Advertisement

Topics

Intervention to Reduce Dietary Sodium in Hemodialysis

2014-08-27 03:13:39 | BioPortfolio

Summary

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.

Description

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 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 IDWGA 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. 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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Conditions

Renal Dialysis

Intervention

Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring, Attention Control

Location

University of Pittsburgh School of Medicine
Pittsburgh
Pennsylvania
United States
15213

Status

Recruiting

Source

University of Pittsburgh

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:39-0400

Clinical Trials [3451 Associated Clinical Trials listed on BioPortfolio]

Diabetes CKD Lifestyle Technology Study

The purpose of this study is to pilot test an mHealth technology-supported behavioral intervention designed to engage patients with diabetes and concurrent chronic kidney disease (CKD) in ...

Physical Activity After Endometrial Cancer

Researchers propose to apply Social Cognitive Theory to improve understanding of the mechanisms of physical activity adherence for endometrial cancer survivors participating in a physical ...

RC2S+: Remediation of Social Cognitive Impairments

Background: Difficulties in social interactions are a central characteristic of people with schizophrenia, and can be partly explained by impairments of social cognitive processes. ...

Internet-delivered CBT vs Internet-delivered Support and Counseling for Youth With Social Anxiety Disorder - An RCT

Social anxiety disorder among youth is highly prevalent and causes significant impairment in the lives of the affected. In spite of cognitive behavior therapy (CBT) being an effective trea...

Description of the Evolution of a Cohort of Adolescents With Type 1 Diabetes Following Their Participation in Therapeutic Education Program Based on Social Cognitive Theory: Socio-cognitive Profile, Physiological Behaviour of Therapeutic Adherence and Qua

Introduction: Therapeutic Patient Education (TPE) is the key of the interdisciplinary management of type 1 diabetes for adolescents, favoring their adherence and improving their quality of...

PubMed Articles [24833 Associated PubMed Articles listed on BioPortfolio]

What psycho-social factors determine intimate partner violence of men against women? A social cognitive theory-based study.

Despite the multidimensionality of intimate partner violence (IPV) against women, there is a lack of research on the perspectives of men toward the phenomenon. Our aim in this cross-sectional study wa...

The efficacy of social cognitive theory-based self-care intervention for rational antibiotic use: a randomized trial.

Misuse of antibiotics can be described as a failure to complete treatment, skipping of the doses and reuse of leftover medicines and overuse of antibiotics. Health education interventions are expected...

Emotion perception, non-social cognition and symptoms as predictors of theory of mind in schizophrenia.

Theory of mind (ToM) can be divided into cognitive and affective ToM, and a distinction can be made between overmentalizing and undermentalizing errors. Research has shown that ToM in schizophrenia is...

Social cognitive abilities predict psychosocial dysfunction in major depressive disorder.

Major depressive disorder (MDD) is associated with social cognitive deficits (e.g., poor affect recognition and impaired theory of mind). However, the contribution of social cognitive issues to psycho...

Interventions for the treatment of theory of mind deficits in schizophrenia: Systematic literature review.

Theory of Mind (ToM) plays a central role in regulating social interactions and its impairment is consistently reported in schizophrenia. Regarding schizophrenia, ToM is usually discussed as a sub-dom...

Medical and Biotech [MESH] Definitions

Frameworks of empirical evidence used to study and interpret social phenomena.

A psychological theory based on dimensions or categories used by a given person in describing or explaining the personality and behavior of others or of himself. The basic idea is that different people will use consistently different categories. The theory was formulated in the fifties by George Kelly. Two tests devised by him are the role construct repertory test and the repertory grid test. (From Stuart Sutherland, The International Dictionary of Psychology, 1989)

A direct form of psychotherapy based on the interpretation of situations (cognitive structure of experiences) that determine how an individual feels and behaves. It is based on the premise that cognition, the process of acquiring knowledge and forming beliefs, is a primary determinant of mood and behavior. The therapy uses behavioral and verbal techniques to identify and correct negative thinking that is at the root of the aberrant behavior.

Counseling during which a professional plays an active role in a client's or patient's decision making by offering advice, guidance, and/or recommendations.

Counseling conducted via electronic or other non-face-to-face interactions.

More From BioPortfolio on "Intervention to Reduce Dietary Sodium in Hemodialysis"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Dialysis
In medicine, dialysis is a process for removing waste and excess water from the blood, and is primarily used to provide an artificial replacement for lost kidney function in people with renal failure. Dialysis may be used for those with an acute disturba...


Searches Linking to this Trial