Kidney Transplant RecipientNCT03697317
Televideo Exercise and Nutrition Program for Kidney Transplant Recipients
A study testing Televideo Lifestyle Coaching in people with Kidney Transplant Recipient and Diet Modification, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The improvement in morbidity and mortality observed with kidney transplantation is often curtailed by post-transplant weight gain, which is common among kidney transplant recipients (KTR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Recipient, Diet Modification, Physical Activity
- What is being tested?
- Televideo Lifestyle Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2017to 30 Mar 2018
- 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
- Age 18 years or older
- Between 6 and 12 months post kidney transplantation
- Kidney allograft only
- Functioning allograft (not on dialysis)
- BMI ≥ 22 kg/m2
- Available to participate in assessments over 6 months
Show all 9Show fewer
- Ability to speak and understand English
- Able to report data weekly by at least one of three alternative methods: telephone, email, or fax
- Access to wireless internet
Who cannot join
- Multi-organ transplant recipient
- Uncontrolled diabetes (Hemoglobin A1c≥8%)
- Currently pregnant or planning on becoming pregnant during the study
- Participation in a formal weight management, nutrition, or physical activity program
- Diagnosis of a major psychiatric illness
- Major dietary restrictions
Show all 9Show fewer
- Inability to perform moderate to vigorous physical activity
- Unwillingness to be randomized
- Receiving supplemental nutrition
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The improvement in morbidity and mortality observed with kidney transplantation is often curtailed by post-transplant weight gain, which is common among kidney transplant recipients (KTR). Post-transplant weight gain is associated with serious health issues such as cardiovascular disease, new onset diabetes after transplantation, and graft failure. Although these adverse effects of post-transplant weight gain are well recognized, interventions that target the modifiable risk factors of diet and physical activity to address post-transplantation weight gain are lacking. The purpose of this study is to test the feasibility of an in-home, televideo health coaching to increase the healthy behaviors of KTRs who are 6 months post-transplantation.
- Being tested
- Televideo Lifestyle Coaching, Enhanced Usual Care
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Televideo Lifestyle CoachingBehavioural
Six month total intervention: Three months of weekly 1-hour televideo healthy lifestyle coaching sessions involving 30 minutes of structured physical activity and 30 minutes of nutrition education and daily healthy lifestyle habit tracking. This is followed by 3 months of healthy lifestyle habit tracking only.
Enhanced Usual CareBehavioural
Six months of healthy lifestyle habit tracking with access to written diet and physical activity materials.
| Study group | Role | What they receive |
|---|---|---|
| Televideo Lifestyle Coaching | Experimental | Not described Receives: Behavioral: Televideo Lifestyle Coaching |
| Enhanced Usual Care | Active comparator | Not described Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment of participants
Achievement of 10 participants in 1 months
Measured: 1 month
Attendance to group sessions
Maintain 80% attendance or better to program sessions
Measured: 3 months
Participant retention in study assessments
85% or greater participant retention in study assessments
Measured: 6 months
Secondary outcomes (2)
Change in diet quality assessed by Healthy Eating Index Scores
Changes in dietary quality will be determined by calculating Healthy Eating Index- 2010 scores from 3 day food records. A total HEI-2010 score will be calculated, which is comprised of a summative score across 12 subscales, with higher scores indicative of a better diet quality (maximum score 100).
Measured: Change from baseline to month 6
Change in weight
Weight in kilograms will be measured with a digital scale
Measured: Change from baseline to month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start12 Sep 2017
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
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 Kidney Transplant RecipientStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheryl Gibson, University of Kansas Medical Center
- Investigators
- Cheryl A Gibson, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697317
- Sponsor's protocol ID
- STUDY00140695
- Status last verified
- Oct 2018
- First submitted
- 21 Sep 2018
- Last updated
- 5 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gibson CA, Gupta A, Greene JL, Lee J, Mount RR, Sullivan DK. Feasibility and acceptability of a televideo physical activity and nutrition program for recent kidney transplant recipients. Pilot Feasibility Stud. 2020 Sep 10;6:126. doi: 10.1186/s40814-020-00672-4. eCollection 2020.
PubMed 32944274
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Televideo Exercise and Nutrition Program for Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT03697317
- Acronym / sponsor ID
- STUDY00140695
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 5 Oct 2018 (actual)
- 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.
The improvement in morbidity and mortality observed with kidney transplantation is often curtailed by post-transplant weight gain, which is common among kidney transplant recipients (KTR). Post-transplant weight gain is associated with serious health issues such as cardiovascular disease, new onset diabetes after transplantation, and graft failure. Although these adverse effects of post-transplant weight gain are well recognized, interventions that target the modifiable risk factors of diet and physical activity to address post-transplantation weight gain are lacking. The purpose of this study is to test the feasibility of an in-home, televideo health coaching to increase the healthy behaviors of KTRs who are 6 months post-transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Televideo Lifestyle Coaching | Experimental | Behavioral: Televideo Lifestyle Coaching |
| Enhanced Usual Care | Active comparator | Behavioral: Enhanced Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 years or older
- Between 6 and 12 months post kidney transplantation
- Kidney allograft only
- Functioning allograft (not on dialysis)
- BMI ≥ 22 kg/m2
Key exclusion criteria (9 listed)
- Multi-organ transplant recipient
- Uncontrolled diabetes (Hemoglobin A1c≥8%)
- Currently pregnant or planning on becoming pregnant during the study
- Participation in a formal weight management, nutrition, or physical activity program
- Diagnosis of a major psychiatric illness
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 |
|---|---|---|
| Televideo Lifestyle CoachingSix month total intervention: Three months of weekly 1-hour televideo healthy lifestyle coaching sessions involving 30 minutes of structured physical activity and 30 minutes of nutrition education and daily healthy lifestyle habit tracking. This is followed by 3 months of healthy lifestyle habit tracking only. | Behavioural | Televideo Lifestyle Coaching |
| Enhanced Usual CareSix months of healthy lifestyle habit tracking with access to written diet and physical activity materials. | Behavioural | Enhanced Usual Care |
Primary outcome
Recruitment of participants
Time frame: 1 month
Achievement of 10 participants in 1 months
Attendance to group sessions
Time frame: 3 months
Maintain 80% attendance or better to program sessions
Participant retention in study assessments
Time frame: 6 months
85% or greater participant retention in study assessments
2 secondary outcomes
Change in diet quality assessed by Healthy Eating Index Scores
Time frame: Change from baseline to month 6
Change in weight
Time frame: Change from baseline to month 6
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 5 Oct 2018.
- Derived from this study: PubMed 32944274Gibson CA, Gupta A, Greene JL, Lee J, Mount RR, Sullivan DK. Feasibility and acceptability of a televideo physical activity and nutrition program for recent kidney transplant recipients. Pilot Feasibility Stud. 2020 Sep 10;6:126. doi: 10.1186/s40814-020-00672-4. eCollection 2020.
Related trials for Kidney Transplant Recipient
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Not yet recruitingPhase 2
(TNX-1500) in Kidney Transplant Recipients
Kidney Transplant, Kidney Transplant Failure and Rejection
Not yet recruitingPhase 2/3
Semaglutide for the Prevention Of Post-Transplant Diabetes Mellitus
Kidney Transplant Recipient
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.
Cheryl A Gibson, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Televideo Lifestyle Coaching in people with Kidney Transplant Recipient and Diet Modification, run by University of Kansas Medical Center 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 9 inclusion and 9 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 5 Oct 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 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?
Recruitment of participants (time frame: 1 month). 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 NCT03697317, 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 5 Oct 2018.