Effective Means to Address Moderately Malnourished Children
Primary Purpose
Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Food supplementation and nutrition education
Nutrition education
Control Group
Sponsored by
About this trial
This is an interventional supportive care trial for Malnutrition focused on measuring nutrition, education, supplementation
Eligibility Criteria
Inclusion Criteria:
- Less than 2 years moderately malnourished children
Exclusion Criteria:
- Nourished children
Sites / Locations
- ICDDRB
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
2
1
Arm Description
Food supplementation and nutrition education
Nutrition Education only
Outcomes
Primary Outcome Measures
Weight and length to assess nutritional status of the children
Secondary Outcome Measures
Full Information
NCT ID
NCT00751582
First Posted
May 17, 2008
Last Updated
March 20, 2016
Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators
World Bank
1. Study Identification
Unique Protocol Identification Number
NCT00751582
Brief Title
Effective Means to Address Moderately Malnourished Children
Official Title
Effective Means to Address Moderately Malnourished Children Within BINP Communities
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
July 1998 (undefined)
Primary Completion Date
November 1998 (Actual)
Study Completion Date
November 1998 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators
World Bank
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
nutrition, education, supplementation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Experimental
Arm Description
Food supplementation and nutrition education
Arm Title
1
Arm Type
Experimental
Arm Description
Nutrition Education only
Intervention Type
Dietary Supplement
Intervention Name(s)
Food supplementation and nutrition education
Other Intervention Name(s)
PUSHTI PACKET
Intervention Description
Food supplementation and nutrition education for three months
Intervention Type
Behavioral
Intervention Name(s)
Nutrition education
Other Intervention Name(s)
PUSHTI PACKET
Intervention Description
Nutrition education for children for three months
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
No Nutrition Education
Primary Outcome Measure Information:
Title
Weight and length to assess nutritional status of the children
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Less than 2 years moderately malnourished children
Exclusion Criteria:
Nourished children
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Swapan K Roy, PhD, FRCP
Organizational Affiliation
Senior Scientist, ICDDR,B
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICDDRB
City
Dhaka
ZIP/Postal Code
1212
Country
Bangladesh
12. IPD Sharing Statement
Learn more about this trial
Effective Means to Address Moderately Malnourished Children
We'll reach out to this number within 24 hrs