Effect of Tailored Nutrition Plan Intervention on Children in Food Insecure Households.
18. juli 2026 oppdatert av: 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).
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
144
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Cairo, Egypt
- Cairo University Faculty of medicine
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in household food security status
Tidsramme: Baseline and 12 weeks
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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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juni 2025
Primær fullføring (Faktiske)
1. januar 2026
Studiet fullført (Faktiske)
1. april 2026
Datoer for studieregistrering
Først innsendt
9. juli 2026
Først innsendt som oppfylte QC-kriteriene
18. juli 2026
Først lagt ut (Faktiske)
23. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
23. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- MD-184-2024
Plan for individuelle deltakerdata (IPD)
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