Hypertension,NCT02848690
Educational Intervention for Sodium Restriction in Patients With Hypertension
A study testing Educational Intervention in people with Hypertension,, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
This parallel, randomized clinical trial will include 120 participants. They will be allocated to a sodium restriction educational intervention or usual care groups. The educational intervention will be planned based on the DSRQ application and sessions will be conducted once a month for the period of six months. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Hypertension,
- What is being tested?
- Educational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2015to Dec 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female and male individuals, ageing from 40 to 80 years old, in treatment and monitored at the hypertensive outpatient department of HCPA. Participants must not have been monitored by a nutritionist or followed a nutritional orientation for over than six months
Who cannot join
- pregnancy or lactating; gastrointestinal tract disease; inflammatory disease; chemotherapy treatment; diabetes diagnosis; incapacity to follow an interview and/or to participate in the intervention program without the need of a third party involvement
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Leila Beltrami Moreira
Porto Alegre, Rio Grande do Sul, : 90035-903
About this study
Official title: The Effectiveness of an Educational Intervention for Sodium Restriction in Patients With Hypertension: Study Protocol for a Randomized Controlled Trial
This parallel, randomized clinical trial will include 120 participants. They will be allocated to a sodium restriction educational intervention or usual care groups. The educational intervention will be planned based on the DSRQ application and sessions will be conducted once a month for the period of six months. Both spot urine collection to estimate sodium intake and the DSRQ will be applied at the baseline, in the eighth week and at the end of the follow-up. Blood sample and 24-hour ambulatory blood pressure monitoring (ABPM) will be conducted at the beginning and at the end of the follow-up. Anthropometric measurements, blood pressure measurement and 24-hour food recall will be collected during follow-up.
Read the detailed description
This parallel, randomized clinical trial will include 120 participants. They will be allocated to a sodium restriction educational intervention or usual care groups. The educational intervention will be planned based on the DSRQ application and sessions will be conducted once a month for the period of six months. Both spot urine collection to estimate sodium intake and the DSRQ will be applied at the baseline, in the eighth week and at the end of the follow-up. Blood sample and 24-hour ambulatory blood pressure monitoring (ABPM) will be conducted at the beginning and at the end of the follow-up. Anthropometric measurements, blood pressure measurement and 24-hour food recall will be collected during follow-up. The study 'The effectiveness of an educational intervention to sodium restriction in patients with hypertension' is based on the results of the DSRQ application, whose objective is to evaluate aspects related to non-adherence to the recommendation of a low-sodium diet, identifying adherence barriers and facilitators, contributing to the planning of interventions for improving the adoption of a low-sodium diet and, consequently, better hypertension control.
- Conditions
- Hypertension,
- Being tested
- Educational Intervention, Usual Care Intervention Group
- Keywords
- Sodium restriction, Dietary sodium restriction questionnaire (DSRQ), Low-sodium diet, Adherence, Educational intervention
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionBehavioural
Also called Intervention Group
The educational intervention sessions will be conducted face-to-face, one hour-long and with the aim to encourage and motivate the low-sodium diet adherence. The dietitian's approaches will provide individual skills to achieve the goals (sodium restriction), developing changes in behavior and monitoring the progress towards the skills needed to reduce patient's barriers and difficulties for sodium restricted diet adherence.
