Feasible Means to Address Moderately Malnourished Children Within BINP Communities
Primary Purpose
Mild and Moderate Malnourished Children
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prospective Longitudinal Interventional Stury
Sponsored by
About this trial
This is an interventional prevention trial for Mild and Moderate Malnourished Children focused on measuring Mal-nutrition, Morbidity, Nutrition Education, Complementary Feeding, Weight gain, Height
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Mothers understanding and ability to identify moderate malnutrition in children.
Mothers understanding on consequence of moderate malnutrition.
Change in knowledge of mothers in feeding practices.
Frequency of home feeding (Breast-feeding and supplementary feeding).
Frequency of seeking medical care during illness, referral, incidence, duration of illness.
Adequacy of child feeding, frequency & type of feeding.
Weight gain, weight for age and weight for height at the end of intervention.
Proportion of complementary feeds in 6-9 months age group.
Nutritional status of children at various phases of intervention and observation.
Adaptation level of nutrition education program by CNP, CNO.
Constant of not practicing education knowledge.
Secondary Outcome Measures
Incidence and prevalence of diarrhoea and ALRI
Referral success and failure
Resistance to education
Food insecurity for child
Mothers time constraint for CF preparation
CNP time constraints for INE
Full Information
NCT ID
NCT00372242
First Posted
September 4, 2006
Last Updated
September 4, 2006
Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
1. Study Identification
Unique Protocol Identification Number
NCT00372242
Brief Title
Feasible Means to Address Moderately Malnourished Children Within BINP Communities
Study Type
Interventional
2. Study Status
Record Verification Date
April 2003
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
4. Oversight
5. Study Description
Brief Summary
The Bangladesh Integrated Nutrition Project (BINP) of the Government of Bangladesh has started showing reduction in malnutrition of women and children under two years of age in last 3 years of it's activities. That was a demonstration study to test the efficacy of the approach on a relatively small number of children with intensive intervention. A study will be therefore conducted in 4 division of BINP thanas of Bangladesh over an 18-month period. Moderately malnourished children will be in management intervention and mildly malnourished and well-nourished infants will be in preventive intervention group. For management intervention, a total of 750 moderately malnourished will be randomized to receive either intensive nutrition education or less intensive education. For preventive purpose, 380 mildly malnourished children of 6 months to 2 years of age and 240 well nourished infants of 6 to 9 months of age will receive either less intensive education or no education. Infants between 6 to 9 month ages will be brought under less INE to ensure their complementary feeding practice. Care givers of one group of mildly malnourished children and one group of 6-9 month old infants will not receive any education to serve as controls. Focus group discussion will be held before the educational intervention to identify the perception of the mother, her husband and female decision maker of her family on child nutrition, caring practice and common practice of health care. BCC materials will be developed after FGD and that will be used during nutrition education. Mothers of the first intervention group will receive intensive nutrition education for child feeding twice weekly for first three months, which will be then reinforced once in a week for the last three months of intervention. The less intensive intervention group will receive nutrition education twice a week for the first month then once a week for two months and then twice monthly for the last three months of intervention. INE will be given for a total of 6 months. An observation will be done to identify for sustainability effect for an additional period of 6 months. Their weight and length gain will be recorded. It is expected that the results of the study will help define the effectiveness of our nutrition education package to prevent and reduce moderate malnutrition existing in large proportion of children in setting with different geographical, and cultural and feeding practices.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild and Moderate Malnourished Children
Keywords
Mal-nutrition, Morbidity, Nutrition Education, Complementary Feeding, Weight gain, Height
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1231 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Prospective Longitudinal Interventional Stury
Primary Outcome Measure Information:
Title
Mothers understanding and ability to identify moderate malnutrition in children.
Title
Mothers understanding on consequence of moderate malnutrition.
Title
Change in knowledge of mothers in feeding practices.
Title
Frequency of home feeding (Breast-feeding and supplementary feeding).
Title
Frequency of seeking medical care during illness, referral, incidence, duration of illness.
Title
Adequacy of child feeding, frequency & type of feeding.
Title
Weight gain, weight for age and weight for height at the end of intervention.
Title
Proportion of complementary feeds in 6-9 months age group.
Title
Nutritional status of children at various phases of intervention and observation.
Title
Adaptation level of nutrition education program by CNP, CNO.
Title
Constant of not practicing education knowledge.
Secondary Outcome Measure Information:
Title
Incidence and prevalence of diarrhoea and ALRI
Title
Referral success and failure
Title
Resistance to education
Title
Food insecurity for child
Title
Mothers time constraint for CF preparation
Title
CNP time constraints for INE
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Swapan K Roy, MBBS, PhD
Organizational Affiliation
International Centre for Diarrhoeal Disease Research, Bangladesh
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Feasible Means to Address Moderately Malnourished Children Within BINP Communities
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