Impact of a Personal Digital Assistant (PDA) - Based Dietary Adherence Intervention on Interdialytic Weight Gain and Blood Pressure in Hemodialysis Patients

NCT00447408 | Completed DMC

• 1 other identifier: 0605006
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

With this study the investigators will test, in a randomised clinical trial (RCT), the efficacy of a behavioral dietary adherence enhancement intervention paired with PDA-based dietary self-monitoring for controlling sodium intake. Seventy hemodialysis patients will be recruited from units in Pittsburgh, Pennsylvania. Participants will be randomized to a 4-month PDA-based dietary counseling intervention or to a 4-month attention control. Potential participants will be stratified by whether or not they have diabetes. Data on primary and secondary outcomes will be obtained at baseline and four months. Primary dependent variables are:

1. 1.adherence to dietary sodium targets as assessed from 3-day food recalls,
2. 2.average monthly interdialytic weight gain, and
3. 3.average pulse pressure. Secondary dependent variables are:
4. 4.adherence to dietary targets for calories, protein, carbohydrates, fats, saturated fats, potassium, and phosphorus, as assessed from 3-day food recalls, (5) serum potassium and phosphorus levels determined on a monthly basis, and (6) nutritional status as determined from serum albumin. Laboratory data, interdialytic weight gain, and blood pressure data will be obtained per dialysis center routine and abstracted from the medical record. Three-day food recalls will be obtained at baseline, 4 and 8 months and analyzed using the Nutrient Data System.

Conditions

End-Stage Renal Disease

Keywords

hemodialysis; dietary adherence; sodium

Outcome Measures

Primary Outcomes (3)

• adherence to dietary sodium targets as assessed from 3-day food recalls

  baseline and 4 months

• average daily interdialytic weight gain (IDWG)

  IDWG gathered with each dialysis treatment

• average pulse pressure from pre-dialysis blood pressures

  with each dialysis treatment

Secondary Outcomes (3)

• adherence to dietary targets for calories, protein, carbohydrates, fats, saturated fats, potassium, and phosphorus, as assessed from 3-day food recalls

  collected at baseline and 4 months

• serum potassium and phosphorus levels

  baseline, and 1, 2, 3, and 4 months

• nutritional status as determined from serum albumin

  baseline, 1, 2, 3, and 4 months

Study Arms (2)

A

ACTIVE COMPARATOR

Education in the hemodialysis diet.

Behavioral: Standard hemodialysis dietary instruction

B

EXPERIMENTAL

Education in the hemodialysis diet. Behavioral counseling paired with PDA-based self-monitoring of dietary sodium intake.

Behavioral: Behavioral counseling plus PDA-based self-monitoring of diet

Interventions

Standard hemodialysis dietary instruction BEHAVIORAL

Participants receive standard hemodialysis dietary instruction via a PowerPoint presentation delivered during routinely scheduled dialysis treatments.

A

Behavioral counseling plus PDA-based self-monitoring of diet BEHAVIORAL

Participants receive standard hemodialysis dietary instruction via a PowerPoint presentation delivered during routinely scheduled dialysis treatments. In addition they receive behavioral counseling paired with PDA-based self-monitoring of dietary sodium intake.

B

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those individuals who are 21 years of age or older
• Literate
• Community-dwelling adults
• Receiving maintenance HD for at least 3 months

You may not qualify if:

• Individuals 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 6 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.
• Those individuals with a score ≤ 26 on the Mini Mental Status Exam.
• Also excluded will be 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
• Paul Teschan Research Fund: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Campbell ZC, Dawson JK, Kirkendall SM, McCaffery KJ, Jansen J, Campbell KL, Lee VW, Webster AC. Interventions for improving health literacy in people with chronic kidney disease. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD012026. doi: 10.1002/14651858.CD012026.pub2.

  PMID: 36472416 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Behavior Therapy

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

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

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: January 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: June 28, 2010

Record last verified: 2010-06

Locations

US (1)