[logo] HealthTree Foundation
search more_vert
close
person Sign In / Create Account
arrow_back

Go back to trials list

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


Description

* 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.

Trial Eligibility

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

Study Info

Organization

University of Utah


Primary Outcome

Average Change in Sedentary Duration at Months 8, 10 and 12 from Randomization


Outcome Timeframe Randomization to 12 Months

NCTID NCT05173714

Phases PHASE2

Primary Purpose TREATMENT

Start Date 2021-12-01

Completion Date 2026-12-31

Enrollment Target 156

Interventions

BEHAVIORAL SLIMM

BEHAVIORAL Standard Resistance Training

BEHAVIORAL Guided Resistance Training

DRUG Placebo

DRUG Semaglutide

Locations Recruiting

Stanford University

United States, California, Stanford


University of Utah

United States, Utah, Salt Lake City


Interested in joining this trial?

Our dedicated patient navigators are here to guide you through the validation and enrollment process with ease.

newsletter icon

Get the latest thought leadership on your Kidney Disease delivered straight to your inbox

Subscribe to the weekly newsletter for news, stories, clinical trial updates, and helpful resources and events with cancer experts.