Open-label placebo treatment for reducing overeating in children: A study protocol for a randomized clinical trial with an app-assisted approach

Abstract

Food advertising has become almost ubiquitous in Western societies. In adults as well as in children this omnipresence of food cues has been shown to trigger cravings and overeating, which can lead to overweight or even obesity. This is concerning because obesity is a leading cause of preventable diseases. The planned project aims at reducing craving and overeating in overweight/obese children using a placebo treatment. A total of 80 children (40 girls, 40 boys; aged between 8 and 12 years; body mass index >90th percentile) will take part in the study. A randomized controlled cross-over design will be implemented, which will include four weeks with daily placebo treatment and four weeks without placebo treatment. The placebo will be introduced without deception as an open-label placebo (OLP), that can help to control food cravings. The study will use an app-assisted approach: The children will rate the intensity of their cravings, the occurrence of binge-eating episodes, their emotional state, and placebo usage via a smartphone application. It is expected that the OLP will help the children to reduce cravings and body weight. If effective, this OLP approach could be implemented in weight-control programs for children.