Investigating the Effect of Lifestyle Coaching Program Based on Self-Determination Theory on Self-Care Management and Self-Advocacy Behavior in Patients with Diabetes Mellitus Type 2

Determining the effect of a lifestyle coaching program based on personal determination theory on self-management and self advocacy in patients with type 2 diabetes

A randomized, double-blind, parallel-group, controlled clinical trial with 32 patients in each group. the Block Randomization method was employed for the randomization process.

This clinical trial will be conducted at Taleghani, Imam Hossein, Shohada Tajrish, and Loghman Hakim Hospitals in Tehran. The research assistant involved in outcome assessment phase and the statistical analyzer involved in data analysis phase will be blinded to the type of group assignment of participants.

Inclusion criteria: 1) The age range of 18 to 70 years. 2) Referring to the internal or endocrinology departments or endocrinology outpatient clinics of hospitals affiliated to Shahid Beheshti University of Medical Sciences 3) Not suffering from other chronic debilitating diseases. 4) Having the ability to read and write. Exclusion criteria: 1) Deterioration of the patient's physical and mental condition during the study, making it impossible to continue participating in the study. 2) Do not attend two (or more) of the total number of training and follow-up sessions. 3) participation in another training program during the study.

Participants in the intervention group will receive a lifestyle coaching program based on self-determination theory in five 30- to 40-minute in-person sessions and five virtual sessions. The training sessions will cover healthy diet, hemoglobin A1c management, physical activity, foot care, medication adherence, regular blood sugar monitoring (hypoglycemia and hyperglycemia management), and insulin injections. The control group will receive standard hospital training.

Self-management; Self-advocacy

Participants will be selected conveniently and then allocated to two intervention and control groups using block randomization. In this method, blocks are formed based on the variables of interest, and block randomization works by randomizing participants in blocks, so that an equal number are assigned to each group. Equal numbers of participants will enter the experimental and control groups at successive time intervals. After visiting the inpatient ward or outpatient clinic, each patient will be randomly assigned to group A (experimental) or B (control group) according to the four-block prepared in the first stage. The random sequences created are recorded on a card and the cards are placed in the envelopes in order. Then, at the beginning of the study, the envelopes are opened in order and individuals are randomly assigned to the desired group in the order of their entry into the study and through the randomized blocks.

In the present study, blinding will be performed during the outcome assessment and statistical analysis phases. A research assistant who will not be involved in random allocation phase and a statistical analyzer who will not be involved in data collection phase will be used.

Participants data file

One year after the publication of the article

Researchers working in academic and scientific institutions

On request, the corresponding author of the article will provide the datasets that will be used and analyzed in the current study.

Responsible author of the article: Mitra Zandi; Email: mitra.zandi@yahoo.com; Tell: +98-21-88202511; Address: Intersection of Valiasr St. and Niayesh Highway, in front of Rajaei Hospital, Tehran, Iran. First Author of the article: Amir Mohamad Nazari; Email: nazari.amir7009@gmail.com; Tell: +989160957427; Address: Intersection of Valiasr St. and Niayesh Highway, in front of Rajaei Hospital, Tehran, Iran.

Less than a month