Educational Intervention for Sodium Restriction in Patients With Hypertension

Hypertension, Clinical Trial

Official title:

The Effectiveness of an Educational Intervention for Sodium Restriction in Patients With Hypertension: Study Protocol for a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02848690
• Other study ID #: 150496
• Status: Recruiting
• Phase: N/A
• First received: July 26, 2016
• Last updated: July 28, 2016
• Start date: November 2015
• Est. completion date: December 2017

Study information

• Verified date: July 2016
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Leila B Moreira, MD PhD
• Phone: 555133597695
• Email: lbmoreira[@]hcpa.edu.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension,

Intervention

Behavioral:
• Educational Intervention
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.

Other:
• Usual Care Intervention 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

Locations

Country	Name	City	State
Brazil	Leila Beltrami Moreira	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (22)

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline, after 8 weeks and 6 months in Dietary Sodium Restriction Questionnaire (DSRQ) score		6 months	Yes
Secondary	Questionnaire sensitivity and specificity by the comparison of Dietary Sodium Restriction Questionnaire (DSRQ) scores to urinary sodium values		6 months	Yes
Secondary	Changes from baseline, after 8 weeks and 6 months in urinary sodium values		6 months	Yes
Secondary	Changes from baseline, after 8 weeks and 6 months in blood pressure mean assessed by ABPM		6 months	Yes