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. Author manuscript; available in PMC: 2010 Jan 12.
Published in final edited form as: Clin Trials. 2008;5(5):546–556. doi: 10.1177/1740774508096315

Table 4. Schedule of WLM Measurements.

Entry Measures Phase I Intervention Baseline Measures Follow-up Measures
Phase I Phase I End of Phase I/Start of Phase II Phase II (time since randomization)
Screening Phase I Randomization 6 mo 12 mo 18 mo 24 mo 30 mo
Info consent X X1
Demographics X
Internet ques X
Medical Hx ques X
Height X
Weight X2 X2 X X2 X X X2
Rose angina ques X X1 X X X X X
Medication ques X X1 X X
FFQ* X X1 X X
Accelerometry X X1 X X
Blood Pressure3 X1 X X
Fasting blood4,5 X4 X1 X X
Adverse Event ques X X X X X X
Psychosocial ques X X1 X X
Perceptions ques X6
Beliefs ques X7 X7
Interv adherence** X X8
1

only collected for those eligible for Phase II. Weight and adverse event questionnaire are collected for everyone

2

weight is collected on two separate days at entry, baseline, 12 and 30 months

3

blood pressure is collected on two separate occasions for each measurement point

4

includes serum for analysis of glucose and lipids. Aliquots of plasma, serum, and buffy coat are collected for long-term storage

5

only analyzed on individuals who are subsequently randomized to Phase II

6

once, preferably during screening, but may be collected later if unable to obtain

7

once during screening, but can be completed up to 4 months after the participant has enrolled in Phase I

8

PC and IT participants

*

FFQ = Food Frequency Questionnaire

**

adherence measures including attendance, food and activity records