NCT01821144

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
832

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 29, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

January 10, 2023

Status Verified

December 1, 2022

Enrollment Period

11 months

First QC Date

March 21, 2013

Last Update Submit

December 31, 2022

Conditions

Healthy Volunteer

Keywords

dietary salt24 hour urinary sodiumblood pressure

Outcome Measures

Primary Outcomes (1)

  • 24-h urinary sodium

    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 Outcomes (1)

  • Blood pressure

    4.5 month

Study Arms (2)

Control

OTHER

No salt awareness education

Other: Control

Salt reduction

EXPERIMENTAL

Salt reduction

Behavioral: Salt reduction

Interventions

Salt reductionBEHAVIORAL

Salt reduction

Salt reduction
ControlOTHER

No salt awareness education

Control

Eligibility Criteria

Age9 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changzhi Medical College

Changzhi, Shanxi, China

Location

Related Publications (5)

  • Ma Y, Feng X, Ma J, He FJ, Wang H, Zhang J, Xie W, Wu T, Yin Y, Yuan J, MacGregor GA, Wu Y. Social support, social network and salt-reduction behaviours in children: a substudy of the School-EduSalt trial. BMJ Open. 2019 Jun 14;9(6):e028126. doi: 10.1136/bmjopen-2018-028126.

    PMID: 31203245DERIVED

  • Li X, Jan S, Yan LL, Hayes A, Chu Y, Wang H, Feng X, Niu W, He FJ, Ma J, Han Y, MacGregor GA, Wu Y. Cost and cost-effectiveness of a school-based education program to reduce salt intake in children and their families in China. PLoS One. 2017 Sep 13;12(9):e0183033. doi: 10.1371/journal.pone.0183033. eCollection 2017.

    PMID: 28902880DERIVED

  • He FJ, Ma Y, Feng X, Zhang W, Lin L, Guo X, Zhang J, Niu W, Wu Y, MacGregor GA. Effect of salt reduction on iodine status assessed by 24 hour urinary iodine excretion in children and their families in northern China: a substudy of a cluster randomised controlled trial. BMJ Open. 2016 Sep 26;6(9):e011168. doi: 10.1136/bmjopen-2016-011168.

    PMID: 27670515DERIVED

  • He FJ, Wu Y, Feng XX, Ma J, Ma Y, Wang H, Zhang J, Yuan J, Lin CP, Nowson C, MacGregor GA. School based education programme to reduce salt intake in children and their families (School-EduSalt): cluster randomised controlled trial. BMJ. 2015 Mar 18;350:h770. doi: 10.1136/bmj.h770.

    PMID: 25788018DERIVED

  • He FJ, Wu Y, Ma J, Feng X, Wang H, Zhang J, Lin CP, Yuan J, Ma Y, Yang Y, Yan LL, Jan S, Nowson C, Macgregor GA. A school-based education programme to reduce salt intake in children and their families (School-EduSalt): protocol of a cluster randomised controlled trial. BMJ Open. 2013 Jul 16;3(7):e003388. doi: 10.1136/bmjopen-2013-003388. Print 2013.

    PMID: 23864214DERIVED

Study Officials

  • Feng He, PhD

    Queen Mary University of London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Fellow

Study Record Dates

First Submitted

March 21, 2013

First Posted

March 29, 2013

Study Start

March 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

January 10, 2023

Record last verified: 2022-12

Locations

CN(1)