Randomised controlled trial of a nursery and home based intervention for obesity prevention and cardiovascular risk factor reduction

ISRCTN ISRCTN36363490
DOI https://doi.org/10.1186/ISRCTN36363490
Protocol serial number PG/2001/134
Sponsor British Heart Foundation (UK)
Funder British Heart Foundation (UK) (ref: PG/2001/134)
Submission date
30/10/2001
Registration date
30/10/2001
Last edited
26/10/2022
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

Dr John J Reilly
Scientific

Reader in Paediatric Energy Metabolism
University of Glasgow Division of Developmental Medicine
1st Floor Tower Block QMH
Yorkhill Hospitals
Dalnair Street
Glasgow
G3 8SJ
United Kingdom

Phone +44 (0)141 201 0710
Email jjr2y@clinmed.gla.ac.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleRandomised controlled trial of a nursery and home based intervention for obesity prevention and cardiovascular risk factor reduction
Study acronymMAGIC (Movement and Activity Glasgow Intervention in Children)
Study objectivesCluster randomised controlled trial. 545 children in 36 clusters (nurseries). This study aims to test the hypothesis that a simple, generalisable, intervention can reduce change in body mass index (BMI) SD-score over a 12 month period in children in their pre-school year. The intervention is in two parts: enhanced physical activity programme in nursery; distribution of play resources/physical activity promotion at home.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedOverweight, obesity, hypertension
Intervention1. Intervention: nursery and home based physical activity programme
2. Control: standard nursery curriculum
Intervention typeOther
Primary outcome measure(s)

BMI SD-score.

Key secondary outcome measure(s)

1. Habitual physical activity and sedentary behaviour (both measured objectively, by accelerometry)
2. Motor skills (measured using the Movement Assessment Battery)
3. Blood pressure
4. Waist circumference and waist: arm circumference ratio (both indices of fat distribution)
5. Process evaluation

Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit3 Years
Upper age limit4 Years
SexAll
Target sample size at registration545
Key inclusion criteriaHealthy 3 - 4 year-old children in their pre-school year in nursery.
Key exclusion criteriaNo exclusion criteria
Date of first enrolment01/06/2002
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • United Kingdom
  • Scotland

Study participating centre

Reader in Paediatric Energy Metabolism
Glasgow
G3 8SJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 18/11/2006 Yes No
Other publications 01/04/2005 Yes No

Editorial Notes

26/10/2022: Internal review.