Assessing the Feasibility and Acceptability of Health Coaching as a New Diabetes Management Approach for the People with Type 2 Diabetes in Saudi Arabia: A Protocol for a Mixed Methods Feasibility Study

Abstract

Background: Over recent years, the Middle East, and especially Saudi Arabia, has faced multiple changes, including structural-demographic and economic shifts. This has led to massive changes in the population’s lifestyle, including more unhealthy diets and increases in physical inactivity. As a result, accelerating rates of chronic diseases, including type 2 diabetes mellitus (T2DM) are a major public health concern. Current diabetes care in Saudi Arabia focuses on increasing the awareness of patients through various approaches, mainly based on health education, which is found to be suboptimal and ineffective for improving long-term outcomes. This study aims to assess the feasibility and acceptability of using a client-centred approach called health coaching that supports, enables, and engages T2DM patients to take the central role of controlling their own conditions by developing new crucial skills. Methods: A mixed methods randomised controlled feasibility study of health coaching will be used. Participants (n = 30) are adults with T2DM with poorly controlled diabetes (A1C ≥7) who can read and write in Arabic. Eligible participants are randomly allocated to either an intervention or control group for 12 weeks. COM-B model and Behaviour Change Technique Taxonomy version 1 (BCTTv1) guide the intervention curriculum. Predetermined progression criteria will be used to determine whether to proceed to a larger trial or not. Outcomes will be measured at baseline and 3 months. The study’s primary aim is to assess the process of eligibility, recruitment, retention and completion rates, acceptability and suitability of intervention and the time to complete each procedure. The preliminary efficacy of health coaching is the secondary outcome that includes different measurements, such as HbA1c, blood pressure, body mass index (BMI), waist circumference, weight, patients’ self-efficacy, and diabetes self-management. Discussion: This is the first study to explore the feasibility, acceptability, and preliminary efficacy of health coaching that used the Capability, Opportunity, Motivation, Behaviour (COM-B) model and BCTTv1 as guidance to develop the intervention for adults with T2DM in Saudi Arabia. The findings of this study will be used to inform the larger RCT trial if it is shown to be feasible and acceptable.

Feasibility and acceptability of a tailored health coaching intervention to improve type 2 diabetes self-management in Saudi Arabia: a mixed-methods randomised feasibility trial

“…14 A comprehensive protocol for this study has already been published. 15 Design This is a randomised two-arm feasibility trial evaluating a 3-month intervention. The study adopted a mixed-methods approach, enabling the collection of both quantitative and qualitative data.…”

“…18 Further information on the intervention can be found in a prior publication. 15 Patient and public involvement Patients and the public were not involved during the process of this research.…”

“…A detailed explanation has been published elsewhere. 15 It is important to note that participants did not directly receive or review the intervention curriculum. Our approach involved ensuring uniformity in intervention procedures by providing health coaches with the curriculum.…”

“…As per the study protocol, 15 this study aimed to recruit a minimum of 9% (n=30) of the required sample size for conducting a complete trial. 22 Each group was expected to have a minimum of 12 participants to ensure meaningful data interpretation for informing a future definitive RCT.…”

“… 23 A total of 24 participants in each group would be required to detect a meaningful clinical difference in HbA1c. The retention rate was evaluated based on the predefined progression criteria described elsewhere, 15 with successful retention defined as achieving an 83% retention rate at the intervention endpoint.…”