Protocol and Rationale for the Russian-Japanese “Tackle Obesity and Metabolic Syndrome Outcome by Diet, Activities and Checking Body Weight Intervention” (RJ-TOMODACHI) Randomized Controlled Trial

Background: The prevalence of obesity in Russia has increased sharply since the mid-1990s. Interestingly, the prevalence of obesity in Japan is lower than in many Western countries. Japan has implemented different types of weight control programs using a smart device to monitor patients remotely. New health promotion methods from Japan are now being used in Russia. The Russian-Japanese "Tackle Obesity and Metabolic Syndrome Outcome by Diet, Activities and Checking Body Weight Intervention" (RJ-TOMODACHI) study aims to evaluate a preventive intervention using Japanese health monitoring technology in reducing excess body weight, compared with standard care, in Russia. Methods and Results: The trial is a single-center, 3-armed, parallel group randomized controlled trial conducted among overweight/obese adults. It has been designed to compare the effectiveness of 2 newly developed interventions against standard care for 6 months. Participants in the low- and high-intensity intervention groups will have 3 and 6 consultations over the study period, respectively. In all, 260 adults were screened at baseline; 65 did not participate in the trial for various reasons. The remaining 195 people were randomized into 3 groups (high-intensity intervention, n=73, low-intensity, n=73; standard care group, n=49). Conclusions: The trial protocol has been designed so that the methodology can be adapted for use in Russia.