Effect of Tailored Nutrition Plan Intervention on Children in Food Insecure Households.

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).

Study Overview

• Status: Completed
• Conditions: Food Insecurity; Nutrition Assessment
• Intervention / Treatment: Behavioral: Tailored Nutritional Counseling; Behavioral: Standard Nutrition Education Group

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Egyptian children aging 4 to 11 years.
2. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Tailored Nutritional Counseling; Includes individualizing meal times, implementing budget-friendly local food substitutions (e.g., local beans/lentils), and teaching simple cooking methods to preserve dietary nutrients
Experimental: Standard Nutrition Education Group; Households assigned to this arm follow standard, generalized healthy dietary guidelines.	Behavioral: Standard Nutrition Education Group; Households assigned to this arm follow standard, generalized healthy dietary guidelines includes food guide pyramid and how to apply.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in household food security status	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.	Baseline and 12 weeks
Change in pediatric anthropometric growth metrics	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.	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Publications and helpful links

General Publications

• 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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Actual): January 1, 2026
• Study Completion (Actual): April 1, 2026

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 18, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 18, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MD-184-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No