UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056356 |
|---|---|
| Receipt number | R000064376 |
| Scientific Title | Development and evaluation of PUTRA Community Nutrition Ambassador Programme (PUTRACNAP) Among Urban Poor Communities (B40) in Kuala Lumpur |
| Date of disclosure of the study information | 2024/12/04 |
| Last modified on | 2024/12/04 15:44:08 |
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Basic information
Public title
Improving Nutrition in Urban Poor Communities: The PUTRA Community Nutrition Ambassador Programme
Acronym
PUTRACNAP
Scientific Title
Development and evaluation of PUTRA Community Nutrition Ambassador Programme (PUTRACNAP) Among Urban Poor Communities (B40) in Kuala Lumpur
Scientific Title:Acronym
PUTRACNAP
Region
| Asia(except Japan) |
Condition
Condition
Food and nutrition security
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The Putra Community Nutrition Ambassador Programme (PUTRACNAP) seeks to empower and support mother and child pairs in urban poor communities in Kuala Lumpur by addressing the critical issue of food and nutrition security. Through the development and implementation of this community-based initiative, PUTRACNAP aims to create lasting change in the lives of these families. The program will train and deploy local nutrition ambassadors, who will work directly with the community to provide education, resources, and practical support in improving access to nutritious food. The ultimate goal is to ensure that mothers and children in these underserved areas can enjoy better health outcomes through improved knowledge of nutrition and enhanced food security, contributing to the overall well-being of the community. By evaluating the effectiveness of PUTRACNAP, we will gain valuable insights into how such community-driven interventions can make a significant impact on public health in urban poor populations.
Basic objectives2
Others
Basic objectives -Others
To develop and evaluate the effectiveness of the Putra Community Nutrition Ambassador Programme (PUTRACNAP) in improving food and nutrition security among mother and child pairs in urban poor communities in Kuala Lumpur
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
To determine the differences of the PUTRACNAP in household food security, dietary quality of mothers and children, eating behaviour of children, nutrition knowledge of mothers and children, physical activity of mothers and children, self-efficacy for healthy eating of mothers and children, and mother-child relationship between intervention and control groups before the program, after 12 weeks of the program and six-months follow-up after the program.
Key secondary outcomes
To determine the differences of the PUTRACNAP in body compositions of mother and children, psychological distress of mothers and children, and metabolic syndrome of mothers between intervention and control groups before the program, after 12 weeks of the program and six-months follow-up after the program.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Intervention received nutrition education and gardening practices for 12 weeks (3 months)
Interventions/Control_2
Control does not receive any intervention
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
| 7 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Mother who are physically fit aged between 18 and 55 years old, Malaysian Citizens, Non- pregnant, Non- lactating, living in selected low-cost flats in Kuala Lumpur and have at least one child aged 7-12 years old living in one household
Key exclusion criteria
Mother and child who have physical disabilities and chronic illness that required special treatment based on screening medical history information provided in socio-demographic report. Child who has learning disabilities as confirm by their parents. Mother and child from households with a functioning garden
Target sample size
132
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
Serdang, Selangor
TEL
+603-97692680
chinys@upm.edu.my
Public contact
Name of contact person
| 1st name | Chin |
| Middle name | Yit |
| Last name | Siew |
Organization
Universiti Putra Malaysia
Division name
Department of Nutrition
Zip code
43400
Address
Serdang, Selangor
TEL
+603-97692680
Homepage URL
chinys@upm.edu.my
Sponsor or person
Institute
Nestle Products Sdn Bhd
Institute
Department
Personal name
Funding Source
Organization
Nestle Products Sdn Bhd
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Universiti Putra Malaysia
Address
Jalan Universiti 1, 43400 Serdang, Selangor
Tel
+603-97692680
chinys@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
Universiti Putra Malaysia (UPM), Serdang, Selangor
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 04 | 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
74
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 | 02 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 16 | 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 | 12 | Month | 04 | Day |
Last modified on
| 2024 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064376
