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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000024349 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Overweight and obesity, disordered eating. | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 234 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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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 |
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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 |
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Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |