A randomized controlled trial for overweight and obesity in preschoolers: the More and Less Europe study - an intervention within the STOP project.
Children
Family
Obesity
Overweight
Stop
Treatment
mHealth
Journal
BMC public health
ISSN: 1471-2458
Titre abrégé: BMC Public Health
Pays: England
ID NLM: 100968562
Informations de publication
Date de publication:
15 Jul 2019
15 Jul 2019
Historique:
received:
03
06
2019
accepted:
13
06
2019
entrez:
17
7
2019
pubmed:
17
7
2019
medline:
12
10
2019
Statut:
epublish
Résumé
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. 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. 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. ClinicalTrials.gov NCT03800823; 11 Jan 2019.
Sections du résumé
BACKGROUND
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
METHODS
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
CONCLUSIONS
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
BACKGROUND
ClinicalTrials.gov NCT03800823; 11 Jan 2019.
Identifiants
pubmed: 31307412
doi: 10.1186/s12889-019-7161-y
pii: 10.1186/s12889-019-7161-y
pmc: PMC6631737
doi:
Banques de données
ClinicalTrials.gov
['NCT03800823']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
945Subventions
Organisme : European Union, Horizon 2020
ID : 774548
Organisme : Instituto de Salud Carlos III
ID : CIBEROBN (CB12/03/30038)
Organisme : Fernando Tarongí Bauzà Award
ID : 2018
Organisme : CIBERESP
ID : MPCUdG2016/69 and GDRCompetUdG2017
Références
J Consult Clin Psychol. 1999 Oct;67(5):711-24
pubmed: 10535238
Int J Obes Relat Metab Disord. 2000 Nov;24(11):1500-6
pubmed: 11126348
J Child Psychol Psychiatry. 2001 Oct;42(7):963-70
pubmed: 11693591
Nature. 2004 May 27;429(6990):457-63
pubmed: 15164071
J Clin Endocrinol Metab. 2005 Dec;90(12):6386-91
pubmed: 16204364
Appetite. 2007 Jan;48(1):104-13
pubmed: 16962207
J Pediatr Psychol. 2007 Sep;32(8):960-72
pubmed: 17535817
Child Maltreat. 2008 Feb;13(1):64-75
pubmed: 18174349
Prev Sci. 2008 Mar;9(1):17-27
pubmed: 18185995
Int J Behav Nutr Phys Act. 2008 Oct 20;5:49
pubmed: 18937832
Cochrane Database Syst Rev. 2009 Jan 21;(1):CD001872
pubmed: 19160202
Br J Nutr. 2009 Jul;101 Suppl 2:S73-85
pubmed: 19594967
Klin Padiatr. 2009 Sep;221(5):290-4
pubmed: 19707991
Adm Policy Ment Health. 2010 Mar;37(1-2):27-39
pubmed: 20143150
Int J Pediatr Obes. 2011 Jun;6(2-2):e501-7
pubmed: 20831463
Dev Psychopathol. 2010 Nov;22(4):949-70
pubmed: 20883592
Diabetes. 2011 May;60(5):1528-34
pubmed: 21471513
Int J Behav Nutr Phys Act. 2011 Dec 08;8:134
pubmed: 22152012
Eat Behav. 2012 Aug;13(3):267-70
pubmed: 22664409
Pediatr Obes. 2012 Aug;7(4):284-94
pubmed: 22715120
Ann Intern Med. 2013 Feb 5;158(3):200-7
pubmed: 23295957
BMJ. 2013 Jan 08;346:e7586
pubmed: 23303884
Appetite. 2013 May;64:48-55
pubmed: 23333562
J Med Internet Res. 2013 Dec 06;15(12):e272
pubmed: 24317406
Int J Obes (Lond). 2015 Jan;39(1):85-97
pubmed: 24566855
Lancet. 2014 Jun 7;383(9933):1990-8
pubmed: 24630777
Obes Facts. 2014;7(4):274-81
pubmed: 25096302
BMC Public Health. 2015 Feb 07;15:95
pubmed: 25886009
BMC Public Health. 2015 Aug 01;15:735
pubmed: 26231850
J Pediatr Health Care. 2016 May-Jun;30(3):252-60
pubmed: 26429638
Lancet Diabetes Endocrinol. 2015 Nov;3(11):838-40
pubmed: 26466771
J Med Internet Res. 2015 Nov 10;17(11):e253
pubmed: 26554314
Curr Opin Endocrinol Diabetes Obes. 2016 Feb;23(1):18-22
pubmed: 26702847
Pediatr Obes. 2017 Feb;12(1):19-27
pubmed: 26780939
Cochrane Database Syst Rev. 2016 Mar 10;3:CD012105
pubmed: 26961576
JMIR Mhealth Uhealth. 2016 Mar 14;4(1):e21
pubmed: 26976387
Pediatr Obes. 2017 Jun;12(3):195-202
pubmed: 26990034
Obes Facts. 2016;9(3):206-20
pubmed: 27319017
BMC Public Health. 2016 Jul 19;16:603
pubmed: 27435192
Am Psychol. 1989 Sep;44(9):1175-84
pubmed: 2782727
Int J Behav Nutr Phys Act. 2016 Dec 7;13(1):127
pubmed: 27927218
Lancet Diabetes Endocrinol. 2017 Mar;5(3):184-195
pubmed: 28089709
Obes Rev. 2017 Apr;18(4):450-459
pubmed: 28187246
Am J Prev Med. 2017 Jul;53(1):102-112
pubmed: 28237633
Am J Clin Nutr. 2017 Jun;105(6):1327-1335
pubmed: 28446496
Child Obes. 2017 Oct;13(5):347-355
pubmed: 28471699
N Engl J Med. 2017 Jul 6;377(1):13-27
pubmed: 28604169
Nutrients. 2017 Dec 23;10(1):null
pubmed: 29295516
Breast Cancer Res Treat. 2018 Jul;170(1):55-67
pubmed: 29511965
Children (Basel). 2018 Jun 19;5(6):null
pubmed: 29921811
Int J Obes (Lond). 2018 Oct;42(10):1691-1703
pubmed: 30206333
N Engl J Med. 2018 Oct 04;379(14):1303-1312
pubmed: 30281992
JMIR Mhealth Uhealth. 2019 Jan 21;7(1):e9967
pubmed: 30664489
Pediatr Res. 2019 Feb 18;:null
pubmed: 30776792
Sci Rep. 2019 Feb 21;9(1):2445
pubmed: 30792424
Pediatrics. 2019 Jul 12;:null
pubmed: 31300528