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.

dc.contributor.author

Hall, KS

dc.contributor.author

Pieper, CF

dc.contributor.author

Edelman, DE

dc.contributor.author

Yancy Jr, WS

dc.contributor.author

Green, JB

dc.contributor.author

Lum, H

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Peterson, MJ

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Sloane, R

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Cowper, PA

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Bosworth, HB

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Huffman, KM

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Cavanaugh, JT

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Chapman, JG

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Pearson, MP

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Howard, TA

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Ekelund, CC

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McCraw, BL

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Burrell, JB

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Taylor, GA

dc.contributor.author

Morey, MC

dc.date.accessioned

2024-02-01T20:14:23Z

dc.date.available

2024-02-01T20:14:23Z

dc.date.issued

2011-11

dc.description.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.

dc.identifier.issn

1613-9860

dc.identifier.issn

1613-9860

dc.identifier.uri

https://hdl.handle.net/10161/30101

dc.language

English

dc.publisher

Oxford University Press (OUP)

dc.relation.ispartof

Translational behavioral medicine

dc.relation.isversionof

10.1007/s13142-011-0075-6

dc.rights.uri

https://creativecommons.org/licenses/by-nc/4.0

dc.subject

Science & Technology

dc.subject

Life Sciences & Biomedicine

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Public, Environmental & Occupational Health

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Prediabetes

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Adaptive design

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Randomized controlled trial

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Telephone

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Exercise

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Aging

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HEALTH SURVEY SF-36

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PHYSICAL-ACTIVITY

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IMPROVE FITNESS

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ADULTS

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PROMOTION

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EXERCISE

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DESIGN

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ELDERS

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CHAMPS

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TESTS

dc.title

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.

dc.type

Journal article

duke.contributor.orcid

Hall, KS|0000-0002-9834-2011

duke.contributor.orcid

Pieper, CF|0000-0003-4809-1725

duke.contributor.orcid

Edelman, DE|0000-0001-7112-6151

duke.contributor.orcid

Green, JB|0000-0002-9967-5352

duke.contributor.orcid

Bosworth, HB|0000-0001-6188-9825

duke.contributor.orcid

Taylor, GA|0000-0003-1966-0917

pubs.begin-page

573

pubs.end-page

587

pubs.issue

4

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Duke

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School of Medicine

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Faculty

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Basic Science Departments

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Clinical Science Departments

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Institutes and Centers

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Biostatistics & Bioinformatics

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Integrative Immunobiology

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Molecular Genetics and Microbiology

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Medicine

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Psychiatry & Behavioral Sciences

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Medicine, Endocrinology, Metabolism, and Nutrition

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Medicine, General Internal Medicine

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Medicine, Geriatrics

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Medicine, Rheumatology and Immunology

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Duke Cancer Institute

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Duke Clinical Research Institute

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Institutes and Provost's Academic Units

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Duke Molecular Physiology Institute

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Center for the Study of Aging and Human Development

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Initiatives

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Duke Science & Society

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Population Health Sciences

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Duke Innovation & Entrepreneurship

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Psychiatry & Behavioral Sciences, Behavioral Medicine & Neurosciences

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Regeneration Next Initiative

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Duke - Margolis Center For Health Policy

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Biostatistics & Bioinformatics, Division of Biostatistics

pubs.publication-status

Published

pubs.volume

1

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