Malnutrition, ChildNCT03017209
Locally Prepared Supplement to Support Growth and Brain Health
A study testing Locally-prepared bar and USAID Corn Soy Blend Plus in people with Malnutrition, Child and Cognitive Function, run by Tufts University at 1 site in Guinea-Bissau.
Trial summary
This study is a randomized controlled trial with a main goal to assess the effects of a locally-prepared food for prevention of malnutrition and stunting, in comparison with standard village practices and also a widely available aid food supplement in 8-12 villages in Guinea-Bissau. Read more about this study
- Who is it for?
- Ages 15 months to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Child, Cognitive Function
- What is being tested?
- Locally-prepared bar and USAID Corn Soy Blend Plus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,059 participants
- Where
- 1 siteGuinea-Bissau
- Study dates
- Jan 2017to Jan 2018
- 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 15 months to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent or legal guardian provides consent for all children <7 years and the parent plus the child provide consent for any child > 7 years.
- Age 15 months to 6.99 years old or any age enrolled in first grade in the same village.
- The family plans to remain in the village for the duration of the study (up to 30 weeks) based on self-report by a parent;
- The child does not have any known food allergies as reported by the mother or guardian.
- Exclusion Criteria: If any child is identified as malnourished at baseline, defined as a mid-upper arm circumference in the red zone of the paper tape, the child will be excluded from the study due to malnutrition, and the parents will be advised to take the child to the nearest malnutrition clinic.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Guinea-Bissau1 site
International Partnership for Health Development
Bissau, 1000
About this study
Official title: Study on a Locally Prepared Food Supplement to Support Growth and Brain Health
This study is a randomized controlled trial with a main goal to assess the effects of a locally-prepared food for prevention of malnutrition and stunting, in comparison with standard village practices and also a widely available aid food supplement in 8-12 villages in Guinea-Bissau. The supplement intervention will be for 24-30 weeks. The primary outcome will be cognitive tests of executive function. Secondary outcomes will be changes in standard anthropometric benchmarks of growth, hemoglobin and skin carotenoids in young children living in villages in rural Guinea-Bissau. This is a within-village randomization at the level of the family, and all children will receive a dietary intervention.
Read the detailed description
Up to 1050 children aged 15 months to 6.99 years, and older children if in 1st grade elementary school, in 8-12 villages in the Oio and Cachau regions of Guinea-Bissau will be recruited for this study along with their maternal caregiver and father. Child ages will be based on the official birth records which families possess. The mothers/primary caregivers and fathers of the children will also be recruited for simple outcome assessments. Villages will be a convenience sample chosen from villages within the network of our local research partner International Partnership for Human Development. Each village in this region has one school and one community health center per village, which will be involved in supplement distribution and some outcome assessments.
Families with enrolling children will be randomized within 8-12 villages to receive 1 of 3 supplements and if any family (defined based on the father of the children since this is a polygamous community) has more than one enrolling child all those children will be randomized to the same supplement arm.
- One supplement will be the locally-prepared bar
- One will be an isocaloric amount of porridge prepared with USAIDs Corn Soy Blend Plus, prepared as recommended in a 10:3 ratio with fortified vegetable oil.
- One supplement will be an isocaloric amount of cooked rice with vegetable oil, which is the typical local breakfast.
Villagers will be informed of the randomization after baseline testing is complete.
Following baseline measurements in children of anthropometry and body composition, grip strength, cognition, hemoglobin, and skin carotenoids, children will receive their intervention for 24-30 weeks and the same measurements taken at baseline will be repeated during the last study week. The flexible end data is given to accommodate the local rainy season and its impact on transportation. Please note that cell phone access to villages is not influenced by local weather, thus communication regarding safety issues with community health workers will remain possible throughout the entire trial.
Addendum: The pre-planned primary method of analysis was a per-protocol analysis, predefined as children consuming ≥75% of their supplement. However, a clerical error in this clinical trial registration did not describe this predetermined focus on a per-protocol population. The registration implies an intention-to-treat (ITT) analysis by default. Investigators therefore revised our analytical approach to designate the ITT cohort as the primary cohort of interest. The secondary cohort of interest is the predefined per-protocol cohort (children consuming ≥75% of their supplement).
- Conditions
- Malnutrition, Child, Cognitive Function
- Being tested
- Locally-prepared bar, USAID Corn Soy Blend Plus, Placebo
- 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.
Locally-prepared barDietary supplement
School children in first grade will receive their supplement 5 days a week in the morning before school starts. Younger children will receive the supplement 5 days a week in the morning at the community health center, distributed by community health workers. The teachers and community health workers will record amount of supplement consumption daily during the study, and will report the information weekly to the local research team throughout the intervention period.
USAID Corn Soy Blend PlusDietary supplement
School children in first grade will receive their supplement 5 days a week in the morning before school starts. Younger children will receive the supplement 5 days a week in the morning at the community health center, distributed by community health workers. The teachers and community health workers will record amount of supplement consumption daily during the study, and will report the information weekly to the local research team throughout the intervention period.
PlaceboOther
Also called Locally-purchased rice
School children in first grade will receive their supplement 5 days a week in the morning before school starts. Younger children will receive the supplement 5 days a week in the morning at the community health center, distributed by community health workers. The teachers and community health workers will record amount of supplement consumption daily during the study, and will report the information weekly to the local research team throughout the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Locally-prepared bar | Experimental | The bar is similar to one tested recently in a pilot study and is a locally prepared bar designed to facilitate growth and cognitive development. It will provide 300 kcal/day and will have ≈20-30% of energy from protein (of which 25-50% is from an animal protein source), 20-35% from total carbohydrate and ≈40-60% from fat. The bar will be fortified with vitamins and minerals to meet USAID recommendations for moderate malnutrition and Dietary Reference Intake recommendations for at-risk and healthy children of the ages studied, and at the same time will not exceed Upper Level nutrient recommendations for any micronutrient. Ingredients in the bar will be a combination of local products and imported shelf-stable ingredients. Receives: Dietary Supplement: Locally-prepared bar |
| USAID Corn Soy Blend Plus | Active comparator | The usual-intervention condition will be 300 kcal/day of USAID Corn Soy Blend Plus cooked in the usual manner with fortified vegetable oil (10:3 ratio) and sugar. The community health workers or other designated villagers will prepare the supplement freshly each intervention day using locally accepted standards for hygiene, and a quality control process for ratios of ingredients assigned by the research team to ensure consistent composition. Receives: Dietary Supplement: USAID Corn Soy Blend Plus |
| Locally-purchased rice | Placebo comparator | The placebo condition will be 300 kcal/day of locally-purchased rice cooked with a small amount of oil (10:2 ratio), which mimics the usual breakfast of children in this region. The community health workers or other designated villagers will prepare the rice freshly each intervention day using locally accepted standards for hygiene, and a quality control process for ratios of ingredients assigned by the research team to ensure consistent composition. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive function measured using executive functions tasks in children ages 15 months to 3 years
Measured: baseline and 24-30 weeks after baseline testing
Secondary outcomes (8)
Hemoglobin
Measured: baseline and 24-30 weeks after baseline testing
Changes in z-scores for weight (WAZ)
Measured: baseline and 24-30 weeks after baseline testing
Changes in z-scores for height (HAZ)
Measured: baseline and 24-30 weeks after baseline testing
Cognitive tests for children >3 years old
Looking to see changes in executive function who attend supplement distribution at least 75% of the days it is offered.
Measured: baseline and 24-30 weeks after baseline testing
Mid-upper arm circumference
Measured: baseline and 24-30 weeks after baseline testing
Cerebral blood flow
By infrared spectroscopy
Measured: baseline and 24-30 weeks after baseline testing
% Lean tissue and lean growth
Measured: baseline and 24-30 weeks after baseline testing
Changes in weight for height Z scores
Measured: baseline and 24-30 weeks after baseline testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startJan 2017
- Primary completion31 Dec 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Malnutrition, ChildStudies 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
- Masking
- None (open label)
- Enrolment
- 1,059 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Global Food & Nutrition Inc.
- Responsible party
- Sponsor
- Investigators
- Susan B Roberts, PHD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017209
- Sponsor's protocol ID
- 12356
- Status last verified
- May 2019
- First submitted
- 17 Dec 2016
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Roberts SB, Franceschini MA, Silver RE, Taylor SF, de Sa AB, Co R, Sonco A, Krauss A, Taetzsch A, Webb P, Das SK, Chen CY, Rogers BL, Saltzman E, Lin PY, Schlossman N, Pruzensky W, Bale C, Chui KKH, Muentener P. Effects of food supplementation on cognitive function, cerebral blood flow, and nutritional status in young children at risk of undernutrition: randomized controlled trial. BMJ. 2020 Jul 22;370:m2397. doi: 10.1136/bmj.m2397.
PubMed 32699176Roberts SB, Franceschini MA, Krauss A, Lin PY, de Sa AB, Co R, Taylor S, Brown C, Chen O, Johnson EJ, Pruzensky W, Schlossman N, Bale C, Wu KT, Hagan K, Saltzman E, Muentener P. A Pilot Randomized Controlled Trial of a New Supplementary Food Designed to Enhance Cognitive Performance during Prevention and Treatment of Malnutrition in Childhood. Curr Dev Nutr. 2017 Nov;1(11):e000885. doi: 10.3945/cdn.117.000885. Epub 2017 Oct 12.
PubMed 29658962
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on a Locally Prepared Food Supplement to Support Growth and Brain Health
- ClinicalTrials.gov ID
- NCT03017209
- Acronym / sponsor ID
- 12356
- Conditions
- Malnutrition, Child, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,059 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Global Food & Nutrition Inc.
- Study start
- Jan 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 11 Jan 2017 (estimated)
- 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.
This study is a randomized controlled trial with a main goal to assess the effects of a locally-prepared food for prevention of malnutrition and stunting, in comparison with standard village practices and also a widely available aid food supplement in 8-12 villages in Guinea-Bissau. The supplement intervention will be for 24-30 weeks. The primary outcome will be cognitive tests of executive function. Secondary outcomes will be changes in standard anthropometric benchmarks of growth, hemoglobin and skin carotenoids in young children living in villages in rural Guinea-Bissau. This is a within-village randomization at the level of the family, and all children will receive a dietary intervention.
Detailed description
Up to 1050 children aged 15 months to 6.99 years, and older children if in 1st grade elementary school, in 8-12 villages in the Oio and Cachau regions of Guinea-Bissau will be recruited for this study along with their maternal caregiver and father. Child ages will be based on the official birth records which families possess. The mothers/primary caregivers and fathers of the children will also be recruited for simple outcome assessments. Villages will be a convenience sample chosen from villages within the network of our local research partner International Partnership for Human Development. Each village in this region has one school and one community health center per village, which will be involved in supplement distribution and some outcome assessments.
Families with enrolling children will be randomized within 8-12 villages to receive 1 of 3 supplements and if any family (defined based on the father of the children since this is a polygamous community) has more than one enrolling child all those children will be randomized to the same supplement arm.
- One supplement will be the locally-prepared bar
- One will be an isocaloric amount of porridge prepared with USAIDs Corn Soy Blend Plus, prepared as recommended in a 10:3 ratio with fortified vegetable oil.
- One supplement will be an isocaloric amount of cooked rice with vegetable oil, which is the typical local breakfast.
Villagers will be informed of the randomization after baseline testing is complete.
Following baseline measurements in children of anthropometry and body composition, grip strength, cognition, hemoglobin, and skin carotenoids, children will receive their intervention for 24-30 weeks and the same measurements taken at baseline will be repeated during the last study week. The flexible end data is given to accommodate the local rainy season and its impact on transportation. Please note that cell phone access to villages is not influenced by local weather, thus communication regarding safety issues with community health workers will remain possible throughout the entire trial.
Addendum: The pre-planned primary method of analysis was a per-protocol analysis, predefined as children consuming ≥75% of their supplement. However, a clerical error in this clinical trial registration did not describe this predetermined focus on a per-protocol population. The registration implies an intention-to-treat (ITT) analysis by default. Investigators therefore revised our analytical approach to designate the ITT cohort as the primary cohort of interest. The secondary cohort of interest is the predefined per-protocol cohort (children consuming ≥75% of their supplement).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Locally-prepared bar | Experimental | Dietary Supplement: Locally-prepared barThe bar is similar to one tested recently in a pilot study and is a locally prepared bar designed to facilitate growth and cognitive development. It will provide 300 kcal/day and will have ≈20-30% of energy from protein (of which 25-50% is from an animal protein source), 20-35% from total carbohydrate and ≈40-60% from fat. The bar will be fortified with vitamins and minerals to meet USAID recommendations for moderate malnutrition and Dietary Reference Intake recommendations for at-risk and healthy children of the ages studied, and at the same time will not exceed Upper Level nutrient recommendations for any micronutrient. Ingredients in the bar will be a combination of local products and imported shelf-stable ingredients. |
| USAID Corn Soy Blend Plus | Active comparator | Dietary Supplement: USAID Corn Soy Blend PlusThe usual-intervention condition will be 300 kcal/day of USAID Corn Soy Blend Plus cooked in the usual manner with fortified vegetable oil (10:3 ratio) and sugar. The community health workers or other designated villagers will prepare the supplement freshly each intervention day using locally accepted standards for hygiene, and a quality control process for ratios of ingredients assigned by the research team to ensure consistent composition. |
| Locally-purchased rice | Placebo comparator | Other: PlaceboThe placebo condition will be 300 kcal/day of locally-purchased rice cooked with a small amount of oil (10:2 ratio), which mimics the usual breakfast of children in this region. The community health workers or other designated villagers will prepare the rice freshly each intervention day using locally accepted standards for hygiene, and a quality control process for ratios of ingredients assigned by the research team to ensure consistent composition. |
Who may qualify
- Ages
- 15 months to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Parent or legal guardian provides consent for all children <7 years and the parent plus the child provide consent for any child > 7 years.
