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

doi:10.1186/s12889-019-7161-y

Randomized Controlled Trial

. 2019 Jul 15;19(1):945.

doi: 10.1186/s12889-019-7161-y.

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

Anna Ek¹, Christine Delisle Nyström², Adela Chirita-Emandi^{3

4}, Josep A Tur^{5

6}, Karin Nordin⁷, Cristina Bouzas^{5

6}, Emma Argelich^{5

6}, J Alfredo Martínez^{6

8

9}, Gary Frost¹⁰, Isabel Garcia-Perez¹¹, Marc Saez^{12

13}, Corina Paul^{14

15}, Marie Löf^{2

16}, Paulina Nowicka^{7

17}

Affiliations

¹ Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm, Sweden. anna.ek@ki.se.
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 Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.
⁸ Department of Nutrition, Food Science, and Physiology, Centre for Nutrition Research, University of Navarra, Pamplona, Spain.
⁹ IMDEA Food Precision Nutrition, Madrid, Spain.
¹⁰ Section for Nutrition Research, Department of Medicine, Imperial College London, Hammersmith Campus, London, UK.
¹¹ Division of Systems and Digestive Medicine, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, South Kensington Campus, London, UK.
¹² Research Group on Statistics, Econometrics and Health (GRECS), University of Girona, Campus de Montilivi, Girona, Spain.
¹³ CIBER of Epidemiology and Public Health (CIBERESP), Instituto Carlos III, Madrid, Spain.
¹⁴ Pediatrics Department, University of Medicine and Pharmacy "Victor Babes", Timisoara, Romania.
¹⁵ 2nd Pediatrics Clinic, Clinical Emergency County Hospital Timisoara, Timisoara, Romania.
¹⁶ Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.
¹⁷ Department of Food Studies, Nutrition, and Dietetics, Uppsala University, Uppsala, Sweden.

PMID: 31307412
PMCID: PMC6631737
DOI: 10.1186/s12889-019-7161-y

Randomized Controlled Trial

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

Anna Ek et al. BMC Public Health. 2019.

. 2019 Jul 15;19(1):945.

doi: 10.1186/s12889-019-7161-y.

Authors

Affiliations

¹ Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm, Sweden. anna.ek@ki.se.
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 Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.
⁸ Department of Nutrition, Food Science, and Physiology, Centre for Nutrition Research, University of Navarra, Pamplona, Spain.
⁹ IMDEA Food Precision Nutrition, Madrid, Spain.
¹⁰ Section for Nutrition Research, Department of Medicine, Imperial College London, Hammersmith Campus, London, UK.
¹¹ Division of Systems and Digestive Medicine, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, South Kensington Campus, London, UK.
¹² Research Group on Statistics, Econometrics and Health (GRECS), University of Girona, Campus de Montilivi, Girona, Spain.
¹³ CIBER of Epidemiology and Public Health (CIBERESP), Instituto Carlos III, Madrid, Spain.
¹⁴ Pediatrics Department, University of Medicine and Pharmacy "Victor Babes", Timisoara, Romania.
¹⁵ 2nd Pediatrics Clinic, Clinical Emergency County Hospital Timisoara, Timisoara, Romania.
¹⁶ Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.
¹⁷ Department of Food Studies, Nutrition, and Dietetics, Uppsala University, Uppsala, Sweden.

PMID: 31307412
PMCID: PMC6631737
DOI: 10.1186/s12889-019-7161-y

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.

Trial registration: ClinicalTrials.gov NCT03800823; 11 Jan 2019.

Keywords: Children; Family; Obesity; Overweight; Stop; Treatment; mHealth.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

**Fig. 1**
Flow-chart of the More and Less Europe trial design

See this image and copyright information in PMC

Cited by

Parents' experiences following conversations about their young child's weight in the primary health care setting: a study within the STOP project.
Eli K, Neovius C, Nordin K, Brissman M, Ek A. Eli K, et al. BMC Public Health. 2022 Aug 12;22(1):1540. doi: 10.1186/s12889-022-13803-8. BMC Public Health. 2022. PMID: 35962359 Free PMC article. Clinical Trial.
Making Childhood Obesity a Priority: A Qualitative Study of Healthcare Professionals' Perspectives on Facilitating Communication and Improving Treatment.
Serban CL, Putnoky S, Ek A, Eli K, Nowicka P, Chirita-Emandi A. Serban CL, et al. Front Public Health. 2021 Jul 15;9:652491. doi: 10.3389/fpubh.2021.652491. eCollection 2021. Front Public Health. 2021. PMID: 34336760 Free PMC article.
Healthy Lifestyle Management of Pediatric Obesity with a Hybrid System of Customized Mobile Technology: The PediaFit Pilot Project.
Delli Bovi AP, Manco Cesari G, Rocco MC, Di Michele L, Rimauro I, Lugiero A, Mottola S, De Anseris AGE, Nazzaro L, Massa G, Vajro P. Delli Bovi AP, et al. Nutrients. 2021 Feb 16;13(2):631. doi: 10.3390/nu13020631. Nutrients. 2021. PMID: 33669174 Free PMC article.
Effectiveness of an Intervention Programme on Adherence to the Mediterranean Diet in a Preschool Child: A Randomised Controlled Trial.
Martíncrespo-Blanco MC, Varillas-Delgado D, Blanco-Abril S, Cid-Exposito MG, Robledo-Martín J. Martíncrespo-Blanco MC, et al. Nutrients. 2022 Apr 7;14(8):1536. doi: 10.3390/nu14081536. Nutrients. 2022. PMID: 35458098 Free PMC article. Clinical Trial.
Development of obesity from childhood to adolescents.
Majcher A, Czerwonogrodzka-Senczyna A, Kądziela K, Rumińska M, Pyrżak B. Majcher A, et al. Pediatr Endocrinol Diabetes Metab. 2021;27(2):70-75. doi: 10.5114/pedm.2021.105297. Pediatr Endocrinol Diabetes Metab. 2021. PMID: 33860660 Free PMC article.

