ISRCTN ISRCTN96347873
DOI https://doi.org/10.1186/ISRCTN96347873
Secondary identifying numbers N/A
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

Study designCluster randomised, controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Scientific titleA four-year, cluster randomised controlled childhood obesity prevention study
Study acronymSTOPP
Study objectivesTo 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) studiedChildhood overweight and obesity
InterventionTen 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 typeOther
Primary outcome measureTo 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 measures1. 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 study start date08/01/2001
Completion date07/01/2005

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Years
Upper age limit10 Years
SexBoth
Target number of participants3000
Total final enrolment3135
Key inclusion criteria1. 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 criteriaSchools with children from high socio-economic families
Date of first enrolment08/01/2001
Date of final enrolment07/01/2005

Locations

Countries of recruitment

  • Sweden

Study participating centre

Karolinska Institutet
Stockholm
141 86
Sweden

Sponsor information

Stockholm County Council (Sweden)
Government

Hantverkargatan 45
Stockholm
104 22
Sweden

Email landstinget@sll.se
Website http://www.sll.se/
ROR logo "ROR" https://ror.org/02zrae794

Funders

Funder type

Government

Stockholm County Council (Sweden)
Government organisation / Local government
Alternative name(s)
Stockholm County Council
Location
Sweden
Swedish Council for Working Life and Social Research (Sweden)
Private sector organisation / Other non-profit organizations
Alternative name(s)
Swedish Council for Working Life and Social Research, FAS
Location
Sweden
Swedish Research Council (Sweden)
Government organisation / National government
Alternative name(s)
Swedish Research Council, VR
Location
Sweden
Freemason’s in Stockholm Foundation for Children’s Welfare (Sweden)

No information available

Signhild Engkvist Foundation (Sweden)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.