UMIN-CTR Clinical Trial

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

overweight, obesity

Classification by specialty

Medicine in general

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

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

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

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

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

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

Institute

National Center for Global Health and Medicine

Institute

Department

Personal name

Organization

National Center for Global Health and Medicine

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Bac Mai Hospital

Name of secondary funder(s)

Manpei Suzuki Diabetes Foundation
Minister of Health, labour and Welfare

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

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）

Date of disclosure of the study information

2014

Year

08

Month

29

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

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 related information

Registered date

2014

Year

08

Month

29

Day

Last modified on

2014

Year

08

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017426