Supporting families to achieve a healthy weight development for their child with overweight/obesity using the STARKIDS intervention: study protocol for a cluster-randomized controlled trial.
Adolescent
Body weight
Childhood
Diet
Family-centered
Lifestyle intervention
Media consumption
Obesity
Overweight
Pediatricians
Physical activity
Quality of life
e-Health
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
23 Jul 2022
23 Jul 2022
Historique:
received:
20
12
2021
accepted:
06
07
2022
entrez:
23
7
2022
pubmed:
24
7
2022
medline:
27
7
2022
Statut:
epublish
Résumé
Childhood and adolescent overweight and obesity are among the most serious health challenges today. Structured weight reduction programs can be helpful to reduce severe health consequences but evidence is partly scarce. The STARKIDS program aims to improve on some of these limitations and is designed to be a structured, stepwise, digitally supported intervention program for the whole family. It is divided into two intervention steps spanning over 1.5 years and aims at promoting a healthy weight development of children/adolescents with overweight/obesity and an increase in quality of life. The STARKIDS intervention is evaluated in a cluster-randomized study design by comparing it with a control group receiving a one-time structured counselling in the pediatric practice. The study aims to include 1000 families with children/adolescents with overweight/obesity from 100 pediatric practices. The main outcomes are reduction in body mass index percentiles and improvements in children's/adolescent's quality of life, secondary outcomes refer to the contents of the intervention such as diet, physical activity, stress, and media habits. All outcomes are measured on three measurement time points: (T0) at baseline/inclusion in the study, (T1) baseline + 12 months which is the end of step 1 of the STARKIDS intervention, and (T2) baseline + 18 months which is the end of step 2 of the STARKIDS intervention. The stepwise, e-health-supported STARKIDS program is a low-threshold intervention program for families with children/adolescents with overweight/obesity. With the proof of concept, STARKIDS provides the potential to be implemented as a standard care tool for the prevention and intervention of childhood/adolescence obesity in the German health system. German Clinical Trials Register (DRKS) DRKS00022813 (acknowledged primary register of the World Health Organization). Registered on 27 November 2020 (Universal Trial Number U1111-1254-9536).
Sections du résumé
BACKGROUND
BACKGROUND
Childhood and adolescent overweight and obesity are among the most serious health challenges today. Structured weight reduction programs can be helpful to reduce severe health consequences but evidence is partly scarce. The STARKIDS program aims to improve on some of these limitations and is designed to be a structured, stepwise, digitally supported intervention program for the whole family. It is divided into two intervention steps spanning over 1.5 years and aims at promoting a healthy weight development of children/adolescents with overweight/obesity and an increase in quality of life.
METHODS
METHODS
The STARKIDS intervention is evaluated in a cluster-randomized study design by comparing it with a control group receiving a one-time structured counselling in the pediatric practice. The study aims to include 1000 families with children/adolescents with overweight/obesity from 100 pediatric practices. The main outcomes are reduction in body mass index percentiles and improvements in children's/adolescent's quality of life, secondary outcomes refer to the contents of the intervention such as diet, physical activity, stress, and media habits. All outcomes are measured on three measurement time points: (T0) at baseline/inclusion in the study, (T1) baseline + 12 months which is the end of step 1 of the STARKIDS intervention, and (T2) baseline + 18 months which is the end of step 2 of the STARKIDS intervention.
DISCUSSION
CONCLUSIONS
The stepwise, e-health-supported STARKIDS program is a low-threshold intervention program for families with children/adolescents with overweight/obesity. With the proof of concept, STARKIDS provides the potential to be implemented as a standard care tool for the prevention and intervention of childhood/adolescence obesity in the German health system.
TRIAL REGISTRATION
BACKGROUND
German Clinical Trials Register (DRKS) DRKS00022813 (acknowledged primary register of the World Health Organization). Registered on 27 November 2020 (Universal Trial Number U1111-1254-9536).
Identifiants
pubmed: 35871013
doi: 10.1186/s13063-022-06525-0
pii: 10.1186/s13063-022-06525-0
pmc: PMC9308115
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
590Subventions
Organisme : Innovation Committee of the German Joint Federal Committee (G-BA)
ID : 01NVF18013
Organisme : Innovation Committee of the German Joint Federal Committee (G-BA)
ID : 01NVF18013
Informations de copyright
© 2022. The Author(s).
