Randomized Controlled Trial of Breakfast Recommendations on Weight: A Multi-Site Effectiveness Trial

This study is a multi-site, 3 parallel arm, randomized, controlled trial. The study was conducted over sixteen weeks. Body weight and height were measured at the beginning of the trial, and body weight again at the end of the trial period. Three hundred and twenty four participants were enrolled, with each of six sites randomizing fifty four participants, with equal allocation of participants randomized to the breakfast, no breakfast, and control groups. The first subject contact included the initial telephone screening, in which participants who passed the level of screening and were interested in proceeding were invited and scheduled for a clinical screening visit. Participants who were passed into the clinical screening were consented and then height, weight, and BMI were measured. Participants were also randomized into the control, breakfast, and no breakfast groups during this time. The study then had 3 telephone calls, all 3 weeks apart (4-week telephone call, 8-week telephone call, 12-week telephone call), in which they were asked about their weight loss from time of last contact, if they had any problems/adverse reactions, or any questions. During the 16th week (final visit), weight was measured, their diaries collected, and participants were compensated for their time. Demographic information collected includes age, sex, and ethnicity.