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Completed

NCT Number: NCT02281513

Activity and Nutrition Trial in Lupus to Energize and Renew

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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Behavior Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Motor Activity Physical Activity Skin and Connective Tissue Diseases Sleep

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smartphone Application

Other

Is a self-monitoring tool to document fruit and vegetable consumption, sleep quantity and quality, and physical activity

Other names: ANTLER

Fitbit Activity Monitor

Other

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

Other

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

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Acronym: ANTLER

Important dates

Study start
2014
Primary completion
2015
Study completion
2023
First posted
Nov 3, 2014
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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