Investigating the effect of educational therapy intervention based on the theory of planned behavior on self-care behaviors of people with type 2 diabetes

Determining the effect of educational intervention on self-care behaviors in patients with type 2 diabetes referring to comprehensive health centers in Khorramshahr city based on the theory of planned behavior

This study is a multi-center single‑blind cluster randomized controlled trial on 180 patients selected through systematic random sampling.

This study is designed as a multi‑center cluster randomized controlled trial. The study population consists of patients with type 2 diabetes who attend urban, rural, and urban–rural comprehensive health service centers in Khorramshahr. In this study, comprehensive health service centers are considered as clusters. First, a complete list of all comprehensive health service centers in Khorramshahr will be prepared, and six centers will then be selected using simple random sampling. These centers will be allocated by a statistician to either the intervention group (three centers) or the control group (three centers). A total of 180 participants will be enrolled in the study, with 30 patients with type 2 diabetes selected from each center using systematic random sampling.

Inclusion criteria were a confirmed diagnosis of type 2 diabetes, absence of neurological diseases or learning disorders, and informed consent to participate. Exclusion criteria included unwillingness to continue participation, absence from at least half of the educational sessions, change of address or contact number, and death of the participant.

The intervention group will receive two face‑to‑face and four virtual educational sessions over four weeks, while the control group will receive routine health care.

Knowledge, attitude, abstract norms, perceived behavioral control, behavioral intention, social support, diabetes-related behavior, fasting blood sugar

The information recorded in the IRCT system was revised to resolve certain writing and methodological inconsistencies, clarify intervention details, align the description of the randomization method and study design with the actual conduct of the research (including changing the blinding from double-blind to single-blind), and update the final study status and the number of participants analyzed.

This study will be conducted as a multi-center cluster randomized controlled trial among patients with type 2 diabetes attending urban, rural, and urban-rural comprehensive health service centers in Khorramshahr, Khuzestan Province, Iran. In this study, the comprehensive health service center will be considered the cluster and the unit of randomization. A multistage sampling method will be used. First, a list of all urban, rural, and urban–rural comprehensive health service centers in Khorramshahr will be prepared, and six centers will be selected using simple random sampling. These six centers (clusters) will then be randomly allocated by a statistician to either the intervention group (three centers) or the control group (three centers) using simple random allocation. After the allocation of clusters, the list of patients with type 2 diabetes covered by each center will be obtained and used as the sampling frame. From each center, 30 eligible participants will be selected using systematic random sampling. Additionally, a list of 30 replacement participants will be prepared to substitute individuals who do not meet the inclusion criteria or decline participation. All participants in centers allocated to the intervention group will receive the educational intervention, whereas participants in centers allocated to the control group will receive routine care provided by the health centers. In this design, all patients within each center will be assigned to the same study group according to the cluster allocation in order to prevent contamination between the intervention and control groups.

This study is designed as a single‑blind trial. In this study, the data analyst will be blinded to the allocation of participants to the intervention and control groups as well as to the details of the intervention. Due to the educational nature of the intervention, blinding of participants is not feasible.

No further information available.