title: Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) study: Methodology and baseline characteristics of a randomized controlled trial evaluating an occupation-based diabetes management intervention for young adults.
abstract: This paper describes the study protocol used to evaluate the Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) intervention and reports on baseline characteristics of recruited participants. REAL Diabetes is an activity-based intervention designed to address the needs of young adults diagnosed with type 1 (T1D) or type 2 diabetes (T2D) from low socioeconomic status or racial/ethnic minority backgrounds. The REAL intervention incorporates tailored delivery of seven content modules addressing various dimensions of health and well-being as they relate to diabetes, delivered by a licensed occupational therapist.
  
  
  
  In this pilot randomized controlled trial, participants are assigned to the REAL Diabetes intervention or an attention control condition. The study's primary recruitment strategies included in-person recruitment at diabetes clinics, mass mailings to clinic patients, and social media advertising. Data collection includes baseline and 6-month assessments of primary outcomes, secondary outcomes, and hypothesized mediators of intervention effects, as well as ongoing process evaluation assessment to ensure study protocol adherence and intervention fidelity.
  
  
  
  At baseline, participants (n=81) were 51% female, 78% Latino, and on average 22.6years old with an average HbA1c of 10.8%. A majority of participants (61.7%) demonstrated clinically significant diabetes distress and 27.2% reported symptoms consistent with major depressive disorder. Compared to participants with T1D, participants with T2D had lower diabetes-related self-efficacy and problem-solving skills. Compared to participants recruited at clinics, participants recruited through other strategies had greater diabetes knowledge but weaker medication adherence.
  
  
  
  Participants in the REAL study demonstrate clinically significant medical and psychosocial needs.
authors.affiliation: Division of Occupational Science and Occupational Therapy, University of Southern California, 1540 Alcazar St., CHP-133, Los Angeles, USA. Electronic address: Beth.pyatak@chan.usc.edu.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Pyatak
authors.affiliation: Division of Occupational Science and Occupational Therapy, University of Southern California, 1540 Alcazar St., CHP-133, Los Angeles, USA.
authors.forename: Kristine
authors.initials: K
authors.lastname: Carandang
authors.affiliation: Division of Occupational Science and Occupational Therapy, University of Southern California, 1540 Alcazar St., CHP-133, Los Angeles, USA.
authors.forename: Cheryl
authors.initials: C
authors.lastname: Vigen
authors.affiliation: Division of Occupational Science and Occupational Therapy, University of Southern California, 1540 Alcazar St., CHP-133, Los Angeles, USA.
authors.forename: Jeanine
authors.initials: J
authors.lastname: Blanchard
authors.affiliation: Department of Pediatrics, University of Southern California, 2020 Zonal Ave, Rm. 115, Los Angeles, CA 90033, USA.
authors.forename: Paola A
authors.initials: PA
authors.lastname: Sequeira
authors.affiliation: Department of Pediatrics, University of Southern California, 2020 Zonal Ave, Rm. 115, Los Angeles, CA 90033, USA; Children's Hospital Los Angeles, 4650 Sunset Boulevard, MS # 61, Los Angeles, CA 90027, USA.
authors.forename: Jamie R
authors.initials: JR
authors.lastname: Wood
authors.affiliation: Department of Preventive Medicine, Keck School of Medicine, University of Southern California, 2001 N. Soto Street, MC 9239, Los Angeles, CA 90089, USA.
authors.forename: Donna
authors.initials: D
authors.lastname: Spruijt-Metz
authors.affiliation: Yale School of Nursing, 100 Church Street South, P.O. Box 9740, New Haven, CT 06536-0740, USA.
authors.forename: Robin
authors.initials: R
authors.lastname: Whittemore
authors.affiliation: Division of Endocrinology, University of Southern California, 9033 Wilshire Blvd. Suite 406, Beverly Hills, CA 90211, USA.
authors.forename: Anne L
authors.initials: AL
authors.lastname: Peters
mesh_terms: D000328:Adult; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy / Q000378:metabolism / Q000523:psychology / Q000534:rehabilitation*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D015438:Health Behavior; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D008297:Male; D009788:Occupational Therapy; D010358:Patient Participation; D010865:Pilot Projects; D055500:Resilience, Psychological; D012648:Self Care; D000073278:Self-Management; D055815:Young Adult
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; C517652:hemoglobin A1c protein, human
keywords: Diabetes mellitus; Health behavior; Occupational therapy; Randomized controlled trial; Young adult