Educational Intervention for Sodium Restriction in Patients With Hypertension
2016年7月28日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (予想される)
120
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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RS
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Porto Alegre、RS、ブラジル、: 90035-903
- 募集
- Leila Beltrami Moreira
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
40年～80年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
他の名前：
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偽コンパレータ：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
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
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Changes from baseline, after 8 weeks and 6 months in Dietary Sodium Restriction Questionnaire (DSRQ) score
時間枠：6 months
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6 months
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二次結果の測定
結果測定 |
時間枠 |
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Questionnaire sensitivity and specificity by the comparison of Dietary Sodium Restriction Questionnaire (DSRQ) scores to urinary sodium values
時間枠：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
時間枠：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
時間枠：6 months
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6 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Leila Moreira, MD PhD、Hospital de Clinicas de Porto Alegre
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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- 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.
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- 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.
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- 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.
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- 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.
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年11月1日
一次修了 (予想される)
2017年6月1日
研究の完了 (予想される)
2017年12月1日
試験登録日
最初に提出
2016年7月26日
QC基準を満たした最初の提出物
2016年7月26日
最初の投稿 (見積もり)
2016年7月28日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年7月29日
QC基準を満たした最後の更新が送信されました
2016年7月28日
最終確認日
2016年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 150496
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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