title: The efficacy of motivational counseling and SMS-reminders on daily sitting time in patients with rheumatoid arthritis: protocol for a randomized controlled trial.
abstract: BACKGROUND
  Patients with RA (Rheumatoid Arthritis) are more sedentary than the general population. Reduction of Sedentary Behaviour (SB) has been suggested as a mean for improvement of health in patients with chronic diseases and mobility problems. Short-term intervention studies have demonstrated that SB can be reduced by behavioural interventions in healthy populations. However, it remains unexplored whether it is valid for patients with RA also. Therefore, the aim of this trial is to investigate the efficacy of an individually tailored, theory-based motivational counseling intervention on reducing daily sitting time in sedentary patients with RA. Additionally, to explore whether a reduction in daily sitting time is associated with reduced pain and fatigue, self-reported physical function, self-efficacy, improved health-related quality of life (HR-QoL) and cardiovascular biomarker levels, and finally to assess the cost-effectiveness of the intervention.
  
  
  METHODS
  For this parallel group randomized trial, 150 patients with RA and at least 5 hours of sitting time per day, will be recruited from a rheumatology outpatient clinic, and block-randomized to the intervention group or the control group receiving usual care. The intervention includes: 1) individual motivational counseling (in total 3 sessions) on reduction of daily sitting time in combination with 2) individual Short Text Message Service (SMS) reminders over a 16-week intervention period. Primary outcome is change in daily sitting time (minutes) from baseline to 16 weeks measured objectively using an ActivPAL® Activity Monitor. Secondary outcomes include fatigue, pain, physical function, HR-QoL, self-efficacy, costs and cost-effectiveness. Furthermore, anthropometric measures will be included as well as measurement of blood pressure and serum lipids. All outcomes are assessed at baseline and repeated after 16 weeks. Follow-up assessments are made at 6 and 18 months post-intervention.
  
  
  CONCLUSIONS
  The intervention is simple, non-invasive and may be implemented at low costs. If the study confirms the positive results expected, the intervention might be implemented in clinical practice and potentially transferred to other clinical populations.
  
  
  BACKGROUND
  ClinicalTrial.gov registration number: NCT01969604 . Date of registration: 17 October 2013.
authors.affiliation: Nursing and Health Science Research Unit, Glostrup Hospital, University of Copenhagen, Glostrup, Denmark. bente.appel.esbensen@regionh.dk.|Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Glostrup Hospital University of Copenhagen, Glostrup, Denmark. bente.appel.esbensen@regionh.dk.|Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. bente.appel.esbensen@regionh.dk.
authors.forename: Bente Appel
authors.initials: BA
authors.lastname: Esbensen
authors.affiliation: Nursing and Health Science Research Unit, Glostrup Hospital, University of Copenhagen, Glostrup, Denmark. tanja.thomsen.01@regionh.dk.|Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Glostrup Hospital University of Copenhagen, Glostrup, Denmark. tanja.thomsen.01@regionh.dk.|Department of Physio- and Occupational Therapy, Glostrup Hospital, University of Copenhagen, Glostrup, Denmark. tanja.thomsen.01@regionh.dk.
authors.forename: Tanja
authors.initials: T
authors.lastname: Thomsen
authors.affiliation: Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Glostrup Hospital University of Copenhagen, Glostrup, Denmark. merete.hetland@dadlnet.dk.|Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. merete.hetland@dadlnet.dk.|DANBIO registry, Center for Rheumatology and Spine Diseases, Glostrup Hospital, University of Copenhagen, Copenhagen, Denmark. merete.hetland@dadlnet.dk.
authors.forename: Merete L
authors.initials: ML
authors.lastname: Hetland
authors.affiliation: Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. ninabeyer.privat@gmail.com.|Department of Physical Therapy, Musculoskeletal Rehabilitation Research Unit, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark. ninabeyer.privat@gmail.com.
authors.forename: Nina
authors.initials: N
authors.lastname: Beyer
authors.affiliation: Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. julie@ucsf.dk.|Center for Health Research, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. julie@ucsf.dk.
authors.forename: Julie
authors.initials: J
authors.lastname: Midtgaard
authors.affiliation: Nursing and Health Science Research Unit, Glostrup Hospital, University of Copenhagen, Glostrup, Denmark. katrine.bjerre.loeppenthin@regionh.dk.|Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Glostrup Hospital University of Copenhagen, Glostrup, Denmark. katrine.bjerre.loeppenthin@regionh.dk.|Department of Clinical Neurophysiology, Danish Center for Sleep Medicine, Glostrup Hospital, University of Copenhagen, Copenhagen, Denmark. katrine.bjerre.loeppenthin@regionh.dk.
authors.forename: Katrine
authors.initials: K
authors.lastname: Løppenthin
authors.affiliation: Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. poul.joergen.jennum@regionh.dk.|Department of Clinical Neurophysiology, Danish Center for Sleep Medicine, Glostrup Hospital, University of Copenhagen, Copenhagen, Denmark. poul.joergen.jennum@regionh.dk.
authors.forename: Poul
authors.initials: P
authors.lastname: Jennum
authors.affiliation: Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Glostrup Hospital University of Copenhagen, Glostrup, Denmark. mo@dadlnet.dk.|Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. mo@dadlnet.dk.
authors.forename: Mikkel
authors.initials: M
authors.lastname: Østergaard
authors.affiliation: Center for Applied Health Services Research, University of Southern Denmark, Odense, Denmark. jas@sdu.dk.
authors.forename: Jan
authors.initials: J
authors.lastname: Sørensen
authors.affiliation: Department of Rheumatology, Bispebjerg and Frederiksberg Hospital, Musculoskeletal Statistics Unit, the Parker Institute, University of Copenhagen, Copenhagen, Denmark. Robin.Christensen@regionh.dk.
authors.forename: Robin
authors.initials: R
authors.lastname: Christensen
authors.affiliation: Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. mette.aadahl@regionh.dk.|Research Center for Prevention and Health, The Capital Region of Denmark, Glostrup Hospital, University of Copenhagen, Copenhagen, Denmark. mette.aadahl@regionh.dk.
authors.forename: Mette
authors.initials: M
authors.lastname: Aadahl
mesh_terms: D001172:Arthritis, Rheumatoid / Q000523:psychology*; D002985:Clinical Protocols; D003365:Costs and Cost Analysis; D003376:Counseling; D003627:Data Interpretation, Statistical; D006801:Humans; D008055:Lipids / Q000097:blood; D009042:Motivation; D017063:Outcome Assessment, Health Care; D011788:Quality of Life; D057185:Sedentary Behavior; D060145:Text Messaging
chemical_list: D008055:Lipids