UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037151
Receipt number 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 2023/12/28 09:15:20

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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 or person

Institute

University Putra Malaysia

Institute

Department

Personal name



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

https://doi.org/10.1016/j.hnm.2023.200229

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1016/j.hnm.2023.200229

Number of participants that the trial has enrolled

400

Results

Findings from this study demonstrated that the integrated school-based intervention program was effective in reducing Body Mass Index (BMI) and BMI-for-age z-scores among overweight and obese participants. In addition, the program was also effective in improving breakfast consumption frequency, physical activity levels, self-efficacy in terms of healthy eating, healthy weight and perceived physical activity and body satisfaction.

Results date posted

2020 Year 12 Month 17 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2023 Year 11 Month 11 Day

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

200 participants in each intervention and control during baseline.
During immediate post-intervention, there were 182 participants in the intervention group and 193 in the control group.
During 3-month post intervention follow-up, there were 160 in the intervention group and 161 in the control group.

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

Completed

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

2023 Year 12 Month 28 Day



Link to view the page

Value
https://center6.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