Pilot Study on a Locally Prepared Food Supplement to Support Growth and Brain Health
Przegląd badań
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02111
- Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Supplement Arm
School children (age 6 to 6.5) will receive their supplement 5 days a week in the morning before school starts.
They will either receive the supplement at school or at the community health center depending on the preference of the villagers after recruitment.
Young children (age 24 to 30 months) will receive the supplement 5 days a week in the morning at the community health center, distributed by community health workers.
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locally prepared biscuit with low sugar content (less than 10% weight) designed to facilitate growth and cognitive development
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Brak interwencji: Control Arm
Children in the active intervention village will be compared with assessment-only controls in a separate village having comparable demographic characteristics
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in executive cognitive function
Ramy czasowe: Baseline and end line (12 weeks difference)
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Two measures of executive function, working memory and task-switching abilities, will be administered through play-based games by local research team members.
"Spin the Pots" and "Reverse Categorization" tasks, modeled after Carlson et al., have been age modified and culturally adopted.
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Baseline and end line (12 weeks difference)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Supplementation Attendance
Ramy czasowe: Through study completion (12 weeks)
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community health workers will record attendance of children to consume the supplement.
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Through study completion (12 weeks)
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Sicknesses
Ramy czasowe: Through study completion (12 weeks)
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Community health workers will record sickness (malaria, stomach issues, fever) if children to consume the supplement are unwell.
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Through study completion (12 weeks)
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Change in hand grip strength
Ramy czasowe: Baseline and end line (12 weeks difference)
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. In the children aged 6-6.5 years, grip strength in both hands will be measured in duplicate using a dynamometer suitable for pediatric populations
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Baseline and end line (12 weeks difference)
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Change in Hemoglobin
Ramy czasowe: Baseline and end line (12 weeks difference)
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Hemoglobin will be measured non-invasively using a standard technique that uses light of different wavelengths directed at the finger
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Baseline and end line (12 weeks difference)
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Change in skin carotenoids
Ramy czasowe: Baseline and end line (12 weeks difference)
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a non-invasive optical measure of carotenoids in tissue, measured by shining light in the palm of the hand
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Baseline and end line (12 weeks difference)
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Change in immune function
Ramy czasowe: Baseline and end line (12 weeks difference)
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In this study we will measure delayed-type hypersensitivity (DTH) response using a standard Mantoux test composed of 3 antigens and a negative control via 4 intradermal skin injections that will be performed at baseline and the end of the study
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Baseline and end line (12 weeks difference)
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Food Product Acceptability
Ramy czasowe: Baseline
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Mothers (for the young children) and school children will be asked on a 4-point scale of '1=not at all' '2=a little', '3=moderately' and '4=very much' how much they enjoy eating the two types biscuits and the multivitamin.
Preference for one biscuit over another will be determined by a higher total summed up score.
The biscuit with a greater score will be used during the study.
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Baseline
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Mother's Height Change
Ramy czasowe: Baseline and end line (12 weeks difference)
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Height of the mothers measured in cm.
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Baseline and end line (12 weeks difference)
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Mother's Weight Change
Ramy czasowe: Baseline and end line (12 weeks difference)
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Weight of the mothers measured in kg.
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Baseline and end line (12 weeks difference)
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Mother's MUAC change
Ramy czasowe: Baseline and end line (12 weeks difference)
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The weight, height and MUAC of the mothers will also be measured, and family demographic data (family size, number of wives and children and ages) will be collected by questioning the mother.
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Baseline and end line (12 weeks difference)
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Family Demographics Change
Ramy czasowe: Baseline and end line (12 weeks difference)
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Family demographic data (family size, number of wives and children and ages) will be collected by questioning the mother.
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Baseline and end line (12 weeks difference)
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Photographs
Ramy czasowe: through study completion, 12 weeks
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Parents (and children, in the case of the school children) will be asked for permission to take photographs of them that illustrate the outcome measurements and supplement consumption, for the purpose of using in presentations on the research.
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through study completion, 12 weeks
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Change in weight
Ramy czasowe: Baseline and end line (12 weeks difference)
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Multiple measurements of weight to ±0.1 kg will be taken using a calibrated digital scale
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Baseline and end line (12 weeks difference)
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Change in height
Ramy czasowe: Baseline and end line (12 weeks difference)
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Duplicate measures of height will be made with an upright stadiometer measuring to 0.1 cm
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Baseline and end line (12 weeks difference)
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Change in circumferences
Ramy czasowe: Baseline and end line (12 weeks difference)
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Duplicate measurements of mid-upper arm circumference (MUAC) will be taken at the midpoint between the acromion process of scapula and olecranon process, and head circumference will be measured in duplicate at the widest diameter, using standardized World Health Organization (WHO) methods.
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Baseline and end line (12 weeks difference)
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Brain Hemoglobin
Ramy czasowe: Endline at up to 12 weeks
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Near infrared spectroscopy
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Endline at up to 12 weeks
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Brain Oxygenation
Ramy czasowe: Endline at up to 12 weeks
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Near infrared spectroscopy
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Endline at up to 12 weeks
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Brain Blood Flow
Ramy czasowe: Endline at up to 12 weeks
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Near infrared spectroscopy
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Endline at up to 12 weeks
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Współpracownicy i badacze
Sponsor
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 1200
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
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