Effective Means to Address Moderately Malnourished Children

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

Tracking Information

• First Submitted Date: May 17, 2008
• First Posted Date: September 12, 2008
• Last Update Posted Date: March 22, 2016
• Study Start Date: July 1998
• Actual Primary Completion Date: November 1998 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 11, 2008): Weight and length to assess nutritional status of the children [ Time Frame: 6 months ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effective Means to Address Moderately Malnourished Children
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Malnutrition

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 11, 2008): 300
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: November 1998
• Actual Primary Completion Date: November 1998 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Less than 2 years moderately malnourished children

Exclusion Criteria:

• Nourished children

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Months to 2 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Bangladesh

Administrative Information

• NCT Number: NCT00751582
• Other Study ID Numbers: 98-018
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Principal Investigator, ICDDRB
• Study Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
• Collaborators: World Bank

Investigators

• Principal Investigator: Swapan K Roy, PhD, FRCP; Senior Scientist, ICDDR,B

• PRS Account: International Centre for Diarrhoeal Disease Research, Bangladesh
• Verification Date: September 2008