See all "Cited by" articles

References

1. World Health Organization. The Commision on ending childhood obesity. https://www.who.int/end-childhood-obesity/publications/echo-plan-executi.... Accessed 20 Feb 2019.
1. Collaborators GBDO, Afshin A, Forouzanfar MH, Reitsma MB, Sur P, Estep K, et al. Health effects of overweight and obesity in 195 countries over 25 years. N Engl J Med. 2017;377(1):13–27. - PMC - PubMed
1. World Health Organization. Facts and figures on childhood obesity. http://www.who.int/end-childhood-obesity/facts/en/. Accessed 20 Feb 2019.
1. Geserick M, Vogel M, Gausche R, Lipek T, Spielau U, Keller E, et al. Acceleration of BMI in early childhood and risk of sustained obesity. N Engl J Med. 2018;379(14):1303–1312. - PubMed
1. Colquitt JL, Loveman E, O'Malley C, Azevedo LB, Mead E, Al-Khudairy L, et al. Diet, physical activity, and behavioural interventions for the treatment of overweight or obesity in preschool children up to the age of 6 years. Cochrane Database Syst Rev. 2016;(3):CD012105. - PMC - PubMed

Publication types

Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Associated data

Actions
- Search in PubMed
- Search in ClinicalTrials.gov

Grants and funding

LinkOut - more resources

Full Text Sources
Medical
- ClinicalTrials.gov
- MedlinePlus Health Information

[1] World Health Organization. The Commision on ending childhood obesity. https://www.who.int/end-childhood-obesity/publications/echo-plan-executi.... Accessed 20 Feb 2019.

[2] World Health Organization. The Commision on ending childhood obesity. https://www.who.int/end-childhood-obesity/publications/echo-plan-executi.... Accessed 20 Feb 2019.

[3] Collaborators GBDO, Afshin A, Forouzanfar MH, Reitsma MB, Sur P, Estep K, et al. Health effects of overweight and obesity in 195 countries over 25 years. N Engl J Med. 2017;377(1):13–27. - PMC - PubMed

[4] Collaborators GBDO, Afshin A, Forouzanfar MH, Reitsma MB, Sur P, Estep K, et al. Health effects of overweight and obesity in 195 countries over 25 years. N Engl J Med. 2017;377(1):13–27. - PMC - PubMed

[5] World Health Organization. Facts and figures on childhood obesity. http://www.who.int/end-childhood-obesity/facts/en/. Accessed 20 Feb 2019.

[6] World Health Organization. Facts and figures on childhood obesity. http://www.who.int/end-childhood-obesity/facts/en/. Accessed 20 Feb 2019.

[7] Geserick M, Vogel M, Gausche R, Lipek T, Spielau U, Keller E, et al. Acceleration of BMI in early childhood and risk of sustained obesity. N Engl J Med. 2018;379(14):1303–1312. - PubMed

[8] Geserick M, Vogel M, Gausche R, Lipek T, Spielau U, Keller E, et al. Acceleration of BMI in early childhood and risk of sustained obesity. N Engl J Med. 2018;379(14):1303–1312. - PubMed

[9] Colquitt JL, Loveman E, O'Malley C, Azevedo LB, Mead E, Al-Khudairy L, et al. Diet, physical activity, and behavioural interventions for the treatment of overweight or obesity in preschool children up to the age of 6 years. Cochrane Database Syst Rev. 2016;(3):CD012105. - PMC - PubMed

[10] Colquitt JL, Loveman E, O'Malley C, Azevedo LB, Mead E, Al-Khudairy L, et al. Diet, physical activity, and behavioural interventions for the treatment of overweight or obesity in preschool children up to the age of 6 years. Cochrane Database Syst Rev. 2016;(3):CD012105. - PMC - PubMed

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

Similar articles

Cited by

References

Publication types

MeSH terms

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Medical

Abstract

Conflict of interest statement

Figures

Similar articles

Cited by

References

Publication types

MeSH terms

Associated data

Related information

Grants and funding

LinkOut - more resources

Full Text Sources

Medical