Usual Care Intervention GroupOther
Also called Control Group
Participants assigned to the control group will have a dietitian consultation receiving general recommendations for hypertension, such as increasing the consumption of fruits and vegetables, reducing salt intake, avoiding processed and high-sodium foods, reducing body weight if BMI> 25Kg/m2 and limiting consumption of alcoholic beverages. They will be provided with an explanatory folder about hypertension. During six months, participants assigned to the control group will be monitored in monthly visits to the dietitian without modifying their usual care
| Study group | Role | What they receive |
|---|---|---|
| Educational Intervention Group | Experimental | Participants assigned to the educational intervention group will have dietitian consultation to receive a dietary planning based on diet rich of fruits, vegetables, low fat, low processed foods and high nonfat dairy. During six months they will have monthly dietitian appointments including educational sessions to stimulate sodium restriction and enhance to follow the dietary planning. Each 15 days they will be contacted by phone to reinforce adherence to sodium restriction diet. Receives: Behavioral: Educational Intervention |
| Usual Care Intervention Group | Sham comparator | Participants assigned to the control group will have a dietitian consultation receiving general recommendations for hypertension, such as increasing the consumption of fruits and vegetables, reducing salt intake, avoiding processed and high-sodium foods, reducing body weight if BMI> 25Kg/m2 and limiting consumption of alcoholic beverages. They will be provided with an explanatory folder about hypertension. During six months, participants assigned to the control group will be monitored in monthly visits to the dietitian without modifying their usual care Receives: Other: Usual Care Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline, after 8 weeks and 6 months in Dietary Sodium Restriction Questionnaire (DSRQ) score
Measured: 6 months
Secondary outcomes (3)
Questionnaire sensitivity and specificity by the comparison of Dietary Sodium Restriction Questionnaire (DSRQ) scores to urinary sodium values
Measured: 6 months
Changes from baseline, after 8 weeks and 6 months in urinary sodium values
Measured: 6 months
Changes from baseline, after 8 weeks and 6 months in blood pressure mean assessed by ABPM
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startNov 2015
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Hypertension,Studies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leila Moreira, MD PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848690
- Sponsor's protocol ID
- 150496
- Status last verified
- Jul 2016
- First submitted
- 26 Jul 2016
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Appel LJ, Moore TJ, Obarzanek E, Vollmer WM, Svetkey LP, Sacks FM, Bray GA, Vogt TM, Cutler JA, Windhauser MM, Lin PH, Karanja N. A clinical trial of the effects of dietary patterns on blood pressure. DASH Collaborative Research Group. N Engl J Med. 1997 Apr 17;336(16):1117-24. doi: 10.1056/NEJM199704173361601.
PubMed 9099655Sacks FM, Svetkey LP, Vollmer WM, Appel LJ, Bray GA, Harsha D, Obarzanek E, Conlin PR, Miller ER 3rd, Simons-Morton DG, Karanja N, Lin PH; DASH-Sodium Collaborative Research Group. Effects on blood pressure of reduced dietary sodium and the Dietary Approaches to Stop Hypertension (DASH) diet. DASH-Sodium Collaborative Research Group. N Engl J Med. 2001 Jan 4;344(1):3-10. doi: 10.1056/NEJM200101043440101.
PubMed 11136953Appel LJ, Champagne CM, Harsha DW, Cooper LS, Obarzanek E, Elmer PJ, Stevens VJ, Vollmer WM, Lin PH, Svetkey LP, Stedman SW, Young DR; Writing Group of the PREMIER Collaborative Research Group. Effects of comprehensive lifestyle modification on blood pressure control: main results of the PREMIER clinical trial. JAMA. 2003 Apr 23-30;289(16):2083-93. doi: 10.1001/jama.289.16.2083.
PubMed 12709466He FJ, MacGregor GA. Effect of longer-term modest salt reduction on blood pressure. Cochrane Database Syst Rev. 2004;(3):CD004937. doi: 10.1002/14651858.CD004937.
PubMed 15266549Aucott L, Rothnie H, McIntyre L, Thapa M, Waweru C, Gray D. Long-term weight loss from lifestyle intervention benefits blood pressure?: a systematic review. Hypertension. 2009 Oct;54(4):756-62. doi: 10.1161/HYPERTENSIONAHA.109.135178. Epub 2009 Aug 24.
PubMed 19704106Whelton SP, Chin A, Xin X, He J. Effect of aerobic exercise on blood pressure: a meta-analysis of randomized, controlled trials. Ann Intern Med. 2002 Apr 2;136(7):493-503. doi: 10.7326/0003-4819-136-7-200204020-00006.
PubMed 11926784Ajani UA, Dunbar SB, Ford ES, Mokdad AH, Mensah GA. Sodium intake among people with normal and high blood pressure. Am J Prev Med. 2005 Dec;29(5 Suppl 1):63-7. doi: 10.1016/j.amepre.2005.07.008.
PubMed 16389128Reinivuo H, Valsta LM, Laatikainen T, Tuomilehto J, Pietinen P. Sodium in the Finnish diet: II trends in dietary sodium intake and comparison between intake and 24-h excretion of sodium. Eur J Clin Nutr. 2006 Oct;60(10):1160-7. doi: 10.1038/sj.ejcn.1602431. Epub 2006 Apr 26.
