|
ISRCTN
|
ISRCTN37457227
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
National Adolescent Treatment Trial for Obesity in Kuwait
|
|
Scientific title
|
Randomised controlled trial of a behavioural treatment programme for obesity in Kuwaiti adolescents
|
|
Acronym
|
NATTO
|
|
Serial number at source
|
N/A
|
|
Study hypothesis
|
To test whether parent-directed group-based behavioural treatment offers improved weight management over standard care.
|
|
Ethics approval
|
Ethics Committee for Medical Research, Ministry of Health of Kuwait, approved on the 12th February 2009 (ref: MPH/112)
|
|
Study design
|
Assessor blinded two arm randomised controlled trial
|
|
Countries of recruitment
|
Kuwait
|
|
Disease/condition/study domain
|
Obesity
|
|
Participants - 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
|
|
Participants - 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
|
|
Anticipated start date
|
11/11/2009
|
|
Anticipated end date
|
31/12/2010
|
|
Status of trial
|
Ongoing |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
100 - 140 at study entry
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
Change in BMI z score from baseline to 6 months after the start of treatment or standard care control.
|
|
Secondary outcome measure(s)
|
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)
|
|
Sources of funding
|
Civil Service Commission (Kuwait)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Prof
John
Reilly
|
|
Address
|
University of Glasgow Division of Developmental Medicine
1st Floor Tower QMH
Yorkhill Hospitals
|
|
City/town
|
Glasgow
|
|
Zip/Postcode
|
G3 8SJ
|
|
Country
|
United Kingdom
|
|
Sponsor
|
Civil Service Commission (Kuwait)
|
|
Address
|
Scholarships Department
State of Kuwait
|
|
City/town
|
Kuwait City
|
|
Zip/Postcode
|
KCL889
|
|
Country
|
Kuwait
|
|
Sponsor website:
|
http://www.csc.net.kw/
|
|
Date applied
|
09/10/2009
|
|
Last edited
|
01/12/2009
|
|
Date ISRCTN assigned
|
01/12/2009
|
