Systemic Lupus ErythematosusANTLERNCT02281513
Activity and Nutrition Trial in Lupus to Energize and Renew
A study testing Smartphone Application, Fitbit Activity Monitor and Coaching Sessions in people with Systemic Lupus Erythematosus and Physical Activity, run by Northwestern University at 1 site in United States.
Trial summary
Participants from the Fatigue and Lifestyle Physical Activity and SLE Study will be approached to enroll in a 6 week pilot intervention. This study will look at the barriers and facilitators to increasing physical activity, improving dietary/nutritional intake, and improving sleep.This study will offer support and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus, Physical Activity, Sleep
- What is being tested?
- Smartphone Application, Fitbit Activity Monitor and Coaching Sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to 11 Sep 2023
- 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
- 1) meet at least 4 of 11 ACR classification criteria for definite SLE 2) at least 18 years of age, 3) BMI between 14 and 40 kg/m2, 4) able to ambulate at least household distances (50ft), 5) ability to complete the dietary recall assessment, and 6) able to provide informed consent.
- After informed consent is obtained, a medical record review will determine whether there is a history of uncontrolled diabetes mellitus or cardiovascular disease. Potential participants will be asked to complete the PAR-Q to determine restriction in physical activity. Blood pressure will be assessed and potential participants will be excluded if SBP>160 or DBP >110.
Who cannot join
- Does not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Participants from the Fatigue and Lifestyle Physical Activity and SLE Study will be approached to enroll in a 6 week pilot intervention. This study will look at the barriers and facilitators to increasing physical activity, improving dietary/nutritional intake, and improving sleep.This study will offer support and information for people with SLE to increase their physical activity, improve their dietary/nutritional intake, and improve their sleep and will utilize a smartphone application to self-monitor changes in these behaviors.
Read the detailed description
Description of ANTLER pilot intervention: a 6 week intensive program which combines the following goals
- Ability of participants to utilize a smart phone application for self-monitoring behavior change of physical activity, fruit/vegetable consumption, and sleep. This would include entering data on fruit/vegetable consumption, hours of sleep and monitoring feedback.
- Ability of participants to wear Actigraph accelerometer 24 hours/day and complete a sleep log for measurement of physical activity and sleep.
- Ability of Nutrition Data System for Research (NDSR) software to collect adequate nutrition data.
The intervention is a unique combination of two individual counseling sessions and the utilization of a combination of a smartphone application and the use of a Fitbit physical activity monitor. The individual sessions will provide a tailored personalized intervention including problem-solving and goal setting for increasing physical activity, consumption of more fruits and vegetables, and getting more sleep. Healthy Lifestyle Coaches (RN or Exercise Physiologist) will be responsible for conducting the individual sessions for a limited caseload of participants.
Individual sessions will
- utilize motivational interviewing techniques to enhance motivation for meeting individualized physical activity, dietary/nutritional and sleep goals
- identify specific barriers and supports leading to tailored intervention to increase program success (The Arthritis Comprehensive Treatment Assessment)
- provide emotional support
Self-monitoring of behavior change
- On a daily basis, participants will log fruit/vegetable consumption and hours of sleep via a smartphone application and receive feedback
- On a daily basis, participants will monitor their physical activity via the Fitbit and receive feedback on the smartphone.
Online activities will include communication between the client and coach in between and after scheduled intervention visits.
- Conditions
- Systemic Lupus Erythematosus, Physical Activity, Sleep
- Being tested
- Smartphone Application, Fitbit Activity Monitor, Coaching Sessions
- Keywords
- Nutrition
- Medical subject headings
- Lupus Erythematosus, Systemic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone ApplicationOther
Also called ANTLER
Is a self-monitoring tool to document fruit and vegetable consumption, sleep quantity and quality, and physical activity
Fitbit Activity MonitorOther
Is connected to this smartphone application so that participants who wear this monitor have data that automatically populates the smartphone application for physical activity.
Coaching SessionsOther
Using motivational interviewing (a counseling style used in helping persons change their behavior) at baseline after completion of all baseline assessments and at follow up after completion of all follow up assessments. Coaching session includes discussion of facilitators and barriers to increasing physical activity, fruit and vegetable consumption and sleep, as well as setting goals to work towards at next meeting. The coach will monitor the information that the participant enters into the smartphone application and will provide feedback on a weekly basis to the participant.
| Study group | Role | What they receive |
|---|---|---|
| ANTLER Pilot Cohort | Other | Pilot study participants will be provided the smartphone application, fitbit activity monitor, and coaching sessions. Receives: Other: Smartphone Application; Other: Fitbit Activity Monitor; Other: Coaching Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Fatigue
It is measured by the Fatigue Severity Scale and the PROMIS Fatigue Short-Form online via the Assessment Center. Change from baseline to 6-week follow-up is measured. The Fatigue Severity Scale is 9 items scored on a 7-point scale from 1= strongly disagree to 7=strongly agree. Minimum score =9 and maximum score=63. Higher score=greater fatigue severity. The PROMIS Fatigue Short Form is 8 items looking back at the past 7 days assessing amount of fatigue and trouble getting things done because of fatigue on a 5-point scale.
