Contact information
Type
Scientific
Primary contact
Dr Lefa Eddy
ORCID ID
Contact details
Plaza de la Vila 15
Principal 1
Santa Coloma de Gramanet
Barcelona
08921
Spain
+34 93 4662444
lefaseddy@comb.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
OBESCAT
Study hypothesis
A regular systematic educational intervention by primary care paediatricians will reduce the Body Mass Index (BMI) of the overweight and obese adolescents.
Ethics approval
Ethics approval received from the Ethics Committee of Clinical Investigation at the Institute of Health Care, Santa Caterina Hospital (Comite etic d'investigacio clinica de l'institut d'assistencia sanitaria del Hospital Santa Caterina) on the 2nd March 2006.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Condition
Overweight and obesity
Intervention
Intervention:
Diet and exercice education and counselling. Weight, height, BMI, waist and hip perimeter and blood pressure measures will be taken at each visit. A questionnaire about eating and physical activity habits and the AF-5 autoconcept questionnaire will be filled by the adolescent at the inclusion and final visits. The number of scheduled visits will be 6 (at inclusion, month 1, 3, 6, 9 and 12).
Control:
Adolescents in the control group will follow usual care given by paediatricians. Weight, height, BMI, waist and hip perimeter and blood pressure measures will be taken at each visit. A questionnaire about eating and physical activity habits and the AF-5 autoconcept questionnaire will be filled by the adolescent at the inclusion and final visits. The number of scheduled visits will be 2 (inclusion visit and final visit at 12 months).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Reduction in BMI.
Secondary outcome measures
1. Social-economic class
2. Eating and physical activity habits
3. Emotional status (AF-5)
Overall trial start date
01/06/2006
Overall trial end date
01/06/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adolescents aged 10 to 14 years
2. Overweight (BMI greater than 85th percentile) or obese (BMI greater than 95th percentile)
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
200
Participant exclusion criteria
1. Adolescents following an intervention to reduce BMI at the moment of inclusion
2. Morbid obesity
3. Secondary obesity
4. Bulimia nervosa
5. Adolescents with poor mental function, or any other reason to expect that the patient may have difficulty in complying with the requirements of the study
6. Adolescents participating in another clinical trial in the last four weeks
Recruitment start date
01/06/2006
Recruitment end date
01/06/2008
Locations
Countries of recruitment
Spain
Trial participating centre
Plaza de la Vila 15
Barcelona
08921
Spain
Sponsor information
Organisation
Sant Ramon SL Medical Centre and the Sardenya Primary Care Centre (Spain)
Sponsor details
Plaza de la Vila 15
Santa Coloma de Gramanet
Barcelona
08921
Spain
+34 93 4662444
lefaseddy@comb.es
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
The Spanish Paediatric Association (Asociación Española de Pediatría [AEP]) (Spain) - awarded Nutriben prize
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