Pilot Study on a Locally Prepared Food Supplement to Support Growth and Brain Health
| Status: | Completed |
|---|---|
| Conditions: | Food Studies |
| Therapuetic Areas: | Pharmacology / Toxicology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/26/2017 |
| Start Date: | March 2016 |
| End Date: | July 2016 |
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.
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.
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.
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.
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
We found this trial at
1
site
Boston, Massachusetts 02111
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