Condition category
Nutritional, Metabolic, Endocrine
Date applied
11/10/2007
Date assigned
06/11/2007
Last edited
06/11/2007
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

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

Publication citations

Additional files

Editorial Notes