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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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07722195
Enrollment
144
Registered
2026-07-23
Start date
2025-06-01
Completion date
2026-04-01
Last updated
2026-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Insecurity, Nutrition Assessment

Brief summary

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).

Interventions

BEHAVIORALTailored 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

BEHAVIORALStandard Nutrition Education Group

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

Sponsors

Kasr El Aini Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
5 Years to 11 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in household food security statusBaseline and 12 weeksMeasured 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.
Change in pediatric anthropometric growth metricsBaseline and 12 weeksEvaluated 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 24, 2026