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

Part of paid clinical trials in Stanford, California.

Sponsor
Srinvasan Beddhu
Study ID
NCT05173714
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SLIMM — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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.
  • Placebo — DRUG
    Oral placebo tablets (matching the experimental semaglutide) will be administered from the first through ninth months of the drug intervention period.
  • Semaglutide — DRUG
    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.

Study Details

* 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.

Key Dates

Start date
Dec 1, 2021
Status verified
Jun 2025
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
156 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: 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
  • Active Comparator: SLIMM + Guided RT + Placebo
    SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, guided resistance training and oral placebo
  • Experimental: SLIMM + Guided RT + Semaglutide
    SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, guided resistance training and oral semaglutide

Primary Outcome Measure

Average Change in Sedentary Duration at Months 8, 10 and 12 from Randomization [ Time Frame: Randomization to 12 Months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305
Edison Lee
[email protected]
650-497-7526
Glenn M Chertow, M.D. (PRINCIPAL_INVESTIGATOR)
University of UtahSalt Lake CityUtah84108
Judy Carle
[email protected]
801-585-1113
Srinivasan Beddhu, M.D. (PRINCIPAL_INVESTIGATOR)

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