- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00372242
Feasible Means to Address Moderately Malnourished Children Within BINP Communities
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Bangladesh has the highest proportion of malnourished children in the world. The infant and child mortality are also among the highest in south Asia. In Bangladesh, '. The Government of Bangladesh has been trying different ways for reducing childhood malnutrition. Such programs include the Vulnerable Group Development (VGD) Project, vitamin A distribution project, iodine deficiency disorder control program, iron supplementation program and improving food availability for the underprivileged sections of the society. Despite these, not enough improvement has been observed in the field of nutrition. In review of the past fifty-year's information of dietary intake and growth, it has been observed that food intake has substantially decreased and growth faltering in children has worsened (Roy et al 1988). Materal malnutrition is evidenced by low weight, short stature and anemia in pregnant and lactating women. Micronutrient deficiencies are evidenced by prevalence of xerophthalmia, iron deficiency anemia and iodine deficiency disorders. The effects of childhood under nutrition, begin with a low birth weight (estimated to occur among 35-50% of births in Bangladesh) (Hasan et al 1995) and continue into adulthood.
The prevalence of PEM among children is very high, and has remained almost the same for the last decade. Thirty percent of all children under six years of age are severely stunted and another 31.2% are moderately stunted (BBS 1995). As many as 68.3% of the total children are under -weight and 16.7% are wasted, the highest rates are in Asia (BBS 1995). Given the greatly disadvantaged start by the way of a low birth-weight followed by inadequate breast-feeding by their undernourished mothers, average Bangladeshi infants are already below the lower end of the range of anthropometric values found among western babies during the first three to six months. The late and insufficient introduction of complementary feeding further retards the infant's growth; usually the child do not pick up its pace of growth before two years of age. By then, it is too late to reverse the early growth lag, which persists throughout the life, and similarly some of the damages done to mental development are irreparable. The weight for age curve of Bangladeshi children continues to lie below the third percentile of the NCHS Standard, though it runs roughly parallel to the standard from around the second year of life onward; the older children cope better with the adverse milieu of food-insecure and unhealthy household, while being unable to regain lost ground.
Study Type
Enrollment
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Mildly malnourished children without growth faltering aged 6 to 24 months
- Moderately malnourished children without growth faltering aged 6 to 24 months
- Well-nourished children aged 6 to 9 months
Exclusion Criteria:
- >2 years children
- Severely malnourished children
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Mothers understanding and ability to identify moderate malnutrition in children.
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Mothers understanding on consequence of moderate malnutrition.
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Change in knowledge of mothers in feeding practices.
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Frequency of home feeding (Breast-feeding and supplementary feeding).
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Frequency of seeking medical care during illness, referral, incidence, duration of illness.
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Adequacy of child feeding, frequency & type of feeding.
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Weight gain, weight for age and weight for height at the end of intervention.
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Proportion of complementary feeds in 6-9 months age group.
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Nutritional status of children at various phases of intervention and observation.
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Adaptation level of nutrition education program by CNP, CNO.
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Constant of not practicing education knowledge.
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Secondary Outcome Measures
Outcome Measure |
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Incidence and prevalence of diarrhoea and ALRI
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Referral success and failure
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Resistance to education
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Food insecurity for child
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Mothers time constraint for CF preparation
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CNP time constraints for INE
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Collaborators and Investigators
Investigators
- Principal Investigator: Swapan K Roy, MBBS, PhD, International Centre for Diarrhoeal Disease Research, Bangladesh
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 99-041
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