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Completed

NCT Number: NCT00447317

Dietary Adherence Enhancement in Peritoneal Dialysis: BalanceWise-PD

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dialysis Clinics, Inc.

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BalanceWise-PD

Behavioral

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

Attention Control

Behavioral

Standard peritoneal dialysis dietary education

Primary outcomes

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

    Time frame: baseline and 4 months

  2. Dietary sodium effluent and urine concentration.

    Time frame: baseline and 4 months

  3. Morning blood pressure.

    Time frame: baseline and 4 months

  4. Morning post dialysis weight.

    Time frame: baseline and 4 months

  5. Feasibility and acceptability of PDA-based dietary monitoring.

    Time frame: 4 months

Secondary outcomes

  1. Dietary intake of protein, calories, and phosphorus.

    Time frame: baseline and 4 months

  2. Perceived dietary barriers.

    Time frame: baseline and 4 months

  3. Perceived dietary therapeutic efficacy.

    Time frame: baseline and 4 months

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

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

Registry information

Official study title

Dietary Adherence Enhancement in Peritoneal Dialysis

Acronym: BalanceWise-PD

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 14, 2007
Registry last updated
May 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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