Clinical trial NCT03017209: Locally Prepared Supplement to Support Growth and Brain Health
Official title: Study on a Locally Prepared Food Supplement to Support Growth and Brain Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition, Child
Cognitive Function
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Global Food & Nutrition Inc.
First posted: 2017-01-11
Enrollment: 1059
Sex: ALL
Minimum age (years): 15
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

* 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.

Primary outcomes:
measure: Change in cognitive function measured using executive functions tasks in children ages 15 months to 3 years
timeFrame: baseline and 24-30 weeks after baseline testing
Secondary outcomes:
measure: Hemoglobin
timeFrame: baseline and 24-30 weeks after baseline testing
measure: Changes in z-scores for weight (WAZ)
timeFrame: baseline and 24-30 weeks after baseline testing
measure: Changes in z-scores for height (HAZ)
timeFrame: baseline and 24-30 weeks after baseline testing
measure: Cognitive tests for children >3 years old
timeFrame: baseline and 24-30 weeks after baseline testing
measure: Mid-upper arm circumference
timeFrame: baseline and 24-30 weeks after baseline testing
measure: Cerebral blood flow
timeFrame: baseline and 24-30 weeks after baseline testing
measure: % Lean tissue and lean growth
timeFrame: baseline and 24-30 weeks after baseline testing
measure: Changes in weight for height Z scores
timeFrame: baseline and 24-30 weeks after baseline testing
Other outcomes:
measure: Carotenoids
timeFrame: baseline and 24-30 weeks after baseline testing
measure: Grip strength
timeFrame: baseline and 24-30 weeks after baseline testing
measure: Weight of female-caregivers and fathers
timeFrame: baseline and 24-30 weeks after baseline testing
measure: Head circumference of child
timeFrame: baseline and 24-30 weeks after baseline testing
measure: Height of female-caregivers and fathers
timeFrame: baseline and 24-30 weeks after baseline testing
measure: Mid upper arm circumference of female caregivers
timeFrame: baseline and 24-30 weeks after baseline testing
Locations:
city: Bissau
country: Guinea-Bissau
facility: International Partnership for Health Development
Study officials:
affiliation: Tufts University
name: Susan B Roberts, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Roberts 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.