Educational Intervention for Sodium Restriction in Patients With Hypertension

NCT02848690 | Unknown

• 1 other identifier: 150496
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension,

Keywords

Sodium restriction; Dietary sodium restriction questionnaire (DSRQ); Low-sodium diet; Adherence; Educational intervention

Outcome Measures

Primary Outcomes (1)

• Changes from baseline, after 8 weeks and 6 months in Dietary Sodium Restriction Questionnaire (DSRQ) score

  6 months

Secondary Outcomes (3)

• Questionnaire sensitivity and specificity by the comparison of Dietary Sodium Restriction Questionnaire (DSRQ) scores to urinary sodium values

  6 months

• Changes from baseline, after 8 weeks and 6 months in urinary sodium values

  6 months

• Changes from baseline, after 8 weeks and 6 months in blood pressure mean assessed by ABPM

  6 months

Study Arms (2)

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.

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

Other: Usual Care Intervention Group

Interventions

Educational Intervention BEHAVIORAL

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.

Also known as: Intervention Group

Educational Intervention Group

Usual Care Intervention Group OTHER

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

Also known as: Control Group

Usual Care Intervention Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Leila Beltrami Moreira

Porto Alegre, Rio Grande do Sul, : 90035-903, Brazil

RECRUITING

Related Publications (23)

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• Rodrigues MP, Dos Santos LKJ, Fuchs FD, Fuchs SC, Moreira LB. The effectiveness of an educational intervention for sodium restriction in patients with hypertension: study protocol for a randomized controlled trial. Trials. 2017 Jul 21;18(1):347. doi: 10.1186/s13063-017-2091-4.

  PMID: 28732546 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Early Intervention, Educational; Control Groups

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Leila Moreira, MD PhD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leila B Moreira, MD PhD

CONTACT

555133597695; lbmoreira@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: July 28, 2016
• Study Start: November 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 29, 2016

Record last verified: 2016-07

Locations

BR (1)