Condition category
Circulatory System
Date applied
28/11/2011
Date assigned
03/01/2012
Last edited
11/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Eating less salt can prevent cardiovascular diseases (CVD) such as heart attack and stroke. The World Health Organization has recommended the reduction of dietary salt as a CVD prevention strategy in developing countries where 80% of current global CVD deaths happen.
In order to make lifestyle changes including eating less salt, people have to first realize how high their daily salt intake is. We will support participants in the study group to be aware of their salt consumption. We will measure 24 hour salt intake by overnight urinary sodium measurement and the participants will know their actual daily salt intake. We will then ask the participants to bring their food to the health center. The salt content of food will be measured and shown to the participants. They will be aware of the salt content of their food, and start voluntarily changing their dietary pattern. Such life style changes will decrease CVD events on long term. We will test this hypothesis by providing a special health education program which makes people realize the actual daily salt intake and salt content of daily meals.

Aims:
To compare the effectiveness of health education program making participants realize the actual daily salt intake versus routine health education in high cardiovascular risk patients.
The following will be measured between the two study groups:
1. Behaviour change
2. Blood pressure
3. Incidence of cardiovascular disease
To compare the cost-effectiveness of health education of actual daily salt intake versus routine health education in high cardiovascular risk patients.

Who can participate?
Both men and women, above age of 35 years can participate in the study.
The participants are patients attending to the diabetes and hypertension clinic at the community hospitals and they are having higher CVD risk. We will use "the general Framingham scoring for CVD risks" to screen high risk CVD patients.

What does the study involve?
Study group participants will be informed of the salt content in their usual meals by measuring salt content using a food salt metre 5 times a year at health centre. They will also be informed of how much salt they have eaten in the last 24 hours, which is measured using an overnight urinary sodium measurement, once a month. They will also receive dietary advice to reduce the salt consumption based on their salt intake. They will receive group education by a nutritionist and individual counselling by a nurse.
The other group will receive the health education routinely given by the health centres and participants will be asked for overnight urine samples to measure salt intake in the last 24 hours, once a month. The health centre staff will give advice based on your salt intake but participants will receive the results at the end of one year.

What are the possible benefits and risks of participating?
Participants in both groups will know the 24 hour salt consumption by overnight urinary sodium measurement. The study will not introduce any particular risk to participants.

Where is the study run from?
We will run the study at eight health centres in Muang district, Chiang rai province, Northern Thailand. The Primary Care Unit at the Chiang rai provincial hospital is the leading centre.

When is study starting and how long is it expected to run for?
The trial will recruit participants for two months from December 2011 and the study will end in 2013.

Who is funding the study?
Department of Public Health, Graduate School of Medicine, Juntendo University, Japan - Ministry of Education, Culture, Sports, Science and Technology Grant ref: 22256002

Who is the main contact?
Associate Professor Motoyuki Yuasa
moyuasa@juntendo.ac.jp

Trial website

Contact information

Type

Scientific

Primary contact

Dr Motoyuki Yuasa

ORCID ID

Contact details

Department of Public Health
Graduate School of Medicine
Juntendo University
Hongo 2-1-1
Bunkyo-ku
Tokyo
113-8421
Japan
+81 3 5802 1049
moyuasa@juntendo.ac.jp

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11/2011

Study information

Scientific title

REducing Salt Intake for Prevention of CardioVascular Disease in high risk patients: a cluster randomized trial of advanced health education intervention in northern Thailand (RESIP-CVD study)

Acronym

RESIP-CVD

Study hypothesis

Health education together with visualization of the salt content in daily food and the individual daily salt intake will have greater effect than routine health education to change the lifestyle of eating a high salt diet.

Ethics approval

Juntendo University, Japan, 1 July 2011, ref: 2011036
Chiang Rai Regional Hospital, Thailand, 17 November 2011, ref: CR0027.102/research/207

Study design

Cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cadiovascular disease

Intervention

Health Education intervention:
1. Special Health Education class by dietician
2. Visualization of salt content in sample of patient’s food/soup
3. Explanation of dangers of high salt diet leading to cardiovascular death

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Blood pressure
2. Omron Digital BP monitor HEM 907

Secondary outcome measures

1. Behaviour change: salt intake estimated by urine sodium using KME-03
2. Clinical outcome: cardiovascular disease (CVD) risk measured using the General Framingham Score (10 year risk)
3. CVD incidence: diagnosis of each CVD event
4. Surrogate outcome: retinal caliber

Overall trial start date

20/12/2011

Overall trial end date

20/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diabetic patients with high risk of cardiovascular risk by General Framingham scoring 10 years risk (>15%)
2. Hypertensive patients with high risk of cardiovascular risk by Framingham scoring (>15%)
3. Patient who are willing to participate in the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

800

Participant exclusion criteria

1. Any female patients who are pregnant
2. Patients aged younger than 35 years
3. Patients with documented type I diabetes
4. Those on long term steroid therapy (more than 2 weeks)
5. Those on long term non-steroidal anti-inflammatory drugs (NSAIDs) (i.e. every day for at least one year)
6. Patients with cancer
7. Patients with known secondary hypertension such as primary aldosteronism, cushing disease syndrome or Pheochromocytoma
8. Patients with severe chronic pulmonary diseases using home oxygen therapy
9. Patients with chronic renal disease (Creatinine≧2.0 mg/dl)
10. Patients with Congestive Heart Failure

Recruitment start date

20/12/2011

Recruitment end date

20/12/2013

Locations

Countries of recruitment

Thailand

Trial participating centre

Department of Public Health
Tokyo
113-8421
Japan

Sponsor information

Organisation

Ministry of Education, Culture, Sports, Science and Technology (Japan)

Sponsor details

Kasumigaseki 3-2-2
Chiyoda-ku
Tokyo
100-8959
Japan

Sponsor type

Government

Website

http://www.mext.go.jp/english/

Funders

Funder type

Government

Funder name

Ministry of Education, Culture, Sports, Science and Technology (Japan)

Alternative name(s)

MEXT

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Japan

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22947342

Publication citations

  1. Protocol

    Aung MN, Yuasa M, Moolphate S, Nedsuwan S, Yokokawa H, Kitajima T, Minematsu K, Tanimura S, Fukuda H, Hiratsuka Y, Ono K, Kawai S, Marui E, Reducing salt intake for prevention of cardiovascular diseases in high-risk patients by advanced health education intervention (RESIP-CVD study), Northern Thailand: study protocol for a cluster randomized trial., Trials, 2012, 13, 158, doi: 10.1186/1745-6215-13-158.

Additional files

Editorial Notes