Clinical trial NCT01821144: A School-based Education Programme to Reduce Salt Intake in Children and Their Families
Official title: A School-based Education Programme to Reduce Salt Intake in Children and Their Families (School-EduSalt)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteer
Keywords: dietary salt
24 hour urinary sodium
blood pressure
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: The George Institute for Global Health, China
name: Peking University
name: Changzhi Medical College
First posted: 2013-03-29
Enrollment: 832
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 24-h urinary sodium
timeFrame: 4.5 month
Secondary outcomes:
measure: Blood pressure
timeFrame: 4.5 month
Other outcomes:
Locations:
city: Changzhi
country: China
facility: Changzhi Medical College
state: Shanxi
Study officials:
affiliation: Queen Mary University of London
name: Feng He, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.