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
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