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Effective Means to Address Moderately Malnourished Children

This study has been completed.

Sponsors and Collaborators: International Centre for Diarrhoeal Disease Research, Bangladesh
World Bank and Bangladesh Integrated Nutrition Program
Information provided by: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT00751582
  Purpose

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


Condition Intervention
Malnutrition
Dietary Supplement: Food supplementation and nutrition education
Behavioral: Nutrition education
Other: Control Group

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study
Official Title:   Effective Means to Address Moderately Malnourished Children Within BINP Communities

Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • Weight and length to assess nutritional status of the children [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment:   300
Study Start Date:   July 1998
Study Completion Date:   November 1998
Primary Completion Date:   November 1998 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
2: Experimental
Food supplementation and nutrition education
Dietary Supplement: Food supplementation and nutrition education
Food supplementation and nutrition education for three months
1: Experimental
Nutrition Education only
Behavioral: Nutrition education
Nutrition education for children for three months
3: No Intervention Other: Control Group
No Nutrition Education

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.

  Eligibility
Ages Eligible for Study:   6 Months to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Less than 2 years moderately malnourished children

Exclusion Criteria:

  • Nourished children
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751582

Locations
Bangladesh
ICDDRB    
      Dhaka, Bangladesh, 1212

Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
World Bank and Bangladesh Integrated Nutrition Program

Investigators
Principal Investigator:     Swapan K Roy, PhD, FRCP     Senior Scientist, ICDDR,B    
  More Information


Responsible Party:   ICDDRB ( Principal Investigator )
Study ID Numbers:   98-018
First Received:   May 17, 2008
Last Updated:   September 11, 2008
ClinicalTrials.gov Identifier:   NCT00751582
Health Authority:   Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
nutrition  
education  
supplementation  

Study placed in the following topic categories:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on October 06, 2008




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