Measured: Up to 6 weeks
Secondary outcomes (1)
PA, Diet Assessments and Sleep
Physical activity is measured objectively by accelerometer worn for 7 days, 24 hours per day and maintenance of a sleep log and self-report of activity by the International Physical Activity Questionnaire (IPAQ) by interview based on the 7 days that the accelerometer is worn. Fruit/vegetable consumption is measured by the Nutrition Data System for Research per interview. Sleep is measured by the PROMIS sleep disturbance and sleep-related impairment Short Forms online via the Assessment Center. Change from baseline to 6-week follow-up is measured for all of these secondary outcomes.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionApr 2015
- Study completion11 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosalind Ramsey-Goldman, Northwestern University
- Investigators
- Rosalind Ramsey-Goldman, MD, DrPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02281513
- Sponsor's protocol ID
- STU 69201
- Acronym
- ANTLER
- Status last verified
- Sep 2023
- First submitted
- 22 Oct 2014
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plans for Resource Sharing. The final data sets from this project will include lupus disease and damage measurements, raw and processed nutrient intake, raw and processed patient-reported outcomes, raw and processed accelerometer data, and motivational interviewing data. The final data from this project will be de-identified in accordance with HIPAA guidelines. Prior to any type of sharing, all disease activity, nutrient intake, patient-reported outcomes and accelerometer records will be made anonymous by the assignment of a new, unique subject identifier that is not linked to any clinical medical record. Requests for resource sharing will all meet the necessary IRB requirements from Northwestern University and the institution of the individual who requests the data.
Publications
Mancuso CA, Perna M, Sargent AB, Salmon JE. Perceptions and measurements of physical activity in patients with systemic lupus erythematosus. Lupus. 2011 Mar;20(3):231-42. doi: 10.1177/0961203310383737. Epub 2010 Dec 23.
PubMed 21183562Chandrasekhara PK, Jayachandran NV, Rajasekhar L, Thomas J, Narsimulu G. The prevalence and associations of sleep disturbances in patients with systemic lupus erythematosus. Mod Rheumatol. 2009;19(4):407-15. doi: 10.1007/s10165-009-0185-x. Epub 2009 Jun 12.
PubMed 19521744Da Costa D, Bernatsky S, Dritsa M, Clarke AE, Dasgupta K, Keshani A, Pineau C. Determinants of sleep quality in women with systemic lupus erythematosus. Arthritis Rheum. 2005 Apr 15;53(2):272-8. doi: 10.1002/art.21069.
PubMed 15818653Ehrlich-Jones L, Mallinson T, Fischer H, Bateman J, Semanik PA, Spring B, Ruderman E, Chang RW. Increasing physical activity in patients with arthritis: a tailored health promotion program. Chronic Illn. 2010 Dec;6(4):272-81. doi: 10.1177/1742395309351243. Epub 2010 Aug 9.
PubMed 20696695Stephens J, Allen J. Mobile phone interventions to increase physical activity and reduce weight: a systematic review. J Cardiovasc Nurs. 2013 Jul-Aug;28(4):320-9. doi: 10.1097/JCN.0b013e318250a3e7.
PubMed 22635061Miller W, Rollnick S. Motivational Interviewing: Preparing People for Change. 2nd edition ed. New York: Guilford Press; 2002.
Burke LE, Wang J, Sevick MA. Self-monitoring in weight loss: a systematic review of the literature. J Am Diet Assoc. 2011 Jan;111(1):92-102. doi: 10.1016/j.jada.2010.10.008.
PubMed 21185970Hutchesson MJ, Rollo ME, Callister R, Collins CE. Self-monitoring of dietary intake by young women: online food records completed on computer or smartphone are as accurate as paper-based food records but more acceptable. J Acad Nutr Diet. 2015 Jan;115(1):87-94. doi: 10.1016/j.jand.2014.07.036. Epub 2014 Sep 26.
PubMed 25262244Mohr DC, Cuijpers P, Lehman K. Supportive accountability: a model for providing human support to enhance adherence to eHealth interventions. J Med Internet Res. 2011 Mar 10;13(1):e30. doi: 10.2196/jmir.1602.
PubMed 21393123Matthews CE, Ainsworth BE, Thompson RW, Bassett DR Jr. Sources of variance in daily physical activity levels as measured by an accelerometer. Med Sci Sports Exerc. 2002 Aug;34(8):1376-81. doi: 10.1097/00005768-200208000-00021.
PubMed 12165695Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.
