Sit Less, Interact and Move More (SLIMM) 2 Study
- Conditions
- Chronic Kidney DiseasesObesity
- Interventions
- Behavioral: SLIMMBehavioral: Standard Resistance TrainingBehavioral: Guided Resistance TrainingDrug: Placebo
- Registration Number
- NCT05173714
- Lead Sponsor
- Srinvasan Beddhu
- Brief Summary
* 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 156
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SLIMM + Standard RT + Placebo SLIMM SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, standard-of-care resistance training and oral placebo SLIMM + Standard RT + Placebo Standard Resistance Training SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, standard-of-care resistance training and oral placebo SLIMM + Standard RT + Placebo Placebo SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, standard-of-care resistance training and oral placebo SLIMM + Guided RT + Placebo SLIMM SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, guided resistance training and oral placebo SLIMM + Guided RT + Placebo Guided Resistance Training SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, guided resistance training and oral placebo SLIMM + Guided RT + Placebo Placebo SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, guided resistance training and oral placebo SLIMM + Guided RT + Semaglutide SLIMM SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, guided resistance training and oral semaglutide SLIMM + Guided RT + Semaglutide Guided Resistance Training SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, guided resistance training and oral semaglutide SLIMM + Guided RT + Semaglutide Semaglutide SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, guided resistance training and oral semaglutide
- Primary Outcome Measures
Name Time Method Average Change in Sedentary Duration at Months 8, 10 and 12 from Randomization 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
- Secondary Outcome Measures
Name Time Method Average Change in Steps per Day at Months 8, 10 and 12 from Randomization Randomization to 12 Months The analysis will provide estimates and confidence intervals for the three arms comparisons of changes in steps per day from randomization (at 3 months) to the average of changes at months 8, 10 and 12 between the randomized groups.
Average Change in Body Fat % at Months 6 and 12 from Randomization Randomization to 12 Months Changes in average body fat percentage as measured by bioimpedance analysis from randomization (at 3 months) to the average of changes at months 6 and 12
Average Change in Stepping Duration at Months 8, 10 and 12 from Randomization Randomization to 12 Months The analysis will provide estimates and confidence intervals for the three arms comparisons of changes in stepping duration from randomization (at 3 months) to the average of changes at months 8, 10 and 12 between the randomized groups.
Average Change in Six-Minute Walk at Months 6 and 12 from Randomization Randomization to 12 Months Changes in six minute walk distance from randomization (at 3 months) to the average of changes at months 6 and 12
Trial Locations
- Locations (2)
Stanford University
🇺🇸Stanford, California, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States