Homemade Yogurt Supplementation to Prevent Stunting
Condition: Child Malnutrition
MeSH terms: Malnutrition; Child Nutrition Disorders
Study type: Interventional

Summary: 
      Stunting contributes substantially to child mortality and disease burden in low-income
      countries. In Bangladesh the prevalence of stunting among children <5-years of age is high
      (36%) reaching 50% in slum areas. The pathogenesis of stunting is multifaceted, yet
      nutritional inadequacy and repeated infections are established risk factors of stunting.

      A three-arm randomized controlled trial in Dhaka's slum area is proposed. The children will
      be recruited from vaccination clinics. Infants at risk of stunting (-1 SD length-for-age
      z-score, LAZ) aged around 5 months are eligible for the study. Eligible children will be
      randomized to receive: 1) nutrition education on dietary diversity; 2) a combination of
      similar education plus daily supplementation of homemade yogurt; 3) a 'usual care' (control)
      group. The investigators will recruit 120 children (40 per arm). Intervention will be
      initiated a month before starting of complementary feeding with an educational session and
      will last 7 months during which a monthly educational session will be delivered at
      participant's household. The homemade yogurt supplementation will start a week after
      beginning of 6 months of age once the child is introduced to solid foods of the mother's
      choice. The yogurt will be supplied to the mothers every day at time of feeding. Feeding
      behaviors will be self-monitored using a pictorial calendar. Primary outcome (LAZ) and
      secondary outcomes (fecal bio-markers, WAZ, head circumference, and food diversity scores),
      will be measured at baseline (6 months), 9 months and 12 months of child age. Supplementation
      with homemade yogurt is a novel approach with the potential to improve infant gut
      environment, improve food absorption and thus potentially prevent stunting.
    

Detailed description: 
      Hypothesis:

      The investigators hypothesize that, continued breastfeeding, adequate complimentary feeding
      and supplementation with homemade yogurt have the potential to reduce stunting.

      Primary objective:

      The present study is aimed to assess the impact of low-cost nutritional strategies to prevent
      childhood malnutrition in Bangladesh.

      Specific objectives:

        1. To compare differences in growth pattern (length-for-age z-score, weight-for age
           z-score, head circumference) of children at risk of stunting age 6-months between
           infants receiving educational program only, infants receiving education plus homemade
           yogurt supplementation and those receiving the "usual-care" (control).

        2. To evaluate whether amount of gut microbiota necessary to improve gut health was
           associated with weight gain and growth in these children to support the casual mechanism
           behind this approach.
    

Intervention name(s): Nutrition education; Homemade yogurt supplementation; Usual care
Intervention type(s): Behavioral; Dietary Supplement; Other
Intervention description(s): Nutrition Education on
Continued breastfeeding until two years of age
Food groups
Balanced diet
Introduction to locally available nutritious and low-cost foods
Amount and frequency of complementary feeding
Safe water, and
Handwashing with soap before feeding; The homemade yogurt supplementation will start a week after beginning of 6 months of age once the child is introduced to solid foods of the mother's choice. The yogurt will be supplied to the mothers every day at time of feeding.; No intervention/ control group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A three-arm randomized controlled trial in Dhaka's slum area is proposed. Infants at risk of stunting (-1 SD length-for-age z-score, LAZ) aged around 5 months are eligible for the study. Eligible children will be randomised to receive: 1) nutrition education on dietary diversity; 2) a combination of similar education plus daily supplementation of homemade yogurt; 3) a 'usual care' (control) group. We will recruit 120 children (40 per arm).
Masking: None (Open Label)
Primary purpose: Prevention