Overview

This trial is active, not recruiting.

Conditions systemic lupus erythematosus, physical activity, sleep
Treatments smartphone application, fitbit activity monitor, coaching sessions
Phase phase 1
Sponsor Northwestern University
Start date October 2014
End date April 2015
Trial size 12 participants
Trial identifier NCT02281513, STU 69201

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Other)
Pilot study participants will be provided the smartphone application, fitbit activity monitor, and coaching sessions.
smartphone application ANTLER
Is a self-monitoring tool to document fruit and vegetable consumption, sleep quantity and quality, and physical activity
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.
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 Outcomes

Measure
Measurement of Fatigue
time frame: Up to 6 weeks

Secondary Outcomes

Measure
PA, Diet Assessments and Sleep
time frame: Up to 6 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Activity and Nutrition Trial in Lupus to Energize and Renew
Principal investigator Rosalind Ramsey-Goldman, MD, DrPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Northwestern University.