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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014992
Receipt No. R000017426
Scientific Title Impact of a life style intervention in incident and prevalence of overweight and obesity among secondary school children in Hanoi
Date of disclosure of the study information 2014/08/29
Last modified on 2014/08/29

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Basic information
Public title Impact of a life style intervention in incident and prevalence of overweight and obesity among secondary school children in Hanoi
Acronym Impact of a life style intervention in incident and prevalence of overweight and obesity among secondary school children in Hanoi
Scientific Title Impact of a life style intervention in incident and prevalence of overweight and obesity among secondary school children in Hanoi
Scientific Title:Acronym Impact of a life style intervention in incident and prevalence of overweight and obesity among secondary school children in Hanoi
Region
Japan Asia(except Japan)

Condition
Condition overweight, obesity
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Our aim of this study is to study the impact of a life style intervention in incident and prevalence of overweight and obesity among secondary school children in Hanoi.

Basic objectives2 Others
Basic objectives -Others 1) To find whether length of education had an impact on prevalence and incident of overweight and obesity in the children.
2) To evaluate the impact of the intervention to lifestyle changes in dietary control, physical exercise among the children.
3) To improve the knowledge of overweight and obesity and prevention against lifestyle-related diseases in the secondary school children.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes prevalence and incident of overweight or obesity in secondary school children.
Key secondary outcomes 1) Improvement of indicators related with obesity, such as prevalence of metabolic parabolic blood parameters beyond the normal limit
2) Improvement of lifestyle, such as prevalence of the children walking with more than 5,000 or 10,000 steps/ day, prevalence of the children performing physical activities for more than 60 minutes per day, prevalence of the children who do not skip regular eating and duration of sleeping
3) Improvement of the knowledge about overweight and obesity and prevention against lifestyle-related diseases, such as prevalence of correct answers to the questionnaires on obesity

Base
Study type

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment No need to know

Intervention
No. of arms 4
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 1.Physical activity and lifestyle interventions:
Decrease sedentary activity time and increase physical activity time. The project will provide a pedometer and a scale for each student in intervention schools. Results of steps record in the day, the students will write in the notebook. Each week, research team send staffs to schools to review the result of steps of each student on the machine and record the number of steps.
1) Increasing physical activities at school and at home.
-The appropriated exercises according to conditions and ability of each student.
-Children need to walk for 30 minutes per day, it can be divided into 2 times, each time for 15 minutes.
-Exercise must be done regularly, including weekend and holidays.
-Encouraging children to participate in housework.
2) Decrease sedentary activity time in school and at home:
-Decrease spending time in watching TV, playing computer games (Only allowed to watch TV or play games maximum 60 minutes per day), studying after 45 minutes should take a break to exercise 5 - 10 minutes.
3) Outdoor activities: encourage children to participate in outdoor games. We should not pressure to the child.
4) At school ( the activities within curriculum of school):
-Each week has two exercise lessons: program and content appropriate with age and follow the instructions of Ministry of Education.
-Maintain fitness activities in break time of whole school.
-Encourage children to participate in fitness activities in break time, avoid sitting.
-The activities requiring teamworks or group activities for many people with balls are very important.
-Depending on the conditions of each school extracurricular classes, students can participate in after- school activities.

