Locally Prepared Therapeutic Food for Treatment of Severely Underweight Children in Rural India: An Interventional Prospective Controlled Community-Based Study with Long Follow-Up:-'SAMMAN' Trial.

Background: Severely underweight (SUW) children contribute significantly to under-five mortality and morbidity. There are WHO guidelines for the management of severe acute malnutrition but no specific guidelines for SUW management.

Objective: The objectives were to achieve a recovery rate of 30% at 90 days of treatment for severe underweight (SUW) children aged 6-60 months, compare changes in weight-for-age Z (WAZ) scores, growth patterns, and case fatality rates between intervention and reference arms (RA), and reduce the prevalence of SUW in the intervention arm (IA). The target of a 30% recovery rate was achievable and significant based on our past research conducted in similar settings.

Methods: Design: A prospective controlled community-based, longitudinal, two arms (IA, RA), intervention study with long follow-up was conducted between January 2011 and October 2023.

Setting: Primary care for participants from 14 villages in rural Melghat, India.

Participants: The study participants included SUW children aged 6-60 months and age-matched (±2 weeks) normal controls. The SAMMAN (Acronym for SAM-Management) intervention was comprised of local therapeutic food-micronutrient (LTF-MN) therapy for 90 days, intensive behavior change communication, infection treatment, and quarterly anthropometric records. SUW recovery, growth patterns, case fatality rate, prevalence at 90 days of therapy and at 60 months of age, and survival until early adolescence were assessed. ANCOVA analysis was used to obtain changes in Z-scores.

Results: In the IA, the recovery rate was 36.8% at 90 days and 78.2% at 60 months of age. The mean difference in change in WAZ scores between the intervention arm and the reference arm was statistically significant ( < 0.0001). Growth patterns were similar between the two arms up to early adolescence. The SUW case fatality rate was significantly lower in the IA (0.9%) as compared to 4.62% in the RA at 60 months ( = 0.022). The reduction in SUW prevalence in intervention villages was higher than in the control villages ( < 0.001). The cost of management per SUW child was 3888 INR (47 USD) less than RUTF.

Conclusion: The SAMMAN intervention is safe and cost-effective for significantly improving WAZ scores, sustainable, and hence replicable in resource-limited areas.