Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Randomised controlled trial of a behavioural treatment programme for obesity in Kuwaiti adolescents
Acronym
NATTO
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, 12/02/2009, ref: MPH/112
Study design
Assessor blinded two arm randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
11/11/2009
Overall trial end date
31/12/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
100 - 140 at study entry
Participant 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
Recruitment start date
11/11/2009
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Kuwait
Trial participating centre
University of Glasgow Division of Developmental Medicine
Glasgow
G3 8SJ
United Kingdom
Sponsor information
Organisation
Civil Service Commission (Kuwait)
Sponsor details
Scholarships Department
State of Kuwait
Kuwait City
KCL889
Kuwait
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Civil Service Commission (Kuwait)
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
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24943283
Publication citations
-
Results
Boodai SA, McColl JH, Reilly JJ, National Adolescent Treatment Trial for Obesity in Kuwait (NATTO): project design and results of a randomised controlled trial of a good practice approach to treatment of adolescent obesity in Kuwait., Trials, 2014, 15, 234, doi: 10.1186/1745-6215-15-234.