Références
Int J Obes (Lond). 2019 Nov;43(11):2291-2301
pubmed: 31346233
Schweiz Med Wochenschr. 1999 Feb 6;129(5):162-75
pubmed: 10081074
BMJ. 2012 Sep 25;345:e4759
pubmed: 23015032
PLoS One. 2014 Jan 29;9(1):e86303
pubmed: 24489713
J Child Psychol Psychiatry. 1997 Jul;38(5):581-6
pubmed: 9255702
Int J Eat Disord. 2017 Jun;50(6):679-686
pubmed: 28122128
Int J Eat Disord. 2016 Jun;49(6):613-6
pubmed: 26711183
Cochrane Database Syst Rev. 2016 Mar 10;3:CD012105
pubmed: 26961576
Lancet. 2017 Dec 16;390(10113):2627-2642
pubmed: 29029897
Front Psychol. 2019 Jan 24;9:2785
pubmed: 30740081
J Pers Assess. 2012;94(4):404-9
pubmed: 22375603
Int J Epidemiol. 2017 Oct 1;46(5):1394-1395j
pubmed: 28040744
Children (Basel). 2021 Feb 12;8(2):
pubmed: 33673078
Obesity (Silver Spring). 2016 Jan;24(1):200-6
pubmed: 26638187
Stat Med. 1992 Jul;11(10):1305-19
pubmed: 1518992
Health Qual Life Outcomes. 2009 Aug 26;7:77
pubmed: 19709410
Public Health Nutr. 2020 Jan;23(1):53-62
pubmed: 31405404
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2004 Mar;47(3):219-26
pubmed: 15205789
J Clin Endocrinol Metab. 2017 Mar 1;102(3):763-775
pubmed: 28359101
Nutr J. 2011 Dec 07;10:133
pubmed: 22152115
Obes Rev. 2016 Feb;17(2):95-107
pubmed: 26696565
Psychother Psychosom Med Psychol. 1997 Sep-Oct;47(9-10):365-76
pubmed: 9411465
Obes Rev. 2018 Aug;19(8):1065-1079
pubmed: 29671938
Biometrics. 1992 Jun;48(2):577-85
pubmed: 1637980
Int J Obes (Lond). 2018 Nov;42(11):1823-1833
pubmed: 30301964
Pediatr Obes. 2018 Feb;13(2):88-93
pubmed: 27900848
Lancet. 2016 Apr 2;387(10026):1377-1396
pubmed: 27115820
Obes Rev. 2014 Jan;15(1):52-67
pubmed: 23941399
Cochrane Database Syst Rev. 2017 Jun 22;6:CD012651
pubmed: 28639319
J Pediatr Psychol. 2013 Jan-Feb;38(1):104-15
pubmed: 22946084
Cochrane Database Syst Rev. 2009 Jan 21;(1):CD001872
pubmed: 19160202
Obes Surg. 2015 Apr;25(4):750-3
pubmed: 25663147
Obesity (Silver Spring). 2020 Aug;28(8):1382-1385
pubmed: 32352652
Eur J Health Econ. 2016 Dec;17(9):1141-1158
pubmed: 26701837
Front Psychol. 2021 Mar 26;12:631678
pubmed: 33841261
Br J Dev Psychol. 2009 Mar;27(Pt 1):105-21
pubmed: 19972665
Cochrane Database Syst Rev. 2017 Jun 22;6:CD012691
pubmed: 28639320
Int J Pediatr Obes. 2010 Aug;5(4):282-304
pubmed: 20210677
J Psychosom Res. 2006 Oct;61(4):567-9
pubmed: 17011367
BMC Pediatr. 2013 Aug 13;13:121
pubmed: 23941287
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2007 May-Jun;50(5-6):810-8
pubmed: 17514467
Int J Eat Disord. 2008 Jan;41(1):72-81
pubmed: 17634965
Qual Life Res. 1998 Jul;7(5):399-407
pubmed: 9691720
J Adolesc Health. 2017 Dec;61(6):669-677
pubmed: 28822682
J Pediatr Psychol. 2018 Jan 1;43(1):40-51
pubmed: 28482018
Psychotherapy (Chic). 2012 Dec;49(4):519-27
pubmed: 23088312