PubMed 16639417Ferreira-Sae MC, Gallani MC, Nadruz W, Rodrigues RC, Franchini KG, Cabral PC, Sales ML. Reliability and validity of a semi-quantitative FFQ for sodium intake in low-income and low-literacy Brazilian hypertensive subjects. Public Health Nutr. 2009 Nov;12(11):2168-73. doi: 10.1017/S1368980009005825. Epub 2009 May 28.
PubMed 19476677Cornelio ME, Gallani MC, Godin G, Rodrigues RC, Mendes RD, Nadruz Junior W. Development and reliability of an instrument to measure psychosocial determinants of salt consumption among hypertensive patients. Rev Lat Am Enfermagem. 2009 Sep-Oct;17(5):701-7. doi: 10.1590/s0104-11692009000500017.
PubMed 19967221Polonia J, Martins L. A comprehensive review on salt and health and current experience of worldwide salt reduction programmes. J Hum Hypertens. 2009 Nov;23(11):771-2. doi: 10.1038/jhh.2009.64. Epub 2009 Sep 3. No abstract available.
PubMed 19727126Appel LJ, Frohlich ED, Hall JE, Pearson TA, Sacco RL, Seals DR, Sacks FM, Smith SC Jr, Vafiadis DK, Van Horn LV. The importance of population-wide sodium reduction as a means to prevent cardiovascular disease and stroke: a call to action from the American Heart Association. Circulation. 2011 Mar 15;123(10):1138-43. doi: 10.1161/CIR.0b013e31820d0793. Epub 2011 Jan 13. No abstract available.
PubMed 21233236Evers SE, Bass M, Donner A, McWhinney IR. Lack of impact of salt restriction advice on hypertensive patients. Prev Med. 1987 Mar;16(2):213-20. doi: 10.1016/0091-7435(87)90085-5.
PubMed 3588562Cornelio ME, Gallani MC, Godin G, Rodrigues RC, Nadruz W Jr, Mendez RD. Behavioural determinants of salt consumption among hypertensive individuals. J Hum Nutr Diet. 2012 Aug;25(4):334-44. doi: 10.1111/j.1365-277X.2012.01238.x. Epub 2012 Mar 2.
PubMed 22380701Adams SO, Maller O, Cardello AV. Consumer acceptance of foods lower in sodium. J Am Diet Assoc. 1995 Apr;95(4):447-53. doi: 10.1016/S0002-8223(95)00120-4.
PubMed 7699187
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an Educational Intervention for Sodium Restriction in Patients With Hypertension: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02848690
- Acronym / sponsor ID
- 150496
- Conditions
- Hypertension,
- Keywords
- Sodium restriction, Dietary sodium restriction questionnaire (DSRQ), Low-sodium diet, Adherence, Educational intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 28 Jul 2016 (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.
This parallel, randomized clinical trial will include 120 participants. They will be allocated to a sodium restriction educational intervention or usual care groups. The educational intervention will be planned based on the DSRQ application and sessions will be conducted once a month for the period of six months. Both spot urine collection to estimate sodium intake and the DSRQ will be applied at the baseline, in the eighth week and at the end of the follow-up. Blood sample and 24-hour ambulatory blood pressure monitoring (ABPM) will be conducted at the beginning and at the end of the follow-up. Anthropometric measurements, blood pressure measurement and 24-hour food recall will be collected during follow-up.
