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.

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.

journal_name

Transl Behav Med

authors

Hall KS,Pieper CF,Edelman DE,Yancy WS Jr,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

doi

10.1007/s13142-011-0075-6

subject

Has Abstract

pub_date

2011-11-01 00:00:00

pages

573-587

issue

4

eissn

1869-6716

issn

1613-9860

journal_volume

1

pub_type

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