Child MalnutritionNCT04067284
Homemade Yogurt Supplementation to Prevent Stunting
A study testing Nutrition education and Homemade yogurt supplementation in people with Child Malnutrition, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 months
- Conditions the study is for
- Child Malnutrition
- What is being tested?
- Nutrition education and Homemade yogurt supplementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Sep 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Stunting or wasting (<-2SD LAZ)
- Infants with any major congenital abnormality or any chronic conditions (e.g., rheumatic heart disease)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Early Initiation of Homemade Yogurt Supplementation Prevents Stunting - a Pilot Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Child Malnutrition
- Being tested
- Nutrition education, Homemade yogurt supplementation, Usual care
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition educationBehavioural
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
Homemade yogurt supplementationDietary supplement
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.
Usual careOther
No intervention/ control group
| Study group | Role | What they receive |
|---|---|---|
| Education | Active comparator | Nutrition education on dietary diversity. Receives: Behavioral: Nutrition education |
| Yogurt | Experimental | A combination of similar education plus daily supplementation of homemade yogurt Receives: Dietary Supplement: Homemade yogurt supplementation |
| Control | Active comparator | Control group. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Child weight converted to z-score
Measured: 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
Measured: 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.
Measured: 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.
Measured: Will be measured at baseline (6 months), 9 months and 12 months of child age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start1 Sep 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Sydney
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067284
- Sponsor's protocol ID
- PR-19062
- Status last verified
- Aug 2021
- First submitted
- 19 Aug 2019
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Early Initiation of Homemade Yogurt Supplementation Prevents Stunting - a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04067284
- Acronym / sponsor ID
- PR-19062
- Conditions
- Child Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- University of Western Sydney
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 26 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Education | Active comparator | Behavioral: Nutrition educationNutrition education on dietary diversity. |
| Yogurt | Experimental | Dietary Supplement: Homemade yogurt supplementationA combination of similar education plus daily supplementation of homemade yogurt |
| Control | Active comparator | Other: Usual careControl group. |
Who may qualify
- Ages
- 4 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Stunting or wasting (<-2SD LAZ)
- Infants with any major congenital abnormality or any chronic conditions (e.g., rheumatic heart disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition educationNutrition 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 | Behavioural | Education |
| Homemade yogurt supplementationThe 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. | Dietary supplement | Yogurt |
| Usual careNo intervention/ control group | Other | Control |
Primary outcome
Change from baseline (6 months) length for age z-score (LAZ) at 9 months and 12 months of child age.
Time frame: Will be measured at baseline (6 months), 9 months and 12 months of child age
Child length converted to z-score
4 secondary outcomes
Change from baseline (6 months) weight for age z-score (WAZ) at 9 months and 12 months of child age.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Will be measured at baseline (6 months), 9 months and 12 months of child age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition education and Homemade yogurt supplementation in people with Child Malnutrition, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline (6 months) length for age z-score (LAZ) at 9 months and 12 months of child age. (time frame: Will be measured at baseline (6 months), 9 months and 12 months of child age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.