Study protocol for Log2Lose: A randomized controlled trial to evaluate financial incentives for dietary...

Although behavioral weight-loss programs are efficacious for achieving clinically significant weight loss, adherence to such programs is variable. Positive reinforcement through small financial incentives has shown promise for increasing adherence to behaviors and clinical outcomes in some domains. Yet, for weight management, it is unknown whether to incent the behavior (calorie logging), the outcome (weight loss), or both. We report the rationale and design for a two-site clinical trial employing a three-phase, 2 × 2 factorial design to evaluate the impact of financial incentives for calorie logging and/or weekly weight loss. Phase I involved a 26-week incentivized weight-loss period with virtual group sessions every two weeks; Phase II involved a 26-week incentivized weight-loss maintenance period with three monthly group sessions and five individual counseling telephone calls; and Phase III involved a 26-week weight-loss maintenance period without incentives with three bimonthly calls. Participants were asked to record their caloric intake on a smartphone application and to weigh themselves regularly on a cellular scale. These data were processed each week to determine if participants qualified for a financial incentive ranging from $0 to $10. The primary outcome was the proportion of participants achieving clinically significant weight loss of at least 5 % at 26 weeks. Secondary outcomes were the same proportions measured at 52 and 78 weeks, and blood pressure and cardiovascular medication use at 78 weeks. Motivation for weight loss will be examined as a potential mediator of the treatment effect. Intervention cost and cost-effectiveness will be calculated to inform implementation. Clinicaltrials.gov registration: NCT04770909.