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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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210331001
Enrollment
105
Registered
2021-03-31
Start date
2021-07-23
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus Diabetes Nutrition Education Cost-Effectiveness

Interventions

This model consists of 3 nutrition education lessons. For members of this group, open access to the weblog will be possible and they can enter the weblog with their username and password, to be sure t
Active Comparator Other,Active Comparator Other,No Intervention Other
Web-Tel Nutrition Education:,Group Education,Control Group

Sponsors

Vice Chancellor for Research, Shiraz University of Medical sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 65 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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).

Secondary

MeasureTime frame
Fasting Blood Sugar (FBS) At the beginning of the study and at month 3. FBS will be measured by hexokinase (Roche Modular Analyzer; Tokyo, Japan).,Fasting insulin At the beginning of the study and at month 3. Fasting insulin levels will be measured quantitatively by luminescence.,Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) At the beginning of the study and at month 3. HOMA-IR will be calculated by the following formula: [Fasting Insulin (Milli International Unit / Liter) * Fasting Blood Sugar (Mill Mol / L)] / 22.5,QUICKI At the beginning of the study and at month 3. QUICKI will be calculated by Formula: 1/ (Glucose concentration logarithm + insulin concentration logarithm).,waist circumference (WC) At the beginning of the study and at month 3. Waist circumference will be measured on the middle distance between the last ribs and iliac bones, at the end of normal exhalation by using a non-elastic tape meter with an accuracy of 0.1 cm.,body mass index (BMI) At the beginning of the study and at month 3. Body Mass Index (BMI) will be measured by dividing weight (in kilograms) by squares of height (in square meters).,Total Cholesterol (TC) At the beginning of the study and at month 3. will be measured using the ELISA method.,High Density Lipoprotein cholesterol (HDL-C) At the beginning of the study and at month 3. will be measured using the ELISA method.,Low Density Lipoprotein cholesterol (LDL-C) At the beginning of the study and at month 3. will be measured using the ELISA method.,triglycerides (TG) At the beginning of the study and at month 3. will be measured using the ELISA method.,Systolic Blood Pressure (SBP) At the beginning of the study and at month 3. While sitting at rest, blood pressure will be measured on the left arm with mercury sphygmomanometer, 2 times, and the average of 2 times considered as the final blood pressure.,Diastolic Blood Pressure (DBP) At the beginning of the study and at month 3. While sitting at rest, blood pre

Countries

Iran

Contacts

Public ContactShiva Faghih

Shiraz University of Medical Sciences

shivafaghih@gmail.com09176424051

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026