Televideo Exercise and Nutrition Program for Kidney Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Recruitment of participants
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Enhanced Usual Care
干预措施: Enhanced Usual Care (Behavioral)
Televideo Lifestyle Coaching
干预措施: Televideo Lifestyle Coaching (Behavioral)
结局指标
主要结局
Recruitment of participants
时间窗: 1 month
Achievement of 10 participants in 1 months
Participant retention in study assessments
时间窗: 6 months
85% or greater participant retention in study assessments
Attendance to group sessions
时间窗: 3 months
Maintain 80% attendance or better to program sessions
次要结局
- Change in diet quality assessed by Healthy Eating Index Scores(Change from baseline to month 6)
- Change in weight(Change from baseline to month 6)
研究者
Cheryl Gibson
Professor
University of Kansas Medical Center