跳至主要内容
临床试验/CTRI/2025/02/079884
CTRI/2025/02/079884招募中不适用

Fortified Multigrain and Millet based Supplementation to Address Malnutrition in 3-5 years old Children in Rural Communities of Maharashtra (Phase-II)

Mamta Health Institute for Mother and Child1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2025年2月11日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,000
试验地点
1
主要终点
Fortified multigrain and millet based supplementation compliance may improve nutritional status of mildly malnourished children to normal age appropriate growth trajectory and may prevent progression to MAM and SAM

研究概览

简要总结

Adequate nutrition during early childhood is essential to ensure healthy growth, proper organ function, a strong immune system, and neurological and cognitive development. Despite a decade of rapid economic growth, India’s progress in tackling child malnutrition has been slow. In Maharashtra, which has over 112 million people, the prevalence of under-five stunting, underweight, and wasting stands at approximately 35%, 36%, and 26%, respectively, contributing to a high burden of morbidity and mortality among children. In Pune district, the situation is more severe, with wasting rates reaching 31.4%, exceeding both national (19.3%) and state (25.6%) averages. This highest rate of wasting is driven by inadequate dietary intake, poor hygiene, and sanitary practices that lead to recurrent infections.

Mildly malnourished children who are not adequately or timely treated may progress to moderate or even severe forms of acute malnutrition, a condition associated with higher fatality rates. Studies conducted in Guatemala and Mexico has shown that supplementary feeding combined with caregiver counseling, is effective in resolving mild acute malnutrition among preschool children.

Given the high incidence of wasting among children in Pune, this project aims to address mild acute malnutrition among 3-5-year-old children by providing fortified multigrain and millet-based supplementation. This supplementation, delivered in the form of "Panjiri," a traditional food fortified with 18 micronutrients, is designed to prevent progression from mild undernutrition to moderate acute malnutrition. Clinical studies in Mexico have shown that supplementation in the form of cookies, containing nutrients similar to those in *Panjiri,*can significantly improve weight and height in children with moderate acute malnutrition.

The first phase of the project, implemented across 321 Anganwadi Centers in Maval and Mulshi blocks of Pune district, provided “Panjiri” to 1,000 mildly malnourished children for six months. This intervention resulted in a 55% improvement in nutritional status, bringing children up to normal growth standards. Furthermore, caregivers’ knowledge and behaviors regarding nutrition, health, and hygiene showed a significant improvement, increasing from 21.5% at baseline to 96.9% after targeted education and engagement sessions were conducted with them.

The positive outcomes of phase-1 suggest that expanding the initiative could amplify its impact and provide a robust model for addressing child malnutrition in other blocks of Pune district. Government authorities from Integrated Child Development Scheme (ICDS), Department of Women and Child development and Zilha Parishad, Pune district have also recognized the need to address malnutrition in the hard-to-reach areas of Junnar and Ambegaon blocks. These regions, characterized by challenging terrain, hamper regular access to essential healthcare and nutrition services. Expanding this program would provide a comprehensive approach to improving the nutritional status of mildly malnourished children, ultimately contributing to the long-term well-being and development of these communities.

Objectives

·     To assess the impact of additional nutrition supplementation for 3-5 years’ children of mild acute malnutrition [WHZ between -1 SD and -2SD and or MUAC for age Z score between -1 SD and -2SD], along with focused nutrition education intervention to their parents on the nutritional status of children;

·     To assess changes in the Knowledge of nutrition, health, hygiene and sanitation practices among mothers/caretakers of children with mild acute malnutrition.

Expected Outcomes

·         High compliance with fortified multigrain & millet based supplementation may reduce the prevalence of mild acute malnutrition, improving children’s nutritional status to normal grade.

·         Improved child feeding practices of mothers of children aged 3-5 years.

Two thousand mildly malnourished children will be identified through screening, including standard anthropometric measurements. Identified children will be enrolled in the intervention to receive additional supplementation, in addition to their regular diets, both at home and at Anganwadi Centers (AWCs), along with nutrition education sessions for their caregivers. The effectiveness of the program will be evaluated through repeated anthropometric measurements at 3 and 6 months.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
3.00 Year(s) 至 5.00 Year(s)(—)
性别
All

入选标准

  • Child is between 3 to 5 years of age Children who are mildly wasted i.e. [WHZ greater than -1 SD and less than equal to-2SD and or MUAC greater than-1 SD and less than equal to -2SD Children whose parents provide consent for participation.
  • In cases where the child is not residing with their parents, consent will be obtained from their legal guardian.
  • Children should live in the study area for the duration of the intervention.

排除标准

  • Children ongoing consumption of other supplementary foods Any known history of allergy to peanuts or other food ingredients present in the intervention in the child or any direct family member Children who are found to have moderate and severe acute malnutrition (less than -2 SD from the median weight by height, compared to the reference population) Any child who has a known history of medical co-morbidity like HIV/ AIDS, TB, or disability or any other chronic childhood diseases.
  • Any child found to have pedal edema in both the feet.

结局指标

主要结局

Fortified multigrain and millet based supplementation compliance may improve nutritional status of mildly malnourished children to normal age appropriate growth trajectory and may prevent progression to MAM and SAM

时间窗: Evaluation at 3 month and 6 month post intervention for growth parameters | Evaluation at baseline and 6 month post intervention for child feeding practices

Improved child feeding practices among mothers of children aged 3 to 5 years

时间窗: Evaluation at 3 month and 6 month post intervention for growth parameters | Evaluation at baseline and 6 month post intervention for child feeding practices

次要结局

未报告次要终点

研究者

发起方
Mamta Health Institute for Mother and Child
申办方类型
Other [ngo]
责任方
Principal Investigator
主要研究者

Pratibha Verma

Mamta Health Institute for Mother and Child

研究点 (1)

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