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Pilot Study on a Locally Prepared Food Supplement to Support Growth and Brain Health

19. Oktober 2017 aktualisiert von: Tufts University
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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

80

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten, 02111
        • Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

2 Jahre bis 7 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Nahrungsergänzungsmittel: Supplement
locally prepared biscuit with low sugar content (less than 10% weight) designed to facilitate growth and cognitive development
Kein Eingriff: Control Arm
Children in the active intervention village will be compared with assessment-only controls in a separate village having comparable demographic characteristics

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in executive cognitive function
Zeitfenster: Baseline and end line (12 weeks difference)
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.
Baseline and end line (12 weeks difference)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Supplementation Attendance
Zeitfenster: Through study completion (12 weeks)
community health workers will record attendance of children to consume the supplement.
Through study completion (12 weeks)
Sicknesses
Zeitfenster: Through study completion (12 weeks)
Community health workers will record sickness (malaria, stomach issues, fever) if children to consume the supplement are unwell.
Through study completion (12 weeks)
Change in hand grip strength
Zeitfenster: Baseline and end line (12 weeks difference)
. 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
Baseline and end line (12 weeks difference)
Change in Hemoglobin
Zeitfenster: Baseline and end line (12 weeks difference)
Hemoglobin will be measured non-invasively using a standard technique that uses light of different wavelengths directed at the finger
Baseline and end line (12 weeks difference)
Change in skin carotenoids
Zeitfenster: Baseline and end line (12 weeks difference)
a non-invasive optical measure of carotenoids in tissue, measured by shining light in the palm of the hand
Baseline and end line (12 weeks difference)
Change in immune function
Zeitfenster: Baseline and end line (12 weeks difference)
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
Baseline and end line (12 weeks difference)
Food Product Acceptability
Zeitfenster: Baseline
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.
Baseline
Mother's Height Change
Zeitfenster: Baseline and end line (12 weeks difference)
Height of the mothers measured in cm.
Baseline and end line (12 weeks difference)
Mother's Weight Change
Zeitfenster: Baseline and end line (12 weeks difference)
Weight of the mothers measured in kg.
Baseline and end line (12 weeks difference)
Mother's MUAC change
Zeitfenster: Baseline and end line (12 weeks difference)
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.
Baseline and end line (12 weeks difference)
Family Demographics Change
Zeitfenster: Baseline and end line (12 weeks difference)
Family demographic data (family size, number of wives and children and ages) will be collected by questioning the mother.
Baseline and end line (12 weeks difference)
Photographs
Zeitfenster: through study completion, 12 weeks
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.
through study completion, 12 weeks
Change in weight
Zeitfenster: Baseline and end line (12 weeks difference)
Multiple measurements of weight to ±0.1 kg will be taken using a calibrated digital scale
Baseline and end line (12 weeks difference)
Change in height
Zeitfenster: Baseline and end line (12 weeks difference)
Duplicate measures of height will be made with an upright stadiometer measuring to 0.1 cm
Baseline and end line (12 weeks difference)
Change in circumferences
Zeitfenster: Baseline and end line (12 weeks difference)
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.
Baseline and end line (12 weeks difference)
Brain Hemoglobin
Zeitfenster: Endline at up to 12 weeks
Near infrared spectroscopy
Endline at up to 12 weeks
Brain Oxygenation
Zeitfenster: Endline at up to 12 weeks
Near infrared spectroscopy
Endline at up to 12 weeks
Brain Blood Flow
Zeitfenster: Endline at up to 12 weeks
Near infrared spectroscopy
Endline at up to 12 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Tufts University

Mitarbeiter

International Partners for Human Development

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. März 2016

Primärer Abschluss (Tatsächlich)

1. Juni 2016

Studienabschluss (Tatsächlich)

1. Juli 2016

Studienanmeldedaten

Zuerst eingereicht

11. März 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. Oktober 2017

Zuerst gepostet (Tatsächlich)

24. Oktober 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. Oktober 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

19. Oktober 2017

Zuletzt verifiziert

1. Oktober 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 1200

Plan für individuelle Teilnehmerdaten (IPD)

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