Clinical trial NCT03697317: Televideo Exercise and Nutrition Program for Kidney Transplant Recipients
Official title: Televideo Exercise and Nutrition Program for Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplant Recipient
Diet Modification
Physical Activity
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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). 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.


Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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
* Inability to perform moderate to vigorous physical activity
* Unwillingness to be randomized
* Receiving supplemental nutrition

Primary outcomes:
measure: Recruitment of participants
timeFrame: 1 month
measure: Attendance to group sessions
timeFrame: 3 months
measure: Participant retention in study assessments
timeFrame: 6 months
Secondary outcomes:
measure: Change in diet quality assessed by Healthy Eating Index Scores
timeFrame: Change from baseline to month 6
measure: Change in weight
timeFrame: Change from baseline to month 6
Other outcomes:
measure: Quality of Life-Kidney Transplant Questionnaire (KTQ)
timeFrame: Baseline, 3 months, 6 months
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Cheryl A Gibson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.