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

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 ≥30kg/m2 participate in a 16-week, group-based weight loss program. Participants who lose ≥4kg by the end of 16weeks (target n=230) are randomized 1:1 to receive (a) usual care for 56weeks or (b) MAINTAIN, a theoretically-informed weight loss maintenance intervention for 40weeks, followed by 16weeks 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 3.5kg less regain and better relative levels of caloric intake and physical activity over 56weeks, 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