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ISRCTN
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ISRCTN96347873
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ClinicalTrials.gov identifier
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Public title
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STockholm Obesity Prevention Project
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Scientific title
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A four-year, cluster randomised controlled childhood obesity prevention study
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Acronym
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STOPP
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Serial number at source
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N/A
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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The study was approved by the Regional Ethical Review Board in Stockholm on the 10th January 2001 (ref: 2001/336)
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Study design
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Cluster randomised, controlled study
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Countries of recruitment
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Sweden
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Disease/condition/study domain
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Childhood overweight and obesity
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Schools with children from high socio-economic families
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Anticipated start date
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08/01/2001
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Anticipated end date
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07/01/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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3000
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Interventions
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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.
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Primary outcome measure(s)
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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).
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Secondary outcome measure(s)
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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
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Sources of funding
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1. Stockholm County Council (Sweden)
2. Swedish Council for Working Life and Social Research (Sweden)
3. Swedish Research Council (Sweden)
4. Freemason’s in Stockholm Foundation for Children’s Welfare (Sweden)
5. Signhild Engkvist Foundation (Sweden)
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Trial website
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Publications
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Contact name
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Prof
Claude
Marcus
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Address
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Karolinska Institutet
Division of pediatrics, B 57
Department of Clinical Science, Intervention and Technology
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City/town
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Stockholm
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Zip/Postcode
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141 86
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Country
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Sweden
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Email
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claude.marcus@ki.se
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Sponsor
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Stockholm County Council (Sweden)
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Address
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Hantverkargatan 45
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City/town
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Stockholm
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Zip/Postcode
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104 22
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Country
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Sweden
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Email
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landstinget@sll.se
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Sponsor website:
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http://www.sll.se/
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Date applied
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16/10/2008
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Last edited
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27/10/2008
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Date ISRCTN assigned
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27/10/2008
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