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

14 sierpnia 2017 zaktualizowane przez: 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.

Przegląd badań

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Rzeczywisty)

179

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • Pennsylvania
      • Pittsburgh, Pennsylvania, Stany Zjednoczone, 15213
        • University of Pittsburgh School of Medicine

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Aktywny komparator: 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Time Specific Interdialytic Weight Gain (Baseline)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

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Publikacje i pomocne linki

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Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 września 2009

Zakończenie podstawowe (Rzeczywisty)

1 września 2012

Ukończenie studiów (Rzeczywisty)

1 września 2012

Daty rejestracji na studia

Pierwszy przesłany

14 maja 2010

Pierwszy przesłany, który spełnia kryteria kontroli jakości

17 maja 2010

Pierwszy wysłany (Oszacować)

18 maja 2010

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

15 sierpnia 2017

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

14 sierpnia 2017

Ostatnia weryfikacja

1 sierpnia 2017

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • PRO08040361
  • R01NR010135 (Grant/umowa NIH USA)

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