011)

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: The Look AHEAD Research Group, Look AHEAD studyPhysical Activity and Weight Management Research Center, Pittsburgh, PA, USA. jaw15@pitt.edu

ABSTRACT

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.

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Related in: MedlinePlus

Look AHEAD Trial                            Timeline
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fig1-1740774511405858: Look AHEAD Trial Timeline

Mentions: The Diabetes Support and Education (DSE) Committee was formed after the protocol was approved (Figure 1, Timeline). The committee was given the charge of designing a realistic, achievable, and acceptable intervention for the DSE study participants and monitoring clinics to assure standardized delivery. The main goal of the DSE Committee was to maintain a high retention rate for the DSEI participants given the planned follow-up of up to 13.5 years. Thus, the committee specified the following objectives: (1) design and develop interactive DSEI sessions, (2) write and revise the DSEI section of the Manual of Procedures, (3) standardize delivery of the DSEI, (4) review attendance reports and clinic performance, (5) advise the Steering Committee on DSEI matters such as staffing and funding, (6) write the DSEI sections of newsletters, and (7) select and purchase retention items for DSEI participant sessions and annual retention items for all participants. Figure 1


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

Wesche-Thobaben JA - Clin Trials (2011)

Look AHEAD Trial                            Timeline
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3198118&req=5

fig1-1740774511405858: Look AHEAD Trial Timeline
Mentions: The Diabetes Support and Education (DSE) Committee was formed after the protocol was approved (Figure 1, Timeline). The committee was given the charge of designing a realistic, achievable, and acceptable intervention for the DSE study participants and monitoring clinics to assure standardized delivery. The main goal of the DSE Committee was to maintain a high retention rate for the DSEI participants given the planned follow-up of up to 13.5 years. Thus, the committee specified the following objectives: (1) design and develop interactive DSEI sessions, (2) write and revise the DSEI section of the Manual of Procedures, (3) standardize delivery of the DSEI, (4) review attendance reports and clinic performance, (5) advise the Steering Committee on DSEI matters such as staffing and funding, (6) write the DSEI sections of newsletters, and (7) select and purchase retention items for DSEI participant sessions and annual retention items for all participants. Figure 1

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: The Look AHEAD Research Group, Look AHEAD studyPhysical Activity and Weight Management Research Center, Pittsburgh, PA, USA. jaw15@pitt.edu

ABSTRACT

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.

Show MeSH
Related in: MedlinePlus