Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/10/2001
Date assigned
30/10/2001
Last edited
19/02/2008
Prospective/Retrospective
Prospectively 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

Dr John J Reilly

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PG/2001/134

Study information

Scientific title

Acronym

MAGIC (Movement and Activity Glasgow Intervention in Children)

Study hypothesis

Cluster 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Overweight, obesity, hypertension

Intervention

1. Intervention: nursery and home based physical activity programme
2. Control: standard nursery curriculum

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

BMI SD-score.

Secondary outcome measures

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

Overall trial start date

01/06/2002

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy 3 - 4 year-old children in their pre-school year in nursery.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

545

Participant exclusion criteria

No exclusion criteria

Recruitment start date

01/06/2002

Recruitment end date

31/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Reader in Paediatric Energy Metabolism
Glasgow
G3 8SJ
United Kingdom

Sponsor information

Organisation

British Heart Foundation (UK)

Sponsor details

14 Fitzhardinge Street
London
W1H 6DH
United Kingdom
+44 (0)20 7935 0185
research@bhf.org.uk

Sponsor type

Charity

Website

http://www.bhf.org.uk/

Funders

Funder type

Charity

Funder name

British Heart Foundation (UK) (ref: PG/2001/134)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

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

Results:
1. http://www.ncbi.nlm.nih.gov/pubmed/15809570
2. http://www.ncbi.nlm.nih.gov/pubmed/17028105

Publication citations

  1. Fisher A, Reilly JJ, Kelly LA, Montgomery C, Williamson A, Paton JY, Grant S, Fundamental movement skills and habitual physical activity in young children., Med Sci Sports Exerc, 2005, 37, 4, 684-688.

  2. Reilly JJ, Kelly L, Montgomery C, Williamson A, Fisher A, McColl JH, Lo Conte R, Paton JY, Grant S, Physical activity to prevent obesity in young children: cluster randomised controlled trial., BMJ, 2006, 333, 7577, 1041, doi: 10.1136/bmj.38979.623773.55.

Additional files

Editorial Notes