UMIN-CTR Clinical Trial

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
Email	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
Email	chinys@upm.edu.my

Sponsor
Institute	Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia.
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028035

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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