NCT07783646

Brief Summary

The goal of this intervention study is to learn whether providing nutritional supplement packs can reduce hunger at school and improve healthy eating behaviors and classroom concentration among students in grades 3-9 attending schools in remote rural areas. The main questions it aims to answer are: Does receiving nutritional supplement packs reduce hunger at school and improve healthy eating behaviors and classroom concentration after one semester and one school year compared with baseline? Is hunger at school associated with healthy eating behaviors and classroom concentration?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Sep 2025Aug 2028

Study Start

First participant enrolled

September 2, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

3 years

First QC Date

August 21, 2026

Last Update Submit

August 21, 2026

Conditions

Classroom ConcentrationDietary DiversityHunger

Keywords

Nutritional supplement packagesFood securityEating behaviorCognitive performance

Outcome Measures

Primary Outcomes (1)

  • Change in Classroom Concentration Score

    Concentration will be assessed using the Classroom concentration scale. The total score ranges from 19 to 114, with higher scores indicating better classroom concentration. Changes from baseline will be assessed after one semester and one school year.

    Baseline, after one semester, and after one school year

Secondary Outcomes (1)

  • Dietary diversity

    Baseline, after one semester, and after one school year

Study Arms (1)

Nutritional Supplement Pack Group

EXPERIMENTAL

Participants will receive nutritional supplement packs for consumption when they feel hungry at school. Outcomes will be assessed at baseline, after one semester, and after one school year.

Dietary Supplement: Nutritional Supplement Pack

Interventions

Nutritional Supplement PackDIETARY_SUPPLEMENT

Nutritional supplement packs containing shelf-stable milk, cereals, and nuts are provided to participating students for consumption when they feel hungry at school. The intervention is implemented over one school year.

Nutritional Supplement Pack Group

Eligibility Criteria

Age9 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Students in grades 3-9 who are eligible to receive nutritional supplement packs

You may not qualify if:

  • Students who do not provide assent or whose parent or legal guardian does not provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Danan Elementary School

Chiayi City, 603003, Taiwan

COMPLETED

Wengang Elementary School

Chiayi City, 614006, Taiwan

RECRUITING

Yufeng Elementary School

Hsinchu, 313209, Taiwan

COMPLETED

Yudong Junior High School

Hualien City, 981008, Taiwan

COMPLETED

Xuetian Elementary School

Hualien City, 983002, Taiwan

COMPLETED

Dongli Junior High School

Hualien City, 983004, Taiwan

RECRUITING

Duona Elementary School

Kaohsiung City, 851001, Taiwan

COMPLETED

Danlu Elementary School

Pingtung City, 943012, Taiwan

RECRUITING

Pingdeng Elementary School

Taichung, 424123, Taiwan

COMPLETED

Iraraley Elementary School

Taitung, 952304, Taiwan

COMPLETED

Wuling Elementary School

Taitung, 953002, Taiwan

COMPLETED

Daxi Junior High School

Taoyuan, 335013, Taiwan

RECRUITING

Makuang Junior High School

Yuanlin, 633103, Taiwan

RECRUITING

Sinsheng Elementary School

Yuanlin, 655026, Taiwan

RECRUITING

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Central Study Contacts

Ichen Huang, PhD

CONTACT

+886-4-22063366yichenhuang@mail.cmu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2026

First Posted

August 25, 2026

Study Start

September 2, 2025

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

August 25, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Due to the personal privacy issue

Locations

TW(14)