National Adolescent Treatment Trial for Obesity in Kuwait

ISRCTN	ISRCTN37457227
DOI	https://doi.org/10.1186/ISRCTN37457227
Protocol serial number	N/A
Sponsor	Civil Service Commission (Kuwait)
Funder	Civil Service Commission (Kuwait)

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

University of Glasgow Division of Developmental Medicine
1st Floor Tower QMH
Yorkhill Hospitals
Glasgow
G3 8SJ
United Kingdom

Study information

Primary study design	Interventional
Study design	Assessor blinded two arm randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Change in BMI z score from baseline to 6 months after the start of treatment or standard care control.
Key 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)
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	10 Years
Upper age limit	14 Years
Sex	All
Target sample size at registration	140
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

United Kingdom
Scotland
Kuwait

Study participating centre

University of Glasgow Division of Developmental Medicine

Glasgow
G3 8SJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes