跳至主要内容
临床试验/CTRI/2025/08/093763
CTRI/2025/08/093763尚未招募不适用

Effectiveness of Health Education module versus Food Label Training in Reducing pre-school childrens’ Sugar and Salt Intake: A Randomized Controlled Trial

Kasturba Medical College Mangalore1 个研究点 分布在 1 个国家目标入组 375 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
375
试验地点
1
主要终点
Reduction in the consumption of sugar the diet of children,

研究概览

简要总结

Excessive consumption of added sugars and salt among children significantly contributes to childhood obesity and related non-communicable diseases (NCDs), including hypertension, insulin resistance, and poor growth. This study aims to evaluate and compare the effectiveness of two interventions—health education alone versus health education combined with food label training—in reducing added sugar and salt intake in preschool children.

The study is an open label randomized controlled trial conducted in urban Anganwadi centers in Mangalore, Karnataka. Mothers of children aged 3–6 years will be the primary participants. The study consists of three arms: (1) Health Education Module, (2) Health Education + Food Label Training, and (3) Control group receiving standard care. A total of 21 Anganwadi centers will be randomly allocated into these groups.

The health education module will focus on the risks of high sugar and salt intake, identifying food sources, and promoting healthier alternatives. The food label training will equip mothers with skills to interpret nutritional labels and make informed food choices for their children. Data on sugar and salt intake will be collected using a culturally adapted Food Frequency Questionnaire (FFQ) at baseline and three months post-intervention.

The primary outcome is a reduction in the consumption of added sugars and salt. Data analysis will be done using SPSS, with ANCOVA used to compare outcomes across groups. The results will help determine the most effective strategy for improving children’s dietary behavior and can guide community-based nutrition interventions. Ethical approval has been obtained, and the study will adhere to all ethical standards, including informed consent and participant confidentiality.

This intervention, if effective, has the potential to be scaled through Anganwadi services to improve child nutrition and reduce long-term NCD risk in vulnerable populations.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
3.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • Mothers of children aged 3-6 years registered in the participating Anganwadi centres, Residency within the Mangalore urban area, Ability to understand and communicate in Kannada or English.

排除标准

  • Mothers who refuse to consent Mothers of children with known medical conditions requiring specific dietary restrictions related to sugar and salt intake Mothers with cognitive impairments or psychiatric illnesses that may affect their ability to understand and participate in the study.

结局指标

主要结局

Reduction in the consumption of sugar the diet of children,

时间窗: Baseline, 3 months after intervention

Reduction in the consumption of salt in the diet of children

时间窗: Baseline, 3 months after intervention

次要结局

未报告次要终点

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Sara J Ommen

Kasturba Medical College Mangalore

研究点 (1)

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