OBESCAT Study 2006: randomised clinical trial to assess the efficacy of an intervention in order to reduce the body mass index in adolescents in Catalonia
| ISRCTN | ISRCTN35399598 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35399598 |
| Secondary identifying numbers | N/A |
- Submission date
- 11/10/2007
- Registration date
- 06/11/2007
- Last edited
- 10/06/2021
- 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
Dr Lefa Eddy
Scientific
Scientific
Plaza de la Vila 15
Principal 1
Santa Coloma de Gramanet
Barcelona
08921
Spain
| Phone | +34 93 4662444 |
|---|---|
| lefaseddy@comb.es |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Scientific title | OBESCAT Study 2006: randomised clinical trial to assess the efficacy of an intervention in order to reduce the body mass index in adolescents in Catalonia |
| Study acronym | OBESCAT |
| Study objectives | A regular systematic educational intervention by primary care paediatricians will reduce the Body Mass Index (BMI) of the overweight and obese adolescents. |
| Ethics approval(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Reduction in BMI. |
| Secondary outcome measures | 1. Social-economic class 2. Eating and physical activity habits 3. Emotional status (AF-5) |
| Overall study start date | 01/06/2006 |
| Completion date | 01/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 10 Years |
| Upper age limit | 14 Years |
| Sex | Both |
| Target number of participants | 200 |
| Total final enrolment | 174 |
| Key inclusion criteria | 1. Adolescents aged 10 to 14 years 2. Overweight (BMI greater than 85th percentile) or obese (BMI greater than 95th percentile) |
| Key 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 |
| Date of first enrolment | 01/06/2006 |
| Date of final enrolment | 01/06/2008 |
Locations
Countries of recruitment
- Spain
Study participating centre
Plaza de la Vila 15
Barcelona
08921
Spain
08921
Spain
Sponsor information
Sant Ramon SL Medical Centre and the Sardenya Primary Care Centre (Spain)
Hospital/treatment centre
Hospital/treatment centre
Plaza de la Vila 15
Santa Coloma de Gramanet
Barcelona
08921
Spain
| Phone | +34 93 4662444 |
|---|---|
| lefaseddy@comb.es |
Funders
Funder type
Research organisation
The Spanish Paediatric Association (Asociación Española de Pediatría [AEP]) (Spain) - awarded Nutriben prize
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 | 06/07/2012 | 10/06/2021 | Yes | No |
Editorial Notes
10/06/2021: Publication reference and total final enrolment added.