PubMed 2803071Warburton DE, Gledhill N, Jamnik VK, Bredin SS, McKenzie DC, Stone J, Charlesworth S, Shephard RJ. Evidence-based risk assessment and recommendations for physical activity clearance: Consensus Document 2011. Appl Physiol Nutr Metab. 2011 Jul;36 Suppl 1:S266-98. doi: 10.1139/h11-062.
PubMed 21800945
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activity and Nutrition Trial in Lupus to Energize and Renew
- ClinicalTrials.gov ID
- NCT02281513
- Acronym / sponsor ID
- ANTLER / STU 69201
- Conditions
- Systemic Lupus Erythematosus, Physical Activity, Sleep
- Keywords
- Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- 11 Sep 2023 (actual)
- First posted
- 3 Nov 2014 (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.
Participants from the Fatigue and Lifestyle Physical Activity and SLE Study will be approached to enroll in a 6 week pilot intervention. This study will look at the barriers and facilitators to increasing physical activity, improving dietary/nutritional intake, and improving sleep.This study will offer support and information for people with SLE to increase their physical activity, improve their dietary/nutritional intake, and improve their sleep and will utilize a smartphone application to self-monitor changes in these behaviors.
Detailed description
Description of ANTLER pilot intervention: a 6 week intensive program which combines the following goals
- Ability of participants to utilize a smart phone application for self-monitoring behavior change of physical activity, fruit/vegetable consumption, and sleep. This would include entering data on fruit/vegetable consumption, hours of sleep and monitoring feedback.
- Ability of participants to wear Actigraph accelerometer 24 hours/day and complete a sleep log for measurement of physical activity and sleep.
- Ability of Nutrition Data System for Research (NDSR) software to collect adequate nutrition data.
The intervention is a unique combination of two individual counseling sessions and the utilization of a combination of a smartphone application and the use of a Fitbit physical activity monitor. The individual sessions will provide a tailored personalized intervention including problem-solving and goal setting for increasing physical activity, consumption of more fruits and vegetables, and getting more sleep. Healthy Lifestyle Coaches (RN or Exercise Physiologist) will be responsible for conducting the individual sessions for a limited caseload of participants.
Individual sessions will
- utilize motivational interviewing techniques to enhance motivation for meeting individualized physical activity, dietary/nutritional and sleep goals
- identify specific barriers and supports leading to tailored intervention to increase program success (The Arthritis Comprehensive Treatment Assessment)
- provide emotional support
Self-monitoring of behavior change
- On a daily basis, participants will log fruit/vegetable consumption and hours of sleep via a smartphone application and receive feedback
- On a daily basis, participants will monitor their physical activity via the Fitbit and receive feedback on the smartphone.
Online activities will include communication between the client and coach in between and after scheduled intervention visits.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ANTLER Pilot Cohort | Other | Other: Smartphone Application, Other: Fitbit Activity Monitor, Other: Coaching SessionsPilot study participants will be provided the smartphone application, fitbit activity monitor, and coaching sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1) meet at least 4 of 11 ACR classification criteria for definite SLE 2) at least 18 years of age, 3) BMI between 14 and 40 kg/m2, 4) able to ambulate at least household distances (50ft), 5) ability to complete the dietary recall assessment, and 6) able to provide informed consent.
- After informed consent is obtained, a medical record review will determine whether there is a history of uncontrolled diabetes mellitus or cardiovascular disease. Potential participants will be asked to complete the PAR-Q to determine restriction in physical activity. Blood pressure will be assessed and potential participants will be excluded if SBP>160 or DBP >110.
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria
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 |
|---|---|---|
| Smartphone ApplicationAlso: ANTLERIs a self-monitoring tool to document fruit and vegetable consumption, sleep quantity and quality, and physical activity | Other | ANTLER Pilot Cohort |
| Fitbit Activity MonitorIs connected to this smartphone application so that participants who wear this monitor have data that automatically populates the smartphone application for physical activity. | Other | ANTLER Pilot Cohort |
| Coaching SessionsUsing motivational interviewing (a counseling style used in helping persons change their behavior) at baseline after completion of all baseline assessments and at follow up after completion of all follow up assessments. Coaching session includes discussion of facilitators and barriers to increasing physical activity, fruit and vegetable consumption and sleep, as well as setting goals to work towards at next meeting. The coach will monitor the information that the participant enters into the smartphone application and will provide feedback on a weekly basis to the participant. | Other | ANTLER Pilot Cohort |
Primary outcome
Measurement of Fatigue
Time frame: Up to 6 weeks
It is measured by the Fatigue Severity Scale and the PROMIS Fatigue Short-Form online via the Assessment Center. Change from baseline to 6-week follow-up is measured. The Fatigue Severity Scale is 9 items scored on a 7-point scale from 1= strongly disagree to 7=strongly agree. Minimum score =9 and maximum score=63. Higher score=greater fatigue severity. The PROMIS Fatigue Short Form is 8 items looking back at the past 7 days assessing amount of fatigue and trouble getting things done because of fatigue on a 5-point scale.
1 secondary outcome
PA, Diet Assessments and Sleep
Time frame: Up to 6 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 13 Sep 2023.
- Background: PubMed 21183562Mancuso CA, Perna M, Sargent AB, Salmon JE. Perceptions and measurements of physical activity in patients with systemic lupus erythematosus. Lupus. 2011 Mar;20(3):231-42. doi: 10.1177/0961203310383737. Epub 2010 Dec 23.
- Background: PubMed 19521744Chandrasekhara PK, Jayachandran NV, Rajasekhar L, Thomas J, Narsimulu G. The prevalence and associations of sleep disturbances in patients with systemic lupus erythematosus. Mod Rheumatol. 2009;19(4):407-15. doi: 10.1007/s10165-009-0185-x. Epub 2009 Jun 12.
- Background: PubMed 15818653Da Costa D, Bernatsky S, Dritsa M, Clarke AE, Dasgupta K, Keshani A, Pineau C. Determinants of sleep quality in women with systemic lupus erythematosus. Arthritis Rheum. 2005 Apr 15;53(2):272-8. doi: 10.1002/art.21069.
- Background: PubMed 20696695Ehrlich-Jones L, Mallinson T, Fischer H, Bateman J, Semanik PA, Spring B, Ruderman E, Chang RW. Increasing physical activity in patients with arthritis: a tailored health promotion program. Chronic Illn. 2010 Dec;6(4):272-81. doi: 10.1177/1742395309351243. Epub 2010 Aug 9.
- Background: PubMed 22635061Stephens J, Allen J. Mobile phone interventions to increase physical activity and reduce weight: a systematic review. J Cardiovasc Nurs. 2013 Jul-Aug;28(4):320-9. doi: 10.1097/JCN.0b013e318250a3e7.
- BackgroundMiller W, Rollnick S. Motivational Interviewing: Preparing People for Change. 2nd edition ed. New York: Guilford Press; 2002.
- Background: PubMed 21185970Burke LE, Wang J, Sevick MA. Self-monitoring in weight loss: a systematic review of the literature. J Am Diet Assoc. 2011 Jan;111(1):92-102. doi: 10.1016/j.jada.2010.10.008.
- Background: PubMed 25262244Hutchesson MJ, Rollo ME, Callister R, Collins CE. Self-monitoring of dietary intake by young women: online food records completed on computer or smartphone are as accurate as paper-based food records but more acceptable. J Acad Nutr Diet. 2015 Jan;115(1):87-94. doi: 10.1016/j.jand.2014.07.036. Epub 2014 Sep 26.
- Background: PubMed 21393123Mohr DC, Cuijpers P, Lehman K. Supportive accountability: a model for providing human support to enhance adherence to eHealth interventions. J Med Internet Res. 2011 Mar 10;13(1):e30. doi: 10.2196/jmir.1602.
- Background: PubMed 12165695Matthews CE, Ainsworth BE, Thompson RW, Bassett DR Jr. Sources of variance in daily physical activity levels as measured by an accelerometer. Med Sci Sports Exerc. 2002 Aug;34(8):1376-81. doi: 10.1097/00005768-200208000-00021.
- Background: PubMed 2803071Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.
- Background: PubMed 21800945Warburton DE, Gledhill N, Jamnik VK, Bredin SS, McKenzie DC, Stone J, Charlesworth S, Shephard RJ. Evidence-based risk assessment and recommendations for physical activity clearance: Consensus Document 2011. Appl Physiol Nutr Metab. 2011 Jul;36 Suppl 1:S266-98. doi: 10.1139/h11-062.
- Lupus Research Program WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Plans for Resource Sharing. The final data sets from this project will include lupus disease and damage measurements, raw and processed nutrient intake, raw and processed patient-reported outcomes, raw and processed accelerometer data, and motivational interviewing data. The final data from this project will be de-identified in accordance with HIPAA guidelines. Prior to any type of sharing, all disease activity, nutrient intake, patient-reported outcomes and accelerometer records will be made anonymous by the assignment of a new, unique subject identifier that is not linked to any clinical medical record. Requests for resource sharing will all meet the necessary IRB requirements from Northwestern University and the institution of the individual who requests the data.
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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.
Rosalind Ramsey-Goldman, MD, DrPH principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone Application, Fitbit Activity Monitor and Coaching Sessions in people with Systemic Lupus Erythematosus and Physical Activity, run by Northwestern University 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 2 inclusion and 1 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 13 Sep 2023. 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?
Measurement of Fatigue (time frame: Up to 6 weeks). 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 NCT02281513, which also lists 12 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 13 Sep 2023.