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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 20, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Srinvasan Beddhu, University of Utah

Tracking Information
First Submitted Date  ICMJE November 17, 2016
First Posted Date  ICMJE November 21, 2016
Last Update Posted Date May 20, 2019
Actual Study Start Date  ICMJE December 2016
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2016)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02970123 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2016)
  • Change in Waist Circumference [ Time Frame: Baseline and 24 Weeks ]
    Change in waist circumference, measured in centimeters, from baseline to 24 weeks
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sit Less, Interact, Move More (SLIMM) Intervention for Sedentary Behavior in Chronic Kidney Disease (CKD)
Official Title  ICMJE Sit Less, Interact, Move More (SLIMM) Intervention for Sedentary Behavior in Chronic Kidney Disease (CKD)
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.

Detailed Description

There are an estimated 15.5 million adults with stage 3 chronic kidney disease (CKD) while only about 600,000 patients have end-stage renal disease (ESRD) in the United States. This is because most of the people with CKD die before they reach ESRD. In order to decrease the high mortality in the CKD population, the "non-renal" issues that contribute to increased morbidity and mortality in this population need to be addressed.

Relevance of sedentary behavior in CKD: Prolonged sitting time (as assessed by a questionnaire or television viewing time) was associated with lower kidney function. Total and light physical activities, measured objectively with an accelerometer were found to be positively associated with kidney function in a study of community dwelling adults. In an analysis of National Health and Nutrition Examination Survey (NHANES) data, it was noted that participants with CKD spent more than two-thirds of the awake time in sedentary activities and longer sedentary duration was associated with increased mortality. It was also noted in another study that compared to those with CKD, those on maintenance hemodialysis had 3.4 fold higher odds of being sedentary independent of demographics, co-morbidity, body size, serum C-Reactive Protein (CRP) and albumin. Thus, sedentary behavior is very common in CKD, appears to worsen with more advanced kidney failure and increases mortality risk in this population.

Feasibility of replacing sedentary activities with moderate/ vigorous physical activities: Moderate/ vigorous physical activities are less likely to be an effective replacement for sedentary activities as most Americans do not reach even the current goals and achieving the currently recommended levels of 2.5 hrs/ week of moderate/ vigorous activities would account only for 2% of the total awake time (112 hours/week). Therefore, decreasing sedentary activities must involve an increase in activities that are less intensive than moderate/ vigorous activities.

The concept of Non- Exercise Activity Thermogenesis (NEAT) and biological relevance of light intensity activity: In a overfeeding study, it was demonstrated that increase (average 336 kcal/day) in non- exercise activity thermogenesis accounted for 10-fold differences in fat storage, directly predicted resistance to fat gain and explained most of the variations in weight gain between participants. Obese persons have less non-exercise activity thermogenesis and spend an average of 2 hrs/d more in a seated position compared to lean persons. Objectively measured light activity was inversely associated with insulin resistance and cardiometabolic risk factors. Daily lifestyle activities were negatively associated with insulin resistance. Thus, replacing sedentary activities with non-exercise intensity activities of daily living could increase energy expenditure and decrease adiposity.

Determining what kind of light activity would be most beneficial in replacing sedentary activity: As standing (~ 1.5 Metabolic Equivalents of Task (METs)) is by definition non-sedentary (i.e. not sitting or lying down), one might consider replacing sitting duration with standing duration in order to decrease sedentary behavior. However, replacing sitting duration with casual walking (2 to 2.9 METs) duration might be even more beneficial. This notion is supported by the following theoretical calculations of energy expenditure. Assuming 16 hrs/day of awake time, it was calculated that the weekly energy expenditure for a person weighing 80 kg for trade-off of 1 to 5 min/hr of sedentary activity at 1.2 METs with 1.5 METs (standing intensity activities) or 2.5 METs (casual walking intensity activities). Additional kcal/week was calculated as the difference in energy expenditure between sedentary activity and 1.5 or 2.5 METs activity using the equation Kcal/ week = (METs/hr) x weight in kg X weekly duration of the physical activity. Trade-off of 1-5 min/hr of sedentary duration with standing intensity activities duration is expected to result in additional weekly expenditure of 50-250 Kcal only. On the other hand, similar trade off of sedentary duration with casual walking intensity activities duration is expected to result in ~ 200 to 1000 Kcal/ week of additional energy expenditure. This is consistent with prior observation that increase in non-exercise activities could lead to an additional 350 Kcal/d of energy expenditure in obese individuals.

Indeed, in the NHANES analyses, it was noted that trade-off sedentary duration for light intensity (2.0 to 2.9 METs) activities but not for very light intensity (1.5 to 1.9 METs) duration was associated with significantly lower risk of mortality. Thus, replacing sedentary duration with casual walking duration could increase energy expenditure and decrease mortality in CKD.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Chronic Kidney Disease
Intervention  ICMJE Behavioral: Sit Less, Interact, Move More (SLIMM)
Study Arms  ICMJE
  • 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
    Intervention: 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 17, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Robert E Boucher 801-581-3512 robert.boucher@hsc.utah.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02970123
Other Study ID Numbers  ICMJE IRB_00093477
1R21DK106574-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Srinvasan Beddhu, University of Utah
Study Sponsor  ICMJE Srinvasan Beddhu
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Srinivasan Beddhu, M.D. University of Utah
PRS Account University of Utah
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP