Weight management by phone conference call: A comparison with a traditional face-to-face clinic. Rationale and design for a randomized equivalence trial

State-of-the-art treatment for weight management consists of a behavioral intervention to facilitate decreased energy intake and increased physical activity. These interventions are typically delivered face-to-face (FTF) by a health educator to a small group of participants. There are numerous barriers to participation in FTF clinics including availability, scheduling, the expense and time required to travel to the clinic site, and possible need for dependent care. Weight management clinics delivered by conference call have the potential to diminish or eliminate these barriers. The conference call approach may also reduce burden on providers, who could conduct clinic groups from almost any location without the expenses associated with maintaining FTF clinic space. A randomized trial will be conducted in 395 overweight/obese adults (BMI 25-39.9 kg/m2) to determine if weight loss (6 months) and weight maintenance (12 months) are equivalent between weight management interventions utilizing behavioral strategies and pre-packaged meals delivered by either a conference call or the traditional FTF approach. The primary outcome, body weight, will be assessed at baseline, 6, 12 and 18 months. Secondary outcomes including waist circumference, energy and macronutrient intake, and physical activity and will be assessed on the same schedule. In addition, a cost analysis and extensive process evaluation will be completed.