Condition category
Nutritional, Metabolic, Endocrine
Date applied
09/10/2009
Date assigned
01/12/2009
Last edited
20/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof John Reilly

ORCID ID

Contact details

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

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

http://www.csc.net.kw/

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

  1. 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.

Additional files

Editorial Notes