Malaysian Childhood Obesity Treatment Trial (MASCOT)
| ISRCTN | ISRCTN14241825 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14241825 |
| Secondary identifying numbers | MASCOT1 |
- Submission date
- 25/11/2008
- Registration date
- 18/02/2009
- Last edited
- 04/07/2019
- 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
Scientific
University of Glasgow
Division of Developmental Medicine
First Floor Tower QMH
Yorkhill Hospitals
Glasgow
G3 8SJ
United Kingdom
| Phone | +44 (0)1412 010710 |
|---|---|
| jjr2y@clinmed.gla.ac.uk |
Study information
| Study design | Randomised assessor-blinded controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Exploratory randomised controlled trial of a behavioural treatment programme for obesity in Malaysian children |
| Study acronym | MASCOT |
| Study objectives | 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(s) | Ethics Committee of the National University of Malaysia (University Kebangsaan Malaysia) (UKM), approved on 16/10/2008 (ref: FF-255-2008) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/12/2008 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 13 Years |
| Sex | Both |
| Target number of participants | Approximately 110 |
| Total final enrolment | 107 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2008 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Malaysia
- Scotland
- United Kingdom
Study participating centre
University of Glasgow
Glasgow
G3 8SJ
United Kingdom
G3 8SJ
United Kingdom
Sponsor information
National University of Malaysia (University Kebangsaan Malaysia) (Malaysia)
University/education
University/education
Faculty of Allied Health Sciences
Jln Raja Muda Abdul Aziz
Kuala Lumpur
50300
Malaysia
| Phone | +60 3 4040 5512 |
|---|---|
| webmaster@ukm.my | |
| Website | http://www.ukm.my/portal/index.html |
"ROR" |
https://ror.org/00bw8d226 |
Funders
Funder type
Government
Ministry of Higher Education (Malaysia)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Ministry of Higher Education, Egypt, Egyptian Ministry of Higher Education, MOHE
- Location
- Egypt
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 01/06/2011 | 04/07/2019 | Yes | No |
| Results article | results | 01/08/2011 | 04/07/2019 | Yes | No |
Editorial Notes
04/07/2019: Publication reference and total final enrolment added.
