Televideo Exercise and Nutrition Program for Kidney Transplant Recipients

Physical Activity Clinical Trial

Official title:

Televideo Exercise and Nutrition Program for Kidney Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03697317
• Other study ID #: STUDY00140695
• Status: Completed
• Phase: N/A
• Start date: September 12, 2017
• Est. completion date: March 30, 2018

Study information

• Verified date: October 2018
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diet Modification
• Kidney Transplant Recipient
• Physical Activity

Intervention

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.
• Enhanced Usual Care
Six months of healthy lifestyle habit tracking with access to written diet and physical activity materials.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Recruitment of participants	Achievement of 10 participants in 1 months	1 month
Primary	Attendance to group sessions	Maintain 80% attendance or better to program sessions	3 months
Primary	Participant retention in study assessments	85% or greater participant retention in study assessments	6 months
Secondary	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
Secondary	Change in weight	Weight in kilograms will be measured with a digital scale	Change from baseline to month 6