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

Primary Purpose

Child Nutrition Disorders, Malnutrition

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
MAHAN RUTF & MAHAN Vit-Min mix
Sponsored by
MAHAN Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Child Nutrition Disorders focused on measuring Severe Acute Malnutrition, Severe Underweight, IAP Grade III-IV, Severe Stunting, Village Health Workers, MAHAN RUTF & MAHAN Vit-Mim mix

Eligibility Criteria

6 Months - 60 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MAHAN Trust, Melghat (Dharni)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Arm

Control Arm

Arm Description

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. Treatment of severely malnourished children through MAHAN RUTF & MAHAN Vit-Min mix Growth monitoring of all children below the age of 5 years Treatment of associated diseases like Diarrhea, Pneumonia, Malaria, etc. Management of resistant or relapsed severely malnourished cases by pediatrician. 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

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.

Outcomes

Primary Outcome Measures

Recovery rate of SAM (Severe Acute Malnutrition), SUW (Severe Underweight) and IAP Grade III,IV
Case fatality rate of treated severely malnourished children
Prevalence of severe malnutrition (SAM, SUW, IAP Grade III,IV)

Secondary Outcome Measures

Child mortality rate ( 6 months to 60 months age group)

Full Information

First Posted
January 10, 2016
Last Updated
January 29, 2016
Sponsor
MAHAN Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02671786
Brief Title
Community Based Management of Severe Malnutrition in Tribal Area of Melghat- Cluster Randomized Control Field Trial
Acronym
SAMMAN
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

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MAHAN Trust

4. Oversight

5. Study Description

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. Treatment of severely malnourished children. Growth monitoring of all children below the age of 5 years. Treatment of associated diseases like Diarrhea, Pneumonia, Malaria, etc. Management of resistant or relapsed severely malnourished cases by pediatrician. 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 - 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. 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. To achieve Case fatality rate of 2 % of treated severely malnourished children. 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. 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. 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. Treatment of severely malnourished children . Growth monitoring of all children below the age of 5 years. Treatment of associated diseases like Diarrhea, Pneumonia, Malaria, etc. Management of resistant or relapsed severely malnourished cases by pediatrician. 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 Prevalence of severe malnutrition (Severe Acute Malnutrition; Severe Underweight and Indian Academy of Pediatrician (IAP) Grade III, IV) No. of child deaths due to severe malnutrition Case fatality rate of treated severely malnourished children The secondary outcomes Child mortality rate between 6 to 60 months age group The secondary outcomes Child mortality rate between 6 to 60 months age group 8. Scope & end result expected of project Lives of 1500 severely malnourished children from Melghat will be saved. 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. 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. Based on this study, national and international policies related to community based management of severely malnourished children may be framed. It will be a step towards fulfillment of fundamental rights of children guaranteed by constitution of India.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
824 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
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. Treatment of severely malnourished children through MAHAN RUTF & MAHAN Vit-Min mix Growth monitoring of all children below the age of 5 years Treatment of associated diseases like Diarrhea, Pneumonia, Malaria, etc. Management of resistant or relapsed severely malnourished cases by pediatrician. 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
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
MAHAN RUTF & MAHAN Vit-Min mix
Intervention Description
MAHAN RUTF dishes are locally prepared by local tribal women and each packet of RUTF provides 500-550 calories & 15-17 gms of proteins.
Primary Outcome Measure Information:
Title
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
Title
Case fatality rate of treated severely malnourished children
Time Frame
At the end of therapeutic cycle of 3 months
Title
Prevalence of severe malnutrition (SAM, SUW, IAP Grade III,IV)
Time Frame
Over the period of 3 years
Secondary Outcome Measure Information:
Title
Child mortality rate ( 6 months to 60 months age group)
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vibhawari Dani, MBBS; MD
Organizational Affiliation
Research Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
MAHAN Trust, Melghat (Dharni)
City
Amaravati
State/Province
Maharashtra
ZIP/Postal Code
444 702
Country
India

12. IPD Sharing Statement

Citations:
Citation
Management of Severe Under Nutrition, A Manual for Physicians and Other Health Workers. Geneva: WHO; 1999.
Results Reference
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PubMed Identifier
7554015
Citation
Pelletier DL, Frongillo EA Jr, Schroeder DG, Habicht JP. The effects of malnutrition on child mortality in developing countries. Bull World Health Organ. 1995;73(4):443-8.
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PubMed Identifier
21543411
Citation
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Results Reference
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Citation
Dani V, Satav A, Pendharkar J, Ughade S, Jain D, Adhav A et al. Prevalence of under nutrition in under-five tribal children of Melghat: A community based cross sectional study in Central India, Clinical Epidemiology and Global Health 2014 Sept, I-8
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PubMed Identifier
17076212
Citation
Ashworth A. Efficacy and effectiveness of community-based treatment of severe malnutrition. Food Nutr Bull. 2006 Sep;27(3 Suppl):S24-48. doi: 10.1177/15648265060273S303.
Results Reference
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Citation
WHO/UNICEF/WFP/SCN Joint statement. Community-based management of severe malnutrition. Geneva, New York, Rome, 2007
Results Reference
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PubMed Identifier
15155403
Citation
Manary MJ, Ndkeha MJ, Ashorn P, Maleta K, Briend A. Home based therapy for severe malnutrition with ready-to-use food. Arch Dis Child. 2004 Jun;89(6):557-61. doi: 10.1136/adc.2003.034306.
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PubMed Identifier
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Citation
Schoonees A, Lombard M, Musekiwa A, Nel E, Volmink J. Ready-to-use therapeutic food for home-based treatment of severe acute malnutrition in children from six months to five years of age. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD009000. doi: 10.1002/14651858.CD009000.pub2.
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PubMed Identifier
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Citation
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Ashworth A., Community-Based Rehabilitation of Severely Malnourished Children: a Review of Successful Programmes. London School of Hygiene and Tropical Medicine. Report. 2001
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PubMed Identifier
25432212
Citation
Dasgupta R, Sinha D, Yumnam V. Programmatic response to malnutrition in India, room for more than one elephant. Indian Pediatr. 2014 Nov;51(11):863-8. doi: 10.1007/s13312-014-0518-5.
Results Reference
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Citation
Dasgupta R, Ahuja S, Yumnam V. Can nutrition rehabilitation centers address severe malnutrition in India? Indian Pediatr. 2014 Feb;51(2):95-9. doi: 10.1007/s13312-014-0341-z.
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Rogers BL , Rajabiun S, Levinson J, Tucker K. Reducing Chronic Malnutrition in Peru: A Proposed National Strategy
Results Reference
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Citation
READY-TO-USE THERAPEUTIC FOOD FOR CHILDREN WITH SEVERE ACUTE MALNUTRITION- A position paper by UNICEF
Results Reference
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PubMed Identifier
18207566
Citation
Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. No abstract available.
Results Reference
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Available IPD and Supporting Information:
Available IPD/Information Type
Pilot Study Research Paper
Available IPD/Information URL
http://www.worldwidejournals.com/ijar/file.php?val=April_2015_1427896145__152.pdf

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

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