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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000026055 |
Receipt No. | R000029907 |
Scientific Title | Teacher-led Healthy Lifestyle Program for adolescents living in day-school hostels in Malaysia by using the "Healthy Eating and Be Active among Teens" (HEBAT) modules |
Date of disclosure of the study information | 2017/02/11 |
Last modified on | 2017/02/08 |
Basic information | ||
Public title | Teacher-led Healthy Lifestyle Program for adolescents living in day-school hostels in Malaysia by using the "Healthy Eating and Be Active among Teens" (HEBAT) modules | |
Acronym | Healthy Lifestyle Program for adolescents living in day-school hostels in Malaysia | |
Scientific Title | Teacher-led Healthy Lifestyle Program for adolescents living in day-school hostels in Malaysia by using the "Healthy Eating and Be Active among Teens" (HEBAT) modules | |
Scientific Title:Acronym | Healthy Lifestyle Program for adolescents living in day-school hostels in Malaysia | |
Region |
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Condition | ||
Condition | Healthy eating, Active lifestyle, Healthy body weight | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To promote healthy lifestyle (healthy eating and active lifestyle) among Malaysian adolescents living in day-school hostels |
Basic objectives2 | Others |
Basic objectives -Others | To evaluate the effectiveness of the "Healthy Lifestyle Program" among adolescents by determining the difference in:
- Body composition (BMI-for-age, waist circumference, body fat percentage) - Knowledge, attitude and practice of healthy lifestyle - Eating behaviors - Physical Activity - Body image - Psychological well-being - Health related quality of life before and after the intervention program |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Changes in:
- Body composition (BMI-for-age, waist circumference, body fat percentage) - Knowledge, attitude and practice of healthy lifestyle before and after the intervention program |
Key secondary outcomes | Changes in:
- Eating behaviors - Physical Activity - Body image - Psychological well-being - Health related quality of life before and after the intervention program |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Cluster |
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 intervention group, teachers were trained to use the HEBAT modules to educate the students in practicing healthy lifestyle. The HEBAT modules focused on healthy eating and active living that are the important components in energy balance. The intervention is divided to 2 phases, with 4 intervention topics in Phase 1 and 6 intervention topicsin Phase 2. | |
Interventions/Control_2 | In the control group, no intervention is given to both teachers and students. Students received standard physical education at schools. They will receive the education materials from the Healthy Lifestyle Program after the intervention is completed. | |
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 | Form 1 adolescents who are living in day-school hostels | |||
Key exclusion criteria | Adolescent who are physically disabled and have learning disability | |||
Target sample size | 4277 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Universiti Putra Malaysia | ||||||
Division name | Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences | ||||||
Zip code | |||||||
Address | Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia | ||||||
TEL | +60389472680 | ||||||
chinys@upm.edu.my |
Public contact | |||||||
Name of contact person |
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Organization | Universiti Putra Malaysia | ||||||
Division name | Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences | ||||||
Zip code | |||||||
Address | Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia | ||||||
TEL | +60389472680 | ||||||
Homepage URL | |||||||
chinys@upm.edu.my |
Sponsor | |
Institute | Nestle Products Pte Ltd under Nestle Healthy Kids project |
Institute | |
Department |
Funding Source | |
Organization | Nestle Products Pte Ltd under Nestle Healthy Kids project |
Organization | |
Division | |
Category of Funding Organization | Other |
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 | |
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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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Last follow-up date | |||||||
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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=R000029907 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |