Clinical trial NCT02671786: Community Based Management of Severe Malnutrition in Tribal Area of Melghat- Cluster Randomized Control Field Trial
Official title: Community Based Management of Severe Malnutrition in Under 5 Children in Tribal Area of Melghat, Maharashtra- Cluster Randomized Control Field Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Nutrition Disorders
Malnutrition
Keywords: Severe Acute Malnutrition
Severe Underweight
IAP Grade III-IV
Severe Stunting
Village Health Workers
MAHAN RUTF & MAHAN Vit-Mim mix
Lead sponsor: MAHAN Trust
Sponsor class: OTHER
First posted: 2016-02-02
Enrollment: 824
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Provision of community based health care to severely malnourished children (Age group: 6 months through 5 years) in 16 tribal villages by trained semi-literate village health workers.

1. Treatment of severely malnourished children.
2. Growth monitoring of all children below the age of 5 years.
3. Treatment of associated diseases like Diarrhea, Pneumonia, Malaria, etc.
4. Management of resistant or relapsed severely malnourished cases by pediatrician.
5. Intensive behavior change communication of parents of children below the age of 5 years for proper nutrition.

Detailed description: 1. Title of project: SAMMAN- Community based management of severe malnutrition in under 5 children in tribal area of Melghat region

2. Name of Institution: MAHAN Trust, Address: Mahatma Gandhi Tribal Hospital, Karmagram . Utavali, tehsil- Dharni, Melghat (Amaravati)

3. Objectives -

1. To reduce the child mortality (in the age of group of 6 months to 5 years) due to severe malnutrition in tribal area of Melghat by 35% in usual residents population of 15000 (from 16 villages) over a period of 3 years.
2. To reduce the prevalence of severe malnutrition (in the age of group of 6 months to 5 years) by at least 35% in usual residents population of 15000 from 16 villages in tribal area of Melghat over a period of 3 years.
3. To achieve Case fatality rate of 2 % of treated severely malnourished children.
4. Need and rational of the project :

   Melghat is a hilly difficult to approach tribal forest terrain in Amaravati district of Maharashtra, India . Population is 2,80,000 \& 75% of them are tribal. Most of the tribal (\>90 %) are farmers or laborers, living below poverty line(\>75%) \& very hard life in huts without electricity (\>90%) \& illiterate (\>50%). Medical facilities are worst in Melghat as compared to rest of Maharashtra. A detailed study conducted by MAHAN showed that more than 20% of tribal children are severely malnourished and the under 5 children mortality rate is more than 100 per 1000 live births due to lack of proper nutrition, medical facilities, superstitions \& reluctance for hospitalization of severely malnourished children. There is an immediate need to fight severe malnutrition in children between the ages of 6 months to 5 years. This project is being implemented as a pilot project in 16 villages of Melghat which has potential for replication in all tribal and rural part of India.
5. Methodology Study design: The study is a cluster randomized parallel group controlled field trial Study area: 35 tribal villages selected from 5 clusters of Melghat by lottery method divided into intervention and control area.

   Sample size - 1500 severely malnourished children from intervention and control area each.
6. Intervention:

Provision of community based health care to severely malnourished children (Age group: 6 months through 5 years) in 16 tribal villages by trained semi-literate village health workers.

1. Treatment of severely malnourished children .
2. Growth monitoring of all children below the age of 5 years.
3. Treatment of associated diseases like Diarrhea, Pneumonia, Malaria, etc.
4. Management of resistant or relapsed severely malnourished cases by pediatrician.
5. Intensive behavior change communication of parents of children below the age of 5 years for proper nutrition.

   6. Duration: 5 years (May 2011 to September 2015)

   7. Monitoring indicators for the outcome objectives:

Primary outcomes

1. Prevalence of severe malnutrition (Severe Acute Malnutrition; Severe Underweight and Indian Academy of Pediatrician (IAP) Grade III, IV)
2. No. of child deaths due to severe malnutrition
3. Case fatality rate of treated severely malnourished children

   The secondary outcomes
4. Child mortality rate between 6 to 60 months age group

   The secondary outcomes
5. Child mortality rate between 6 to 60 months age group

8. Scope \& end result expected of project

1. Lives of 1500 severely malnourished children from Melghat will be saved.
2. This model of community based management of severe malnourished children using RUTF prepared by local tribal females from local produce will have better socio-cultural acceptance by parents, and will be palatable for children, hence will be more effective.
3. It will also be useful in long term for preventing recurrences and roll back cases as parents awareness will be improved with behavior change communication.
4. Based on this study, national and international policies related to community based management of severely malnourished children may be framed.
5. It will be a step towards fulfillment of fundamental rights of children guaranteed by constitution of India.

Eligibility criteria: Inclusion Criteria:

* Children suffering from severe malnutrition as per weight for height criteria (WHO), weight for age criteria (WHO), MUAC (WHO), IAP grade III \& IV. Defacto method.

Exclusion Criteria:

* Children who have failed in appetite test and cannot tolerate oral F75 food. Also,
* Parents, guardian refuse to give consent.

Primary outcomes:
measure: Recovery rate of SAM (Severe Acute Malnutrition), SUW (Severe Underweight) and IAP Grade III,IV
timeFrame: At the end of therapeutic cycle of 3 months
measure: Case fatality rate of treated severely malnourished children
timeFrame: At the end of therapeutic cycle of 3 months
measure: Prevalence of severe malnutrition (SAM, SUW, IAP Grade III,IV)
timeFrame: Over the period of 3 years
Secondary outcomes:
measure: Child mortality rate ( 6 months to 60 months age group)
timeFrame: 3 years
Other outcomes:
Locations:
city: Amaravati
country: India
facility: MAHAN Trust, Melghat (Dharni)
state: Maharashtra
Study officials:
affiliation: Research Director
name: Vibhawari Dani, MBBS; MD
role: PRINCIPAL_INVESTIGATOR
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