National Adolescent Treatment Trial for Obesity in Kuwait
| ISRCTN | ISRCTN37457227 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37457227 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/10/2009
- Registration date
- 01/12/2009
- Last edited
- 20/06/2014
- 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
Prof John Reilly
Scientific
Scientific
University of Glasgow Division of Developmental Medicine
1st Floor Tower QMH
Yorkhill Hospitals
Glasgow
G3 8SJ
United Kingdom
Study information
| Study design | Assessor blinded two arm randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomised controlled trial of a behavioural treatment programme for obesity in Kuwaiti adolescents |
| Study acronym | NATTO |
| Study objectives | To test whether parent-directed group-based behavioural treatment offers improved weight management over standard care. |
| Ethics approval(s) | Ethics Committee for Medical Research, Ministry of Health of Kuwait, 12/02/2009, ref: MPH/112 |
| Health condition(s) or problem(s) studied | Obesity |
| Intervention | Random allocation to intervention or standard care control group: 1. Standard care control: referral to primary care, where treatment will be limited to a little health education 2. Intervention group: invited to 10 session of behavioural change counselling targeted at changes in physical activity, diet, and sedentary behaviour, over a 24 - 26 week period Of the 10 sessions, five will be delivered by a dietician, five by a physician. Sessions 1 - 8 fortnightly for first 16 weeks, session 9 at week 20 and session 10 at week 26. |
| Intervention type | Other |
| Primary outcome measure | Change in BMI z score from baseline to 6 months after the start of treatment or standard care control. |
| Secondary outcome measures | 1. Change in quality of life from baseline to +6 month follow up 2. Change in blood pressure and blood-based cardiometabolic risk factors (fasting lipids, triglycerides, insulin, glucose) from baseline to +6 months 3. Changes in estimated fat and fat free mass from baseline to +6 month follow up (using bioelectrical impedance) |
| Overall study start date | 11/11/2009 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 10 Years |
| Upper age limit | 14 Years |
| Sex | Both |
| Target number of participants | 100 - 140 at study entry |
| Key inclusion criteria | 1. Boys and girls 2. Obese (body mass index [BMI] at or above 95th percentile on US CDC 200 BMI charts) 3. Aged 10 - 14 years inclusive 4. With no major chronic disease or disability 5. With no obvious underlying pathological cause of obesity 6. At least one parent willing to attend treatment sessions if randomly allocated to intervention 7. Attending a mainstream school in the public sector |
| Key exclusion criteria | 1. Non-obese 2. With major disease 3. With underlying pathological cause of obesity 4. Less than 10 years or greater than 14 years at study inception 5. Not attending a mainstream school in the public sector 6. Unable or unwilling to attend treatment sessions if randomised to intervention group |
| Date of first enrolment | 11/11/2009 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- Kuwait
- Scotland
- United Kingdom
Study participating centre
University of Glasgow Division of Developmental Medicine
Glasgow
G3 8SJ
United Kingdom
G3 8SJ
United Kingdom
Sponsor information
Civil Service Commission (Kuwait)
Government
Government
Scholarships Department
State of Kuwait
Kuwait City
KCL889
Kuwait
| Website | http://www.csc.net.kw/ |
|---|---|
"ROR" |
https://ror.org/02htmn026 |
Funders
Funder type
Government
Civil Service Commission (Kuwait)
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 | results | 19/06/2014 | Yes | No |
