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- Klinische Studie NCT01125202
Intervention to Reduce Dietary Sodium in Hemodialysis (BalanceWise-HD)
14. August 2017 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
179
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Vereinigte Staaten, 15213
- University of Pittsburgh School of Medicine
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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.
|
Aktiver 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Time Specific Interdialytic Weight Gain (Baseline)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. September 2009
Primärer Abschluss (Tatsächlich)
1. September 2012
Studienabschluss (Tatsächlich)
1. September 2012
Studienanmeldedaten
Zuerst eingereicht
14. Mai 2010
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
17. Mai 2010
Zuerst gepostet (Schätzen)
18. Mai 2010
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
15. August 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
14. August 2017
Zuletzt verifiziert
1. August 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- PRO08040361
- R01NR010135 (US NIH Stipendium/Vertrag)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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