Sit Less, Interact and Move More (SLIMM) 2 Study

RECRUITING

I'm interested ...!!

* 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.

Conditions:

🦠 Chronic Kidney Diseases 🦠 Obesity

🗓️ Study Start (Actual) 1 December 2021

🗓️ Primary Completion (Estimated) 31 December 2026

✅ Study Completion (Estimated) 31 March 2027

👥 Enrollment (Estimated) 156

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE2

Locations:

📍 Stanford, California, United States

📍 Salt Lake City, Utah, United States

📋 Eligibility Criteria

Description

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Ages Eligible for Study: 20 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 4 November 2021
First Submitted that Met QC Criteria 20 December 2021
First Posted 30 December 2021

Study Record Updates

Last Update Submitted that Met QC Criteria 19 March 2024
Last Update Posted 20 March 2024
Last Verified March 2024