- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01125202
Intervention to Reduce Dietary Sodium in Hemodialysis (BalanceWise-HD)
14. august 2017 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
179
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- University of Pittsburgh School of Medicine
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.
|
Aktiv 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Time Specific Interdialytic Weight Gain (Baseline)
Tidsramme: Baseline
|
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)
Tidsramme: 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
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Time Specific Interdialytic Weight Gain (12 Weeks)
Tidsramme: 12 weeks
|
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)
Tidsramme: 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.
|
16 weeks
|
Time Specific Dietary Sodium Intake (Baseline)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.
|
Baseline to 16 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2009
Primær færdiggørelse (Faktiske)
1. september 2012
Studieafslutning (Faktiske)
1. september 2012
Datoer for studieregistrering
Først indsendt
14. maj 2010
Først indsendt, der opfyldte QC-kriterier
17. maj 2010
Først opslået (Skøn)
18. maj 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. august 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. august 2017
Sidst verificeret
1. august 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- PRO08040361
- R01NR010135 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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