Exercise looks after you: Piloting a programme to prevent obesity in children

ISRCTN	ISRCTN97887613
DOI	https://doi.org/10.1186/ISRCTN97887613
Secondary identifying numbers	98//2007

Submission date: 28/11/2007
Registration date: 02/01/2008
Last edited: 31/12/2020

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 Narcis Gusi
Scientific

Faculty of Sports Sciences
University of Extremadura
Caceres
10071
Spain

Phone	+34 927 257460
Email	ngusi@unex.es

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet.
Scientific title	Exercise looks after you: Piloting a programme to prevent obesity in children
Study acronym	ETCOI98/07
Study objectives	1. The addition to usual care of an exercise referral from paedriatic team to a supervised exercise programme is effective and cost-effective compared to usual care 2. In addition to the exercise included in the programme, the programme is effective in increasing the level of physical activity in children
Ethics approval(s)	Approved by the Bioethical Committee of the University of Extremadura on 31 October 2007 (ref: 98/2007)
Health condition(s) or problem(s) studied	Obesity
Intervention	Intervention group: The 6-month programme includes two one-hour sessions of an exercise programme per week. Each session includes 20-minute physical exercise to improve fitness, a 30-minute activity to improve sport skills, and 10-minute of healthy lifestyle advice (nutrition, possibilities of doing physical exercise during leisure time). Control group: Usual care only
Intervention type	Other
Primary outcome measure	1. Level of physical activity (minutes per week) in sports and leisure time, assessed by a questionnaire at 12 months 2. Fitness tests (agility, hand-grip, jump test, velocity, endurance, flexibility, body composition, waist-hip index) at baseline and 3 months 3. Health care costs, assessed at baseline and 3 months 4. Health-related quality of life, measured using the EuroQol EQ-5D, EQ-5D (Child) and PedsQSl questionnaires at 12 months
Secondary outcome measures	1. Nutritional intake (24 h recall), assessed at baseline and 3 months 2. Blood samples (cholesterol, glucose, Hb1Ac), assessed at baseline and 3 months
Overall study start date	30/11/2007
Completion date	15/06/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	8 Years
Upper age limit	12 Years
Sex	Both
Target number of participants	200
Total final enrolment	151
Key inclusion criteria	1. Children aged 8 to 12 years old 2. Obesity type I and II (Body Mass Index >= age and gender adjusted 95 percentile) 3. Capacity to walk for 10 minutes
Key exclusion criteria	1. Diabetes type I 2. Hyperactivity 3. Morbid obesity 4. Contraindications to do exercise (biological or mental)
Date of first enrolment	30/11/2007
Date of final enrolment	15/06/2008

Locations

Countries of recruitment

Spain

Study participating centre

Faculty of Sports Sciences

Caceres
10071
Spain

Sponsor information

University of Extremadura (Spain)
University/education

Avda Elvas s/n
Badajoz
06071
Spain

Phone	+34 92 428 93 05
Email	vicein@unex.es
Website	http://www.unex.es
"ROR"	https://ror.org/0174shg90

Funders

Funder type

Government

University of Extremadura (Spain)

No information available

Health & Dependence Department and Young & Sports Department of Junta de Extremadura.(ref. 118/06) (Spain)

No information available

Innovation and Research Department of Junta de Extremadura (ref: GRU07106) (Spain)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2018	31/12/2020	Yes	No

Editorial Notes

31/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.