Homemade Yogurt Supplementation to Prevent Stunting
Primary Purpose
Child Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Nutrition education
Homemade yogurt supplementation
Usual care
Sponsored by
About this trial
This is an interventional prevention trial for Child Malnutrition
Eligibility Criteria
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)
Sites / Locations
- Dr. Mahbubur Rahman
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Active Comparator
Arm Label
Education
Yogurt
Control
Arm Description
Nutrition education on dietary diversity.
A combination of similar education plus daily supplementation of homemade yogurt
Control group.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Change from baseline (6 months) mean head circumference at 9 months and 12 months of child age.
Child head circumference
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.
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.
Full Information
NCT ID
NCT04067284
First Posted
August 19, 2019
Last Updated
March 6, 2022
Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators
University of Western Sydney
1. Study Identification
Unique Protocol Identification Number
NCT04067284
Brief Title
Homemade Yogurt Supplementation to Prevent Stunting
Official Title
Does Early Initiation of Homemade Yogurt Supplementation Prevents Stunting - a Pilot Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators
University of Western Sydney
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Malnutrition
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Education
Arm Type
Active Comparator
Arm Description
Nutrition education on dietary diversity.
Arm Title
Yogurt
Arm Type
Experimental
Arm Description
A combination of similar education plus daily supplementation of homemade yogurt
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control group.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition education
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Homemade yogurt supplementation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
No intervention/ control group
Primary Outcome Measure Information:
Title
Change from baseline (6 months) length for age z-score (LAZ) at 9 months and 12 months of child age.
Description
Child length converted to z-score
Time Frame
Will be measured at baseline (6 months), 9 months and 12 months of child age
Secondary Outcome Measure Information:
Title
Change from baseline (6 months) weight for age z-score (WAZ) at 9 months and 12 months of child age.
Description
Child weight converted to z-score
Time Frame
Will be measured at baseline (6 months), 9 months and 12 months of child age
Title
Change from baseline (6 months) mean head circumference at 9 months and 12 months of child age.
Description
Child head circumference
Time Frame
Will be measured at baseline (6 months), 9 months and 12 months of child age
Title
Change from baseline (6 months) mean concentration of fecal bio-markers at 9 months and 12 months of child age.
Description
Concentration of neopterin, myeloperoxidase, and alpha 1 antitrypsin in stool samples.
Time Frame
Will be measured at baseline (6 months), 9 months and 12 months of child age
Title
Change from baseline (6 months) proportion of children meeting food diversity scores at 9 months and 12 months of child age.
Description
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.
Time Frame
Will be measured at baseline (6 months), 9 months and 12 months of child age
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Dr. Mahbubur Rahman
City
Dhaka
ZIP/Postal Code
1212
Country
Bangladesh
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Homemade Yogurt Supplementation to Prevent Stunting
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