Effect of Tailored Nutrition Plan Intervention on Children in Food Insecure Households.
18. juli 2026 opdateret af: Somaia Nasser Abdelmoneim, Kasr El Aini Hospital
Effect of Tailored Nutrition Plan Intervention on Children in Food Insecure Households: A Randomized Controlled Trial.
The goal of this clinical trial is to evaluate the effectiveness of an individualized dietary intervention in reducing household food insecurity levels and improving growth metrics in Egyptian children aged 5 to 11 years from food-insecure households, excluding those with severe chronic illnesses.
The main questions it aims to answer are: Does a 12-week tailored nutrition plan significantly lower household food insecurity levels compared to general nutrition education?
Does the tailored nutritional intervention significantly improve the anthropometric growth measures (weight, height, and BMI) and hemoglobin levels of these children?
Researchers will compare the intervention group receiving a resource-conscious, tailored nutritional plan to a control group receiving generalized healthy dietary education to see if individualized counseling provides superior protection against severe food insecurity and better promotes linear growth and anemia recovery.
Participants will undergo three primary clinic sessions across a 12-week study period: Complete baseline assessments during Session 1, including socioeconomic surveys, the Arab Family Food Security Scale (AFFS), anthropometric measurements, and venous hemoglobin blood draws.
Follow either an individualized tailored nutrition plan (focusing on structured meal times and local, budget-friendly substitutions like beans or lentils) or a standard general nutrition education model using visual aids.
Attend a final 12-week follow-up session to engage in collaborative healthy habit activities and repeat all primary outcome assessments (AFFS scoring, physical measurements, and hemoglobin verification).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
144
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Cairo, Egypten
- Cairo University Faculty of medicine
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Egyptian children aging 4 to 11 years.
- With food insecurity according to the Arab Family Food security scale..
Exclusion Criteria:
1. Children with chronic diseases: Diabetes mellitus, hypertension, asthma cardiac disease malabsorption syndrome, renal diseases &liver diseases
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Tailored Nutritional Plan Group
Households assigned to this arm receive a personalized, family-centered nutritional plan tailored to their specific socioeconomic conditions and the child's daily routine.
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Includes individualizing meal times, implementing budget-friendly local food substitutions (e.g., local beans/lentils), and teaching simple cooking methods to preserve dietary nutrients
|
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Eksperimentel: Standard Nutrition Education Group
Households assigned to this arm follow standard, generalized healthy dietary guidelines.
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Households assigned to this arm follow standard, generalized healthy dietary guidelines includes food guide pyramid and how to apply.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in household food security status
Tidsramme: Baseline and 12 weeks
|
Measured using the Arab Family Food Security Scale.
The scale consists of 7 items, where a score of 3 or more out of 7 indicates household food insecurity.
A score was generated by categorizing the level of household food security as follows; (0-2) food secure, (3-5) moderately food insecure, and (6-7) severely food insecure .The outcome will evaluate the pre- and post-intervention difference in food security status and the percentage of households achieving complete food security.
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Baseline and 12 weeks
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Change in pediatric anthropometric growth metrics
Tidsramme: Baseline and 12 weeks
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Evaluated by measuring the percentage changes in individual child growth parameters, specifically weight (kg), height (cm), and Body Mass Index (BMI, kg/m²), weight and height will be combined to report BMI in kg/m^2 from the initial encounter to the end of the study.
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Baseline and 12 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Abd El-Fatah, N., & Aboelseoud, A. (2023). Progress in Egypt's Sustainable Development Goals from a Public Health Nutrition Perspective. Journal of High Institute of Public Health, 0(0), 99-107. https://doi.org/10.21608/jhiph.2023.286592 Bidira, K., Tamiru, D., & Belachew, T. (2022). Effect of nutritional education on anthropometric deficits among pre-school aged children in south West Ethiopia: quasi-experimental study. Italian Journal of Pediatrics, 48(1), 1-11. https://doi.org/10.1186/s13052-022-01201-0 De Onis, M., Onyango, A. W., Borghi, E., Siyam, A., Nishida, C., & Siekmann, J. (2007). Development of a WHO growth reference for school-aged children and adolescents. Bulletin of the World Health Organization, 85(9), 660-667. https://doi.org/10.2471/BLT.07.043497 Ebadi-Vanestanagh, M., Molani-Gol, R., & Alizadeh, M. (2023). Effects of the nutrition education intervention on food security, anthropometry, and body composition in women: A randomized controlled trial. Nutrition and Health. https://doi.org/10.1177/02601060231155538
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juni 2025
Primær færdiggørelse (Faktiske)
1. januar 2026
Studieafslutning (Faktiske)
1. april 2026
Datoer for studieregistrering
Først indsendt
9. juli 2026
Først indsendt, der opfyldte QC-kriterier
18. juli 2026
Først opslået (Faktiske)
23. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- MD-184-2024
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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