Clinical trial NCT00447317: Dietary Adherence Enhancement in Peritoneal Dialysis: BalanceWise-PD
Official title: Dietary Adherence Enhancement in Peritoneal Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-Stage Renal Disease
Keywords: peritoneal dialysis
diet
sodium
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2007-03-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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. 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


Eligibility criteria: Inclusion Criteria:

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)

Exclusion Criteria:

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

Primary outcomes:
measure: Dietary sodium intake as assessed from 3-day recalls.
timeFrame: baseline and 4 months
measure: Dietary sodium effluent and urine concentration.
timeFrame: baseline and 4 months
measure: Morning blood pressure.
timeFrame: baseline and 4 months
measure: Morning post dialysis weight.
timeFrame: baseline and 4 months
measure: Feasibility and acceptability of PDA-based dietary monitoring.
timeFrame: 4 months
Secondary outcomes:
measure: Dietary intake of protein, calories, and phosphorus.
timeFrame: baseline and 4 months
measure: Perceived dietary barriers.
timeFrame: baseline and 4 months
measure: Perceived dietary therapeutic efficacy.
timeFrame: baseline and 4 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Dialysis Clinics, Inc.
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Mary A Sevick, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.