The effectiveness of an educational intervention for sodium restriction in patients with hypertension: study protocol for a randomized controlled trial
Abstract Background The effectiveness of nonpharmacological interventions in blood pressure reduction has been evidenced by several studies. Nevertheless, as adherence to a low-sodium diet is poor, interventions regarding habit changing should be of a motivational nature in order to develop the abil...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2017-07-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-017-2091-4 |
| _version_ | 1819228534344777728 |
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| author | Marcela Perdomo Rodrigues Luciana Kaercher John dos Santos Flavio Danni Fuchs Sandra Costa Fuchs Leila Beltrami Moreira |
| author_facet | Marcela Perdomo Rodrigues Luciana Kaercher John dos Santos Flavio Danni Fuchs Sandra Costa Fuchs Leila Beltrami Moreira |
| author_sort | Marcela Perdomo Rodrigues |
| collection | DOAJ |
| description | Abstract Background The effectiveness of nonpharmacological interventions in blood pressure reduction has been evidenced by several studies. Nevertheless, as adherence to a low-sodium diet is poor, interventions regarding habit changing should be of a motivational nature in order to develop the ability of overcoming obstacles regarding sodium-restriction behavior. The present study aims to describe the protocol and randomization of a clinical trial design in order to evaluate the effectiveness of an educational intervention based on Dietary Sodium Restriction Questionnaire (DSRQ) scores. The effectiveness measures are the DSRQ score variation and reduction in urinary sodium values from baseline to after 2 and 6 months. Methods/design This parallel, randomized clinical trial will include 120 participants, recruited and randomized as follows: 60 of them to be allocated to a sodium-restriction educational intervention group whose results are based on the DSRQ application; and the other 60 allocated to a control group with usual care. Educational orientation and usual care sessions will be conducted once a month for a period of 6 months. Both spot urine collection – estimating sodium intake – and the DSRQ will be applied at the baseline, in the eighth week and at the end of the follow-up. There will also be blood collection and 24-h ambulatory blood pressure monitoring (ABPM) at the beginning and end of the follow-up. Anthropometric measurements, blood pressure measurement and 24-h food recall will be collected during follow-up. Discussion 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 nonadherence 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, hypertension control. Trial registration number ClinicalTrials.gov, Identifier: NCT02848690 . Registered retrospectively on 27 July 2016. |
| first_indexed | 2024-12-23T10:58:48Z |
| format | Article |
| id | doaj.art-7b4302ddb6e943b493afabf13582a7ab |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-23T10:58:48Z |
| publishDate | 2017-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-7b4302ddb6e943b493afabf13582a7ab2022-12-21T17:49:42ZengBMCTrials1745-62152017-07-011811810.1186/s13063-017-2091-4The effectiveness of an educational intervention for sodium restriction in patients with hypertension: study protocol for a randomized controlled trialMarcela Perdomo Rodrigues0Luciana Kaercher John dos Santos1Flavio Danni Fuchs2Sandra Costa Fuchs3Leila Beltrami Moreira4Postgraduate Studies Program in Cardiology, Universidade Federal do Rio Grande do SulPostgraduate Studies Program in Cardiology, Universidade Federal do Rio Grande do SulPostgraduate Studies Program in Cardiology, Universidade Federal do Rio Grande do SulPostgraduate Studies Program in Cardiology, Universidade Federal do Rio Grande do SulPostgraduate Studies Program in Cardiology, Universidade Federal do Rio Grande do SulAbstract Background The effectiveness of nonpharmacological interventions in blood pressure reduction has been evidenced by several studies. Nevertheless, as adherence to a low-sodium diet is poor, interventions regarding habit changing should be of a motivational nature in order to develop the ability of overcoming obstacles regarding sodium-restriction behavior. The present study aims to describe the protocol and randomization of a clinical trial design in order to evaluate the effectiveness of an educational intervention based on Dietary Sodium Restriction Questionnaire (DSRQ) scores. The effectiveness measures are the DSRQ score variation and reduction in urinary sodium values from baseline to after 2 and 6 months. Methods/design This parallel, randomized clinical trial will include 120 participants, recruited and randomized as follows: 60 of them to be allocated to a sodium-restriction educational intervention group whose results are based on the DSRQ application; and the other 60 allocated to a control group with usual care. Educational orientation and usual care sessions will be conducted once a month for a period of 6 months. Both spot urine collection – estimating sodium intake – and the DSRQ will be applied at the baseline, in the eighth week and at the end of the follow-up. There will also be blood collection and 24-h ambulatory blood pressure monitoring (ABPM) at the beginning and end of the follow-up. Anthropometric measurements, blood pressure measurement and 24-h food recall will be collected during follow-up. Discussion 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 nonadherence 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, hypertension control. Trial registration number ClinicalTrials.gov, Identifier: NCT02848690 . Registered retrospectively on 27 July 2016.http://link.springer.com/article/10.1186/s13063-017-2091-4HypertensionSodium restrictionEducational interventionDietary sodium restriction questionnaire (DSRQ)Low-sodium dietAdherence |
| spellingShingle | Marcela Perdomo Rodrigues Luciana Kaercher John dos Santos Flavio Danni Fuchs Sandra Costa Fuchs Leila Beltrami Moreira The effectiveness of an educational intervention for sodium restriction in patients with hypertension: study protocol for a randomized controlled trial Trials Hypertension Sodium restriction Educational intervention Dietary sodium restriction questionnaire (DSRQ) Low-sodium diet Adherence |
| title | The effectiveness of an educational intervention for sodium restriction in patients with hypertension: study protocol for a randomized controlled trial |
| title_full | The effectiveness of an educational intervention for sodium restriction in patients with hypertension: study protocol for a randomized controlled trial |
| title_fullStr | The effectiveness of an educational intervention for sodium restriction in patients with hypertension: study protocol for a randomized controlled trial |
| title_full_unstemmed | The effectiveness of an educational intervention for sodium restriction in patients with hypertension: study protocol for a randomized controlled trial |
| title_short | The effectiveness of an educational intervention for sodium restriction in patients with hypertension: study protocol for a randomized controlled trial |
| title_sort | effectiveness of an educational intervention for sodium restriction in patients with hypertension study protocol for a randomized controlled trial |
| topic | Hypertension Sodium restriction Educational intervention Dietary sodium restriction questionnaire (DSRQ) Low-sodium diet Adherence |
| url | http://link.springer.com/article/10.1186/s13063-017-2091-4 |
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