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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Bangladesh1 site
  • ICDDRB

    Dhaka, 1212

Other trials in Bangladesh

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 groups in NCT00751582
Study groupRoleWhat they receive
2ExperimentalFood supplementation and nutrition education
Receives: Dietary Supplement: Food supplementation and nutrition education; Other: Control Group
1ExperimentalNutrition Education only
Receives: Behavioral: Nutrition education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted12 Sep 2008 (estimated)
  2. Study startJul 1998
  3. Primary completionNov 1998
  4. Study completionNov 1998

Resources

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)
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

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.

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