Feasible Means to Address Moderately Malnourished Children Within BINP Communities

This study has been completed.
Sponsor:
Information provided by:
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT00372242
First received: September 4, 2006
Last updated: NA
Last verified: April 2003
History: No changes posted
  Purpose

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.


Condition Intervention
Mild and Moderate Malnourished Children
Behavioral: Prospective Longitudinal Interventional Stury

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


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

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

Estimated Enrollment: 1231
Study Start Date: December 2000
Estimated Study Completion Date: September 2002
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.

  Eligibility

Ages Eligible for Study:   6 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00372242

Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
Principal Investigator: Swapan K Roy, MBBS, PhD International Centre for Diarrhoeal Disease Research, Bangladesh
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00372242     History of Changes
Other Study ID Numbers: 99-041
Study First Received: September 4, 2006
Last Updated: September 4, 2006
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Mal-nutrition
Morbidity
Nutrition Education
Complementary Feeding
Weight gain
Height

Additional relevant MeSH terms:
Nutrition Disorders
Malnutrition

ClinicalTrials.gov processed this record on August 01, 2014