Homemade Yogurt Supplementation to Prevent Stunting

Study Overview
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Brief Summary
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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
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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: 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). 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.

Official Title
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Does Early Initiation of Homemade Yogurt Supplementation Prevents Stunting - a Pilot Randomized Controlled Trial

Conditions
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Child Malnutrition

Intervention / Treatment
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* Behavioral: Nutrition education
* Dietary Supplement: Homemade yogurt supplementation
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants at risk of developing stunting aged 5 months (-1SD LAZ) All gender, religion, language and ethnicity Infants born through normal delivery or cesarean section Breastfeeding or non-breastfeeding Exclusion Criteria: Stunting or wasting (<-2SD LAZ) Infants with any major congenital abnormality or any chronic conditions (e.g., rheumatic heart disease)

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Education<br>Nutrition education on dietary diversity. | Behavioral: Nutrition education<br>* 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<br>|
| Experimental: Yogurt<br>A combination of similar education plus daily supplementation of homemade yogurt | Dietary Supplement: Homemade yogurt supplementation<br>* 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.<br>|
| Active Comparator: Control<br>Control group. | Other: Usual care<br>* No intervention/ control group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline (6 months) length for age z-score (LAZ) at 9 months and 12 months of child age. | Child length converted to z-score | Will be measured at baseline (6 months), 9 months and 12 months of child age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline (6 months) weight for age z-score (WAZ) at 9 months and 12 months of child age. | Child weight converted to z-score | Will be measured at baseline (6 months), 9 months and 12 months of child age | 
| Change from baseline (6 months) mean head circumference at 9 months and 12 months of child age. | Child head circumference | Will be measured at baseline (6 months), 9 months and 12 months of child age | 
| Change from baseline (6 months) mean concentration of fecal bio-markers at 9 months and 12 months of child age. | Concentration of neopterin, myeloperoxidase, and alpha 1 antitrypsin in stool samples. | Will be measured at baseline (6 months), 9 months and 12 months of child age | 
| Change from baseline (6 months) proportion of children meeting food diversity scores at 9 months and 12 months of child age. | Minimum dietary diversity (MDD): the proportion of children who received foods from 4 or more food categories out of 7 specified categories on the previous day will be described as meeting the MDD score. Children will be divided into two groups, those who meet the above criteria will be scored 1 and those who do not meet the criteria will be scored 0. Minimum meal frequency (MMF): the proportion of children who received solid, semi-solid, or soft foods the minimum numbers of time or more on the previous day will be described as meeting the MFF score. Children will be divided into two groups, those who meet the above criteria will be scored 1 and those who do not meet the criteria will be scored 0. Minimum acceptable diet (MAD): the proportion of children who met both the MDD and MMF scores will be described as meeting the MAD score. MDD and MMF scores will be summed to estimate the MAD score. Children will be divided into two groups. | Will be measured at baseline (6 months), 9 months and 12 months of child age |