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Effective Means to Address Moderately Malnourished Children

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ClinicalTrials.gov Identifier: NCT00751582
Recruitment Status : Completed
First Posted : September 12, 2008
Last Update Posted : March 22, 2016
Sponsor:
Collaborator:
World Bank
Information provided by:
International Centre for Diarrhoeal Disease Research, Bangladesh

Tracking Information
First Submitted Date  ICMJE May 17, 2008
First Posted Date  ICMJE September 12, 2008
Last Update Posted Date March 22, 2016
Study Start Date  ICMJE July 1998
Actual Primary Completion Date November 1998   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2008)
Weight and length to assess nutritional status of the children [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effective Means to Address Moderately Malnourished Children
Official Title  ICMJE Effective Means to Address Moderately Malnourished Children Within BINP Communities
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Malnutrition
Intervention  ICMJE
  • Dietary Supplement: Food supplementation and nutrition education
    Food supplementation and nutrition education for three months
    Other Name: PUSHTI PACKET
  • Behavioral: Nutrition education
    Nutrition education for children for three months
    Other Name: PUSHTI PACKET
  • Other: Control Group
    No Nutrition Education
Study Arms  ICMJE
  • Experimental: 2
    Food supplementation and nutrition education
    Interventions:
    • Dietary Supplement: Food supplementation and nutrition education
    • Other: Control Group
  • Experimental: 1
    Nutrition Education only
    Intervention: Behavioral: Nutrition education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2008)
300
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 1998
Actual Primary Completion Date November 1998   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Less than 2 years moderately malnourished children

Exclusion Criteria:

  • Nourished children
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 2 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bangladesh
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00751582
Other Study ID Numbers  ICMJE 98-018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Principal Investigator, ICDDRB
Study Sponsor  ICMJE International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators  ICMJE World Bank
Investigators  ICMJE
Principal Investigator: Swapan K Roy, PhD, FRCP Senior Scientist, ICDDR,B
PRS Account International Centre for Diarrhoeal Disease Research, Bangladesh
Verification Date September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP