Alberta Diabetes and Physical Activity Trial (ADAPT): A randomized theory-based efficacy trial for adults with type 2 diabetes - rationale, design, recruitment, evaluation, and dissemination

BACKGROUND: The primary aim of this study was to compare the efficacy of three physical activity (PA) behavioural intervention strategies in a sample of adults with type 2 diabetes. METHOD/DESIGN: Participants (N = 287) were randomly assigned to one of three groups consisting of the following intervention strategies: (1) standard printed PA educational materials provided by the Canadian Diabetes Association [i.e., Group 1/control group)]; (2) standard printed PA educational materials as in Group 1, pedometers, a log book and printed PA information matched to individuals' PA stage of readiness provided every 3 months (i.e., Group 2); and (3) PA telephone counseling protocol matched to PA stage of readiness and tailored to personal characteristics, in addition to the materials provided in Groups 1 and 2 (i.e., Group 3). PA behaviour measured by the Godin Leisure Time Exercise Questionnaire and related social-cognitive measures were assessed at baseline, 3, 6, 9, 12 and 18-months (i.e., 6-month follow-up). Clinical (biomarkers) and health-related quality of life assessments were conducted at baseline, 12-months, and 18-months. Linear Mixed Model (LMM) analyses will be used to examine time-dependent changes from baseline across study time points for Groups 2 and 3 relative to Group 1. DISCUSSION: ADAPT will determine whether tailored but low-cost interventions can lead to sustainable increases in PA behaviours. The results may have implications for practitioners in designing and implementing theory-based physical activity promotion programs for this population. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov identifier: NCT00221234