The Diabetes Health Coaching Randomized Controlled Trial: Rationale, Design and Baseline Characteristics of Adults Living With Type 2 Diabetes.

OBJECTIVES: The Diabetes Health Coaching Trial was a single-blind, randomized controlled trial designed to evaluate the effect of a 1-year telephone-based diabetes health-coaching intervention for community-dwelling adults living with type 2 diabetes mellitus. It concerned glycated hemoglobin levels, self-care behaviours and cost-effectiveness. The purpose of this article is to describe the rationale, design and participants' characteristics.

METHODS: The eligibility criteria were: 1) adults ≥18 years of age; 2) a diagnosis of type 2 diabetes; 3) glycated hemoglobin levels of ≥7.5% 6 months before randomization; 4) the ability to read, write and understand English; and 5) having telephone access. Participants were randomized to either usual diabetes education or diabetes education plus diabetes health coaching.

RESULTS: From May 2016 to December 2017, 365 participants were randomized into the trial. At baseline, the mean age was 57.9 (11.78) years, the mean duration of diabetes was 8.69 (8.54) years, the mean glycated hemoglobin level was 8.98 (1.58) %, and the mean body mass index was 35.03 (8.07) kg/m2 .

CONCLUSIONS: The baseline characteristics of the participants were equally distributed across the intervention and control groups. The Diabetes Health Coaching Trial is in a position to evaluate a potential treatment alternative and approach for type 2 diabetes and examined the effect of the intervention on clinical outcomes, self-care behaviours and cost-effectiveness.