Hypertensive DiseaseNCT03074851
Activating Media for Salt Reduction
A study testing low sodium salt and informational intervention in people with Hypertensive Disease, run by The George Institute for Global Health, China at 1 site in China.
Trial summary
Mass media plays more and more important role in health education, especially in some chronic diseases which related closely with the behavior and habits. Past experience tells us that with the help of related health education in mass media such as newspaper articles, advertisements and videos on television, peoples… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertensive Disease
- What is being tested?
- low sodium salt and informational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 516 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Feb 2017
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Come from local only Daily company;
- With a national press card;
- Health Column reporters preferred;
- Without leaving plan in the next 12 months;
- With easy access to at least 4 families, including relatives, friends or neighbour;
- Volunteered to participate.
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Activating Mass Media for Salt Reduction Program by Using Media Reporters as Research Investigators in a Randomized Controlled Trial
Mass media plays more and more important role in health education, especially in some chronic diseases which related closely with the behavior and habits. Past experience tells us that with the help of related health education in mass media such as newspaper articles, advertisements and videos on television, peoples can change their behaviors and habits in a short period of time. But when these educational information were stopped, peoples usually return to their original habits. Besides the national policy of the country how to improve the long-term health education in the mass media should be considered.This study hopes to seek an effective method to keep the mass media long-term focus on health education.
Read the detailed description
In this study, reporters just like researchers were in charge of the low-sodium salt intervention. Reporters are responsible for recommended objects and measure their blood pressure personally. By observing personally the change of blood pressure pre and post low-sodium salt intervention, reporters will increase their confidence and come to the conclusion that the low salt diet is an economical way to reduce blood pressure. Those reporters would share their experiment with other people including their colleagues, Hopefully, those reporters that took part in the trial would consciously keep a sustained focus to this topic, thereby retaining a long-time education in mass media.There were two interventions. One is low-sodium salt intervention and the other is informational intervention. Low-sodium salt intervention was carried out on those family members recommended by reporters, and informational intervention. Low-sodium salt intervention was only on the reporters. The evaluation criteria of low-sodium salt intervention is the blood pressure value, and the evaluation criteria of informational intervention are the numbers of related articles in certain newspaper and the awareness of related knowledges in local population.
- Conditions
- Hypertensive Disease
- Being tested
- low sodium salt, informational intervention
- Keywords
- low sodium salt, blood pressure, reporter
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low sodium saltDietary supplement
To give free low sodium salt intervention for 2 months
informational interventionOther
to give reporter informational intervention.
| Study group | Role | What they receive |
|---|---|---|
| Salt Substitute | Experimental | To seek the relationship between blood pressure and low sodium salt. Receives: Dietary Supplement: low sodium salt |
| informational intervention | Other | to give 1 month informational intervention Receives: Other: informational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of local media reports on salt and health
Measured: 5 years
Mean blood pressure
This outcome is only for the build-in randomised trial on salt substitute and blood pressure among reporters' families
Measured: 2 months
Secondary outcomes (1)
Awareness of knowledge on salt and health
A questionnaire will be applied to count the number of participants known the pre-specified answers to the questions raised on salt and health
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study startDec 2012
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive DiseaseStudies 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
- None (open label)
- Enrolment
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Institute for Global Health, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- xiangxian feng, MD, Study director, Changzhi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074851
- Sponsor's protocol ID
- CoESeedGrant_04
- Other IDs
- CoESeedGrant_MediaReportor
- Status last verified
- Apr 2021
- First submitted
- 31 Oct 2013
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activating Mass Media for Salt Reduction Program by Using Media Reporters as Research Investigators in a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03074851
- Acronym / sponsor ID
- CoESeedGrant_04
- Conditions
- Hypertensive Disease
- Keywords
- low sodium salt, blood pressure, reporter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- The George Institute for Global Health, ChinaUniversity, hospital or other
- Study start
- Dec 2012 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 9 Mar 2017 (actual)
- 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.
Mass media plays more and more important role in health education, especially in some chronic diseases which related closely with the behavior and habits. Past experience tells us that with the help of related health education in mass media such as newspaper articles, advertisements and videos on television, peoples can change their behaviors and habits in a short period of time. But when these educational information were stopped, peoples usually return to their original habits. Besides the national policy of the country how to improve the long-term health education in the mass media should be considered.This study hopes to seek an effective method to keep the mass media long-term focus on health education.
Detailed description
In this study, reporters just like researchers were in charge of the low-sodium salt intervention. Reporters are responsible for recommended objects and measure their blood pressure personally. By observing personally the change of blood pressure pre and post low-sodium salt intervention, reporters will increase their confidence and come to the conclusion that the low salt diet is an economical way to reduce blood pressure. Those reporters would share their experiment with other people including their colleagues, Hopefully, those reporters that took part in the trial would consciously keep a sustained focus to this topic, thereby retaining a long-time education in mass media.There were two interventions. One is low-sodium salt intervention and the other is informational intervention. Low-sodium salt intervention was carried out on those family members recommended by reporters, and informational intervention. Low-sodium salt intervention was only on the reporters. The evaluation criteria of low-sodium salt intervention is the blood pressure value, and the evaluation criteria of informational intervention are the numbers of related articles in certain newspaper and the awareness of related knowledges in local population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salt Substitute | Experimental | Dietary Supplement: low sodium saltTo seek the relationship between blood pressure and low sodium salt. |
| informational intervention | Other | Other: informational interventionto give 1 month informational intervention |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Come from local only Daily company;
- With a national press card;
- Health Column reporters preferred;
- Without leaving plan in the next 12 months;
- With easy access to at least 4 families, including relatives, friends or neighbour;
Key exclusion criteria (1 listed)
- n/a
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 |
|---|---|---|
| low sodium saltTo give free low sodium salt intervention for 2 months | Dietary supplement | Salt Substitute |
| informational interventionto give reporter informational intervention. | Other | informational intervention |
Primary outcome
Number of local media reports on salt and health
Time frame: 5 years
Mean blood pressure
Time frame: 2 months
This outcome is only for the build-in randomised trial on salt substitute and blood pressure among reporters' families
1 secondary outcome
Awareness of knowledge on salt and health
Time frame: 5 years
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 15 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
xiangxian feng, MD study director
Changzhi Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low sodium salt and informational intervention in people with Hypertensive Disease, run by The George Institute for Global Health, China 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 6 inclusion and 1 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 15 Apr 2021. 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?
Number of local media reports on salt and health (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2021.