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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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