Televideo Exercise and Nutrition Program for Kidney Transplant Recipients

Not Applicable

Completed

• Conditions: Kidney Transplant Recipient; Physical Activity; Diet Modification

• Registration Number: NCT03697317
• Lead Sponsor: University of Kansas Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-12
• Primary Completion: 2018-03-30
• Study Completion: 2018-03-30
• Study First Submitted: 2018-09-21
• Status Verified: 2018-10
• Study First Submitted QC: 2018-10-03
• Last Update Submitted: 2018-10-03
• Study First Posted: 2018-10-05
• Last Update Posted: 2018-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recruitment of participants	1 month	Achievement of 10 participants in 1 months
Participant retention in study assessments	6 months	85% or greater participant retention in study assessments
Attendance to group sessions	3 months	Maintain 80% attendance or better to program sessions

Secondary Outcome Measures

Name	Time	Method
Change in diet quality assessed by Healthy Eating Index Scores	Change from baseline to month 6	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).
Change in weight	Change from baseline to month 6	Weight in kilograms will be measured with a digital scale

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States