- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT01125202
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
Status
Zakończony
Warunki
Interwencja / Leczenie
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
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Pennsylvania
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15213
- University of Pittsburgh School of Medicine
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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 |
|---|---|
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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.
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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.
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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.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Time Specific Interdialytic Weight Gain (Baseline)
Ramy czasowe: Baseline
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Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to baseline measurement.
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Baseline
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Time Specific Interdialytic Weight Gain (8 Weeks)
Ramy czasowe: 8 weeks
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Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 8-week measurement time point.
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8 weeks
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Time Specific Interdialytic Weight Gain (12 Weeks)
Ramy czasowe: 12 weeks
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Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 12 week measurement time point.
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12 weeks
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Time Specific Interdialytic Weight Gain (16 Weeks)
Ramy czasowe: 16 weeks
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Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 16 week measurement time point.
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16 weeks
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Time Specific Dietary Sodium Intake (Baseline)
Ramy czasowe: Baseline
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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.
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Baseline
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Time Specific Dietary Sodium Intake (8 Weeks)
Ramy czasowe: 8 weeks
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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.
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8 weeks
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Time Specific Dietary Sodium Intake (16 Weeks)
Ramy czasowe: 16 weeks
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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.
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16 weeks
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Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 8 Weeks)
Ramy czasowe: Baseline to 8 weeks
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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.
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Baseline to 8 weeks
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Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 16 Weeks)
Ramy czasowe: Baseline to 16 weeks
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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.
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Baseline to 16 weeks
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Publikacje i pomocne linki
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Publikacje ogólne
- McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6(6):CD010070. doi: 10.1002/14651858.CD010070.pub3.
- Sevick MA, Piraino BM, St-Jules DE, Hough LJ, Hanlon JT, Marcum ZA, Zickmund SL, Snetselaar LG, Steenkiste AR, Stone RA. No Difference in Average Interdialytic Weight Gain Observed in a Randomized Trial With a Technology-Supported Behavioral Intervention to Reduce Dietary Sodium Intake in Adults Undergoing Maintenance Hemodialysis in the United States: Primary Outcomes of the BalanceWise Study. J Ren Nutr. 2016 May;26(3):149-58. doi: 10.1053/j.jrn.2015.11.006. Epub 2016 Feb 9.
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
Słowa kluczowe
Inne numery identyfikacyjne badania
- PRO08040361
- R01NR010135 (Grant/umowa NIH USA)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .