Intervention to Reduce Dietary Sodium in Hemodialysis
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/16/2017 |
| Start Date: | September 2009 |
| End Date: | September 2012 |
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.
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.
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.
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.
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.
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