Study design and protocol for a theory-based behavioral intervention focusing on maintenance of weight loss: The Maintenance After Initiation of Nutrition TrAINing (MAINTAIN) study Corrine I. Voils a,b, ⁎, Jennifer M. Gierisch a,b , Maren K. Olsen a,c , Matthew L. Maciejewski a,b , Janet Grubber a , Megan A. McVay a , Jennifer L. Strauss a,d , Jamiyla Bolton a , Leslie Gaillard a , Elizabeth Strawbridge a , William S. Yancy Jr. a,b a Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC, USA b Department of Medicine, Duke University Medical Center, Durham, NC, USA c Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA d Department of Psychiatry, Duke University Medical Center, Durham, NC, USA article info abstract Article history: Received 16 May 2014 Received in revised form 31 July 2014 Accepted 2 August 2014 Available online 10 August 2014 Background: Obesity is a significant public health problem. Although various lifestyle approaches are effective for inducing significant weight loss, few effective behavioral weight maintenance strategies have been identified. It has been proposed that behavior maintenance is a distinct state that involves different psychological processes and behavioral skills than initial behavior change. Previously, we created a conceptual model that distinguishes behavior initiation from maintenance. This model was used to generate Maintenance After Initiation of Nutrition TrAINing (MAINTAIN), an intervention to enhance weight loss maintenance following initiation. The effectiveness of MAINTAIN is being evaluated in an ongoing trial, the rationale and procedures of which are reported herein. Methods/Design: Veterans aged ≤75 with body mass index ≥30 kg/m 2 participate in a 16-week, group-based weight loss program. Participants who lose ≥4 kg by the end of 16 weeks (target n = 230) are randomized 1:1 to receive (a) usual care for 56 weeks or (b) MAINTAIN, a theoretically-informed weight loss maintenance intervention for 40 weeks, followed by 16 weeks of no intervention contact. MAINTAIN involves 3 in-person group visits that transition to 8 individualized telephone calls with decreasing contact frequency. MAINTAIN focuses on satisfaction with outcomes, weight self-monitoring, relapse prevention, and social support. We hypothesize that, compared to usual care, MAINTAIN will result in at least 3.5 kg less regain and better relative levels of caloric intake and physical activity over 56 weeks, and that it will be cost-effective. Discussion: If effective, MAINTAIN could serve as a model for redesigning existing weight loss programs. ClinicalTrials.gov Identifier: NCT01357551 Published by Elsevier Inc. Keywords: Obesity Randomized controlled trial Behavioral intervention Maintenance 1. Introduction Obesity is prevalent, affecting 36% of adults [1], and is the second leading cause of preventable deaths in the United Contemporary Clinical Trials 39 (2014) 95–105 ⁎ Corresponding author at: Veterans Affairs Medical Center (152), 508 Fulton St., Durham, NC 27705, USA. Tel.: +1 919 286 6936; fax: +1 919 416 4836. http://dx.doi.org/10.1016/j.cct.2014.08.002 1551-7144/Published by Elsevier Inc. Contents lists available at ScienceDirect Contemporary Clinical Trials journal homepage: www.elsevier.com/locate/conclintrial