Research Study Abstract

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

  • Published on July 15, 2019

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.

Author(s)

  • Anna Ek 1
  • Christine Delisle Nyström 2
  • Adela Chirita-Emandi 3,4
  • Josep A. Tur 5,6
  • Karin Nordin 1
  • Cristina Bouzas 5,6
  • Emma Argelich 5,6
  • J. Alfredo Martínez 6,7,8
  • Gary Frost 9
  • Isabel Garcia-Perez 10
  • Marc Saez 11,12
  • Corina Paul 13,14
  • Marie Löf 2,15
  • Paulina Nowicka 1,16

Institution(s)

  • 1

    Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm, Sweden
  • 2

    Department of Biosciences and Nutrition, Karolinska Institutet, Stockholm, Sweden
  • 3

    Genetics Department, University of Medicine and Pharmacy “Victor Babes”, Timisoara, Romania
  • 4

    “Louis Turcanu” Clinical Emergency Hospital for Children, Timisoara, Romania
  • 5

    Research Group on Community Nutrition & Oxidative Stress, University of the Balearic Islands, Palma de Mallorca, Spain
  • 6

    CIBER of Physiology of Obesity and Nutrition (CIBEROBN), Instituto Carlos III, Madrid, Spain
  • 7

    Department of Nutrition, Food Science, and Physiology, Centre for Nutrition Research, University of Navarra, Pamplona, Spain
  • 8

    IMDEA Food Precision Nutrition, Madrid, Spain
  • 9

    Section for Nutrition Research, Department of Medicine, Imperial College London, Hammersmith Campus, London, UK
  • 10

    Division of Systems and Digestive Medicine, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, South Kensington Campus, London, UK
  • 11

    Research Group on Statistics, Econometrics and Health (GRECS), University of Girona, Campus de Montilivi, Girona, Spain
  • 12

    CIBER of Epidemiology and Public Health (CIBERESP), Instituto Carlos III, Madrid, Spain
  • 13

    Pediatrics Department, University of Medicine and Pharmacy “Victor Babes”, Timisoara, Romania
  • 14

    2nd Pediatrics Clinic, Clinical Emergency County Hospital Timisoara, Timisoara, Romania
  • 15

    Department of Medical and Health Sciences, Linköping University, Linköping, Sweden
  • 16

    Department of Food Studies, Nutrition, and Dietetics, Uppsala University, Uppsala, Sweden

Journal

BMC Public Health

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s12889-019-7161-y

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