ObesityNCT01859104
Feasibility of Use of BariCare App in Pre-transplant Population
A study testing Use of smartphone app in people with Obesity and Pre-Renal Transplant Candidate, run by Mayo Clinic at 1 site in United States.
Trial summary
This current study aims to evaluate the efficacy of engagement modules in assisting patients who are candidates for renal and liver transplantation make significant lifestyle modifications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Pre-Renal Transplant Candidate, Pre-liver Transplant Candidate
- What is being tested?
- Use of smartphone app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Mar 2017
- 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
- Individuals who are candidates for liver or renal transplant.
- Individuals who own a smartphone.
- Individuals who are obese.
Who cannot join
- Patients with prior history of bariatric surgery.
- Patients with active psychiatric disorder.
- Patients with active tobacco use.
- Patients with active substance use (alcohol, illicit drugs, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Feasibility and Efficacy of Engagement Modules for Renal and Liver Transplant Candidates
This current study aims to evaluate the efficacy of engagement modules in assisting patients who are candidates for renal and liver transplantation make significant lifestyle modifications. With the help of the Center for Innovation (CFI), a smartphone app (Android and iOS compatible) has been created to assist in both educating and engaging patients to develop and maintain healthy lifestyle modifications. Our goal is to create a cost-effective, smartphone-based platform that serves to not only efficiently educate but to also verify competence and keep our patients engaged.
- Being tested
- Use of smartphone app
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of smartphone appBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Smartphone Arm | Other | This is a feasibility trial and thus all participants in the study will be provided a smartphone app to assist them in making lifestyle modifications Receives: Behavioral: Use of smartphone app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smart Phone App Feasibility
The primary objective will be to assess ease and feasibility of use by subjects. They will provide information through questionnaires developed to assess these factors.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startSep 2015
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Why it stopped: App to be used in study needs revision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manpreet S. Mundi, Mayo Clinic
- Investigators
- Manpreet Mundi, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859104
- Sponsor's protocol ID
- 13-001535
- Status last verified
- Mar 2018
- First submitted
- 17 May 2013
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of Engagement Modules for Renal and Liver Transplant Candidates
- ClinicalTrials.gov ID
- NCT01859104
- Acronym / sponsor ID
- 13-001535
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: App to be used in study needs revision.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 21 May 2013 (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 current study aims to evaluate the efficacy of engagement modules in assisting patients who are candidates for renal and liver transplantation make significant lifestyle modifications. With the help of the Center for Innovation (CFI), a smartphone app (Android and iOS compatible) has been created to assist in both educating and engaging patients to develop and maintain healthy lifestyle modifications. Our goal is to create a cost-effective, smartphone-based platform that serves to not only efficiently educate but to also verify competence and keep our patients engaged.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smartphone Arm | Other | Behavioral: Use of smartphone appThis is a feasibility trial and thus all participants in the study will be provided a smartphone app to assist them in making lifestyle modifications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals who are candidates for liver or renal transplant.
- Individuals who own a smartphone.
- Individuals who are obese.
Key exclusion criteria (4 listed)
- Patients with prior history of bariatric surgery.
- Patients with active psychiatric disorder.
- Patients with active tobacco use.
- Patients with active substance use (alcohol, illicit drugs, etc.)
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 |
|---|---|---|
| Use of smartphone app | Behavioural | Smartphone Arm |
Primary outcome
Smart Phone App Feasibility
Time frame: 3 months
The primary objective will be to assess ease and feasibility of use by subjects. They will provide information through questionnaires developed to assess these factors.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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.
Manpreet Mundi, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of smartphone app in people with Obesity and Pre-Renal Transplant Candidate, run by Mayo Clinic 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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 22 Mar 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
Smart Phone App Feasibility (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2018.