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Activity and Nutrition Trial in Lupus to Energize and Renew (ANTLER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02281513
Recruitment Status : Active, not recruiting
First Posted : November 2, 2014
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
Rosalind Ramsey-Goldman, Northwestern University

Brief 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 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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Physical Activity Sleep Other: Smartphone Application Other: Fitbit Activity Monitor Other: Coaching Sessions Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Activity and Nutrition Trial in Lupus to Energize and Renew
Study Start Date : October 2014
Actual Primary Completion Date : April 2015
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
ANTLER Pilot Cohort
Pilot study participants will be provided the smartphone application, fitbit activity monitor, and coaching sessions.
Other: Smartphone Application
Is a self-monitoring tool to document fruit and vegetable consumption, sleep quantity and quality, and physical activity
Other Name: ANTLER

Other: Fitbit Activity Monitor
Is connected to this smartphone application so that participants who wear this monitor have data that automatically populates the smartphone application for physical activity.

Other: Coaching Sessions
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. PA, Diet Assessments and Sleep [ Time Frame: Up to 6 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • 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.

Exclusion Criteria:

  • Does not meet inclusion criteria

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): NCT02281513


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Rosalind Ramsey-Goldman, MD, DrPH Northwestern University
Additional Information:
Publications:
Miller W, Rollnick S. Motivational Interviewing: Preparing People for Change. 2nd edition ed. New York: Guilford Press; 2002.

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Responsible Party: Rosalind Ramsey-Goldman, Solovy Arthritis Research Society Research Professor of Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT02281513    
Other Study ID Numbers: STU 69201
First Posted: November 2, 2014    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rosalind Ramsey-Goldman, Northwestern University:
Nutrition
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases