2269-PUB: Early Attrition from a Randomized Lifestyle Modification Protocol.

Assigned exercise and other lifestyle modification can alter the natural history of diabetic neuropathy, but adherence to lifestyle change protocols poses a challenge in a clinical trial setting. In particular, the commitment for participants to begin engagement with the assigned intervention is a critical juncture. The Activity for DiAbetic neuroPaThy (ADAPT) trial is an NIDDK sponsored two-center single blinded protocol that randomizes type 2 diabetic neuropathy patients for 18 months to either brief lifestyle counseling or a combination of monitored exercise, diet counseling and actigraphy driven anti-sedentary behavioral modification. 103 participants have consented, screened, and been found eligible for ADAPT. Of these, 20 dropped from the trial during baseline evaluation (n=3), randomization (n=1), or before the first intervention visit or 3-month follow-up (n=16). Of the 83 who have reached 3-month follow-up, only 7 participants have dropped from the study. The pattern of early attrition has differed at the two sites. At one site, early attrition was essentially equal between assigned groups. The second site 9 of those randomized to intervention and one assigned to control dropped before 3 months. At the second site, protocol changes to improve "hand-off" from the assessment to intervention coordinators, and marked reduction in time from randomization to first intervention visit has improved retention. Structured counseling to set expectations, reduce performance anxiety, and address disappointment with assignment to the less intensive arm has improved initial retention at both sites. Once familiar with the intervention process, most participants will continue with behavioral modification. Clinical trials utilizing patient-motivated lifestyle modification protocols should seek to minimize physical barriers to initial engagement, and focus counseling and motivational effort on the critical early trial period during which participants commit internally to the intervention process. Disclosure: C. Revere: None. A. Smith: Consultant; Self; Alexion Pharmaceuticals, Inc., Disarm, Regenesis. P. Kluding: None. R.L. Marcus: None. M. Dimachkie: Research Support; Self; Viromed. F. Vivanco: None. S.C. Foster-Palmer: None. P.E. Hauer: None. A.B. Aperghis: None. M. Pasnoor: Advisory Panel; Self; Alexion Pharmaceuticals, Inc., Terumo BCT. Consultant; Self; Momenta Pharmaceuticals. A. Stonebraker: None. A.N. Hawks: None. L. Herbelin: None. J. Singleton: None. Funding: National Institute of Diabetes and Digestive and Kidney Diseases; National Center for Advancing Translational Sciences [ABSTRACT FROM AUTHOR]