INTRODUCTION: Among US veterans, more than 78% have a body mass index (BMI) in the overweight (≥25 kg/m2) or obese range (≥30 kg/m2). Clinical guidelines recommend multicomponent lifestyle programmes to promote modest, clinically significant body mass (BM) loss. Primary care providers (PCPs) often lack time to counsel and refer patients to intensive programmes (≥6 sessions over 3 months). Using peer coaches to deliver obesity counselling in primary care may increase patient motivation, promote behavioural change and address the specific needs of veterans. We describe the rationale and design of a cluster-randomised controlled trial to test the efficacy of the Peer-Assisted Lifestyle (PAL) intervention compared with enhanced usual care (EUC) to improve BM loss, clinical and behavioural outcomes (aim 1); identify BM-loss predictors (aim 2); and increase PCP counselling (aim 3).
METHODS AND ANALYSIS: We are recruiting 461 veterans aged 18-69 years with obesity or overweight with an obesity-associated condition under the care of a PCP at the Brooklyn campus of the Veterans Affairs NY Harbor Healthcare System. To deliver counselling, PAL uses in-person and telephone-based peer support, a tablet-delivered goal-setting tool and PCP training. Patients in the EUC arm receive non-tailored healthy living handouts. In-person data collection occurs at baseline, month 6 and month 12 for patients in both arms. Repeated measures modelling based on mixed models will compare mean BM loss (primary outcome) between study arms.
ETHICS AND DISSEMINATION: The protocol has been approved by the Institutional Review Board and the Research and Development Committee at the VA NY Harbor Health Systems (#01607). We will disseminate the results via peer-reviewed publications, conference presentations and meetings with stakeholders.
TRIAL REGISTRATION NUMBER: NCT03163264; Pre-results.