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Intervention to Reduce Dietary Sodium in Hemodialysis (BalanceWise-HD)

14. srpna 2017 aktualizováno: Mary Ann Sevick, University of Pittsburgh
The purpose of this study is to test, in a randomized clinical trial of 200 hemodialysis patients, a behavioral intervention to reduce dietary sodium intake. The investigators will assess the impact on weight gain between dialysis treatments, blood pressures, symptoms, and health-related quality of life. The primary study hypotheses are that participants will gain less weight in between dialysis treatments, and that dietary recalls will demonstrate reduced consumption of dietary sodium.

Přehled studie

Detailní popis

Cardiovascular disease is the single most common cause of death in hemodialysis (HD) patients. Most HD patients have left ventricular hypertrophy(LVH), a significant predictor of death in this population. LVH is related to extracellular volume expansion and hypertension, both of which are amenable to dietary sodium restriction. However, dietary change is widely known to be difficult to achieve and sustain. Controlling dietary sodium is particularly difficult for HD because many foods are naturally high in sodium, and most prepared/prepackaged foods have significant amounts of sodium added to enhance taste and shelf-life. Research on behavioral methods that are effective in reducing dietary sodium intake in HD is very limited. The purpose of this study is to test, in a randomized clinical trial of 200 HD patients, a behavioral intervention, paired with personal digital assistant (PDA)-based dietary self-monitoring, to enhance adherence to dietary sodium restrictions. Specifically the investigators will: (a) Assess the impact of the intervention on average daily interdialytic weight gains (IDWG-A). (b) Examine the impact of the intervention on self-reported dietary sodium intake. The study hypotheses are that compared to the control group, the intervention group will: (1) demonstrate a statistically significant decline in IDWG-A over the 4-month intervention period, and (2) experience a greater decline in dietary sodium intake. Secondarily, the investigators will explore the impact of the intervention on: (a) pre-dialysis pulse pressure and mean arterial blood pressure, (b) hemodialysis dietary self-efficacy, and (c) intradialytic and postdialytic symptoms and general health-related quality of life. In addition, the investigators will characterize the barriers/facilitators to adherence to the HD dietary regimen and patient experience of the intervention through the use of qualitative methods. The intervention is based on Social Cognitive Theory (SCT). Self-monitoring within the context of the intervention is operationalized as PDA-based dietary recording using BalanceLog software. Participants randomized to the attention control will receive computerized dietary education. Attention control participants will be offered an abbreviated version of the intervention after the 4-month study period concludes. Differences in IDWG-A, pulse pressure, and mean arterial pressure will be examined using a random intercept linear regression modeling. Self-reported dietary sodium, self-efficacy, symptoms, and quality of life will be assessed at baseline, 6 weeks, and 4 month and differences will be examined using repeated measures modeling using GEE. Qualitative analysis of narrative data will be performed.

Typ studie

Intervenční

Zápis (Aktuální)

179

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Pennsylvania
      • Pittsburgh, Pennsylvania, Spojené státy, 15213
        • University of Pittsburgh School of Medicine

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Individuals with end stage renal disease (ESRD) who are 18 years of age or older,
  • Individuals who are literate,
  • Community-dwelling adults who have been receiving maintenance dialysis for at least 3 months.

Exclusion Criteria:

  • Individuals who cannot read or write,
  • Individuals who do not speak English,
  • Individuals who plan to move out of the area or change dialysis centers within the next 6 months,
  • Individuals who have a life expectancy of less than 12 months,
  • Individuals who are scheduled for a living donor transplant,
  • Individuals who cannot see the PDA screen or use the stylus to make food selections from the PDA screen, or
  • Individuals who live in an institutional setting in which they would have limited control over their dietary intake.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: SCT-based behavioral intervention
Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.
Intervention group continues to receive routine dialysis care. The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targeted counseling and engaged the participant in problem solving around dietary issues.
Aktivní komparátor: Attention control
Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.
Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Time Specific Interdialytic Weight Gain (Baseline)
Časové okno: Baseline
Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to baseline measurement.
Baseline
Time Specific Interdialytic Weight Gain (8 Weeks)
Časové okno: 8 weeks
Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 8-week measurement time point.
8 weeks
Time Specific Interdialytic Weight Gain (12 Weeks)
Časové okno: 12 weeks
Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 12 week measurement time point.
12 weeks
Time Specific Interdialytic Weight Gain (16 Weeks)
Časové okno: 16 weeks
Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 16 week measurement time point.
16 weeks
Time Specific Dietary Sodium Intake (Baseline)
Časové okno: Baseline
Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls.
Baseline
Time Specific Dietary Sodium Intake (8 Weeks)
Časové okno: 8 weeks
Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls.
8 weeks
Time Specific Dietary Sodium Intake (16 Weeks)
Časové okno: 16 weeks
Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls.
16 weeks
Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 8 Weeks)
Časové okno: Baseline to 8 weeks
Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls. The difference between measurement time points was determined.
Baseline to 8 weeks
Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 16 Weeks)
Časové okno: Baseline to 16 weeks
Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls.
Baseline to 16 weeks

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. září 2009

Primární dokončení (Aktuální)

1. září 2012

Dokončení studie (Aktuální)

1. září 2012

Termíny zápisu do studia

První předloženo

14. května 2010

První předloženo, které splnilo kritéria kontroly kvality

17. května 2010

První zveřejněno (Odhad)

18. května 2010

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

15. srpna 2017

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

14. srpna 2017

Naposledy ověřeno

1. srpna 2017

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • PRO08040361
  • R01NR010135 (Grant/smlouva NIH USA)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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