End-Stage Renal DiseaseBalanceWise-HDNCT00447408
Impact of a Personal Digital Assistant (PDA) - Based Dietary Adherence Intervention on Interdialytic Weight Gain and Blood Pressure in Hemodialysis Patients
A study testing Standard hemodialysis dietary instruction and Behavioral counseling plus PDA-based self-monitoring of diet in people with End-Stage Renal Disease, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- End-Stage Renal Disease
- What is being tested?
- Standard hemodialysis dietary instruction and Behavioral counseling plus PDA-based self-monitoring of diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jan 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those individuals who are 21 years of age or older
- Literate
- Community-dwelling adults
- Receiving maintenance HD for at least 3 months
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Impact of a PDA-Based Dietary Adherence Intervention on Interdialytic Weight Gain and Blood Pressure in Hemodialysis Patients
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:
- adherence to dietary sodium targets as assessed from 3-day food recalls,
- average monthly interdialytic weight gain, and
- average pulse pressure. Secondary dependent variables are:
- 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
- Being tested
- Standard hemodialysis dietary instruction, Behavioral counseling plus PDA-based self-monitoring of diet
- Keywords
- hemodialysis, dietary adherence, sodium
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard hemodialysis dietary instructionBehavioural
Participants receive standard hemodialysis dietary instruction via a PowerPoint presentation delivered during routinely scheduled dialysis treatments.
Behavioral counseling plus PDA-based self-monitoring of dietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Education in the hemodialysis diet. Receives: Behavioral: Standard hemodialysis dietary instruction |
| B | Experimental | Education in the hemodialysis diet. Behavioral counseling paired with PDA-based self-monitoring of dietary sodium intake. Receives: Behavioral: Behavioral counseling plus PDA-based self-monitoring of diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
adherence to dietary sodium targets as assessed from 3-day food recalls
Measured: baseline and 4 months
average daily interdialytic weight gain (IDWG)
Measured: IDWG gathered with each dialysis treatment
average pulse pressure from pre-dialysis blood pressures
Measured: 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
Measured: collected at baseline and 4 months
serum potassium and phosphorus levels
Measured: baseline, and 1, 2, 3, and 4 months
nutritional status as determined from serum albumin
Measured: baseline, 1, 2, 3, and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2007 (estimated)
- Study startJan 2007
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End-Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Paul Teschan Research Fund
- Investigators
- Mary A Sevick, ScD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447408
- Sponsor's protocol ID
- 0605006
- Acronym
- BalanceWise-HD
- Status last verified
- Jun 2010
- First submitted
- 12 Mar 2007
- Last updated
- 28 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36472416
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a PDA-Based Dietary Adherence Intervention on Interdialytic Weight Gain and Blood Pressure in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00447408
- Acronym / sponsor ID
- BalanceWise-HD / 0605006
- Conditions
- End-Stage Renal Disease
- Keywords
- hemodialysis, dietary adherence, sodium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Paul Teschan Research Fund
- Study start
- Jan 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 14 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- adherence to dietary sodium targets as assessed from 3-day food recalls,
- average monthly interdialytic weight gain, and
- average pulse pressure. Secondary dependent variables are:
- 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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Behavioral: Standard hemodialysis dietary instructionEducation in the hemodialysis diet. |
| B | Experimental | Behavioral: Behavioral counseling plus PDA-based self-monitoring of dietEducation in the hemodialysis diet. Behavioral counseling paired with PDA-based self-monitoring of dietary sodium intake. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Those individuals who are 21 years of age or older
- Literate
- Community-dwelling adults
- Receiving maintenance HD for at least 3 months
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard hemodialysis dietary instructionParticipants receive standard hemodialysis dietary instruction via a PowerPoint presentation delivered during routinely scheduled dialysis treatments. | Behavioural | A |
| Behavioral counseling plus PDA-based self-monitoring of dietParticipants 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. | Behavioural | B |
Primary outcome
adherence to dietary sodium targets as assessed from 3-day food recalls
Time frame: baseline and 4 months
average daily interdialytic weight gain (IDWG)
Time frame: IDWG gathered with each dialysis treatment
average pulse pressure from pre-dialysis blood pressures
Time frame: with each dialysis treatment
3 secondary outcomes
adherence to dietary targets for calories, protein, carbohydrates, fats, saturated fats, potassium, and phosphorus, as assessed from 3-day food recalls
Time frame: collected at baseline and 4 months
serum potassium and phosphorus levels
Time frame: baseline, and 1, 2, 3, and 4 months
nutritional status as determined from serum albumin
Time frame: baseline, 1, 2, 3, and 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2010.
- Derived from this study: PubMed 36472416Campbell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary A Sevick, ScD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard hemodialysis dietary instruction and Behavioral counseling plus PDA-based self-monitoring of diet in people with End-Stage Renal Disease, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adherence to dietary sodium targets as assessed from 3-day food recalls (time frame: baseline and 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00447408, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2010.