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Sit Less, Interact, Move More (SLIMM) Intervention for Sedentary Behavior in Chronic Kidney Disease (CKD) (SLIMM)

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ClinicalTrials.gov Identifier: NCT02970123
Recruitment Status : Recruiting
First Posted : November 21, 2016
Last Update Posted : May 11, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Srinvasan Beddhu, University of Utah

Brief Summary:

Sedentary behavior is engaging in activities in the seated or lying position that barely raise the energy expenditure level and has emerged as an important risk factor for obesity, diabetes, cardiovascular disease and mortality.

The primary hypothesis is that the Sit Less, Interact, Move More (SLIMM) intervention in Chronic Kidney Disease (CKD) will be effective in decreasing sedentary duration by increasing casual walking duration and thereby, increase physical activity energy expenditure.


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Behavioral: Sit Less, Interact, Move More (SLIMM) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Sit Less, Interact, Move More (SLIMM) Intervention for Sedentary Behavior in Chronic Kidney Disease (CKD)
Actual Study Start Date : December 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SLIMM Intervention
Sit Less, Interact, Move More (SLIMM): instruction and monitoring feedback to promote decrease in sedentary activity duration, increase in casual walking duration, and increase in sedentary breaks
Behavioral: Sit Less, Interact, Move More (SLIMM)
No Intervention: Standard of Care
Subjects will receive standard of care treatment for chronic kidney disease, with no instruction or feedback to alter sedentary or casual walking durations



Primary Outcome Measures :
  1. Change in Sedentary Activity Duration [ Time Frame: Baseline and 24 Weeks ]
    Change in sedentary activity duration (average sedentary minutes per hour), as measured by a validated accelerometry monitor from baseline to 24 weeks

  2. Change in Casual Walking Duration [ Time Frame: Baseline and 24 Weeks ]
    Change in casual walking activity duration (average walking minutes per hour), as measured by a validated accelerometry monitor from baseline to 24 weeks


Secondary Outcome Measures :
  1. Change in Waist Circumference [ Time Frame: Baseline and 24 Weeks ]
    Change in waist circumference, measured in centimeters, from baseline to 24 weeks

  2. Change in Non-Exercise Activity Thermogenesis [ Time Frame: Baseline and 24 Weeks ]
    Change in non-exercise activity thermogenesis, measured in kilocalorie/kilogram/hour, from baseline to 24 weeks

  3. Change in Physical Function [ Time Frame: Baseline and 24 Weeks ]
    Change in walking distance, measured in meters, using the 6-minute walk test from baseline to 24 weeks



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage 3/4 Chronic Kidney Disease, as defined by estimated glomerular filtration rate (eGFR) 15 to < 60 ml/min/1.73m^2
  • Body Mass Index (BMI): 25 to 39.9 kg/m^2
  • Able to achieve gait speed of > 1 m/sec and able to walk ≥ 320 meters in the 6-minute walk test

Exclusion Criteria:

  • Previous renal replacement therapy
  • Life expectancy < 1 year
  • Pregnancy
  • Prison incarceration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02970123


Contacts
Contact: Robert E Boucher 801-581-3512 robert.boucher@hsc.utah.edu

Locations
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Robert Boucher    801-585-9874    robert.boucher@hsc.utah.edu   
Contact: Srinivasan Beddhu, MD    801-585-3810    srinivasan.beddhu@hsc.utah.edu   
Sponsors and Collaborators
Srinvasan Beddhu
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Srinivasan Beddhu, M.D. University of Utah

Additional Information:
Publications:

Responsible Party: Srinvasan Beddhu, Principal Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT02970123     History of Changes
Other Study ID Numbers: IRB_00093477
1R21DK106574-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 21, 2016    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency