Clinical trial NCT03319589: Pilot Study on a Locally Prepared Food Supplement to Support Growth and Brain Health
Official title: Pilot Study on a Locally Prepared Food Supplement to Support Growth and Brain Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: International Partners for Human Development
First posted: 2017-10-24
Enrollment: 80
Sex: ALL
Minimum age (years): 24
Maximum age (years): 84
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized controlled pilot for a future larger trial. The goals of this pilot are: a) to assess feasibility of delivering a locally prepared supplement in rural communities, and b) to generate pilot data for sample size estimates needed for a larger trial. The study will test the effect of a supplement prepared locally with local and imported ingredients on changes in standard anthropometric benchmarks of growth, cognition, immune function, hemoglobin and skin carotenoids in young children living in 2 villages in rural Guinea-Bissau. Children in the active intervention village will be compared with assessment-only controls in a separate village having comparable demographic characteristics. As part of the study, we will assess the feasibility of having local commercial bakers prepare the supplement.

Detailed description: Up to 20 children aged 24-30 months and 20 school children aged 6-6.5 years living in each of 2 villages in the Oio region of Guinea-Bissau (total study population up to 80, with no minimum recruitment number) will be recruited for this study, with ages documented by the official birth record, which all families possess. 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. The villages will be broadly comparable in terms of size, affluence, rates of malnutrition, the presence or absence of a school meal program, and tribal affiliation and religion.

One village will be randomly assigned to receive the locally-prepared biscuit and a daily multivitamin and the other will be randomly assigned to be an assessment-only control site. Because this is a pilot study designed to develop methodology for a future powered trial, and the logistics of local supplement preparation need to be developed in advance of the study, the randomization will occur prior to baseline testing to allow for development of infrastructure for supplement preparation. However the villagers will not be informed of the randomization until after baseline testing is complete.

Following baseline measurements of anthropometry, grip strength, cognition, non-invasive measurements of hemoglobin, and skin carotenoids, participants will receive their intervention for 12 weeks and the same measurements taken at baseline will be repeated during the last study week. Since access for the final assessment to villages may be hampered by the rainy season we also request permission to terminate the trial between 9-12 weeks of supplement consumption depending on weather conditions. 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.

Eligibility criteria: Inclusion Criteria:

* Non-malnourished children within the 2 villages chosen for study
* Within the specified age range: 24-36 months for young children and 6-7 years for older children, who will also be enrolled in their local school. In the event that researchers cannot enroll at least 15 participants in each age range in each village, will extend the age range up to 35.99 months for young children and up to 6.99 years for older children.
* The family plans to remain in the village for the duration of the study;
* 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 or a weight-for-age or height-for-age z-score of less than or equal to -3.0, 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 executive cognitive function
timeFrame: Baseline and end line (12 weeks difference)
Secondary outcomes:
measure: Supplementation Attendance
timeFrame: Through study completion (12 weeks)
measure: Sicknesses
timeFrame: Through study completion (12 weeks)
measure: Change in hand grip strength
timeFrame: Baseline and end line (12 weeks difference)
measure: Change in Hemoglobin
timeFrame: Baseline and end line (12 weeks difference)
measure: Change in skin carotenoids
timeFrame: Baseline and end line (12 weeks difference)
measure: Change in immune function
timeFrame: Baseline and end line (12 weeks difference)
measure: Food Product Acceptability
timeFrame: Baseline
measure: Mother's Height Change
timeFrame: Baseline and end line (12 weeks difference)
measure: Mother's Weight Change
timeFrame: Baseline and end line (12 weeks difference)
measure: Mother's MUAC change
timeFrame: Baseline and end line (12 weeks difference)
measure: Family Demographics Change
timeFrame: Baseline and end line (12 weeks difference)
measure: Photographs
timeFrame: through study completion, 12 weeks
measure: Change in weight
timeFrame: Baseline and end line (12 weeks difference)
measure: Change in height
timeFrame: Baseline and end line (12 weeks difference)
measure: Change in circumferences
timeFrame: Baseline and end line (12 weeks difference)
measure: Brain Hemoglobin
timeFrame: Endline at up to 12 weeks
measure: Brain Oxygenation
timeFrame: Endline at up to 12 weeks
measure: Brain Blood Flow
timeFrame: Endline at up to 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
state: Massachusetts
Study officials:
References: