Activity and Nutrition Trial in Lupus to Energize and Renew

NCT02281513 | Completed

• 1 other identifier: STU 69201
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus; Physical Activity; Sleep

Keywords

Nutrition

Outcome Measures

Primary Outcomes (1)

• Measurement of Fatigue

  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.

  Up to 6 weeks

Secondary Outcomes (1)

• PA, Diet Assessments and Sleep

  Up to 6 weeks

Study Arms (1)

ANTLER Pilot Cohort

OTHER

Pilot study participants will be provided the smartphone application, fitbit activity monitor, and coaching sessions.

Other: Smartphone Application; Other: Fitbit Activity Monitor; Other: Coaching Sessions

Interventions

Smartphone Application OTHER

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

Also known as: ANTLER

ANTLER Pilot Cohort

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.

ANTLER Pilot Cohort

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.

ANTLER Pilot Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (12)

• Mancuso CA, Perna M, Sargent AB, Salmon JE. Perceptions and measurements of physical activity in patients with systemic lupus erythematosus. Lupus. 2011 Mar;20(3):231-42. doi: 10.1177/0961203310383737. Epub 2010 Dec 23.

  PMID: 21183562 BACKGROUND

• Chandrasekhara PK, Jayachandran NV, Rajasekhar L, Thomas J, Narsimulu G. The prevalence and associations of sleep disturbances in patients with systemic lupus erythematosus. Mod Rheumatol. 2009;19(4):407-15. doi: 10.1007/s10165-009-0185-x. Epub 2009 Jun 12.

  PMID: 19521744 BACKGROUND

• Da Costa D, Bernatsky S, Dritsa M, Clarke AE, Dasgupta K, Keshani A, Pineau C. Determinants of sleep quality in women with systemic lupus erythematosus. Arthritis Rheum. 2005 Apr 15;53(2):272-8. doi: 10.1002/art.21069.

  PMID: 15818653 BACKGROUND

• Ehrlich-Jones L, Mallinson T, Fischer H, Bateman J, Semanik PA, Spring B, Ruderman E, Chang RW. Increasing physical activity in patients with arthritis: a tailored health promotion program. Chronic Illn. 2010 Dec;6(4):272-81. doi: 10.1177/1742395309351243. Epub 2010 Aug 9.

  PMID: 20696695 BACKGROUND

• Stephens J, Allen J. Mobile phone interventions to increase physical activity and reduce weight: a systematic review. J Cardiovasc Nurs. 2013 Jul-Aug;28(4):320-9. doi: 10.1097/JCN.0b013e318250a3e7.

  PMID: 22635061 BACKGROUND

• Miller W, Rollnick S. Motivational Interviewing: Preparing People for Change. 2nd edition ed. New York: Guilford Press; 2002.

  BACKGROUND

• Burke LE, Wang J, Sevick MA. Self-monitoring in weight loss: a systematic review of the literature. J Am Diet Assoc. 2011 Jan;111(1):92-102. doi: 10.1016/j.jada.2010.10.008.

  PMID: 21185970 BACKGROUND

• Hutchesson MJ, Rollo ME, Callister R, Collins CE. Self-monitoring of dietary intake by young women: online food records completed on computer or smartphone are as accurate as paper-based food records but more acceptable. J Acad Nutr Diet. 2015 Jan;115(1):87-94. doi: 10.1016/j.jand.2014.07.036. Epub 2014 Sep 26.

  PMID: 25262244 BACKGROUND

• Mohr DC, Cuijpers P, Lehman K. Supportive accountability: a model for providing human support to enhance adherence to eHealth interventions. J Med Internet Res. 2011 Mar 10;13(1):e30. doi: 10.2196/jmir.1602.

  PMID: 21393123 BACKGROUND

• Matthews CE, Ainsworth BE, Thompson RW, Bassett DR Jr. Sources of variance in daily physical activity levels as measured by an accelerometer. Med Sci Sports Exerc. 2002 Aug;34(8):1376-81. doi: 10.1097/00005768-200208000-00021.

  PMID: 12165695 BACKGROUND

• Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.

  PMID: 2803071 BACKGROUND

• Warburton DE, Gledhill N, Jamnik VK, Bredin SS, McKenzie DC, Stone J, Charlesworth S, Shephard RJ. Evidence-based risk assessment and recommendations for physical activity clearance: Consensus Document 2011. Appl Physiol Nutr Metab. 2011 Jul;36 Suppl 1:S266-98. doi: 10.1139/h11-062.

  PMID: 21800945 BACKGROUND

Related Links

• Lupus Research Program Website

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Motor Activity

Interventions

pilose antler peptide

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Rosalind Ramsey-Goldman, MD, DrPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Solovy Arthritis Research Society Research Professor of Medicine

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: November 3, 2014
• Study Start: October 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: September 11, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)