- Age 15 months to 6.99 years old or any age enrolled in first grade in the same village.
- The family plans to remain in the village for the duration of the study (up to 30 weeks) based on self-report by a parent;
- The child does not have any known food allergies as reported by the mother or guardian.
- Exclusion Criteria: If any child is identified as malnourished at baseline, defined as a mid-upper arm circumference in the red zone of the paper tape, the child will be excluded from the study due to malnutrition, and the parents will be advised to take the child to the nearest malnutrition clinic.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Locally-prepared barSchool children in first grade will receive their supplement 5 days a week in the morning before school starts. Younger children will receive the supplement 5 days a week in the morning at the community health center, distributed by community health workers. The teachers and community health workers will record amount of supplement consumption daily during the study, and will report the information weekly to the local research team throughout the intervention period. | Dietary supplement | Locally-prepared bar |
| USAID Corn Soy Blend PlusSchool children in first grade will receive their supplement 5 days a week in the morning before school starts. Younger children will receive the supplement 5 days a week in the morning at the community health center, distributed by community health workers. The teachers and community health workers will record amount of supplement consumption daily during the study, and will report the information weekly to the local research team throughout the intervention period. | Dietary supplement | USAID Corn Soy Blend Plus |
| PlaceboAlso: Locally-purchased riceSchool children in first grade will receive their supplement 5 days a week in the morning before school starts. Younger children will receive the supplement 5 days a week in the morning at the community health center, distributed by community health workers. The teachers and community health workers will record amount of supplement consumption daily during the study, and will report the information weekly to the local research team throughout the intervention period. | Other | Locally-purchased rice |
Primary outcome
Change in cognitive function measured using executive functions tasks in children ages 15 months to 3 years
Time frame: baseline and 24-30 weeks after baseline testing
8 secondary outcomes
Hemoglobin
Time frame: baseline and 24-30 weeks after baseline testing
Changes in z-scores for weight (WAZ)
Time frame: baseline and 24-30 weeks after baseline testing
Changes in z-scores for height (HAZ)
Time frame: baseline and 24-30 weeks after baseline testing
Cognitive tests for children >3 years old
Time frame: baseline and 24-30 weeks after baseline testing
Mid-upper arm circumference
Time frame: baseline and 24-30 weeks after baseline testing
Cerebral blood flow
Time frame: baseline and 24-30 weeks after baseline testing
% Lean tissue and lean growth
Time frame: baseline and 24-30 weeks after baseline testing
Changes in weight for height Z scores
Time frame: baseline and 24-30 weeks after baseline testing
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 10 May 2019.
- Derived from this study: PubMed 32699176Roberts SB, Franceschini MA, Silver RE, Taylor SF, de Sa AB, Co R, Sonco A, Krauss A, Taetzsch A, Webb P, Das SK, Chen CY, Rogers BL, Saltzman E, Lin PY, Schlossman N, Pruzensky W, Bale C, Chui KKH, Muentener P. Effects of food supplementation on cognitive function, cerebral blood flow, and nutritional status in young children at risk of undernutrition: randomized controlled trial. BMJ. 2020 Jul 22;370:m2397. doi: 10.1136/bmj.m2397.
- Derived from this study: PubMed 29658962Roberts SB, Franceschini MA, Krauss A, Lin PY, de Sa AB, Co R, Taylor S, Brown C, Chen O, Johnson EJ, Pruzensky W, Schlossman N, Bale C, Wu KT, Hagan K, Saltzman E, Muentener P. A Pilot Randomized Controlled Trial of a New Supplementary Food Designed to Enhance Cognitive Performance during Prevention and Treatment of Malnutrition in Childhood. Curr Dev Nutr. 2017 Nov;1(11):e000885. doi: 10.3945/cdn.117.000885. Epub 2017 Oct 12.
- Individual participant dataSharing planned: No
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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.
Susan B Roberts, PHD principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Locally-prepared bar and USAID Corn Soy Blend Plus in people with Malnutrition, Child and Cognitive Function, run by Tufts University at 1 site in Guinea-Bissau.
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 5 inclusion and 0 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 10 May 2019. 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 Guinea-Bissau. 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. Some participants in this study may receive a placebo. 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 in cognitive function measured using executive functions tasks in children ages 15 months to 3 years (time frame: baseline and 24-30 weeks after baseline testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03017209, which also lists 2 linked publications.
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 10 May 2019.