Chronic Kidney DiseaseSLIMMNCT02970123
Sit Less, Interact, Move More (SLIMM) Intervention for Sedentary Behavior in Chronic Kidney Disease (CKD)
A study testing Sit Less, Interact, Move More (SLIMM) in people with Chronic Kidney Disease, run by Srinvasan Beddhu at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Sit Less, Interact, Move More (SLIMM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 12 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous renal replacement therapy
- Life expectancy < 1 year
- Pregnancy
- Prison incarceration
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Sit Less, Interact, Move More (SLIMM)
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sit Less, Interact, Move More (SLIMM)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| SLIMM Intervention | Experimental | 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 Receives: Behavioral: Sit Less, Interact, Move More (SLIMM) |
| Standard of Care | No intervention | Subjects will receive standard of care treatment for chronic kidney disease, with no instruction or feedback to alter sedentary or casual walking durations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sedentary Activity Duration
Change in sedentary activity duration (average sedentary minutes per hour), as measured by a validated accelerometry monitor from baseline to 24 weeks
Measured: Baseline and 24 Weeks
Change in Casual Walking Duration
Change in casual walking activity duration (average walking minutes per hour), as measured by a validated accelerometry monitor from baseline to 24 weeks
Measured: Baseline and 24 Weeks
Secondary outcomes (3)
Change in Waist Circumference
Change in waist circumference, measured in centimeters, from baseline to 24 weeks
Measured: Baseline and 24 Weeks
Change in Non-Exercise Activity Thermogenesis
Change in non-exercise activity thermogenesis, measured in kilocalorie/kilogram/hour, from baseline to 24 weeks
Measured: Baseline and 24 Weeks
Change in Physical Function
Change in walking distance, measured in meters, using the 6-minute walk test from baseline to 24 weeks
Measured: Baseline and 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startDec 2016
- Primary completion12 Sep 2019
- Study completion12 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (70)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Srinvasan Beddhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Srinvasan Beddhu, University of Utah
- Investigators
- Srinivasan Beddhu, M.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970123
- Sponsor's protocol ID
- IRB_00093477
- Other IDs
- 1R21DK106574-01A1
- Acronym
- SLIMM
- Status last verified
- Sep 2019
- First submitted
- 17 Nov 2016
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Alhassan S, Lyden K, Howe C, Kozey Keadle S, Nwaokelemeh O, Freedson PS. Accuracy of accelerometer regression models in predicting energy expenditure and METs in children and youth. Pediatr Exerc Sci. 2012 Nov;24(4):519-36. doi: 10.1123/pes.24.4.519.
PubMed 23196761Freedson PS, Lyden K, Kozey-Keadle S, Staudenmayer J. Evaluation of artificial neural network algorithms for predicting METs and activity type from accelerometer data: validation on an independent sample. J Appl Physiol (1985). 2011 Dec;111(6):1804-12. doi: 10.1152/japplphysiol.00309.2011. Epub 2011 Sep 1.
PubMed 21885802Kozey SL, Lyden K, Howe CA, Staudenmayer JW, Freedson PS. Accelerometer output and MET values of common physical activities. Med Sci Sports Exerc. 2010 Sep;42(9):1776-84. doi: 10.1249/MSS.0b013e3181d479f2.
PubMed 20142781Kozey-Keadle S, Staudenmayer J, Libertine A, Mavilia M, Lyden K, Braun B, Freedson P. Changes in sedentary time and physical activity in response to an exercise training and/or lifestyle intervention. J Phys Act Health. 2014 Sep;11(7):1324-33. doi: 10.1123/jpah.2012-0340. Epub 2013 Oct 31.
PubMed 24184493Lyden K, Keadle SK, Staudenmayer J, Freedson PS. A method to estimate free-living active and sedentary behavior from an accelerometer. Med Sci Sports Exerc. 2014 Feb;46(2):386-97. doi: 10.1249/MSS.0b013e3182a42a2d.
PubMed 23860415Lyden K, Kozey Keadle SL, Staudenmayer JW, Freedson PS. Validity of two wearable monitors to estimate breaks from sedentary time. Med Sci Sports Exerc. 2012 Nov;44(11):2243-52. doi: 10.1249/MSS.0b013e318260c477.
PubMed 22648343Lyden K, Kozey SL, Staudenmeyer JW, Freedson PS. A comprehensive evaluation of commonly used accelerometer energy expenditure and MET prediction equations. Eur J Appl Physiol. 2011 Feb;111(2):187-201. doi: 10.1007/s00421-010-1639-8. Epub 2010 Sep 15.
