Contact information
Type
Scientific
Primary contact
Prof Claude Marcus
ORCID ID
Contact details
Karolinska Institutet
Division of pediatrics
B 57
Department of Clinical Science
Intervention and Technology
Stockholm
141 86
Sweden
-
claude.marcus@ki.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A four-year, cluster randomised controlled childhood obesity prevention study
Acronym
STOPP
Study hypothesis
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
The study was approved by the Regional Ethical Review Board in Stockholm on the 10th January 2001 (ref: 2001/336)
Study design
Cluster randomised, controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
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).
Secondary outcome measures
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
Overall trial start date
08/01/2001
Overall trial end date
07/01/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
3000
Total final enrolment
3135
Participant exclusion criteria
Schools with children from high socio-economic families
Recruitment start date
08/01/2001
Recruitment end date
07/01/2005
Locations
Countries of recruitment
Sweden
Trial participating centre
Karolinska Institutet
Stockholm
141 86
Sweden
Sponsor information
Organisation
Stockholm County Council (Sweden)
Sponsor details
Hantverkargatan 45
Stockholm
104 22
Sweden
-
landstinget@sll.se
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Stockholm County Council (Sweden)
Alternative name(s)
Stockholm County Council
Funding Body Type
unknown
Funding Body Subtype
Location
Funder name
Swedish Council for Working Life and Social Research (Sweden)
Alternative name(s)
FAS
Funding Body Type
unknown
Funding Body Subtype
Location
Funder name
Swedish Research Council (Sweden)
Alternative name(s)
Swedish Research Council
Funding Body Type
unknown
Funding Body Subtype
Location
Funder name
Freemasons in Stockholm Foundation for Childrens Welfare (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Signhild Engkvist Foundation (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in: https://www.ncbi.nlm.nih.gov/pubmed/19290010 (added 04/07/2019)