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
Nil known
ClinicalTrials.gov number
Nil known
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 measure
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 (if study stopped)
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
Total final enrolment
107
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
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
Basic results (scientific)
Publication list
1. 2011 results in: https://www.ncbi.nlm.nih.gov/pubmed/21604965 (added 04/07/2019)
2. 2011 results in: https://www.ncbi.nlm.nih.gov/pubmed/22303576 (added 04/07/2019)