Activity and Nutrition Trial in Lupus to Energize and Renew (ANTLER)
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|ClinicalTrials.gov Identifier: NCT02281513|
Recruitment Status : Active, not recruiting
First Posted : November 2, 2014
Last Update Posted : November 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus Physical Activity Sleep||Other: Smartphone Application Other: Fitbit Activity Monitor Other: Coaching Sessions||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
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
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Rosalind Ramsey-Goldman, MD, DrPH||Northwestern University|