Ramadan Experience of Individuals With Type 2 Diabetes

NCT07384728 | Not Yet Recruiting

• 1 other identifier: Hm20260001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to examine the effects of fasting during Ramadan on treatment adherence, psychological adjustment, and glycemic control in individuals with type 2 diabetes. While Ramadan fasting is a religious practice, it can also pose health risks such as hypoglycemia, hyperglycemia, and metabolic imbalance in individuals with diabetes. Adherence to treatment and self-care, as well as psychosocial adjustment, are crucial in the effective management of diabetes. Given that a large portion of Turkey's population is Muslim, comparing individuals with type 2 diabetes who fast and those who do not during Ramadan will contribute to improving patient care within a cultural and religious context. The findings of this study are expected to guide nurses in developing personalized, culturally sensitive care plans tailored to the needs of individuals before, during, and after Ramadan.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes; Ramadan experience; Treatment; Psychological; Glycemic control

Outcome Measures

Primary Outcomes (4)

• 1. Parametre

  HbA1c 2-4 weeks before Ramadan (basic assessment).

  2-4 weeks

• 2. Parametre

  Treatment Adherence Scale, 2-4 weeks before Ramadan This scale was developed to evaluate "Patient Adherence in Type 2 Diabetes Mellitus Treatment." Validity and reliability analyses have shown it to be a valid and reliable scale. Based on the scores obtained from the scale, adherence is considered good if patients are doing what they should and not doing what they shouldn't, despite factors affecting treatment adherence. The scale: * Is administered to patients with type 2 diabetes for at least one year. • Consists of 30 items in total. * A 5-point Likert scale is used for scoring. • Patients indicate the most appropriate option for each statement on the scale using a 5-point Likert scale (Strongly agree=1, Agree=2, Partially agree=3, Disagree=4, and Strongly disagree=5). • The scale contains 13 items representing positive attitudes and 17 items representing negative attitudes. In scoring, positive items (1, 3, 5, 8, 13, 15, 16, 17, 19, 23, 25, 26, 29) are scor

  2-4 weeks

• 3. Parametre

  Psychological and Adherence Impact Scale 2-4 weeks before Ramadan. The BASE-6 was developed by Cruz et al. (2019) and it is a self-report instrument of general psychological adjustment comprising of six items. Each item assesses how a participant has been feeling in the past week. Items are rated on a 7-point scale (ranging from 1 = Not at all to 5 = Extremely). A sample item is "To what extent have you felt irritable, angry, and/or resentful this week?". Using three different adult samples, the original study demonstrated good internal consistency (α = .87-.93) and test-retest reliability (intraclass correlation was .77) over one-week period.

  2-4 weeks

• Post-Ramadan 2. Parametre

  Treatment adherence will be assessed using the Treatment Adherence Scale for Type 2 Diabetes Mellitus, a validated and reliable 30-item, 5-point Likert scale. Patients rate each item from strongly agree to strongly disagree. Higher scores indicate better adherence to diabetes treatment.

  Post-Ramadan: 1-2 months after

Secondary Outcomes (2)

• Post-Ramadan 1. Parametre

  Post-Ramadan: 1-2 months after

• Post-Ramadan 3. Parametre

  Post-Ramadan: 1-2 months after

Study Arms (2)

Experimental group: Individuals observing the fast.

EXPERIMENTAL

Patients in the experimental group received face-to-face dietary education from the researcher in the waiting room for approximately 15 minutes, and were given an "Information Brochure." Pre-education (pre-test) data collection tools were administered to diabetic patients. All data collection tools were administered to these patients, except for the structured Patient Information Form, which was completed one month after Ramadan 2026.

Other: The effect of fasting and not fasting during Ramadan.

No Intervention: Control Group

NO INTERVENTION

Diabetic patients in this group were classified as a non-fasting group. No intervention was applied. Only data collection forms were administered before the study (pre-test) and after Ramadan 2026.

Interventions

The effect of fasting and not fasting during Ramadan. OTHER

The effects of fasting and non-fasting during Ramadan on treatment adherence, psychological adjustment, and glycemic control.

Also known as: The effect of fasting during Ramadan

Experimental group: Individuals observing the fast.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals ≥18 years of age
• Able to give informed consent
• Diagnosed with type 2 diabetes
• Planning to fast during Ramadan

You may not qualify if:

• Presence of psychiatric illness
• Presence of cognitive impairment
• Receiving additional treatments that significantly affect glucose levels (e.g., ongoing steroid therapy)
• Individuals who have decided not to fast during Ramadan
• Individuals who have stopped fasting during Ramadan

Sponsors & Collaborators

• Gümüşhane Universıty: collaborator
• Dilan aktepe coşar: lead

Study Sites (2)

Gümüşhane Universıty

Gümüşhane, Kelkit, 2900, Turkey (Türkiye)

Location

Gümüşhane Üniversitesi

Gümüşhane, Kelkit, 29100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Dilan aktepe coşar, PhD

  Gümüşhane Universıty

  STUDY DIRECTOR

Central Study Contacts

Dilan aktepe coşar, PhD

CONTACT

+905075935875; dilan_aktepe@hotmail.com

Hatice Demirağ, PhD

CONTACT

05534267394; hatice_etbas@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients were randomly assigned to groups, and interviews were scheduled at different times to minimize the possibility of interaction between them. Additionally, patients were informed about the study and their consent was obtained prior to the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecture

Model Details: This research is a clinical trial designed to examine the effects of fasting during Ramadan on treatment adherence, psychological adjustment, and glycemic control in individuals with type 2 diabetes. The study compares individuals who fast and those who do not fast during Ramadan to evaluate the relevant variables. Participants are monitored before and after Ramadan; glycemic control, treatment adherence, and psychological adjustment are measured using standardized measurement tools. The study model aims to guide clinical practice and nursing care with the results obtained.

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: February 3, 2026
• Study Start: January 3, 2026
• Primary Completion: February 20, 2026
• Study Completion: March 20, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)