MalnutritionNCT00751582
Effective Means to Address Moderately Malnourished Children
A study testing Food supplementation and nutrition education and Nutrition education in people with Malnutrition, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 2 years
- Conditions the study is for
- Malnutrition
- What is being tested?
- Food supplementation and nutrition education and Nutrition education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBangladesh
- Study dates
- Jul 1998to Nov 1998
- 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 months to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Less than 2 years moderately malnourished children
Who cannot join
- Nourished children
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effective Means to Address Moderately Malnourished Children Within BINP Communities
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
Read the 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.
- Conditions
- Malnutrition
- Being tested
- Food supplementation and nutrition education, Nutrition education, Control Group
- Keywords
- nutrition, education, supplementation
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food supplementation and nutrition educationDietary supplement
Also called PUSHTI PACKET
Food supplementation and nutrition education for three months
Nutrition educationBehavioural
Also called PUSHTI PACKET
Nutrition education for children for three months
Control GroupOther
No Nutrition Education
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Food supplementation and nutrition education Receives: Dietary Supplement: Food supplementation and nutrition education; Other: Control Group |
| 1 | Experimental | Nutrition Education only Receives: Behavioral: Nutrition education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight and length to assess nutritional status of the children
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2008 (estimated)
- Study startJul 1998
- Primary completionNov 1998
- Study completionNov 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- World Bank
- Investigators
- Swapan K Roy, PhD, FRCP, Principal investigator, Senior Scientist, ICDDR,B
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751582
- Sponsor's protocol ID
- 98-018
- Status last verified
- Sep 2008
- First submitted
- 17 May 2008
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Means to Address Moderately Malnourished Children Within BINP Communities
- ClinicalTrials.gov ID
- NCT00751582
- Acronym / sponsor ID
- 98-018
- Conditions
- Malnutrition
- Keywords
- nutrition, education, supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- World Bank
- Study start
- Jul 1998
- Primary completion
- Nov 1998 (actual)
- Study completion
- Nov 1998 (actual)
- First posted
- 12 Sep 2008 (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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Dietary Supplement: Food supplementation and nutrition education, Other: Control GroupFood supplementation and nutrition education |
| 1 | Experimental | Behavioral: Nutrition educationNutrition Education only |
Who may qualify
- Ages
- 6 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Less than 2 years moderately malnourished children
Key exclusion criteria (1 listed)
- Nourished 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 |
|---|---|---|
| Food supplementation and nutrition educationAlso: PUSHTI PACKETFood supplementation and nutrition education for three months | Dietary supplement | 2 |
| Nutrition educationAlso: PUSHTI PACKETNutrition education for children for three months | Behavioural | 1 |
| Control GroupNo Nutrition Education | Other | 2 |
Primary outcome
Weight and length to assess nutritional status of the children
Time frame: 6 months
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 22 Mar 2016.
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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, PhD, FRCP principal investigator
Senior Scientist, ICDDR,B
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food supplementation and nutrition education and Nutrition education in people with Malnutrition, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in 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 1 inclusion and 1 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 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Weight and length to assess nutritional status of the children (time frame: 6 months). 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 22 Mar 2016.