Activity and Nutrition Trial in Lupus to Energize and Renew



Status:Active, not recruiting
Conditions:Insomnia Sleep Studies, Lupus
Therapuetic Areas:Immunology / Infectious Diseases, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:October 2014
End Date:December 2019

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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.

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.

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
We found this trial at
1
site
303 East Superior Street
Chicago, Illinois 60611
?
mi
from
Chicago, IL
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