Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/11/2007
Date assigned
02/01/2008
Last edited
02/01/2008
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 Narcis Gusi

ORCID ID

Contact details

Faculty of Sports Sciences
University of Extremadura
Caceres
10071
Spain
+34 927 257460
ngusi@unex.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

98//2007

Study information

Scientific title

Acronym

ETCOI98/07

Study hypothesis

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

Approved by the Bioethical Committee of the University of Extremadura on 31 October 2007 (ref: 98/2007)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

30/11/2007

Overall trial end date

15/06/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Diabetes type I
2. Hyperactivity
3. Morbid obesity
4. Contraindications to do exercise (biological or mental)

Recruitment start date

30/11/2007

Recruitment end date

15/06/2008

Locations

Countries of recruitment

Spain

Trial participating centre

Faculty of Sports Sciences
Caceres
10071
Spain

Sponsor information

Organisation

University of Extremadura (Spain)

Sponsor details

Avda Elvas s/n
Badajoz
06071
Spain
+34 92 428 93 05
vicein@unex.es

Sponsor type

University/education

Website

http://www.unex.es

Funders

Funder type

Government

Funder name

University of Extremadura (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

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