Healthy VolunteerSchool-EduSaltNCT01821144
A School-based Education Programme to Reduce Salt Intake in Children and Their Families
A study testing Salt reduction in people with Healthy Volunteer, run by Queen Mary University of London at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Salt reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 832 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All children in Grade 5 of primary schools (age about 11 years) are eligible for the study.
- 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.
Who cannot join
- Children who do not have lunch or dinner at their own home will be excluded.
- Adult family members:
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Volunteer
- Being tested
- Salt reduction, Control
- Keywords
- dietary salt, 24 hour urinary sodium, blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salt reductionBehavioural
Salt reduction
ControlOther
No salt awareness education
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | No salt awareness education Receives: Other: Control |
| Salt reduction | Experimental | Salt reduction Receives: Behavioral: Salt reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4.5 month
Secondary outcomes (1)
Blood pressure
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.
Measured: 4.5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 832 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- The George Institute for Global Health, China, Peking University, Changzhi Medical College
- Responsible party
- Principal investigator, Feng J He, Queen Mary University of London
- Investigators
- Feng He, PhD, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821144
- Sponsor's protocol ID
- 008602 QM
- Acronym
- School-EduSalt
- Status last verified
- Dec 2022
- First submitted
- 21 Mar 2013
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31203245Li 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.
PubMed 28902880He 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.
PubMed 27670515He 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.
PubMed 25788018He 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.
PubMed 23864214
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A School-based Education Programme to Reduce Salt Intake in Children and Their Families (School-EduSalt)
- ClinicalTrials.gov ID
- NCT01821144
- Acronym / sponsor ID
- School-EduSalt / 008602 QM
- Conditions
- Healthy Volunteer
- Keywords
- dietary salt, 24 hour urinary sodium, blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 832 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- The George Institute for Global Health, China, Peking University, Changzhi Medical College
- Study start
- Mar 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 29 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: ControlNo salt awareness education |
| Salt reduction | Experimental | Behavioral: Salt reductionSalt reduction |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All children in Grade 5 of primary schools (age about 11 years) are eligible for the study.
- 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.
Key exclusion criteria (3 listed)
- Children who do not have lunch or dinner at their own home will be excluded.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salt reductionSalt reduction | Behavioural | Salt reduction |
| ControlNo salt awareness education | Other | Control |
Primary outcome
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
1 secondary outcome
Blood pressure
Time frame: 4.5 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Derived from this study: PubMed 31203245Ma 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.
- Derived from this study: PubMed 28902880Li 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.
- Derived from this study: PubMed 27670515He 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.
- Derived from this study: PubMed 25788018He 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.
- Derived from this study: PubMed 23864214He 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feng He, PhD principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salt reduction in people with Healthy Volunteer, run by Queen Mary University of London at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-h urinary sodium (time frame: 4.5 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01821144, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.