Condition category
Nutritional, Metabolic, Endocrine
Date applied
25/11/2008
Date assigned
18/02/2009
Last edited
20/02/2009
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
First Floor Tower QMH
Yorkhill Hospitals
Glasgow
G3 8SJ
United Kingdom
+44 (0)1412 010710
jjr2y@clinmed.gla.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MASCOT1

Study information

Scientific title

Exploratory randomised controlled trial of a behavioural treatment programme for obesity in Malaysian children

Acronym

MASCOT

Study hypothesis

To test the hypothesis that group based behavioural change counselling for childhood obesity produces greater improvements in weight status and psychosocial outcomes than (waiting list) control.

Ethics approval

Ethics Committee of the National University of Malaysia (University Kebangsaan Malaysia) (UKM), approved on 16/10/2008 (ref: FF-255-2008)

Study design

Randomised assessor-blinded controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Childhood obesity

Intervention

The participants will be randomly assigned to either the intervention group or the "waiting list" control group.

Exercise sessions with children. 8 x 60 minute sessions involving fun aerobic games led by a physiotherapist.

Behaviour change counselling delivered to parents in group sessions. 8 x 60 minute sessions, 7/8 treatment sessions led by a dietitian, the other one led by a health psychologist.

The 8 treatment sessions are delivered over 6 months (24-26 weeks).

Sessions 1-4 are delivered fortnightly for first 8 weeks.
Session 5 at 12 weeks
Session 6 at 16 weeks
Session 7 at 20 weeks
Session 8 at 24 weeks

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Change in BMI standard deviation score from baseline to 6 and 12 months.

Secondary outcome measures

Changes from baseline to 6 and 12 months in the following:
1. Health related quality of life, assessed by the Pediatric Quality of Life Inventory™ (PedsQL)
2. Objectively measured habitual physical activity and sedentary behaviour (accelerometry)
3. Changes in estimated fat and fat free mass (impedance)

Overall trial start date

01/12/2008

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females
2. Children and adolescents aged 6-13 years
3. No major chronic disease or disability
4. No obvious underlying pathological cause of obesity
5. Obese (Body mass index [BMI] above 95th percentile on US Centers for Disease Control and Prevention [CDC] percentile charts)
6. Parents (at least one) and children willing to attend treatment sessions if randomly allocated to treatment group
7. Attending a mainstream school in the public sector

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Approximately 110

Participant exclusion criteria

1. Non-obese
2. Not attending a mainstream school
3. Serious chronic or acute illness
4. Not within age range
5. Not willing to attend treatment sessions

Recruitment start date

01/12/2008

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Malaysia

Trial participating centre

University of Glasgow
Glasgow
G3 8SJ
United Kingdom

Sponsor information

Organisation

National University of Malaysia (University Kebangsaan Malaysia) (Malaysia)

Sponsor details

Faculty of Allied Health Sciences
Jln Raja Muda Abdul Aziz
Kuala Lumpur
50300
Malaysia
+60 3 4040 5512
webmaster@ukm.my

Sponsor type

University/education

Website

http://www.ukm.my/portal/index.html

Funders

Funder type

Government

Funder name

Ministry of Higher Education (Malaysia)

Alternative name(s)

Ministry of Higher Education, Egypt, Egyptian Ministry of Higher Education, MOHE

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Egypt

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

Publication citations

Additional files

Editorial Notes