UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050289 |
|---|---|
| Receipt number | R000057254 |
| Scientific Title | Effectiveness of Virtual Nutrition Education and Home Exercise Intervention for Children with Overweight and Obesity Problems (10 to 11 Years Old): Young NutriGenius Cluster-Randomized Controlled Trial |
| Date of disclosure of the study information | 2023/04/02 |
| Last modified on | 2023/02/09 12:58:38 |
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Basic information
Public title
Effectiveness of Virtual Nutrition Education and Home Exercise Intervention for Children with Overweight and Obesity Problems (10 to 11 Years Old): Young NutriGenius Cluster-Randomized Controlled Trial
Acronym
EFFECTIVENESS OF VIRTUAL NUTRITION EDUCATION AND HOME EXERCISE INTERVENTION AMONG OVERWEIGHT AND OBESE SCHOOL CHILDREN IN JASIN, MELAKA, MALAYSIA
Scientific Title
Effectiveness of Virtual Nutrition Education and Home Exercise Intervention for Children with Overweight and Obesity Problems (10 to 11 Years Old): Young NutriGenius Cluster-Randomized Controlled Trial
Scientific Title:Acronym
EFFECTIVENESS OF VIRTUAL NUTRITION EDUCATION AND HOME EXERCISE INTERVENTION AMONG OVERWEIGHT AND OBESE SCHOOL CHILDREN IN JASIN, MELAKA, MALAYSIA
Region
| Asia(except Japan) |
Condition
Condition
Childhood Obesity
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of virtual nutrition education and home exercise intervention on nutrition knowledge, attitude, and practice, eating behavior, physical activity, body composition, cognitive performance, and psychological health of children with overweight and obesity problems (10 to 11 years old).
Basic objectives2
Others
Basic objectives -Others
To determine the socio-demographic factors (age, sex, ethnicity, parental education level, and household income level), nutrition knowledge, attitude, and practice, eating behavior (food approach behaviors: food responsiveness, enjoyment of food, emotional overeating, and desire to drink; eating habits: regular meal and snack consumption, fruit and vegetable consumption, whole-grain intake, and sugar-sweetened beverage intake), physical activity (physical activity level and fitness level), body composition (BMI-for-age, waist circumference, body fat and muscle mass), cognitive performance (executive function: working memory and cognitive flexibility), psychological health (anxiety and depression) of children with overweight and obesity problem at baseline and immediately after intervention.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Nutrition knowledge, attitude, and practice
Key secondary outcomes
Eating behavior, physical activity, body composition, cognitive performance, and psychological health
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Intervention group
Virtual nutrition education
i) 60 minutes: Interactive nutrition education
ii) 30 minutes: Physical exercise session
Interventions/Control_2
Control group
Nutrition Talk on Healthy Eating by a Nutritionist
Standard practice based on Guideline for Weight Management in School Children (MOH, 2011)
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
| 10 | years-old | < |
Age-upper limit
| 11 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Male or female children aged 10 to 11 years old
Children with BMI Z-score > +1SD
Participate all sessions and have at least one parent willing to present all the intervention sessions
Have computer or laptop and easy access to internet, and parents agree to use social media namely, WhatsApp for interaction during the intervention period
Ethnicity (Malay, Chinese or Indian)
Malaysian
Key exclusion criteria
Children with co-morbidities (e.g., diabetes mellitus, chronic asthma), psychiatric disabilities (e.g., autism spectrum disorders, attention deficit hyperactivity disorders)
Children taking medication or supplements that can either promote weight gain or weight loss
Underweight, normal weight and overweight children
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Chin |
| Middle name | Yit |
| Last name | Siew |
Organization
Universiti Putra Malaysia
Division name
Department of Nutrition
Zip code
43400
Address
jalan universiti 1 serdang
TEL
0129219338
chinys@upm.edu.my
Public contact
Name of contact person
| 1st name | Asvini |
| Middle name | |
| Last name | Vasthavan |
Organization
Universiti Putra Malaysia
Division name
Department of Nutrition
Zip code
43400
Address
jalan universiti 1 serdang
TEL
0129935414
Homepage URL
asvini0223@gmail.com
Sponsor or person
Institute
Department of Nutrition
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Unit of Ethics Research (Level 5), Office of the Deputy Vice Chancellor (Research & Innovation), Universiti Putra Malaysia
Address
jalan universiti 1 serdang
Tel
03-97691244
jkeupm@upm.edu.my
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
| 2023 | Year | 04 | Month | 02 | 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
92
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
| 2022 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 09 | Day |
Last modified on
| 2023 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057254
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