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Dietary Adherence Enhancement in Peritoneal Dialysis: BalanceWise-PD

NCT00447317 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-05-17

No results posted yet for this study

Summary

This randomized study will pilot test an intervention, based on self-efficacy theory and involving personal digital assistant (PDA)-based dietary self-monitoring, to improve adherence to the peritoneal dialysis dietary regimen. 60 individuals, 21 years of age or older, who are on continuous ambulatory peritoneal dialysis or nightly cycler peritoneal dialysis, will be recruited to the study. Participants will be randomized to one of 2 groups. Group A will receive a 4-month active intervention of decreasing intensity over time delivered via mail, telephone, and during regularly scheduled dialysis clinic visits. Group B will receive a 4-month attention control experience in which they receive reinforcement of standard dietary education. With this study the investigators will:

1. Explore the impact of the intervention on dietary sodium intake,
2. Explore the intervention on blood pressure,
3. Explore the impact of the intervention on morning post dialysis weight (i.e. weight after conclusion of continuous cycling peritoneal dialysis (CCPD) or after long dwell for continuous ambulatory peritoneal dialysis (CAPD) patients, AND
4. Explore the feasibility and acceptability of the intervention

Conditions

  • End-Stage Renal Disease

Interventions

BEHAVIORAL

BalanceWise-PD

Dietary counseling based on Social Cognitive Theory, paired with PDA-based dietary self-monitoring

BEHAVIORAL

Attention control

Standard peritoneal dialysis dietary education

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Mary A Sevick, ScD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00447317 on ClinicalTrials.gov