A School-based Education Programme to Reduce Salt Intake in Children and Their Families (School-EduSalt)

December 31, 2022 updated by: Feng J He, Queen Mary University of London

A School-based Education Programme to Reduce Salt Intake in Children and Their Families (School-EduSalt)

The study is to test whether an education programme targeted at school children can lower salt intake in children and their families. In this study, the investigators will educate children on how to reduce salt intake, and the investigators will empower children by asking them to deliver the salt reduction message home to their families, particularly children need to persuade the person who does the cooking for the whole family to cut down on the amount of salt used during food preparations. The study will involve children aged about 11 years, and their parents and grandparents in Northern China.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

832

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanxi
      • Changzhi, Shanxi, China
        • Changzhi Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Children

Inclusion Criteria:

  • All children in Grade 5 of primary schools (age about 11 years) are eligible for the study.

Exclusion Criteria:

  • Children who do not have lunch or dinner at their own home will be excluded.

Adult family members:

Inclusion Criteria:

  • For each participating child, we will recruit two adult family members. All adult family members who share the same meals with the child are eligible for the study.

Exclusion Criteria:

  • If more than two adults in one family agree to take part in the study, we will select two of them (i.e. one male and one female) in the order of grandparents, parents, uncles and aunties.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
No salt awareness education
Other: Control
No salt awareness education
Experimental: Salt reduction
Behavioral: Salt reduction
Salt reduction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-h urinary sodium
Time Frame: 4.5 month
Difference between the intervention and control group in the change in 24-h urinary sodium from baseline to the end of follow-up for children and for adults
4.5 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: 4.5 month
Difference between the intervention and control group in the change in blood pressure from baseline to the end of follow-up for children and for adults.
4.5 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary University of London

Collaborators

Peking University
Changzhi Medical College
The George Institute for Global Health, China

Investigators

  • Principal Investigator: Feng He, PhD, Queen Mary University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

March 21, 2013

First Submitted That Met QC Criteria

March 26, 2013

First Posted (Estimate)

March 29, 2013

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

December 31, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 008602 QM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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