Abstract
Background: The prevalence rates of childhood obesity are growing. The current multidisciplinary treatments for (childhood) obesity are working, but only in short term and rather moderate. Therefore, research needs to search for underlying mechanisms that can improve the existing multidisciplinary treatments. A possible underlying mechanism can be ‘Emotion Regulation’, referring to “the processes by which individuals influence which emotions they have, when they have them, and how they experience and express these emotions”. Gross (1998) states that these Emotion Regulation processes play a crucial role in whether medical and psychological consequences are developed as a result of negative affect. The research model for this RCT-study states that when high levels of stress are regulated in a maladaptive way, this can contribute to the development of obesity. Three processes are playing a role: 1) stress physiology (cortisol), 2) low grade inflammation and 3) emotional eating. We see that the prevalence of emotional eating is higher in children and adults with obesity, in comparison with average weight individuals. Method: The current study will recruit 140 youngsters (10-14 years) that are involved in an inpatient multidisciplinary obesity treatment program. Seventy of them will receive an Emotion Regulation Training on top of care as usual. The training itself consists of 12 weekly sessions. After the end of this training, two booster sessions will be given. The participants will be tested pre, post and at 6 months’ follow-up. We hypothesize that compared to the control condition, the youngsters in the intervention condition will (1) use more adaptive Emotion Regulation Strategies, (2) use less the strategy of emotional eating, (3) will report a better sleep quality, (4) result in an improved weight-loss and weight-loss maintenance and (5) result in a better long-term (6-months) psychological well-being. This manuscript proposes the protocol for the Randomized Controlled Trial study. Discussion: This study will add to both the scientific and clinical literature on the role of emotion regulation in the development and maintenance of different psychopathologies, as emotion regulation is a transdiagnostic factor. Trial Registration: The RCT-study protocol is registered at ISRCTN Registry, with study ID ‘ISRCTN 83822934’. Registered at 13 december 2017; http://www.isrctn.com/ISRCTN83822934
Change in study randomization allocation needs to be included in statistical analysis: comment on ‘Randomized controlled trial of weight loss versus usual care on telomere length in women with breast cancer: the lifestyle, exercise, and nutrition (LEAN) study’
