- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00751582
Effective Means to Address Moderately Malnourished Children
March 20, 2016 updated by: International Centre for Diarrhoeal Disease Research, Bangladesh
Effective Means to Address Moderately Malnourished Children Within BINP Communities
Supplementary feeding and intensive IEC at the community level will effectively reduce moderate PEM compared to the control children within 3 months .
Intensive nutrition education at the household level will reduce by at least one third of the prevalence of moderate malnutrition (40% of present level) within a short period of 3 months
Study Overview
Status
Completed
Conditions
Detailed Description
Bangladesh is one of the countries having highest proportions of malnourished children in the world.
The Bangladesh Integrated nutrition Project (BINP) is a recent initiative of the Government of Bangladesh to reduce malnutrition of women and children under two years of age.
The BINP includes a specific programme to address severely malnourished children at the community level, however there is no such programme directed toward moderately malnourished children.
Moderately malnourished children form a large proportion of children in the community, and with success of the BINP, this proportion is growing, as severely malnourished children shift to the moderately malnourished category.
To address this, operations research will be undertaken in a BINP thana named Shahrasti, in Chandpur District over a 6 month period.
A total of 300 children in three groups from Community Nutrition Centres (CNC) will be studied.
There will be groups in the study.
In addition to usual component of the BINP, mothers of the first group of intervention will receive intensive nutrition education and motivation for child care, complementary food demonstration, and household food mobilization for child feeding weekly for first four weeks then reinforced every two weeks.
The second intervention group will receive a packet of the usual BINP food supplement daily for 6 days a week for 3 months and nutrition education at the same intensity.
The third group will be a control group and will receive only the usual programme inputs of BINP and their weight gain will be recorded.
The CNP, women group and village nutrition committee will be involved.
Focus group discussion will be held with mothers.
Data on morbidity will be collected and necessary medical advise will be given equal to each group.
Data collection, counseling on child caring practice, food demonstration and nutrition education using IEC will be organized and supervised by project staff.
It is assumed that if the intervention is successful, and once the nutritional status improves, they are likely to maintain good health.
The IEC on dietary practice will be communicated to the village members for preventive measures.
Data will be analyzed for change in nutrition groups from moderate to mild malnutrition or normal nutrition and will be compared between the control and two intervention groups.
It is expected that the results of the study will help to address to reduce moderate malnutrition existing in the large proportion of malnourished children.
This will in turn reduce the risk of regressing to severe malnutrition.
Study Type
Interventional
Enrollment (Actual)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Dhaka, Bangladesh, 1212
- Icddrb
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 2 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Less than 2 years moderately malnourished children
Exclusion Criteria:
- Nourished children
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 2
Food supplementation and nutrition education
|
Food supplementation and nutrition education for three months
Other Names:
No Nutrition Education
|
|
Experimental: 1
Nutrition Education only
|
Nutrition education for children for three months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Weight and length to assess nutritional status of the children
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Swapan K Roy, PhD, FRCP, Senior Scientist, ICDDR,B
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 1998
Primary Completion (Actual)
November 1, 1998
Study Completion (Actual)
November 1, 1998
Study Registration Dates
First Submitted
May 17, 2008
First Submitted That Met QC Criteria
September 11, 2008
First Posted (Estimate)
September 12, 2008
Study Record Updates
Last Update Posted (Estimate)
March 22, 2016
Last Update Submitted That Met QC Criteria
March 20, 2016
Last Verified
September 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 98-018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.