Effectiveness of community-based treatment programs for treatment of uncomplicated severe acute malnourished children aged 6-59 months using locally produced nutrient dense foods: protocol for a multicentric longitudinal quasi-experimental study.

BACKGROUND: Severe acute malnutrition (SAM) is a major underlying cause of mortality among children. Around one third of the world's acutely malnourished children live in India. The WHO recommends community-based management of acute malnutrition (CMAM) for managing children with SAM. In India, different states are implementing community-based SAM treatment programme, hereinafter called CSAM, using varieties of locally produced nutrient dense food items with different nutrient compositions. The study will assess the effectiveness of these state specific CSAM interventions. METHODS: The longitudinal quasi-experimental study will be undertaken in two purposively selected blocks of one district each in the four intervention states and one comparison state. From each state, 200 SAM children identified using weight-for-length/height z-score (WHZ) < - 3 criteria will be enrolled in the study. Their anthropometric data and skinfold thickness will be taken on admission, at sixth week and at discharge by trained field investigators. Other child details, incidence of morbidity and socio-economic details will be collected on admission. To assess food consumption pattern including consumption of locally produced nutrient dense food supplements, dietary assessment, using 24-h dietary recall will be conducted on admission, at sixth week and at discharge. In addition, body composition parameters will be assessed for a sub-set of children using bio-electrical impedance analysis on admission and at discharge to analyse changes in total body water, fat-free mass, and fat mass. Post discharge, all study participants will be followed up monthly until 6 months. Atleast 10% of the sample will be checked for quality assessment. The study's primary outcome is cure rate defined as children attaining WHZ ≥ -2. Secondary outcomes include mean weight gain, mean length of stay, body composition parameters, relapse and mortality rates. Additionally, process evaluation and cost effectiveness analysis will be conducted. DISCUSSION: There is a shortage of robust evidence regarding the effectiveness of locally produced nutrient dense food supplements provided as part of the CSAM intervention in India. This study will contribute to evidence on effective strategies to manage children with uncomplicated SAM in India. The study protocol has all necessary ethical approvals. Written informed consent will be obtained from caregivers of the children. TRIAL REGISTRATION: The study is registered with Clinical Trial Registration of India (Registration No.: CTRI/2020/09/028013 ) Date of registration 24/09/2020.

Integrated multisectoral strategy to improve girls' and women's nutrition before conception, during pregnancy and after birth in India (Swabhimaan): protocol for a prospective, non-randomised controlled evaluation.

INTRODUCTION: Swabhimaan is a community-based programme to improve adolescent girls' and women's nutrition in the rural areas of three Indian states-Bihar, Chhattisgarh and Odisha with high prevalence of undernutrition. METHODS AND ANALYSIS: Swabhimaan has a nested prospective, non-randomised controlled evaluation. Since 2017, five intervention sites receive community-led interventions through national government's livelihood mission supported women's self-help group federations and five control sites will initiate these activities 36 months later, in 2020. Community-led activities aim to improve coverage of 18 interventions including adequacy of food consumed, prevention of micronutrient deficiencies, access to basic health services and special care of nutritionally 'at risk' girls and women, improving hygiene and access to water and sanitation services and access to family planning services. The evaluation includes baseline (2016-2017), midline (2018-2019) and endline (2020-2021) surveys covering 6638 adolescent girls, 2992 pregnant women and 8755 mothers of children under 2. The final impact analysis will be by intention to treat, comparing primary and secondary outcomes in five intervention areas and five control areas. The primary outcomes are: (1) a 15% reduction in the proportion of adolescent girls with a body mass index (BMI) <18.5 kg/m2; (2) a 15% reduction in the proportion of mothers of children under two with a BMI <18.5 kg/m2 and (3) and a 0.4 cm improvement in mean mid-upper arm circumference among pregnant women. ETHICS AND DISSEMINATION: All procedures involving human subjects were approved by the Institutional Ethics Committee of the All India Institute of Medical Sciences, Bihar, Chhattisgarh and Odisha and in compliance with guidelines laid down in the Declaration of Helsinki. Evidence will inform maternal and preconception nutrition policy at national and state level. TRIAL REGISTRATION NUMBER: 58261b2f46876 and CTRI/2016/11/007482; Pre-results.

A review of the vitamin A supplementation program in India: reasons for success in the states of Bihar and Odisha.

BACKGROUND: Preventive vitamin A supplementation (VAS) is an essential child survival intervention. In India, VAS program coverage has remained relatively low, with wide interstate variation. OBJECTIVE: To review the VAS program in India, particularly in Bihar and Odisha, the two states that have had the most successful VAS programs, to define best practices and identify critical success factors. METHODS: A thorough review of existing relevant literature was carried out, supplemented by field visits and interviews with selected partners. RESULTS: Both states have adopted a biannual approach to reach out to children 1 to 5 years of age with VAS every 6 months, while infants below 1 year of age receive their first VAS dose with the measles immunization at 9 months. The critical success factors for the VAS program in the two states include strong leadership and ownership by the state government; close coordination between the two departments that are involved in the VAS program; effective microplanning prior to each biannual round; flexible dosing mechanisms that enhance coverage in hard-to-reach areas; a stable procurement and distribution mechanism to ensure an adequate, timely, and sustainable supply of VAS; intensive social mobilization and communication; and appropriate training and supervision of staff. CONCLUSIONS: The governments of Bihar and Odisha have demonstrated that it is feasible to implement a successful and inclusive VAS program in India. The challenge now is to reach out to the remaining 30% to 40% of children who are undoubtedly the hardest to reach and potentially the most vulnerable.