End-Stage Renal DiseaseBalanceWise-PDNCT00447317
Dietary Adherence Enhancement in Peritoneal Dialysis: BalanceWise-PD
A study testing BalanceWise-PD in people with End-Stage Renal Disease, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Renal Disease
- What is being tested?
- BalanceWise-PD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dialysis Clinics, Inc.
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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:
- Explore the impact of the intervention on dietary sodium intake,
- Explore the intervention on blood pressure,
- 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
- Explore the feasibility and acceptability of the intervention
- Conditions
- End-Stage Renal Disease
- Being tested
- BalanceWise-PD, Attention control
- Keywords
- peritoneal dialysis, diet, 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.
BalanceWise-PDBehavioural
Dietary counseling based on Social Cognitive Theory, paired with PDA-based dietary self-monitoring
Attention controlBehavioural
Standard peritoneal dialysis dietary education
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Intervention Receives: Behavioral: BalanceWise-PD |
| B | Other | Attention control, standard dietary education Receives: Behavioral: Attention control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary sodium intake as assessed from 3-day recalls.
Measured: baseline and 4 months
Dietary sodium effluent and urine concentration.
Measured: baseline and 4 months
Morning blood pressure.
Measured: baseline and 4 months
Morning post dialysis weight.
Measured: baseline and 4 months
Feasibility and acceptability of PDA-based dietary monitoring.
Measured: 4 months
Secondary outcomes (3)
Dietary intake of protein, calories, and phosphorus.
Measured: baseline and 4 months
Perceived dietary barriers.
Measured: baseline and 4 months
Perceived dietary therapeutic efficacy.
Measured: baseline 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 startNov 2007
- Primary completionNov 2009
- Study completionNov 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Investigators
- Mary A Sevick, ScD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447317
- Sponsor's protocol ID
- R21DK067181
- Acronym
- BalanceWise-PD
- Status last verified
- May 2010
- First submitted
- 12 Mar 2007
- Last updated
- 17 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34164803
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Adherence Enhancement in Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT00447317
- Acronym / sponsor ID
- BalanceWise-PD / R21DK067181
- Conditions
- End-Stage Renal Disease
- Keywords
- peritoneal dialysis, diet, sodium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Nov 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 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.
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:
- Explore the impact of the intervention on dietary sodium intake,
- Explore the intervention on blood pressure,
- 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
- Explore the feasibility and acceptability of the intervention
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: BalanceWise-PDIntervention |
| B | Other | Behavioral: Attention controlAttention control, standard dietary education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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,
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 |
|---|---|---|
| BalanceWise-PDDietary counseling based on Social Cognitive Theory, paired with PDA-based dietary self-monitoring | Behavioural | A |
| Attention controlStandard peritoneal dialysis dietary education | Behavioural | B |
Primary outcome
Dietary sodium intake as assessed from 3-day recalls.
Time frame: baseline and 4 months
Dietary sodium effluent and urine concentration.
Time frame: baseline and 4 months
Morning blood pressure.
Time frame: baseline and 4 months
Morning post dialysis weight.
Time frame: baseline and 4 months
Feasibility and acceptability of PDA-based dietary monitoring.
Time frame: 4 months
3 secondary outcomes
Dietary intake of protein, calories, and phosphorus.
Time frame: baseline and 4 months
Perceived dietary barriers.
Time frame: baseline and 4 months
Perceived dietary therapeutic efficacy.
Time frame: baseline 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 17 May 2010.
- Derived from this study: PubMed 34164803McMahon 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.
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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 BalanceWise-PD 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 17 May 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?
Dietary sodium intake as assessed from 3-day recalls. (time frame: baseline and 4 months). The study lists 5 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 NCT00447317, 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 17 May 2010.