Sit Less, Interact and Move More (SLIMM) 2 Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Average Change in Sedentary Duration at Months 8, 10 and 12 from Randomization
研究概览
简要总结
- Prolonged sitting (sedentary behavior) is a risk factor for decreased kidney function, obesity, diabetes and mortality. Prolonged sitting is associated with decreased kidney function and increased risk of diabetes, heart disease and death.
- In a previous pilot study funded by NIH, it was shown that a Sit Less, Interact and Move More (SLIMM) intervention targeting sedentary behavior in people with kidney disease was able to decrease prolonged sitting but that effect was not sustained.
- Therefore, the researchers are currently conducting a follow-up study named Sit Less, Interact and Move More (SLIMM) 2.
- This NIH funded study is conducted at the University of Utah and Stanford University.
- The purpose of this study is to see if guided resistance training (to improve muscle strength) and semaglutide (FDA approved diabetes and weight loss medication that might also improve physical function) can boost adherence to the SLIMM Intervention and reduce sedentary behavior.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Glomerular Filtration Rate (eGFR) 20 to <60 mL/min/1.73m^2
- •Able to perform resistance training
- •Access to compatible "smartphone" or device (i.e., Android, Kindle or Apple with internet connectivity or mobile network), desktop or laptop
排除标准
- •Type 1 Diabetes
- •History of gastroparesis or paralytic ileus
- •At baseline, if sedentary time is 25 min/hr or less, measured by accelerometer
- •Potential contraindications to semaglutide such as a history of pancreatitis, and a family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma.
- •Previous bariatric surgery
- •Medical condition likely to limit survival to less than 1 year
- •Anticipated start of dialysis or kidney transplantation within 6 months
- •Any factors judged by the investigator or study team to likely limit adherence to interventions
- •Vulnerable populations- pregnant or incarcerated
- •Enrolled in interventional trials using drugs or devices
- •Not able to undergo informed consent
- •Recent hospitalizations or major interventional procedures done within the past 60 days
- •Known or suspected hypersensitivity to tegaderm
- •Use of any GLP-1 receptor agonist within 30 days prior to screening
- •Presently classified as being in New York Heart Association (NYHA) Class IV Heart Failure
- •Daytime use of supplemental oxygen (i.e., prescribed a stationary or portable oxygen system)
- •Presence of metastatic cancer
- •Current use of mobility aid(s)
- •Living in the same household of a participant already enrolled in the study
研究组 & 干预措施
SLIMM + Guided RT + Semaglutide
SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, guided resistance training and oral semaglutide
干预措施: Semaglutide (Drug)
SLIMM + Standard RT + Placebo
SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, standard-of-care resistance training and oral placebo
干预措施: SLIMM (Behavioral)
SLIMM + Standard RT + Placebo
SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, standard-of-care resistance training and oral placebo
干预措施: Standard Resistance Training (Behavioral)
SLIMM + Standard RT + Placebo
SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, standard-of-care resistance training and oral placebo
干预措施: Placebo (Drug)
SLIMM + Guided RT + Placebo
SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, guided resistance training and oral placebo
干预措施: SLIMM (Behavioral)
SLIMM + Guided RT + Placebo
SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, guided resistance training and oral placebo
干预措施: Guided Resistance Training (Behavioral)
SLIMM + Guided RT + Placebo
SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, guided resistance training and oral placebo
干预措施: Placebo (Drug)
SLIMM + Guided RT + Semaglutide
SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, guided resistance training and oral semaglutide
干预措施: SLIMM (Behavioral)
SLIMM + Guided RT + Semaglutide
SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, guided resistance training and oral semaglutide
干预措施: Guided Resistance Training (Behavioral)
结局指标
主要结局
Average Change in Sedentary Duration at Months 8, 10 and 12 from Randomization
时间窗: Randomization to 12 Months
The primary analysis will provide estimates and confidence intervals for the three arms comparisons of changes in sedentary duration from randomization (at 3 months) to the average of changes at months 8, 10 and 12 between the randomized groups that constitute the co-primary comparisons under the study design
次要结局
- Average Change in Steps per Day at Months 8, 10 and 12 from Randomization(Randomization to 12 Months)
- Average Change in Body Fat % at Months 6 and 12 from Randomization(Randomization to 12 Months)
- Average Change in Stepping Duration at Months 8, 10 and 12 from Randomization(Randomization to 12 Months)
- Average Change in Six-Minute Walk at Months 6 and 12 from Randomization(Randomization to 12 Months)
研究者
Srinvasan Beddhu
Professor, Internal Medicine
University of Utah