Televideo Exercise and Nutrition Program for Kidney Transplant Recipients

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 Overview

• Status: Completed
• Conditions: Physical Activity; Diet Modification; Kidney Transplant Recipient
• Intervention / Treatment: Behavioral: Televideo Lifestyle Coaching; Behavioral: Enhanced Usual Care

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Televideo Lifestyle Coaching	Behavioral: Televideo Lifestyle Coaching; 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.
Active Comparator: Enhanced Usual Care	Behavioral: Enhanced Usual Care; Six months of healthy lifestyle habit tracking with access to written diet and physical activity materials.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Change from baseline to month 6
Change in weight	Weight in kilograms will be measured with a digital scale	Change from baseline to month 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life-Kidney Transplant Questionnaire (KTQ)	Quality of life will be assessed using the Kidney Transplant Questionnaire, a 25-question disease-specific questionnaire with 5 dimensions measured- physical symptoms, fatigue, uncertainty/fear, appearance, and emotions. A higher score indicates a greater quality of life. A change in score greater than 0.5 in each domain is clinically significant.	Baseline, 3 months, 6 months

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Cheryl A Gibson, PhD, University of Kansas Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2017
• Primary Completion (Actual): March 30, 2018
• Study Completion (Actual): March 30, 2018

Study Registration Dates

• First Submitted: September 21, 2018
• First Submitted That Met QC Criteria: October 3, 2018
• First Posted (Actual): October 5, 2018

Study Record Updates

• Last Update Posted (Actual): October 5, 2018
• Last Update Submitted That Met QC Criteria: October 3, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00140695

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No