Pilot Study on a Locally Prepared Food Supplement to Support Growth and Brain Health
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Massachusetts
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Boston, Massachusetts, États-Unis, 02111
- Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Aucune intervention: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in executive cognitive function
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Supplementation Attendance
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
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Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1200
Plan pour les données individuelles des participants (IPD)
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