Dietary Adherence Enhancement in Peritoneal Dialysis: BalanceWise-PD

NCT00447317 | Completed DMC

• 1 other identifier: R21DK067181
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 1.Explore the impact of the intervention on dietary sodium intake,
2. 2.Explore the intervention on blood pressure,
3. 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. 4.Explore the feasibility and acceptability of the intervention

Conditions

End-Stage Renal Disease

Keywords

peritoneal dialysis; diet; sodium

Outcome Measures

Primary Outcomes (5)

• Dietary sodium intake as assessed from 3-day recalls.

  baseline and 4 months

• Dietary sodium effluent and urine concentration.

  baseline and 4 months

• Morning blood pressure.

  baseline and 4 months

• Morning post dialysis weight.

  baseline and 4 months

• Feasibility and acceptability of PDA-based dietary monitoring.

  4 months

Secondary Outcomes (3)

• Dietary intake of protein, calories, and phosphorus.

  baseline and 4 months

• Perceived dietary barriers.

  baseline and 4 months

• Perceived dietary therapeutic efficacy.

  baseline and 4 months

Study Arms (2)

A

EXPERIMENTAL

Intervention

Behavioral: BalanceWise-PD

B

OTHER

Attention control, standard dietary education

Behavioral: Attention control

Interventions

BalanceWise-PD BEHAVIORAL

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

A

Attention control BEHAVIORAL

Standard peritoneal dialysis dietary education

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The investigators will recruit those individuals:
• who are 18 years of age or older,
• who are literate, community-dwelling adults, and
• who have been receiving maintenance PD for at least 3 months. Individuals on maintenance PD less than 3 months are excluded to allow for patients to adjust to the PD regimen, and for stabilization of nutritional status in the early weeks of dialysis (i.e. they may be considered for the study after 3 months of dialysis)

You may not qualify if:

• Excluded from the study will be individuals:
• who are deemed by dialysis center staff to have a problem with cognitive function and to be chronically noncompliant to the dialysis regimen (e.g. misses multiple appointments and dialysis treatments),
• those who cannot read or write, those who do not speak English,
• those who plan to move out of the area or change dialysis centers within the next 5 months,
• those with a terminal illness and life expectancy of less than 12 months,
• those who are scheduled for a living donor transplant,
• individuals who cannot see the PDA screen or use the stylus to make selections from the PDA screen, or
• individuals who are living in a nursing home or personal care facility, who would have limited control over their dietary intake

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Dialysis Clinics, Inc.

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 34164803 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary A Sevick, ScD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 12, 2007
• First Posted: March 14, 2007
• Study Start: November 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: May 17, 2010

Record last verified: 2010-05

Locations

US (1)