Mild and Moderate Malnourished ChildrenNCT00372242
Feasible Means to Address Moderately Malnourished Children Within BINP Communities
A study testing Prospective Longitudinal Interventional Stury in people with Mild and Moderate Malnourished Children, run by International Centre for Diarrhoeal Disease Research, Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 24 months
- Conditions the study is for
- Mild and Moderate Malnourished Children
- What is being tested?
- Prospective Longitudinal Interventional Stury
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,231 participants
- Where
- No sites listed yet
- Study dates
- Dec 2000to Sep 2002
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- >2 years children
- Severely malnourished children
About this study
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.
Read the 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.
- Conditions
- Mild and Moderate Malnourished Children
- Being tested
- Prospective Longitudinal Interventional Stury
- Keywords
- Mal-nutrition, Morbidity, Nutrition Education, Complementary Feeding, Weight gain, Height
- Medical subject headings
- Lymphoma, Follicular, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective Longitudinal Interventional SturyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (6)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2006 (estimated)
- Study startDec 2000
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild and Moderate Malnourished ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,231 participants
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Investigators
- Swapan K Roy, MBBS, PhD, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372242
- Sponsor's protocol ID
- 99-041
- Status last verified
- Apr 2003
- First submitted
- 4 Sep 2006
- Last updated
- 6 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasible Means to Address Moderately Malnourished Children Within BINP Communities
- ClinicalTrials.gov ID
- NCT00372242
- Acronym / sponsor ID
- 99-041
- Conditions
- Mild and Moderate Malnourished Children
- Keywords
- Mal-nutrition, Morbidity, Nutrition Education, Complementary Feeding, Weight gain, Height
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,231 participants
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Study start
- Dec 2000
- Study completion
- Sep 2002
- First posted
- 6 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- >2 years children
- Severely malnourished children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective Longitudinal Interventional Stury | Behavioural | – |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2006.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Swapan K Roy, MBBS, PhD principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
Questions about this trial
What is this clinical trial studying?
A study testing Prospective Longitudinal Interventional Stury in people with Mild and Moderate Malnourished Children, run by International Centre for Diarrhoeal Disease Research, Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mothers understanding and ability to identify moderate malnutrition in children.. The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2006.