Healthy Volunteer Clinical Trial
— School-EduSaltOfficial title:
A School-based Education Programme to Reduce Salt Intake in Children and Their Families (School-EduSalt)
| NCT number | NCT01821144 |
| Other study ID # | 008602 QM |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 2013 |
| Est. completion date | February 2014 |
| Verified date | December 2022 |
| Source | Queen Mary University of London |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 832 |
| Est. completion date | February 2014 |
| Est. primary completion date | February 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 9 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Changzhi Medical College | Changzhi | Shanxi |
| Lead Sponsor | Collaborator |
|---|---|
| Queen Mary University of London | Changzhi Medical College, Peking University, The George Institute for Global Health, China |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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. | 4.5 month |
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