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Volume
3:
No. 1, January 2006
ORIGINAL RESEARCH
The Behavioral and Clinical Effects of Therapeutic Lifestyle Change on
Middle-aged Adults
This flowchart shows how community volunteers were organized during the enrollment, allocation, follow-up, and analysis of a randomized clinical trial. During the enrollment period, 403 volunteers were assessed for eligibility. Of these, 26 were excluded. Baseline data were collected for the remaining 377 volunteers; of these, 29 refused to participate, leaving 348 participants. Of these 348 volunteers, 174 were allocated to an intervention group, and 174 were allocated to a control group. During the follow-up period, the intervention group lost 21 participants for the following reasons: 3 became ill (unrelated to study), 7 were unwilling to commit to the intervention, 7 failed to complete the follow-up, and 4 could not be located. During the same follow-up period, the control group lost 9 participants for the following reasons: 2 became ill (unrelated to the study), 1 lost interest, 2 were unwilling to commit, and 4 failed to complete follow-up. During analysis, the intervention group consisted of 153 nondropouts and 174 intent-to-treat participants, and the control group consisted of 165 nondropouts and 174 intent-to-treat participants.
Figure 1. Process for a therapeutic
lifestyle-modification intervention on a group of community volunteers,
Rockford, Ill.
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