A randomized controlled trial for overweight and obesity in preschoolers: the More and Less Europe study - an intervention within the STOP project

Abstract

Background: Childhood overweight and obesity is a serious public health issue with an increase being observed in preschool-aged children. Treating childhood obesity is difficult and few countries use standardized treatments. Therefore, there is a need to find effective approaches that are feasible for both health care providers and families. Thus, the overall aim of this study is to assess the acceptance and effectiveness of a parent support program (the More and Less, ML) for the management of overweight and obesity followed by a mobile health (mHealth) program (the MINISTOP application) in a socially diverse population of families. Methods/design: A two-arm, parallel design randomized controlled trial in 300 2-to 6-year-old children with overweight and obesity from Romania, Spain and Sweden (n = 100 from each). Following baseline assessments children are randomized into the intervention or control group in a 1:1 ratio. The intervention, the ML program, consists of 10-weekly group sessions which focus on evidence-based parenting practices, followed by the previously validated MINISTOP application for 6-months to support healthy eating and physical activity behaviors. The primary outcome is change in body mass index (BMI) z-score after 9-months and secondary outcomes include: waist circumference, eating behavior (Child Eating Behavior Questionnaire), parenting behavior (Comprehensive Feeding Practices Questionnaire), physical activity (ActiGraph wGT3x-BT), dietary patterns (based on metabolic markers from urine and 24 h dietary recalls), epigenetic and gut hormones (fasting blood samples), and the overall acceptance of the overweight and obesity management in young children (semi-structured interviews). Outcomes are measured at baseline and after: 10-weeks (only BMI z-score, waist circumference), 9-months (all outcomes), 15-and 21-months (all outcomes except physical activity, dietary patterns, epigenetics and gut hormones) post-baseline. Discussion: This study will evaluate a parent support program for weight management in young children in three European countries. To boost the effect of the ML program the families will be supported by an app for 6-months. If the program is found to be effective, it has the potential to be implemented into routine care to reduce overweight and obesity in young children and the app could prove to be a viable option for sustained effects of the care provided.

Follow-up Evaluation of Association between Weight Changes, Metabolic, and Hormonal Outcomes in Children – a Single-center Pilot Study

“…Longitudinal studies depicted trends in eating behaviours and socioeconomic factors that influence the obesity prevalence 57 and interventions for weight management in adolescents. 31 The major limitations of our study are the small sample size, the retrospective data collection, the patients' age heterogeneity, and the relatively short follow-up duration. The retrospective data collection also contributes to the small sample because not all evaluated data were available in the medical charts.…”

“…20 A randomized-control trial based on a parent-support program for pediatric obesity is in progress since July 2019 in Romania, Spain, and Sweden. 31 Motivational interviewing has been shown to be effective in pediatric obesity management. 32 Previous cross-sectional studies have shown that metabolic and hormonal changes accompany weight excess, but no longitudinal study has evaluated this relationship as provided by Romanian screening for obesity-related comorbidities guidelines.…”

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“…In Romania the authors demonstrated a statistically significant decrease in fruit juice consumption after the intervention, however this was not maintained on follow-up. Another initiative, the More and Less Europe study [71] aimed at preschoolers, proposes a slightly different approach, including a parent support program with group sessions, followed by a 6-month period of support by means of a mobile application. Recruitment has started in 2019 and results are pending.…”

Healthy Lifestyle Management of Pediatric Obesity with a Hybrid System of Customized Mobile Technology: The PediaFit Pilot Project

“…The current orientation for improving adherence to treatments in pediatrics focuses on motivation, problem-solving skills, and reduction of post-treatment influence, resorting to a number of tools including web-based programs [6,7], "exergaming" [8][9][10], school interventions [11], summer camp [12], parent engagement [13][14][15], and automated mobile technology (MT) [16][17][18][19][20][21][22][23][24]. Studies focused on mobile phone interventions to improve lifestyle and preventing overweight and obesity are attracting interest in both the adult and pediatric population.…”