Prevention of Weight Gain and Impaired Glucose Metabolism Post Kidney Transplantation: A Pilot and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Body Weight
研究概览
简要总结
The goal of this clinical trial is to learn whether if it is feasible to implement a study of patients receiving kidney transplantation, to learn if these patients will complete selective outcomes measurements, and to examine if a lifestyle intervention may assist with preventing weight gain compared to standard medical care. The main questions it aims to answer are:
- Is it feasible to recruit and retain patients who have undergone kidney transplantation into a study to compare standard medical care to standard medical care plus a lifestyle intervention focused on prevention of weight gain?
- Will participants engage in the interventions and be compliant to the components of the interventions?
- Will there be any difference between the interventions between the interventions for the occurrence of adverse events specific to kidney transplantation?
- Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on preventing weight gain compared to standard medical care alone?
- Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on body composition compared to standard medical care alone?
- Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on fasting glucose compared to standard medical care alone?
- Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on fasting insulin compared to standard medical care alone?
- Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on insulin sensitivity compared to standard medical care alone?
- Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on physical function compared to standard medical care alone?
- Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on health-related quality of life compared to standard medical care alone?
- Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on changes in dietary intake compared to standard medical care alone?
- Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on physical activity and sedentary behavior compared to standard medical care alone?
Participants will:
- Participants will continue with their standard medical care following kidney transplantation.
- Participants only receiving standard medical care will also complete brief monitoring visits at week 6, 12, and 18.
- Participants receiving the lifestyle intervention will attend weekly intervention sessions and will be recommended to modify their diet and physical activity behaviors in an effort to prevent weight gain.
- Participants will complete outcome measurements as the start of the study and again after 6 months in the study.
- After 6 months in the study, participants will also complete a brief intervention and answer other questions about their experience in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Receiving a kidney transplant within the prior 3-5 months, with the transplant received from a deceased donor or living donor. NOTE: The patient will be eligible for randomization at 3 months following the kidney transplant, or at a subsequent time once clearance from the kidney transplant physician is given, provided that the time does not exceed 5 months following the kidney transplant.
- •Both males and females of all race/ethnic groups are eligible for participation in this study.
- •>=18 years of age.
- •Body mass index (BMI) >22 kg/m
- •There is no maximal BMI provided that the weight does not exceed the weight allowance of the dual-energy x-ray absorptiometer (DXA) that is used to assess body composition (maximal weight for the DXA is 350 pounds).
- •Ability to provide informed consent prior to participation in this study.
- •Ability to provide clearance from their kidney transplant physician to engage in the diet and physical activity components of the proposed intervention and to safely complete the proposed outcome measures.
- •Ability to walk for exercise.
排除标准
- •Females who are pregnant, breastfeeding, or reporting a planned pregnancy during the study period. Female participants of childbearing age who are not currently taking contraceptive medication, are not post-menopausal, or have not been surgically sterilized will need to agree to use a double barrier method of contraception.
- •History of bariatric surgery.
- •Currently prescribed an anti-obesity medication.
- •Report current medical condition or treatment for a medical condition that could affect body weight. These may include the following: diabetes mellitus; hyperthyroidism; inadequately controlled hypothyroidism; chronic liver disease; cancer; gastrointestinal disorders including ulcerative colitis, Crohn's disease, or malabsorption syndromes; etc.
- •Current congestive heart failure, angina, uncontrolled arrhythmia, symptoms indicative of an increased acute risk for a cardiovascular event, prior myocardial infarction, coronary artery bypass grafting or angioplasty, conditions requiring chronic anticoagulation (i.e., recent or recurrent DVT).
- •Resting systolic blood pressure of >=160 mmHg or resting diastolic blood pressure of >=100 mmHg or not on a stable medical treatment to control hypertension (stable dose is defined as the same dose and type of medication for a period of at least 6 months).
- •Eating disorders that would contraindicate modifying eating or physical activity behaviors.
- •Alcohol or substance abuse.
- •Currently treated for psychological issues (i.e., depression, bipolar disorder, etc.) that is accompanied by the following: 1) not on a stable dose of medications for treatment within the previous 12 months, or 2) hospitalized for depression within the previous 5 years.
- •Report plans to relocate to a location not accessible to the study site or having employment, personal, or travel commitments that prohibit attendance at scheduled intervention sessions or assessments.
研究组 & 干预措施
Standard Medical Care
Standard Care Intervention will continue to receive their regular standard clinical care during the 6-month intervention period of this study and will also receive brief conducts (<10 minutes) from the research staff at weeks 6, 12, and 18.
干预措施: Standard medical care (Other)
Standard Medical Care
Standard Care Intervention will continue to receive their regular standard clinical care during the 6-month intervention period of this study and will also receive brief conducts (<10 minutes) from the research staff at weeks 6, 12, and 18.
干预措施: Monitoring Contacts (Behavioral)
Standard Medical Care plus Lifestyle Intervention
Standard Medical Care plus Lifestyle Intervention will continue to receive their regular standard clinical care and a behavioral intervention focused on dietary modification and physical activity for body weight regulation.
干预措施: Standard medical care (Other)
Standard Medical Care plus Lifestyle Intervention
Standard Medical Care plus Lifestyle Intervention will continue to receive their regular standard clinical care and a behavioral intervention focused on dietary modification and physical activity for body weight regulation.
干预措施: Behavioral Sessions (Behavioral)
Standard Medical Care plus Lifestyle Intervention
Standard Medical Care plus Lifestyle Intervention will continue to receive their regular standard clinical care and a behavioral intervention focused on dietary modification and physical activity for body weight regulation.
干预措施: Diet (Behavioral)
Standard Medical Care plus Lifestyle Intervention
Standard Medical Care plus Lifestyle Intervention will continue to receive their regular standard clinical care and a behavioral intervention focused on dietary modification and physical activity for body weight regulation.
干预措施: Physical Activity (Behavioral)
结局指标
主要结局
Body Weight
时间窗: 0 and 6 months
Body weight will be assessed in duplicate using a calibrated digital scale to the nearest 0.1 kg.
次要结局
- Weight Loss Strategies(0 and 6 months)
- Body Mass Index(0 and 6 months)
- Percent body fat(0 and 6 months)
- Body Fat Mass(0 and 6 months)
- Lean Body Mass(0 and 6 months)
- Bone mineral content(0 and 6 months)
- Waist Circumference(0 and 6 months)
- Hip Circumference(0 and 6 months)
- Resting blood pressure(0 and 6 months)
- Resting heart rate(0 and 6 months)
- Physical Function(0 and 6 months)
- Fasting glucose(0 and 6 months)
- Fasting Insulin(0 and 6 months)
- Insulin Resistance(0 and 6 months)
- Kidney function(0 and 6 months)
- Physical activity(0 and 6 months)
- Physical Activity(0 and 6 months)
- Sedentary behavior(0 and 6 months)
- Energy Intake (Dietary Intake)(0 and 6 months)
- Health-Related Quality of Life(0 and 6 months)
- Adverse and Serious Adverse Events(0 and 6 months and at other times when reported by the participant)
研究者
John M. Jakicic, PhD
Professor
University of Kansas Medical Center