UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056139 |
|---|---|
| Receipt number | R000064145 |
| Scientific Title | Evaluation of a Obesity Prevention Nutrition Program for Schoolchildren in Urban Uganda: A pilot study |
| Date of disclosure of the study information | 2024/11/14 |
| Last modified on | 2024/11/13 11:27:06 |
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Basic information
Public title
Evaluation of a Obesity Prevention Nutrition Program for Schoolchildren in Urban Uganda: A pilot study
Acronym
Obesity Prevention Nutrition Program for Schoolchildren in Urban Uganda
Scientific Title
Evaluation of a Obesity Prevention Nutrition Program for Schoolchildren in Urban Uganda: A pilot study
Scientific Title:Acronym
Obesity Prevention Nutrition Program for Schoolchildren in Urban Uganda
Region
| Africa |
Condition
Condition
Obesity, Overweight
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to conduct a cluster randomized controlled trial of a school children's obesity prevention dietary education program in collaboration with Uganda, in order to contribute to the growth of school children at a healthy weight and contribute to NCDs prevention. It is to conduct an evaluation.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to conduct a cluster randomized controlled trial of a school children's obesity prevention dietary education program in collaboration with Uganda, in order to contribute to the growth of school children at a healthy weight and contribute to NCDs prevention.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Severity of obesity: After the program implementation (post-test, 3 months later), the proportion of people with BMI and body fat percentage in the appropriate range was significantly higher in the intervention group than in the control group. (Primary Outcome)
2. Knowledge, attitude, and behavior: The test scores after the program implementation (post-test, 3 months later) were significantly higher in the intervention group than in the control group.(Secondary Outcome)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention Arm: 40 schoolchildren:
1. Physical measurement (Height, weight, bodyfat), questionnaire (40 minutes) at Day 1 as baseline
2. Obesity prevention classes (30 minutes) 4 times (120 minutes) at Day 1-4
3. Physical measurement (Height, weight, bodyfat), questionnaire (40 minutes) at Day 4
4. Questionnaire (20 minutes) after 3 months sfter the program
Interventions/Control_2
Controlled Arm: 40 schoolchildren: Physical measurement (Height, weight, bodyfat)=2 times
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
| 9 | years-old | <= |
Age-upper limit
| 10 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) School children aged 9 to 10 enrolled in the fourth grade of an elementary school in Kampala, an urban area of Uganda.
(2) School children who can read and write English.
Key exclusion criteria
(1) School children with a history of repeating a grade, long-term absenteeism, chronic illness, or taking medication.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Ai |
| Middle name | |
| Last name | Ogata |
Organization
Japanese Red Cross College of Nursing
Division name
Faculty of Nursing
Zip code
1130033
Address
4-1-3, Hiroo, Shibuya, Tokyo, Japan
TEL
+81-3-3409-0683
a-ogata@redcross.ac.jp
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Ogata |
Organization
Japanese Red Cross College of Nursing
Division name
Faculty of Nursing
Zip code
1130033
Address
4-1-3, Hiroo, Shibuya, Tokyo, Japan
TEL
+81-3-3409-0683
Homepage URL
a-ogata@redcross.ac.jp
Sponsor or person
Institute
Japanese Red Cross College of Nursing
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Red Cross College of Nursing
Address
4-1-3, Hiroo, Shibuya, Tokyo
Tel
03-3409-0875
soumu@redcross.ac.jp
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
| 2024 | Year | 11 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 11 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 13 | Day |
Last modified on
| 2024 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064145
