Healthy School mEAls With Less Salt：an Action to Reduce Salt Intake in School Meals for Children in Rural China

NCT06097884 | Unknown DMC

• 1 other identifier: 2023157
• Study Type: interventional
• Target: 16,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to assess the impact of the HEALS-Child action project on children's health in rural China. The goal of the project is to evaluate the effectiveness, feasibility, safety and cost-effectiveness of two salt reduction strategies: replacing usual salt with salt substitute in school meals, and replacing bowls with trays in school cafeteria. The study has two parts: the main study evaluates the salt substitute intervention, and the ancillary study evaluates the tray intervention. In the main study, over 16000 students from around 320 elementary or junior high school in rural China will be cluster-randomized into the two groups: 1. Salt substitute 2.usual salt. The primary outcome in the main study will be the change in systolic blood pressure. In the ancillary study, over 500 students from 10 elementary or junior high school will be cluster-randomized into the two groups: 1. meal trays 2.bowls. The primary outcome in the ancillary study will be the change in spot urine sodium. The interventions will last over 1 years. To evaluate the impact of interventions, 50 students were randomly selected from each school.

Conditions

Blood Pressure

Keywords

Salt reduction

Outcome Measures

Primary Outcomes (2)

• Primary outcome for the main study-Systolic blood pressure

  The change in systolic blood pressure from baseline to follow-up

  10-month

• Primary outcome for the ancillary study-Spot urinary sodium

  The change in spot urinary sodium from baseline to follow-up

  10-month

Secondary Outcomes (6)

• Secondary outcome for the main study-Incidence of hypertension

  10-month

• Secondary outcome for the main study-Spot urinary sodium

  10-month

• Secondary outcome for the main study-Spot urinary potassium

  10-month

• Secondary outcome for the main study-Diastolic blood pressure

  10-month

• Secondary outcome for the main study-ICER

  10-month

Study Arms (4)

Main study intervention- Salt substitute

EXPERIMENTAL

Replacing usual salt with salt substitute in school meals

Other: Main study intervention-Salt substitute

Main study control- Usual salt

PLACEBO COMPARATOR

Using usual salt in school meals

Other: Main study control-Usual salt

Ancillary study intervention- Meal tray

EXPERIMENTAL

Replacing bowls with trays in school cafeteria

Other: Ancillary study intervention-Meal trays

Ancillary study control- Bowl

PLACEBO COMPARATOR

Using bowls in school cafeteria

Other: Ancillary study control-Bowls

Interventions

Main study intervention-Salt substitute OTHER

replacing regular salt with salt substitute in school meals

Main study intervention- Salt substitute

Main study control-Usual salt OTHER

Use usual salt in school meals

Main study control- Usual salt

Ancillary study intervention-Meal trays OTHER

Replacing bowls with trays in school cafeteria

Ancillary study intervention- Meal tray

Ancillary study control-Bowls OTHER

Use bowls in school cafeteria

Ancillary study control- Bowl

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Attend school stably in this academic year, and expect to take no more than one month of leave for the whole academic year； Have lunch at school at least three times a week.

You may not qualify if:

• Unable to complete the baseline blood pressure measurement and spot urine collection.

Sponsors & Collaborators

• Peking University: lead
• China development research foundation: collaborator

Study Officials

• Yangfeng Wu, PhD

  Peking University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yifang Yuan, MD

CONTACT

+8617310387323; yyfjulie@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 24, 2023
• Study Start: October 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: October 24, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share