Televideo Exercise and Nutrition Program for Kidney Transplant Recipients

Study Overview
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Brief Summary
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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.

Official Title
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Televideo Exercise and Nutrition Program for Kidney Transplant Recipients

Conditions
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Kidney Transplant Recipient, Diet Modification, Physical Activity

Intervention / Treatment
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* Behavioral: Televideo Lifestyle Coaching
* Behavioral: Enhanced Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |