Community Based Management of Severe Malnutrition in Tribal Area of Melghat- Cluster Randomized Control Field Trial (SAMMAN)

January 29, 2016 updated by: MAHAN Trust

Community Based Management of Severe Malnutrition in Under 5 Children in Tribal Area of Melghat, Maharashtra- Cluster Randomized Control Field Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

824

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Amaravati, Maharashtra, India, 444 702
        • MAHAN Trust, Melghat (Dharni)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm

Intervention area: Provision of community based health care to severely malnourished children 6 months age in 16 tribal villages by trained semi-literate village health workers.

  1. Treatment of severely malnourished children through MAHAN RUTF & MAHAN Vit-Min mix
  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.

Dose: 46 gms of proteins/kg/day & 100170 calories/kg/day with gradual escalation with micro nutrient supplementation Route: Oral Frequency: 4 times a day Duration: 12 weeks
Other: MAHAN RUTF & MAHAN Vit-Min mix
MAHAN RUTF dishes are locally prepared by local tribal women and each packet of RUTF provides 500-550 calories & 15-17 gms of proteins.
No Intervention: Control Arm
Control area: In control area, the V.H.W. and supervisor records weight of all under 5 children. They also collect data related to birth, deaths and verbal autopsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recovery rate of SAM (Severe Acute Malnutrition), SUW (Severe Underweight) and IAP Grade III,IV
Time Frame: At the end of therapeutic cycle of 3 months
At the end of therapeutic cycle of 3 months
Case fatality rate of treated severely malnourished children
Time Frame: At the end of therapeutic cycle of 3 months
At the end of therapeutic cycle of 3 months
Prevalence of severe malnutrition (SAM, SUW, IAP Grade III,IV)
Time Frame: Over the period of 3 years
Over the period of 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Child mortality rate ( 6 months to 60 months age group)
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MAHAN Trust

Investigators

  • Principal Investigator: Vibhawari Dani, MBBS; MD, Research Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

January 10, 2016

First Submitted That Met QC Criteria

January 29, 2016

First Posted (Estimate)

February 2, 2016

Study Record Updates

Last Update Posted (Estimate)

February 2, 2016

Last Update Submitted That Met QC Criteria

January 29, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT-2 SAMMAN

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Pilot Study Research Paper

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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