PubMed 20842375Beddhu S, Wei G, Marcus RL, Chonchol M, Greene T. Light-intensity physical activities and mortality in the United States general population and CKD subpopulation. Clin J Am Soc Nephrol. 2015 Jul 7;10(7):1145-53. doi: 10.2215/CJN.08410814. Epub 2015 Apr 30.
PubMed 25931456Ryan CG, Grant PM, Tigbe WW, Granat MH. The validity and reliability of a novel activity monitor as a measure of walking. Br J Sports Med. 2006 Sep;40(9):779-84. doi: 10.1136/bjsm.2006.027276. Epub 2006 Jul 6.
PubMed 16825270Dowd KP, Harrington DM, Donnelly AE. Criterion and concurrent validity of the activPAL professional physical activity monitor in adolescent females. PLoS One. 2012;7(10):e47633. doi: 10.1371/journal.pone.0047633. Epub 2012 Oct 19.
PubMed 23094069Harrington DM, Welk GJ, Donnelly AE. Validation of MET estimates and step measurement using the ActivPAL physical activity logger. J Sports Sci. 2011 Mar;29(6):627-33. doi: 10.1080/02640414.2010.549499.
PubMed 21360402Ainsworth BE, Haskell WL, Herrmann SD, Meckes N, Bassett DR Jr, Tudor-Locke C, Greer JL, Vezina J, Whitt-Glover MC, Leon AS. 2011 Compendium of Physical Activities: a second update of codes and MET values. Med Sci Sports Exerc. 2011 Aug;43(8):1575-81. doi: 10.1249/MSS.0b013e31821ece12.
PubMed 21681120Hu FB. Sedentary lifestyle and risk of obesity and type 2 diabetes. Lipids. 2003 Feb;38(2):103-8. doi: 10.1007/s11745-003-1038-4.
PubMed 12733740Freak-Poli R, Wolfe R, Peeters A. Risk of cardiovascular disease and diabetes in a working population with sedentary occupations. J Occup Environ Med. 2010 Nov;52(11):1132-7. doi: 10.1097/JOM.0b013e3181f8da77.
PubMed 21063192Hu FB, Li TY, Colditz GA, Willett WC, Manson JE. Television watching and other sedentary behaviors in relation to risk of obesity and type 2 diabetes mellitus in women. JAMA. 2003 Apr 9;289(14):1785-91. doi: 10.1001/jama.289.14.1785.
PubMed 12684356
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sit Less, Interact, Move More (SLIMM) Intervention for Sedentary Behavior in Chronic Kidney Disease (CKD)
- ClinicalTrials.gov ID
- NCT02970123
- Acronym / sponsor ID
- SLIMM / IRB_00093477
- Conditions
- Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Srinvasan BeddhuUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Dec 2016 (actual)
- Primary completion
- 12 Sep 2019 (actual)
- Study completion
- 12 Sep 2019 (actual)
- First posted
- 21 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLIMM Intervention | Experimental | Behavioral: Sit Less, Interact, Move More (SLIMM)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 |
| Standard of Care | No intervention | –Subjects will receive standard of care treatment for chronic kidney disease, with no instruction or feedback to alter sedentary or casual walking durations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Previous renal replacement therapy
- Life expectancy < 1 year
- Pregnancy
- Prison incarceration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sit Less, Interact, Move More (SLIMM) | Behavioural | SLIMM Intervention |
Primary outcome
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
3 secondary outcomes
Change in Waist Circumference
Time frame: Baseline and 24 Weeks
Change in Non-Exercise Activity Thermogenesis
Time frame: Baseline and 24 Weeks
Change in Physical Function
Time frame: Baseline and 24 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Background: PubMed 23196761Alhassan S, Lyden K, Howe C, Kozey Keadle S, Nwaokelemeh O, Freedson PS. Accuracy of accelerometer regression models in predicting energy expenditure and METs in children and youth. Pediatr Exerc Sci. 2012 Nov;24(4):519-36. doi: 10.1123/pes.24.4.519.
- Background: PubMed 21885802Freedson PS, Lyden K, Kozey-Keadle S, Staudenmayer J. Evaluation of artificial neural network algorithms for predicting METs and activity type from accelerometer data: validation on an independent sample. J Appl Physiol (1985). 2011 Dec;111(6):1804-12. doi: 10.1152/japplphysiol.00309.2011. Epub 2011 Sep 1.
