Homemade Yogurt Supplementation to Prevent Stunting
Does Early Initiation of Homemade Yogurt Supplementation Prevents Stunting - a Pilot Randomized Controlled Trial
1 other identifier
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2019
CompletedFirst Posted
Study publicly available on registry
August 26, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedMarch 8, 2022
August 1, 2021
7 months
August 19, 2019
March 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Change from baseline (6 months) weight for age z-score (WAZ) at 9 months and 12 months of child age.
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.
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.
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.
Will be measured at baseline (6 months), 9 months and 12 months of child age
Study Arms (3)
Education
ACTIVE COMPARATORNutrition education on dietary diversity.
Yogurt
EXPERIMENTALA combination of similar education plus daily supplementation of homemade yogurt
Control
ACTIVE COMPARATORControl group.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Stunting or wasting (\<-2SD LAZ)
- Infants with any major congenital abnormality or any chronic conditions (e.g., rheumatic heart disease)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr. Mahbubur Rahman
Dhaka, 1212, Bangladesh
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2019
First Posted
August 26, 2019
Study Start
September 1, 2019
Primary Completion
March 31, 2020
Study Completion
March 31, 2020
Last Updated
March 8, 2022
Record last verified: 2021-08