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OpenTrials
Completed

NCT Number: NCT07722195

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

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).

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Key information

Age range

5 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University Faculty of medicine

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Egyptian children aging 4 to 11 years.
  • With food insecurity according to the Arab Family Food security scale..

Exclusion criteria

  • Children with chronic diseases: Diabetes mellitus, hypertension, asthma cardiac disease malabsorption syndrome, renal diseases &liver diseases

Treatment and study plan

Tailored Nutritional Counseling

Behavioral

Includes individualizing meal times, implementing budget-friendly local food substitutions (e.g., local beans/lentils), and teaching simple cooking methods to preserve dietary nutrients

Standard Nutrition Education Group

Behavioral

Households assigned to this arm follow standard, generalized healthy dietary guidelines includes food guide pyramid and how to apply.

Primary outcomes

  1. Change in household food security status

    Time frame: 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.

  2. Change in pediatric anthropometric growth metrics

    Time frame: Baseline and 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

Effect of Tailored Nutrition Plan Intervention on Children in Food Insecure Households: A Randomized Controlled Trial.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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