Diet Modification, Kidney Transplant Recipient, Physical Activity
Conditions
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.
Interventions
BEHAVIORALTelevideo 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.
BEHAVIORALEnhanced Usual Care
Six months of healthy lifestyle habit tracking with access to written diet and physical activity materials.
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment of participants | 1 month | Achievement of 10 participants in 1 months |
| Attendance to group sessions | 3 months | Maintain 80% attendance or better to program sessions |
| Participant retention in study assessments | 6 months | 85% or greater participant retention in study assessments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life-Kidney Transplant Questionnaire (KTQ) | Baseline, 3 months, 6 months | 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. |
Countries
United States
Outcome results
None listed