Detailed description
This parallel, randomized clinical trial will include 120 participants. They will be allocated to a sodium restriction educational intervention or usual care groups. The educational intervention will be planned based on the DSRQ application and sessions will be conducted once a month for the period of six months. Both spot urine collection to estimate sodium intake and the DSRQ will be applied at the baseline, in the eighth week and at the end of the follow-up. Blood sample and 24-hour ambulatory blood pressure monitoring (ABPM) will be conducted at the beginning and at the end of the follow-up. Anthropometric measurements, blood pressure measurement and 24-hour food recall will be collected during follow-up. The study 'The effectiveness of an educational intervention to sodium restriction in patients with hypertension' is based on the results of the DSRQ application, whose objective is to evaluate aspects related to non-adherence to the recommendation of a low-sodium diet, identifying adherence barriers and facilitators, contributing to the planning of interventions for improving the adoption of a low-sodium diet and, consequently, better hypertension control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Intervention Group | Experimental | Behavioral: Educational InterventionParticipants assigned to the educational intervention group will have dietitian consultation to receive a dietary planning based on diet rich of fruits, vegetables, low fat, low processed foods and high nonfat dairy. During six months they will have monthly dietitian appointments including educational sessions to stimulate sodium restriction and enhance to follow the dietary planning. Each 15 days they will be contacted by phone to reinforce adherence to sodium restriction diet. |
| Usual Care Intervention Group | Sham comparator | Other: Usual Care Intervention GroupParticipants assigned to the control group will have a dietitian consultation receiving general recommendations for hypertension, such as increasing the consumption of fruits and vegetables, reducing salt intake, avoiding processed and high-sodium foods, reducing body weight if BMI> 25Kg/m2 and limiting consumption of alcoholic beverages. They will be provided with an explanatory folder about hypertension. During six months, participants assigned to the control group will be monitored in monthly visits to the dietitian without modifying their usual care |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- female and male individuals, ageing from 40 to 80 years old, in treatment and monitored at the hypertensive outpatient department of HCPA. Participants must not have been monitored by a nutritionist or followed a nutritional orientation for over than six months
Key exclusion criteria (1 listed)
- pregnancy or lactating; gastrointestinal tract disease; inflammatory disease; chemotherapy treatment; diabetes diagnosis; incapacity to follow an interview and/or to participate in the intervention program without the need of a third party involvement
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 |
|---|---|---|
| Educational InterventionAlso: Intervention GroupThe educational intervention sessions will be conducted face-to-face, one hour-long and with the aim to encourage and motivate the low-sodium diet adherence. The dietitian's approaches will provide individual skills to achieve the goals (sodium restriction), developing changes in behavior and monitoring the progress towards the skills needed to reduce patient's barriers and difficulties for sodium restricted diet adherence. | Behavioural | Educational Intervention Group |
| Usual Care Intervention GroupAlso: Control GroupParticipants assigned to the control group will have a dietitian consultation receiving general recommendations for hypertension, such as increasing the consumption of fruits and vegetables, reducing salt intake, avoiding processed and high-sodium foods, reducing body weight if BMI> 25Kg/m2 and limiting consumption of alcoholic beverages. They will be provided with an explanatory folder about hypertension. During six months, participants assigned to the control group will be monitored in monthly visits to the dietitian without modifying their usual care | Other | Usual Care Intervention Group |
Primary outcome
Changes from baseline, after 8 weeks and 6 months in Dietary Sodium Restriction Questionnaire (DSRQ) score
Time frame: 6 months
3 secondary outcomes
Questionnaire sensitivity and specificity by the comparison of Dietary Sodium Restriction Questionnaire (DSRQ) scores to urinary sodium values
Time frame: 6 months
Changes from baseline, after 8 weeks and 6 months in urinary sodium values
Time frame: 6 months
Changes from baseline, after 8 weeks and 6 months in blood pressure mean assessed by ABPM
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Results publication: PubMed 9099655Appel LJ, Moore TJ, Obarzanek E, Vollmer WM, Svetkey LP, Sacks FM, Bray GA, Vogt TM, Cutler JA, Windhauser MM, Lin PH, Karanja N. A clinical trial of the effects of dietary patterns on blood pressure. DASH Collaborative Research Group. N Engl J Med. 1997 Apr 17;336(16):1117-24. doi: 10.1056/NEJM199704173361601.
- Results publication: PubMed 11136953Sacks FM, Svetkey LP, Vollmer WM, Appel LJ, Bray GA, Harsha D, Obarzanek E, Conlin PR, Miller ER 3rd, Simons-Morton DG, Karanja N, Lin PH; DASH-Sodium Collaborative Research Group. Effects on blood pressure of reduced dietary sodium and the Dietary Approaches to Stop Hypertension (DASH) diet. DASH-Sodium Collaborative Research Group. N Engl J Med. 2001 Jan 4;344(1):3-10. doi: 10.1056/NEJM200101043440101.
- Results publication: PubMed 12709466Appel LJ, Champagne CM, Harsha DW, Cooper LS, Obarzanek E, Elmer PJ, Stevens VJ, Vollmer WM, Lin PH, Svetkey LP, Stedman SW, Young DR; Writing Group of the PREMIER Collaborative Research Group. Effects of comprehensive lifestyle modification on blood pressure control: main results of the PREMIER clinical trial. JAMA. 2003 Apr 23-30;289(16):2083-93. doi: 10.1001/jama.289.16.2083.
- Results publication: PubMed 15266549He FJ, MacGregor GA. Effect of longer-term modest salt reduction on blood pressure. Cochrane Database Syst Rev. 2004;(3):CD004937. doi: 10.1002/14651858.CD004937.
- Results publication: PubMed 19704106Aucott L, Rothnie H, McIntyre L, Thapa M, Waweru C, Gray D. Long-term weight loss from lifestyle intervention benefits blood pressure?: a systematic review. Hypertension. 2009 Oct;54(4):756-62. doi: 10.1161/HYPERTENSIONAHA.109.135178. Epub 2009 Aug 24.
- Results publication: PubMed 11926784Whelton SP, Chin A, Xin X, He J. Effect of aerobic exercise on blood pressure: a meta-analysis of randomized, controlled trials. Ann Intern Med. 2002 Apr 2;136(7):493-503. doi: 10.7326/0003-4819-136-7-200204020-00006.
- Results publication: PubMed 16389128Ajani UA, Dunbar SB, Ford ES, Mokdad AH, Mensah GA. Sodium intake among people with normal and high blood pressure. Am J Prev Med. 2005 Dec;29(5 Suppl 1):63-7. doi: 10.1016/j.amepre.2005.07.008.
- Results publication: PubMed 16639417Reinivuo H, Valsta LM, Laatikainen T, Tuomilehto J, Pietinen P. Sodium in the Finnish diet: II trends in dietary sodium intake and comparison between intake and 24-h excretion of sodium. Eur J Clin Nutr. 2006 Oct;60(10):1160-7. doi: 10.1038/sj.ejcn.1602431. Epub 2006 Apr 26.
- Results publication: PubMed 19476677Ferreira-Sae MC, Gallani MC, Nadruz W, Rodrigues RC, Franchini KG, Cabral PC, Sales ML. Reliability and validity of a semi-quantitative FFQ for sodium intake in low-income and low-literacy Brazilian hypertensive subjects. Public Health Nutr. 2009 Nov;12(11):2168-73. doi: 10.1017/S1368980009005825. Epub 2009 May 28.
- Results publication: PubMed 19967221Cornelio ME, Gallani MC, Godin G, Rodrigues RC, Mendes RD, Nadruz Junior W. Development and reliability of an instrument to measure psychosocial determinants of salt consumption among hypertensive patients. Rev Lat Am Enfermagem. 2009 Sep-Oct;17(5):701-7. doi: 10.1590/s0104-11692009000500017.
- Results publication: PubMed 19727126Polonia J, Martins L. A comprehensive review on salt and health and current experience of worldwide salt reduction programmes. J Hum Hypertens. 2009 Nov;23(11):771-2. doi: 10.1038/jhh.2009.64. Epub 2009 Sep 3. No abstract available.
- Results publication: PubMed 21233236Appel LJ, Frohlich ED, Hall JE, Pearson TA, Sacco RL, Seals DR, Sacks FM, Smith SC Jr, Vafiadis DK, Van Horn LV. The importance of population-wide sodium reduction as a means to prevent cardiovascular disease and stroke: a call to action from the American Heart Association. Circulation. 2011 Mar 15;123(10):1138-43. doi: 10.1161/CIR.0b013e31820d0793. Epub 2011 Jan 13. No abstract available.
- 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.
Leila Moreira, MD PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention in people with Hypertension,, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 1 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: status not confirmed, as of the sponsor's last update on 29 Jul 2016. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leila B Moreira, MD PhD (555133597695, lbmoreira@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline, after 8 weeks and 6 months in Dietary Sodium Restriction Questionnaire (DSRQ) score (time frame: 6 months). 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 NCT02848690, which also lists 23 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 29 Jul 2016.