- Background: PubMed 20142781Kozey SL, Lyden K, Howe CA, Staudenmayer JW, Freedson PS. Accelerometer output and MET values of common physical activities. Med Sci Sports Exerc. 2010 Sep;42(9):1776-84. doi: 10.1249/MSS.0b013e3181d479f2.
- Background: PubMed 24184493Kozey-Keadle S, Staudenmayer J, Libertine A, Mavilia M, Lyden K, Braun B, Freedson P. Changes in sedentary time and physical activity in response to an exercise training and/or lifestyle intervention. J Phys Act Health. 2014 Sep;11(7):1324-33. doi: 10.1123/jpah.2012-0340. Epub 2013 Oct 31.
- Background: PubMed 23860415Lyden K, Keadle SK, Staudenmayer J, Freedson PS. A method to estimate free-living active and sedentary behavior from an accelerometer. Med Sci Sports Exerc. 2014 Feb;46(2):386-97. doi: 10.1249/MSS.0b013e3182a42a2d.
- Background: PubMed 22648343Lyden K, Kozey Keadle SL, Staudenmayer JW, Freedson PS. Validity of two wearable monitors to estimate breaks from sedentary time. Med Sci Sports Exerc. 2012 Nov;44(11):2243-52. doi: 10.1249/MSS.0b013e318260c477.
- Background: PubMed 20842375Lyden K, Kozey SL, Staudenmeyer JW, Freedson PS. A comprehensive evaluation of commonly used accelerometer energy expenditure and MET prediction equations. Eur J Appl Physiol. 2011 Feb;111(2):187-201. doi: 10.1007/s00421-010-1639-8. Epub 2010 Sep 15.
- Background: PubMed 25931456Beddhu S, Wei G, Marcus RL, Chonchol M, Greene T. Light-intensity physical activities and mortality in the United States general population and CKD subpopulation. Clin J Am Soc Nephrol. 2015 Jul 7;10(7):1145-53. doi: 10.2215/CJN.08410814. Epub 2015 Apr 30.
- Background: PubMed 16825270Ryan CG, Grant PM, Tigbe WW, Granat MH. The validity and reliability of a novel activity monitor as a measure of walking. Br J Sports Med. 2006 Sep;40(9):779-84. doi: 10.1136/bjsm.2006.027276. Epub 2006 Jul 6.
- Background: PubMed 23094069Dowd KP, Harrington DM, Donnelly AE. Criterion and concurrent validity of the activPAL professional physical activity monitor in adolescent females. PLoS One. 2012;7(10):e47633. doi: 10.1371/journal.pone.0047633. Epub 2012 Oct 19.
- Background: PubMed 21360402Harrington DM, Welk GJ, Donnelly AE. Validation of MET estimates and step measurement using the ActivPAL physical activity logger. J Sports Sci. 2011 Mar;29(6):627-33. doi: 10.1080/02640414.2010.549499.
- Background: PubMed 21681120Ainsworth BE, Haskell WL, Herrmann SD, Meckes N, Bassett DR Jr, Tudor-Locke C, Greer JL, Vezina J, Whitt-Glover MC, Leon AS. 2011 Compendium of Physical Activities: a second update of codes and MET values. Med Sci Sports Exerc. 2011 Aug;43(8):1575-81. doi: 10.1249/MSS.0b013e31821ece12.
- A 2-Minute Walk May Counter the Harms of Sitting: By Gretchen ReynoldsLink provided by the sponsor.
- . Walking 2 Minutes An Hour Boosts Health, But It's No Panacea. By Patti NeighmondLink provided by the sponsor.
- The Department of Health. The Sedentary Behaviour and Obesity Expert Working Group: Sedentary Behaviour and Obesity: Review of the Current Scientific EvidenceLink provided by the sponsor.
- Centers for Disease Control and Prevenion. National Center for Health Statistics -NHANES 2003-2004Link provided by the sponsor.
- Utah's Population: Growing fast, Concentrating more, Diversifying rapidly. Utah Legislature Briefing PaperLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Srinivasan Beddhu, M.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sit Less, Interact, Move More (SLIMM) in people with Chronic Kidney Disease, run by Srinvasan Beddhu at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sedentary Activity Duration (time frame: Baseline and 24 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02970123, which also lists 70 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.