Lessons learned when innovations go awry: A baseline description of a behavioral trial-the Enhancing Fitness in Older Overweight Veterans with Impaired Fasting Glucose study

Katherine S. Hall, Carl F. Pieper, David E. Edelman, William S. Yancy, Jennifer B. Green, Helen Lum, Matthew J. Peterson, Richard Sloane, Patricia A. Cowper, Hayden B. Bosworth, Kim M. Huffman, James T. Cavanaugh, Jennifer G. Chapman, Megan P. Pearson, Teresa A. Howard, Carola C. Ekelund, Beverly L. McCraw, Joi B. Burrell, Gregory A. Taylor, Miriam C. Morey

Research output: Contribution to journalArticlepeer-review

8 Scopus citations

Abstract

Individuals diagnosed with impaired glucose tolerance (i. e., prediabetes) are at increased risk for developing diabetes. We proposed a clinical trial with a novel adaptive randomization designed to examine the impact of a home-based physical activity (PA) counseling intervention on metabolic risk in prediabetic elders. This manuscript details the lessons learned relative to recruitment, study design, and implementation of a 12-month randomized controlled PA counseling trial. A detailed discussion on how we responded to unforeseen challenges is provided. A total of 302 older patients with prediabetes were randomly assigned to either PA counseling or usual care. A novel adaptive design that reallocated counseling intensity based on self-report of adherence to PA was initiated but revised when rates of non-response were lower than projected. This study presents baseline participant characteristics and discusses unwelcome adaptations to a highly innovative study design to increase PA and enhance glucose metabolism when the best-laid plans went awry.

Original languageEnglish (US)
Pages (from-to)573-587
Number of pages15
JournalTranslational Behavioral Medicine
Volume1
Issue number4
DOIs
StatePublished - Dec 2011

Keywords

  • Adaptive design
  • Aging
  • Exercise
  • Prediabetes
  • Randomized controlled trial
  • Telephone

ASJC Scopus subject areas

  • Applied Psychology
  • Behavioral Neuroscience

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