Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/10/2008
Date assigned
27/10/2008
Last edited
27/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

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

http://www.sll.se/

Funders

Funder type

Government

Funder name

Stockholm County Council (Sweden)

Alternative name(s)

Stockholm County Council

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Sweden

Funder name

Swedish Council for Working Life and Social Research (Sweden)

Alternative name(s)

Swedish Council for Working Life and Social Research, FAS

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Sweden

Funder name

Swedish Research Council (Sweden)

Alternative name(s)

Swedish Research Council, VR

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Sweden

Funder name

Freemason’s in Stockholm Foundation for Children’s 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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes