Investigating the Effect of an Educational Intervention Based on King's Theory of Goal Attainment on Self-Efficacy and Self-Care Behaviors in Patients with Type 2 Diabetes

To investigate the effectiveness of a King's Theory based educational program on improving self efficacy in patients with type 2 diabetes

Two arm randomized controlled trial with pre test post test design and three month follow up in 80 patients; simple randomization via Excel; single blind

This two-arm randomized controlled trial at comprehensive health service After screening and applying criteria, 80 patients with type 2 diabetes will be individually allocated via simple randomization (Microsoft Excel) to either the intervention group (4-week King's Theory-based educational program) or control group (standard diabetes care). Data will be collected using the Diabetes Self-Efficacy Scale at three time points: Before, after and 3 months after intervention. employs single-blinding: outcome assessors and data analysts remain blinded to group allocation, while blinding of participants is not feasible due to the educational nature of the intervention

Inclusion Criteria: Patients with type 2 diabetes mellitus aged 30 to 70 years providing written informed consent.Exclusion Criteria: History of severe psychiatric disorders or advanced cardiac/renal failure.

Intervention group: type 2 diabetes patients receiving a 4-week King's Theory-based educational program (personal, interpersonal, social systems and purposeful transaction) via 90-minute interactive group sessions. Control group: patients receiving standard 45-minute diabetes counseling on diet, medications and blood glucose monitoring without theoretical content.

Self efficacy score for diabetes management & diabetes self care behaviors

In this study, randomization at the individual level will be utilized to maintain a precise balance between the two groups throughout the recruitment period, and given this approach, no stratification will be applied. The random sequence will be generated using the random number generation function in Microsoft Excel software. To allocate 80 patients into two groups of 40 each, 20 blocks of four will be used. Within each block, two allocations are assigned to the intervention group and two to the control group, and their sequence will be completely randomized using the RAND function in Excel. This ensures that exactly 40 patients will ultimately be placed in each group, and no quasi-randomization methods, such as allocation based on the date of visit, medical record number, or alternation, will be employed. Regarding allocation concealment, which is a distinct process from blinding and is aimed at preventing selection bias, the standard method of sequentially numbered, opaque, sealed envelopes (SNOSE) will be implemented. The sequence generated in Excel will be written on identical cards and placed inside opaque envelopes so that the contents cannot be seen from the outside. The envelopes will then be sealed and numbered sequentially from 1 to 80, strictly according to the random sequence order, and kept securely by the principal investigator in a safe location. After verifying the inclusion criteria and obtaining written informed consent from each patient, the researcher will open the lowest available numbered envelope to determine the assigned group. Prior to opening the envelope, the next assignment will remain completely concealed and unpredictable to both the researcher and the patient.

Due to the educational nature of intervention, blinding of participants and interventionist is not feasible. Outcome assessors (data collectors) and data analysts will be blinded to group allocation status.

Study protocol and statistical analysis plan: The complete study protocol including objectives, methodology, inclusion/exclusion criteria, randomization and blinding procedures, and the statistical analysis plan detailing descriptive and inferential methods (independent and paired t-tests, analysis of covariance),all data , questionnaires will be made available six months after publication of the primary manuscript. The data dictionary will include variable definitions, measurement scales, and coding schemes used in questionnaires. The final clinical study report will be disseminated through publication in a peer-reviewed scientific journal. Availability timeframe: Six months after publication of the primary manuscript and until the end of the third year following study completion. Authorized recipients: Researchers holding valid ethics approval from an accredited academic institution with research objectives related to diabetes or health education. Access conditions: Submission of written request with research proposal and institutional ethics approval to the principal investigator; use strictly for non-commercial research purposes with proper citation of the original study. Request mechanism: Email request to the principal investigator (Dr. Mohammad Hossein Delshad) at delshad264@gmail.com including institutional affiliation and research purpose.

Six months after publication of the primary manuscript until the end of the third year following study completion

Researchers holding valid ethics approval from accredited academic and research institutions (universities and research centers under the supervision of the Ministry of Science or Ministry of Health) with research objectives related to diabetes, health education, or health psychology, requesting access solely for non-commercial research purposes.

De-identified data and study documents may be used only for non-commercial academic research and educational purposes. Conditions for use include: Submission of valid institutional ethics approval from the requesting organization Provision of a research proposal related to diabetes, health education, or health psychology Mandatory citation of the original study in any resulting publications or presentations Prohibition of commercial use, marketing activities, or attempts to re-identify participants No redistribution of data to third parties without written permission from the principal investigator

Principal Investigator: Dr. Mohammad Hossein Delshad, Assistant/Associate Professor, Department of Public Health, Research Center for Health Sciences, School of Public Health, Torbat Heydariyeh University of Medical Sciences Postal Address: Research Center for Health Sciences, School of Public Health, Torbat Heydariyeh University of Medical Sciences, Torbat Heydariyeh, Razavi Khorasan Province, Iran, Postal Code: 9417966579 Official Institutional Email: delshad@thums.ac.ir Office Phone: +98 51 52421 ext. 248(if applicable)

The data request process follows four sequential steps: Step 1) Submission of written request via institutional email including research proposal, valid ethics approval certificate, and institutional letter of introduction to the principal investigator's official email address; Step 2) Review by the Study Data Access Committee (comprising the principal investigator and two independent faculty members) within 15 working days; Step 3) Upon approval, signing of a Data Use Agreement that legally prohibits commercial use and any attempt to re-identify participants; Step 4) Delivery of de-identified data in Excel or SPSS format within 10 working days after agreement execution. The entire process typically takes 25 to 35 working days from initial submission to data delivery. Incomplete requests or those lacking valid ethics approval will be rejected without review.

Raw data containing personally identifiable information (name, medical record number, contact details) will be permanently deleted immediately after initial coding; only de-identified coded data will be retained for analysis. No fees will be charged to participants and participation is entirely voluntary. The study has no financial or organizational conflicts of interest and is fully funded by the Vice-Chancellor for Research and Technology of Torbat Heydariyeh University of Medical Sciences. All study procedures are conducted under the supervision of the University Ethics Committee (Code: IR.THUMS.REC.1401.036).