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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.

Publication ,  Journal Article
Hall, KS; Pieper, CF; Edelman, DE; Yancy, WS; Green, JB; Lum, H; Peterson, MJ; Sloane, R; Cowper, PA; Bosworth, HB; Huffman, KM; Cavanaugh, JT ...
Published in: Transl Behav Med
November 2011

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.

Duke Scholars

Published In

Transl Behav Med

DOI

ISSN

1869-6716

Publication Date

November 2011

Volume

1

Issue

4

Start / End Page

573 / 587

Location

England

Related Subject Headings

  • 52 Psychology
  • 42 Health sciences
  • 32 Biomedical and clinical sciences
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences
 

Citation

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Hall, K. S., Pieper, C. F., Edelman, D. E., Yancy, W. S., Green, J. B., Lum, H., … Morey, M. C. (2011). 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. Transl Behav Med, 1(4), 573–587. https://doi.org/10.1007/s13142-011-0075-6
Hall, Katherine S., Carl F. Pieper, David E. Edelman, William S. Yancy, Jennifer B. Green, Helen Lum, Matthew J. Peterson, et al. “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.Transl Behav Med 1, no. 4 (November 2011): 573–87. https://doi.org/10.1007/s13142-011-0075-6.
Hall, Katherine S., et al. “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.Transl Behav Med, vol. 1, no. 4, Nov. 2011, pp. 573–87. Pubmed, doi:10.1007/s13142-011-0075-6.
Hall KS, Pieper CF, Edelman DE, Yancy WS, Green JB, Lum H, Peterson MJ, Sloane R, Cowper PA, Bosworth HB, Huffman KM, Cavanaugh JT, Chapman JG, Pearson MP, Howard TA, Ekelund CC, McCraw BL, Burrell JB, Taylor GA, Morey MC. 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. Transl Behav Med. 2011 Nov;1(4):573–587.
Journal cover image

Published In

Transl Behav Med

DOI

ISSN

1869-6716

Publication Date

November 2011

Volume

1

Issue

4

Start / End Page

573 / 587

Location

England

Related Subject Headings

  • 52 Psychology
  • 42 Health sciences
  • 32 Biomedical and clinical sciences
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences