Malaysian Childhood Obesity Treatment Trial (MASCOT)
| ISRCTN | ISRCTN14241825 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14241825 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | MASCOT1 |
| Sponsor | National University of Malaysia (University Kebangsaan Malaysia) (Malaysia) |
| Funder | Ministry of Higher Education (Malaysia) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised assessor-blinded controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Change in BMI standard deviation score from baseline to 6 and 12 months. |
| Key secondary outcome measure(s) |
Changes from baseline to 6 and 12 months in the following: |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 13 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- Scotland
- Malaysia
Study participating centre
University of Glasgow
Glasgow
G3 8SJ
United Kingdom
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 | 01/06/2011 | 04/07/2019 | Yes | No |
| Results article | results | 01/08/2011 | 04/07/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/07/2019: Publication reference and total final enrolment added.
