Educational Intervention for Sodium Restriction in Patients With Hypertension
28 juli 2016 uppdaterad av: Hospital de Clinicas de Porto Alegre
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.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
120
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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RS
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Porto Alegre, RS, Brasilien, : 90035-903
- Rekrytering
- Leila Beltrami Moreira
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
40 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Educational Intervention Group
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.
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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.
Andra namn:
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Sham Comparator: 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
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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
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Changes from baseline, after 8 weeks and 6 months in Dietary Sodium Restriction Questionnaire (DSRQ) score
Tidsram: 6 months
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6 months
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Questionnaire sensitivity and specificity by the comparison of Dietary Sodium Restriction Questionnaire (DSRQ) scores to urinary sodium values
Tidsram: 6 months
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6 months
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Changes from baseline, after 8 weeks and 6 months in urinary sodium values
Tidsram: 6 months
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6 months
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Changes from baseline, after 8 weeks and 6 months in blood pressure mean assessed by ABPM
Tidsram: 6 months
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6 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Leila Moreira, MD PhD, Hospital de Clinicas de Porto Alegre
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Sacks 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.
- 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.
- Appel 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.
- He 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.
- Aucott 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.
- Whelton 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.
- Ajani 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.
- Reinivuo 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.
- Ferreira-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.
- Cornelio 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.
- Polonia 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.
- Appel 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.
- Evers 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.
- Cornelio 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.
- Adams 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.
- Mattes RD. The taste for salt in humans. Am J Clin Nutr. 1997 Feb;65(2 Suppl):692S-697S. doi: 10.1093/ajcn/65.2.692S.
- Kumanyika SK, Hebert PR, Cutler JA, Lasser VI, Sugars CP, Steffen-Batey L, Brewer AA, Cameron M, Shepek LD, Cook NR, et al. Feasibility and efficacy of sodium reduction in the Trials of Hypertension Prevention, phase I. Trials of Hypertension Prevention Collaborative Research Group. Hypertension. 1993 Oct;22(4):502-12. doi: 10.1161/01.hyp.22.4.502.
- Kumanyika SK, Cook NR, Cutler JA, Belden L, Brewer A, Cohen JD, Hebert PR, Lasser VI, Raines J, Raczynski J, Shepek L, Diller L, Whelton PK, Yamamoto M; Trials of Hypertension Prevention Collaborative Research Group. Sodium reduction for hypertension prevention in overweight adults: further results from the Trials of Hypertension Prevention Phase II. J Hum Hypertens. 2005 Jan;19(1):33-45. doi: 10.1038/sj.jhh.1001774.
- Welsh D, Lennie TA, Marcinek R, Biddle MJ, Abshire D, Bentley B, Moser DK. Low-sodium diet self-management intervention in heart failure: pilot study results. Eur J Cardiovasc Nurs. 2013 Feb;12(1):87-95. doi: 10.1177/1474515111435604. Epub 2012 Apr 4.
- d'Almeida KS, Souza GC, Rabelo ER. Cross-cultural adaptation into Brazilian portuguese of the Dietary Sodium Restriction Questionnaire (DSRQ). Arq Bras Cardiol. 2012 Jan;98(1):70-5. doi: 10.1590/s0066-782x2011005000122. Epub 2011 Dec 15. Erratum In: Arq Bras Cardiol. 2012 Jan;98(1):1. English, Portuguese, Spanish.
- d'Almeida KS, Souza GC, Rabelo-Silva ER. Validity and reliability of the Dietary Sodium Restriction Questionnaire (DSRQ). Nutr Hosp. 2013 Sep-Oct;28(5):1702-9. doi: 10.3305/nh.2013.28.5.6679.
- Bentley B, Lennie TA, Biddle M, Chung ML, Moser DK. Demonstration of psychometric soundness of the Dietary Sodium Restriction Questionnaire in patients with heart failure. Heart Lung. 2009 Mar-Apr;38(2):121-8. doi: 10.1016/j.hrtlng.2008.05.006. Epub 2008 Aug 28.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2015
Primärt slutförande (Förväntat)
1 juni 2017
Avslutad studie (Förväntat)
1 december 2017
Studieregistreringsdatum
Först inskickad
26 juli 2016
Först inskickad som uppfyllde QC-kriterierna
26 juli 2016
Första postat (Uppskatta)
28 juli 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
29 juli 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 juli 2016
Senast verifierad
1 juli 2016
Mer information
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Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 150496
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