Interventions/Control_2 2. Intervention and nutrition education
1) Nutrition education (Group education):
Training for students, parents, teachers, school health staff, kitchen staff, canteen staff
Emphasize the importance of implementing reasonable diet, healthy lifestyle, intergrated exercise and physical activities.
2)Practice direction
2)-1 Teachers are promoted to have enough ability to teach students about behavior, lifestyle change and nutrition to prevent from overweight and obesity.
2)-2 Guiding for kitchen staffs, canteen staffs:
Creating a menu form by age, the staffs can apply to cook for school lunch.
2)-3 Counseling and guiding parents to nutritional practice:
Offer reference menus, way to choose reasonable food, how to combine several kind of foods and avoid rich energy foods. Advice about what they should not do,such as skipping meals, eating while watching TV, eating after 8p.m. Emphasize the importance of implementing reasonable diet and intergraded with exercise, healthy lifestyle.Parents can consult and discuss directly with the lectures or the research team.
2)-4 Practice on nutrition for children.
Reasonable diet of children by age. Checking weight and height regularly. Keeping adequate diet with intergraded physical activities. Promotion of lifestyle changing: Decrease sedentary activity time, such as watching TV, computer. Increase labor time for housework, outdoor activities, playing sports. Choose a good food.The activity should focus on student-centered: getting information on overweight or obesity in group discussion, in class sessions, and through extracurricular activities. Distributing leaflets on nutrition and obesity prevention of school age. Launching whole school: campaign or competition on understanding of nutrition, overweight and obesity via dramas, songs performed and designed by students, teachers and research group.
Interventions/Control_3 3. Media, tools and wide communication schedule
Communication activities, messages, and support materials promote the benefits of and attempt to lower some key barriers to targeted physical activity and dietary changes.
Materials matching closely the identified needs of the committees will be involved in the intervention (Behavior, PE, and Nutrition/Food Service)
Meeting/seminars with teachers, parents
In the first month of the study: educating about nutrition for all objects (teachers, canteen staffs, kitchen staffs, students, parents). Providing menus and apply in intervention schools.
Seminar group discussion, group meeting (every 2 months)
Students and parents need to counsel directly, have to register via email or phone to get schedule advice.
Providing handouts, pedometer (step counter), leaflets, template menu (alternative food, food conversion unit with illustrations)
Health record diaries/ Personal recorded book
Recorded book for physical exercise.
Organizing game show for the students.
Promoting physical activity in school: provide scales (minimum unit: 100g), measure height (minimum unit: 0.1 cm), measuring tape (to measure waist measurement in cm), electronic sphygmomanometer, stopwatch (to counter circuit in 1 minute). Supporting instuments for physical extracurricular classes.
Practical diets: Using the self-recorded questions to assess food consumption in 24 hours.
Interventions/Control_4 4. Target of behavior Intervention
Increasing water consumption
Substituting water for added sugar beverages
Drinking water for health, nutrition, and hydration
Choosing healthier foods and drinks for meals and snacks
Substituting nutrient dense, lower caloric foods for low nutrient, higher caloric foods
Self-monitoring, goal setting, and problem solving to increase intake of water, fruits, and vegetables
Increasing movement and accumulation of time spent being active
Decreasing time spent in sedentary behavior
Substituting physical activity for sedentary behavior
Self-monitoring, goal setting, and problem solving to increase physical activity and decrease sedentary behavior
Newsletters contain information about the value of recommended behaviors (e.g., increasing water intake, increasing physical activity, reducing sedentary behavior) and the nature of the physical education, nutrition, and behavior intervention components at their local school.
Involve families in the dissemination of the intervention messages. Suggestions are made about how to stimulate communications between parents and children related to the behavior goals.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
10 years-old <=
Age-upper limit
12 years-old >=
Gender Male and Female
Key inclusion criteria 1) Students at grade 6 who are studying at selected schools
2) Parents and children agree to sign in consent
3) Both genders

Key exclusion criteria none
Target sample size 800

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Kajio
Organization National Center for Global Health and Medicine Hospital
Division name Department of Diabetes, Endocrinology and Metabolism
Zip code
Address 1-21-1. Toyama, Shinjuku-ku, Tokyo, Japan
TEL +81-3-3202-7181
Email hkajio@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Kajio
Organization National Center for Global Health and Medicine Hospital
Division name Department of Diabetes, Endocrinology and Metabolism
Zip code
Address 1-21-1. Toyama, Shinjuku-ku, Tokyo, Japan
TEL +81-3-3202-7181
Homepage URL
Email hkajio@hospncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Bac Mai Hospital
Name of secondary funder(s) Manpei Suzuki Diabetes Foundation
Minister of Health, labour and Welfare

IRB Contact (For public release)
Organization
Address
Tel
Email

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 国立国際医療研究センター(東京都)、バクマイ病院(ベトナム国ハノイ市)

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 29 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
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 No longer recruiting
Date of protocol fixation
2013 Year 09 Month 27 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 08 Month 29 Day
Last modified on
2014 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017426

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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