UMIN-CTR Clinical Trial

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

Overweight and obesity, disordered eating.

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Ministry of Higher Education of Malaysia.

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Malaysia

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

10

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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