UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024349 |
|---|---|
| Receipt number | R000028035 |
| Scientific Title | Development of an Integrated Intervention for Preventing Overweight and Disordered Eating In Malaysian Adolescents |
| Date of disclosure of the study information | 2016/10/11 |
| Last modified on | 2016/10/11 00:31:59 |
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Basic information
Public title
Development of an Integrated Intervention for Preventing Overweight and Disordered Eating In Malaysian Adolescents
Acronym
Intervention for Preventing Overweight and Disordered Eating In Malaysian Adolescents
Scientific Title
Development of an Integrated Intervention for Preventing Overweight and Disordered Eating In Malaysian Adolescents
Scientific Title:Acronym
Intervention for Preventing Overweight and Disordered Eating In Malaysian Adolescents
Region
| Asia(except Japan) |
Condition
Condition
Overweight and obesity, disordered eating.
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness of an integrated intervention for preventing overweight and disordered eating in Malaysian adolescents.
Basic objectives2
Others
Basic objectives -Others
To evaluate the effectiveness of the intervention module of 'Eat Right, Be Positive About Your Body and Live Actively' (EPaL) for adolescents by determining the difference in:
- the BMI-for-age
- the level of knowledge, attitude and practice towards nutrition and eating, physical activity and body image
- the disordered eating behaviour (binge eating, restraint eating and bulimic symptom)
- the energy intake, energy expenditure and energy balance
- the level of physical activity
- the body image
among adolescents in pre-intervention, post-intervention and in 3-month follow-up.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Changes in BMI-for-age.
2) Changes in the level of knowledge, attitude and practice towards nutrition and eating, physical activity and body image.
3) Changes in disordered eating behaviour (binge eating, restraint eating and bulimic symptom).
Key secondary outcomes
1) Changes in energy intake, energy expenditure and energy balance.
2) Changes in the level of physical activity.3) Changes in the body image.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
In the intervention group, the EPaL intervention which consisted three main components of healthy lifestyles, which were healthy eating, positive body image and active lifestyle, and was included in eight topics delivered by peer educators over the course of 16 weeks, with a two-week gap between every two topics. Each session taken about 60-90 min and the sessions were held during co-curriculum periods at the school hall in EPaL club.
Interventions/Control_2
Adolescents in the comparison group were not subjected to the intervention until the end of the period of the study. Adolescents in the comparison group attended a standard physical and health education class at least once a week.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 13 | years-old | <= |
Age-upper limit
| 14 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Schools which were coeducational, multiracial, non-residential and non-religious.
2) Subjects were studied in Form 1 and Form 2 (aged 13 and 14 years, respectively) and have consent from parents.
Key exclusion criteria
1) Schools which were racial-based, residential and religious.
2) Subjects were not studied in Form 1 and Form 2 (aged other than 13 and 14 years) and have no consent from parents.
Target sample size
234
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chin Yit Siew |
Organization
Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia.
Division name
Department of Nutrition and Dietetics
Zip code
Address
Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia.
TEL
+603-89472680
chinys@upm.edu.my
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chin Yit Siew |
Organization
Faculty of Medicine and Health Sciences, Universiti Putra Malaysia
Division name
Department of Nutrition and Dietetics
Zip code
Address
Faculty of Medicine and Health Sciences, Universiti Putra Malaysia
TEL
+603-89472680
Homepage URL
chinys@upm.edu.my
Sponsor or person
Institute
Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia.
Institute
Department
Personal name
Funding Source
Organization
Ministry of Higher Education of Malaysia.
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Malaysia
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 11 | Day |
Last modified on
| 2016 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028035
