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临床试验/NCT07722195
NCT07722195已完成不适用

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

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2025年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
144
试验地点
1
主要终点
Change in household food security status

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
5 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Change in household food security status

时间窗: 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.

Change in pediatric anthropometric growth metrics

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Somaia Nasser Abdelmoneim

Assistant lecturer of Family medicine

Kasr El Aini Hospital

研究点 (1)

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