This paper describes the methodology, design and procedures used in the HEADS UP Project, an observational study to examine the feasibility of a state-funded weight loss program. HEADS UP offered two weight loss approaches: bariatric surgery or a non-surgical intervention composed of medical management, a low-calorie liquid diet and lifestyle change promotion. Participants were recruited through a multi-stage screening process, in-person interviews, and an initial low-calorie diet program. Eligible participants were entered into a lottery system, with 100 participants selected for the surgical group and 200 selected for the non-surgical group annually for five years. Anthropometric, clinical, and psychosocial assessments were completed at baseline and follow-ups. More than 6800 individuals completed the initial web screening. Screening procedures yielded 1412 participants (490 surgical and 922 non-surgical). Approximately 84% of the total participant population were female and 38% were Black. Participants had an average body mass index of 47.9 and 43 kg/m2 in the surgical and non-surgical groups, respectively. Recruitment and enrollment results of the HEADS UP study demonstrated significant interest in both the surgical and non-surgical treatment programs for obesity. These results support the feasibility of providing a state-funded weight loss program within a healthcare setting.
Keywords: bariatric surgery; intensive medical intervention; obesity; observation study; weight loss.