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

NCT02671786 | Completed

• 1 other identifier: MT-2 SAMMAN
• Study Type: interventional
• Target: 824
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (3)

• Recovery rate of SAM (Severe Acute Malnutrition), SUW (Severe Underweight) and IAP Grade III,IV

  At the end of therapeutic cycle of 3 months

• Case fatality rate of treated severely malnourished children

  At the end of therapeutic cycle of 3 months

• Prevalence of severe malnutrition (SAM, SUW, IAP Grade III,IV)

  Over the period of 3 years

Secondary Outcomes (1)

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

  3 years

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

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.

Interventions

MAHAN RUTF & MAHAN Vit-Min mix OTHER

MAHAN RUTF dishes are locally prepared by local tribal women and each packet of RUTF provides 500-550 calories \& 15-17 gms of proteins.

Intervention Arm

Eligibility Criteria

• Age: 6 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• MAHAN Trust: lead

Study Sites (1)

MAHAN Trust, Melghat (Dharni)

Amravati, Maharashtra, 444 702, India

Location

Related Publications (16)

• Management of Severe Under Nutrition, A Manual for Physicians and Other Health Workers. Geneva: WHO; 1999.

  BACKGROUND

• 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.

  PMID: 7554015 BACKGROUND

• Meshram II, Arlappa N, Balakrishna N, Laxmaiah A, Mallikarjun Rao K, Gal Reddy Ch, Ravindranath M, Sharad Kumar S, Brahmam GN. Prevalence and determinants of undernutrition and its trends among pre-school tribal children of Maharashtra State, India. J Trop Pediatr. 2012 Apr;58(2):125-32. doi: 10.1093/tropej/fmr035. Epub 2011 May 4.

  PMID: 21543411 BACKGROUND

• 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

  BACKGROUND

• Amsalu S, Tigabu Z. Risk factors for severe acute malnutrition in children under the age of five: A case-control study. Ethiop J Health Dev. 2008; 22(1): 21-5.

  BACKGROUND

• 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.

  PMID: 17076212 BACKGROUND

• WHO/UNICEF/WFP/SCN Joint statement. Community-based management of severe malnutrition. Geneva, New York, Rome, 2007

  BACKGROUND

• 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.

  PMID: 15155403 BACKGROUND

• 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.

  PMID: 23744450 BACKGROUND

• Bergeron G, Castleman T. Program responses to acute and chronic malnutrition: divergences and convergences. Adv Nutr. 2012 Mar 1;3(2):242-9. doi: 10.3945/an.111.001263.

  PMID: 22516735 BACKGROUND

• Ashworth A., Community-Based Rehabilitation of Severely Malnourished Children: a Review of Successful Programmes. London School of Hygiene and Tropical Medicine. Report. 2001

  BACKGROUND

• 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.

  PMID: 25432212 BACKGROUND

• 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.

  PMID: 24632690 BACKGROUND

• Rogers BL , Rajabiun S, Levinson J, Tucker K. Reducing Chronic Malnutrition in Peru: A Proposed National Strategy

  BACKGROUND

• READY-TO-USE THERAPEUTIC FOOD FOR CHILDREN WITH SEVERE ACUTE MALNUTRITION- A position paper by UNICEF

  BACKGROUND

• 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.

  PMID: 18207566 BACKGROUND

MeSH Terms

Conditions

Child Nutrition Disorders; Malnutrition; Severe Acute Malnutrition; Thinness; Growth Disorders

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Vibhawari Dani, MBBS; MD

  Research Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2016
• First Posted: February 2, 2016
• Study Start: May 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 2, 2016

Record last verified: 2016-01

Locations

IN (1)