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.
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.
authors.affiliation: Veterans Affairs Medical Center, Durham, NC, USA.
authors.forename: Katherine S
authors.initials: KS
authors.lastname: Hall
authors.forename: Carl F
authors.initials: CF
authors.lastname: Pieper
authors.forename: David E
authors.initials: DE
authors.lastname: Edelman
authors.forename: William S
authors.initials: WS
authors.lastname: Yancy
authors.forename: Jennifer B
authors.initials: JB
authors.lastname: Green
authors.forename: Helen
authors.initials: H
authors.lastname: Lum
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Peterson
authors.forename: Richard
authors.initials: R
authors.lastname: Sloane
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Cowper
authors.forename: Hayden B
authors.initials: HB
authors.lastname: Bosworth
authors.forename: Kim M
authors.initials: KM
authors.lastname: Huffman
authors.forename: James T
authors.initials: JT
authors.lastname: Cavanaugh
authors.forename: Jennifer G
authors.initials: JG
authors.lastname: Chapman
authors.forename: Megan P
authors.initials: MP
authors.lastname: Pearson
authors.forename: Teresa A
authors.initials: TA
authors.lastname: Howard
authors.forename: Carola C
authors.initials: CC
authors.lastname: Ekelund
authors.forename: Beverly L
authors.initials: BL
authors.lastname: McCraw
authors.forename: Joi B
authors.initials: JB
authors.lastname: Burrell
authors.forename: Gregory A
authors.initials: GA
authors.lastname: Taylor
authors.forename: Miriam C
authors.initials: MC
authors.lastname: Morey