title: Health Coaching Reduces HbA1c in Type 2 Diabetic Patients From a Lower-Socioeconomic Status Community: A Randomized Controlled Trial.
abstract: BACKGROUND
  Adoptions of health behaviors are crucial for maintaining good health after type 2 diabetes mellitus (T2DM) diagnoses. However, adherence to glucoregulating behaviors like regular exercise and balanced diet can be challenging, especially for people living in lower-socioeconomic status (SES) communities. Providing cost-effective interventions that improve self-management is important for improving quality of life and the sustainability of health care systems.
  
  
  OBJECTIVE
  To evaluate a health coach intervention with and without the use of mobile phones to support health behavior change in patients with type 2 diabetes.
  
  
  METHODS
  In this noninferiority, pragmatic randomized controlled trial (RCT), patients from two primary care health centers in Toronto, Canada, with type 2 diabetes and a glycated hemoglobin/hemoglobin A1c (HbA1c) level of ≥7.3% (56.3 mmol/mol) were randomized to receive 6 months of health coaching with or without mobile phone monitoring support. We hypothesized that both approaches would result in significant HbA1c reductions, although health coaching with mobile phone monitoring would result in significantly larger effects. Participants were evaluated at baseline, 3 months, and 6 months. The primary outcome was the change in HbA1c from baseline to 6 months (difference between and within groups). Other outcomes included weight, waist circumference, body mass index (BMI), satisfaction with life, depression and anxiety (Hospital Anxiety and Depression Scale [HADS]), positive and negative affect (Positive and Negative Affect Schedule [PANAS]), and quality of life (Short Form Health Survey-12 [SF-12]).
  
  
  RESULTS
  A total of 138 patients were randomized and 7 were excluded for a substudy; of the remaining 131, 67 were allocated to the intervention group and 64 to the control group. Primary outcome data were available for 97 participants (74.0%). While both groups reduced their HbA1c levels, there were no significant between-group differences in change of HbA1c at 6 months using intention-to-treat (last observation carried forward [LOCF]) (P=.48) or per-protocol (P=.83) principles. However, the intervention group did achieve an accelerated HbA1c reduction, leading to a significant between-group difference at 3 months (P=.03). This difference was reduced at the 6-month follow-up as the control group continued to improve, achieving a reduction of 0.81% (8.9 mmol/mol) (P=.001) compared with a reduction of 0.84% (9.2 mmol/mol)(P=.001) in the intervention group. Intervention group participants also had significant decreases in weight (P=.006) and waist circumference (P=.01) while controls did not. Both groups reported improvements in mood, satisfaction with life, and quality of life.
  
  
  CONCLUSIONS
  Health coaching with and without access to mobile technology appeared to improve glucoregulation and mental health in a lower-SES, T2DM population. The accelerated improvement in the mobile phone group suggests the connectivity provided may more quickly improve adoption and adherence to health behaviors within a clinical diabetes management program. Overall, health coaching in primary care appears to lead to significant benefits for patients from lower-SES communities with poorly controlled type 2 diabetes.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02036892; http://clinicaltrials.gov/ct2/show/NCT02036892 (Archived by WebCite at http://www.webcitation.org/6b3cJYJOD).
authors.affiliation: School of Kinesiology & Health Science, Faculty of Health, York University, Toronto, ON, Canada.
authors.forename: Noah
authors.identifier: http://orcid.org/0000-0002-8513-3616
authors.initials: N
authors.lastname: Wayne
authors.forename: Daniel F
authors.identifier: http://orcid.org/0000-0002-3056-2421
authors.initials: DF
authors.lastname: Perez
authors.forename: David M
authors.identifier: http://orcid.org/0000-0001-9046-1879
authors.initials: DM
authors.lastname: Kaplan
authors.forename: Paul
authors.identifier: http://orcid.org/0000-0003-1141-0083
authors.initials: P
authors.lastname: Ritvo
mesh_terms: D000328:Adult; D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000628:therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis / Q000737:chemistry*; D015438:Health Behavior; D006801:Humans; D008297:Male; D008875:Middle Aged; D011320:Primary Health Care / Q000379:methods*; D011788:Quality of Life; D012923:Social Class; D017216:Telemedicine / Q000379:methods*
chemical_list: D006442:Glycated Hemoglobin
keywords: RCT; diabetes mellitus, type 2; health coaching; mHealth; randomized controlled trial; telehealth