STockholm Obesity Prevention Project

ISRCTN	ISRCTN96347873
DOI	https://doi.org/10.1186/ISRCTN96347873
Protocol serial number	N/A
Sponsor	Stockholm County Council (Sweden)
Funders	Stockholm County Council (Sweden), Swedish Council for Working Life and Social Research (Sweden), Swedish Research Council (Sweden), Freemasons in Stockholm Foundation for Childrens Welfare (Sweden), Signhild Engkvist Foundation (Sweden)

Submission date: 16/10/2008
Registration date: 27/10/2008
Last edited: 04/07/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Claude Marcus
Scientific

Karolinska Institutet
Division of pediatrics, B 57
Department of Clinical Science, Intervention and Technology
Stockholm
141 86
Sweden

Email	claude.marcus@ki.se

Study information

Primary study design	Interventional
Study design	Cluster randomised, controlled study
Secondary study design	Randomised controlled trial
Scientific title	A four-year, cluster randomised controlled childhood obesity prevention study
Study acronym	STOPP
Study objectives	To assess whether a school-based prevention programme focused on reduced unhealthy eating and increased physical activity during school time over a four-year period could reduce the prevalence of overweight and obesity among 6 - 10 year old children. Also, to assess whether the intervention affected physical activity measured objectively by accelerometry and whether eating habits at home differed between control and intervention schools at the end of the intervention.
Ethics approval(s)	The study was approved by the Regional Ethical Review Board in Stockholm on the 10th January 2001 (ref: 2001/336)
Health condition(s) or problem(s) studied	Childhood overweight and obesity
Intervention	Ten schools were selected in Stockholm county area and randomised to intervention (n = 5) and control (n = 5) schools. In the intervention group, low fat dairy products and whole grain bread were promoted and all sweets and sweetened drinks were eliminated in intervention schools. Physical activity was aimed to increase by 30 minutes per day during school time and sedentary behaviour restricted during after school care time. The control group received no intervention and continued as usual. The children entered the study during their first school year (6 years of age) and participated in the study until their fourth school year (9 - 10 years of age). Thus, the children who entered the study during their first school year in August 2001 participated in the programme for four years whereas children who started school at a later year participated in the programme for shorter time periods. The study terminated in June 2005.
Intervention type	Other
Primary outcome measure(s)	To measure body mass index standard deviation score (BMIsds) changes from the first to the last measurement of height and weight. Weight and height measures were performed in all children at the yearly school start in the autumn. For children who finished the fourth grade and therefore left the study, weight and height were also were measured at the end of the school year (May - June).
Key secondary outcome measure(s)	1. Prevalence of overweight and obesity at start and end of the intervention 2. Physical activity measured by accelerometry: 10 children from the intervention schools and 10 from the control schools were randomly selected for weekly accelerometer assessments each week during the intervention 3. Eating habits at home assessed by parental report: at the end of the study a questionnaire regarding eating habits at home were distributed to all children in the third and the fourth grade 4. Prevalence of eating disorders evaluated by self-report: assessed by a Swedish version of ChEAT (Children's Eating Attitude Test) and all children participating in the project were requested to fill in the questionnaire before terminating the project in grade 4
Completion date	07/01/2005

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Years
Upper age limit	10 Years
Sex	All
Target sample size at registration	3000
Total final enrolment	3135
Key inclusion criteria	1. Schools with a mixed pupil population with children from middle and working class families living both in blocks of flats and in detached houses 2. Children aged 6 - 10 years, either sex
Key exclusion criteria	Schools with children from high socio-economic families
Date of first enrolment	08/01/2001
Date of final enrolment	07/01/2005

Locations

Countries of recruitment

Sweden

Study participating centre

Karolinska Institutet

Stockholm
141 86
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2009	04/07/2019	Yes	No

Editorial Notes

04/07/2019: Publication reference and total final enrolment added.