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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05173714
• Other study ID #: 138494
• Secondary ID: 1R01DK128640-01
• Status: Recruiting
• Phase: Phase 2
• Start date: December 1, 2021
• Est. completion date: March 31, 2027

Study information

• Verified date: March 2024
• Source: University of Utah
• Contact: Amara Sarwal, M.D.
• Phone: 801-585-9815
• Email: Amara.Sarwal[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: March 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Obesity
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• SLIMM
Increase in light walking activity, replacing 1 hour/day of sedentary duration with casual walking duration. Increase in sedentary breaks, from sitting/lying position to standing position, at least once every hour as independent of the total time spent on sedentary activities.
• Standard Resistance Training
Participants will be provided a standard resistance training regimen to follow during the course of the study. Participants will not receive individualized instruction, guidance or modification to the resistance training regimen.
• Guided Resistance Training
Supervised resistance training sessions are individualized for a low-resistance, high-repetition regimen of lower body major muscle groups with established guidelines. Instructions and resistance training bands will be provided for home use. Study participants will record compliance to the resistance training regimen for further guidance and potential modification.

Drug:
• Placebo
Oral placebo tablets (matching the experimental semaglutide) will be administered from the first through ninth months of the drug intervention period.
• Semaglutide
Oral semaglutide 3 mg/day will be administered for the first month of study drug intervention period, if tolerated, the dose will increase to 7 mg/day for the second month and to a maximum dose of 14 mg/day from the third through ninth months of the drug intervention period.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah
United States	Stanford University	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
Srinvasan Beddhu	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Average Change in Patient Reported Fatigue at Months 6 and 12 from Randomization	Changes in patient reported fatigue as measured by questionaires from randomization (at 3 months) to the average of changes at months 6 and 12	Randomization to 12 Months
Other	Average Change in Patient Reported Sleep at Months 6 and 12 from Randomization	Changes in patient reported sleep as measured by questionaires from randomization (at 3 months) to the average of changes at months 6 and 12	Randomization to 12 Months
Other	Average Change in Patient Reported Quality of Life at Months 6 and 12 from Randomization	Changes in patient reported quality of life as measured by questionaires from randomization (at 3 months) to the average of changes at months 6 and 12	Randomization to 12 Months
Other	Average Change in Lower Extremity Performance Battery Composite Score (LEP-CS) at Months 6 and 12 from Randomization	Changes in Lower Extremity Performance Battery Composite Score (LEP-CS) from randomization (at 3 months) to the average of changes at months 6 and 12	Randomization to 12 Months
Other	Average Change in Circulating Protein Markers of Inflammation at Months 6 and 12 from Randomization	Changes in circulating protein markers of inflammation from randomization (at 3 months) to the average of changes at months 6 and 12	Randomization to 12 Months
Other	Average Change in microRNA (miRNA) Markers of Inflammation at Months 6 and 12 from Randomization	Changes in microRNA (miRNA) markers of inflammation from randomization (at 3 months) to the average of changes at months 6 and 12	Randomization to 12 Months
Primary	Average Change in Sedentary Duration at Months 8, 10 and 12 from Randomization	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	Randomization to 12 Months
Secondary	Average Change in Steps per Day at Months 8, 10 and 12 from Randomization	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.	Randomization to 12 Months
Secondary	Average Change in Stepping Duration at Months 8, 10 and 12 from Randomization	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.	Randomization to 12 Months
Secondary	Average Change in Six-Minute Walk at Months 6 and 12 from Randomization	Changes in six minute walk distance from randomization (at 3 months) to the average of changes at months 6 and 12	Randomization to 12 Months
Secondary	Average Change in Body Fat % at Months 6 and 12 from Randomization	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	Randomization to 12 Months