A randomized controlled trial to compare the cost-effectiveness of group vs. Web-Tel nutrition education program on glycemic, lipids, and anthropometric control of patients with type 2 diabetes

Phase 3

• Conditions: Type 2 Diabetes Mellitus; Diabetes Nutrition Education Cost-Effectiveness

• Registration Number: TCTR20210331001
• Lead Sponsor: Vice Chancellor for Research, Shiraz University of Medical sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-31
• Study Completion: 2021-12-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

The study population consists of the patients with T2DM adults which will be recruited from health centers of Bushehr province of Iran. In the present study, positive inclusion criteria include: the patients with uncontrolled type 2 diabetes mellitus (HbA1c of at least 7); diagnosis of the disease under 1 year; Adults above 20 years old; reading and writing literacy; Having access and ability to use the Internet and mobile phones; Tendency to participate in the study. Negative inclusion criteria consist of: People with mental and emotional disorders or with disabilities; People under treatment for AIDs, cancers, chronic heart, cerebrovascular, renal, and hepatic diseases; Pregnant or lactating women; Participation in professional group nutrition education of diabetic patients (except for usual care) in the last year; and participation in other clinical studies in the past 6 months.

Exclusion Criteria

While Exclusion criteria includes giving chronic diseases during the trial, failure to attend more than one educational session, and the lack of motivation to participate in the study at any time of the research.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycosylated HemoglobinA1c (HbA1c) At the beginning of the study and at month 3. HbA1c will be measured using a complete blood sample by high performance liquid chromatography (HPLC) (Bio-Rad Variant II, Sydney, Australia).