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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037151
Receipt No. R000042334
Scientific Title Effectiveness of Integrated School-Based Intervention Programme in Reducing Obesity among Adolescents
Date of disclosure of the study information 2020/06/01
Last modified on 2020/12/17

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Basic information
Public title Effectiveness of an Integrated School-Based Intervention Programme in Reducing Obesity among Adolescents in Seremban, Negeri Sembilan
Acronym School-based intervention
Adolescent
Obesity
Scientific Title Effectiveness of Integrated School-Based Intervention Programme in Reducing Obesity among Adolescents
Scientific Title:Acronym Obesity
Region
Asia(except Japan)

Condition
Condition Overweight and obese adolescents
Classification by specialty
Not applicable Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study consists of two phases. Phase one of the study is a cross-sectional study to establish the prevalence and predictors of obesity among adolescents. Phase two of the study is a cluster randomized controlled trial of an intervention program for the same cohort of the adolescents
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Phase One - prevalence of obesity, overweight, normal body weight and thinness based on BMI-Age Z scores

Phase Two - effectiveness of the intervention on reducing body weight and BMI-Age Z scores.
Key secondary outcomes Socio-demographic characteristics (sex, ethnicity and age)
Behavioral factor (dietary behavior, physical activity level)
Personal factor (healthy eating and weight maintenance self-efficacy, physical activity self-efficacy, self-esteem, body image perception, perception of weight management, depression, anxiety, stress, nutrition knowledge)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Food Behavior,custom
Interventions/Control_1 The intervention is a five-session module and delivering once every two week for ten weeks.Each session takes about 90 to 120 minutes and will be conducted during school hours.
Interventions/Control_2 Wait-list control group
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
12 years-old <
Age-upper limit
18 years-old >
Gender Male and Female
Key inclusion criteria Adolescents who are studying in the selected secondary schools and being diagnosed as overweight and/or obese will be invited to participate in this study. Diagnosis of overweight and obesity will be determined by measurement of body mass index for age z-scores (BMIZ) based on the WHO Child Growth Standards. Overweight was determined as BMIZ greater than one standard deviations, while obesity was determined as BMIZ greater than two standard deviations.
Key exclusion criteria Overweight and/ or obese adolescent diagnosed with chronic asthma, diabetes mellitus, psychiatric disorders or other serious medical conditions; those who are taking medications that might promote weight gain or weight loss; those who are already participating in any weight management programme.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Sherina
Middle name
Last name Mohd Sidik
Organization University Putra Malaysia
Division name Department of Psychiatry
Zip code 43400
Address Faculty of Medicine and Health Sciences, 43400 UPM Serdang, Selangor Darul Ehsan.
TEL +60389471011
Email sherina@upm.edu.my

Public contact
Name of contact person
1st name Wai Kent
Middle name
Last name Lai
Organization University Putra Malaysia
Division name Department of Psychiatry
Zip code 43400
Address Faculty of Medicine and Health Sciences, 43400 UPM Serdang, Selangor Darul Ehsan.
TEL +60126164746
Homepage URL
Email wklai85@gmail.com

Sponsor
Institute University Putra Malaysia
Institute
Department

Funding Source
Organization University Putra Malaysia
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Publication NIH Secretariat
Address Ministry of Health Malaysia, c/o Institute for Health Management, Block A, Kompleks Institut Kesihatan Negara (NIH) No 1 Jalan Setia Murni U13/52, Seksyen U13 Bandar Setia Alam, 40170 Shah Alam
Tel +60333628888
Email nihsec@moh.gov.my

Secondary IDs
Secondary IDs YES
Study ID_1 NMRR-19-806-47767
Org. issuing International ID_1 Medical Research Ethics Committee(MREC)
Study ID_2 NMRR-19-159-45671
Org. issuing International ID_2 Medical Research Ethics Committee(MREC)
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 06 Month 01 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 400
Results A total of 400 participants were allocated to intervention and control group. The number of participants reduced to 375 in the immediately post-intervention and to 321 in the follow-up. The reason for the drop-outs from the study was due to absenteeism.
Results date posted
2020 Year 12 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics The baseline socio-demographic characteristics of participants were similar between the intervention and control group, except for the sex. There was no significant difference (p > .05) between the intervention and control group in all the outcome measures.
Participant flow
Adverse events No adverse event was reported.
Outcome measures Weight, height, BMI,BMI-for-age z scores, breakfast consumption, physical activity level, healthy eating and weight self-efficacy,perceived physical activity self-efficacy.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2019 Year 01 Month 15 Day
Date of IRB
2019 Year 05 Month 24 Day
Anticipated trial start date
2019 Year 07 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 24 Day
Last modified on
2020 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042334

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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