Dietary Adherence Enhancement in Peritoneal Dialysis: BalanceWise-PD

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00447317
First received: March 12, 2007
Last updated: May 14, 2010
Last verified: May 2010

March 12, 2007
May 14, 2010
November 2007
November 2009   (final data collection date for primary outcome measure)
  • Dietary sodium intake as assessed from 3-day recalls. [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]
  • Dietary sodium effluent and urine concentration. [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]
  • Morning blood pressure. [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]
  • Morning post dialysis weight. [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]
  • Feasibility and acceptability of PDA-based dietary monitoring. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Dietary sodium intake as assessed from 3-day recalls.
  • Dietary sodium effluent and urine concentration.
  • Morning blood pressure.
  • Morning post dialysis weight.
  • Feasibility and acceptability of PDA-based dietary monitoring.
Complete list of historical versions of study NCT00447317 on ClinicalTrials.gov Archive Site
  • Dietary intake of protein, calories, and phosphorus. [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]
  • Perceived dietary barriers. [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]
  • Perceived dietary therapeutic efficacy. [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]
  • Dietary intake of protein, calories, and phosphorus.
  • Perceived dietary barriers.
  • Perceived dietary therapeutic efficacy.
Not Provided
Not Provided
 
Dietary Adherence Enhancement in Peritoneal Dialysis: BalanceWise-PD
Dietary Adherence Enhancement in Peritoneal Dialysis

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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
End-Stage Renal Disease
  • 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
  • Experimental: A
    Intervention
    Intervention: Behavioral: BalanceWise-PD
  • B
    Attention control, standard dietary education
    Intervention: Behavioral: Attention control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
November 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00447317
R21 DK067181
Yes
Mary Ann Sevick, University of Pittsburgh
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Mary A Sevick, ScD University of Pittsburgh
University of Pittsburgh
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP