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. Author manuscript; available in PMC: 2009 May 1.
Published in final edited form as: Contemp Clin Trials. 2007 Oct 11;29(3):418–427. doi: 10.1016/j.cct.2007.09.009

Table 3.

Participant flow and timeline from screening to randomization

Timeline Action Participant Data Collected Purpose
Week 1 Telephone Screen
  • Demographic information

  • Self-reported medical information to screen

To determine initial illegibility
Week 2 Orientation & CRP Screening
  • Informed consent

  • Measurements: height, weight

  • Blood chemistry screening: CRP

To ensure that the participant understands the expectations of the study and meets inclusion criteria
Week 3–4 3 Educational Run-In Sessions
  • Questionnaires: FFQ, medication inventory, detailed medical history

  • Measurements: BP

  • Behavioral Contract

To ensure participant meets inclusion criteria and can visit the intervention site multiple times per week
Week 5 Baseline Evaluations
  • Blood draw

  • Measurements: ECG, CT scan, DXA, height, weight, waist and hip circumference

  • Fitness Testing

Collect baseline data and ensure participant meet remaining study entry criteria
Week 6 Randomization
Week 7–23 Intervention Exercise Group:
  • Exercise 3–5x per wk

  • Self-reported data returned monthlya

Control Group:
  • Self-reported data returned monthlya

Collect intervention data as well as data on potential confounding variables such as health, diet and non-study related activity
Week 24 Follow-Up Evaluations
  • Blood draw

  • Measurements: EBT, DXA, height, weight, waist and hip circumference, BMI, BP

  • Fitness Testing

  • Questionnaires: FFQ, MSQ, Exit Interview

Collect follow-up data
a

Self Report Data Returned Monthly includes: Medical Symptoms Questionnaire, Medication Inventory and Daily Step Log