Web-based Approach in Nutrition and Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Educational Approach, Clinical Nutrition and Type 2 Diabetes: Traditional Strategies and Innovative Technologies

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04386200
• Other study ID #: VITA02
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 13, 2019
• Est. completion date: October 2020

Study information

• Verified date: May 2020
• Source: Università degli Studi 'G. d'Annunzio' Chieti e Pescara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to test web-based strategies, in overweight or obese participants at risk or affected by Type 2 Diabetes Mellitus , to promote adherence over time to a healthy lifestyle and nutritional medical therapy (TMN). The study population includes 40 subjects, randomly allocated to web group (therapeutic reinforcement through web-based strategies) or traditional group (traditional educational approach). Anthropometric and clinical parameters will be collected, as well as scores of validated questionnaires will be administered up to 12 months from the enrollment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Overweight or obesity (BMI =25 kg/m2)

• Participants with or at risk of Type 2 Diabetes Mellitus

• Skills in the use web-based technologies and internet accessibility

Exclusion Criteria:

• Conditions that could interfere with the execution and completion of the project or failure adherence to the protocol.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Metabolic Diseases
• Nutritional and Metabolic Diseases
• Overweight
• Overweight and Obesity
• Type 2 Diabetes Mellitus

Intervention

Other:
• web-based thecnologies
Integration of "traditional" face-to-face educational approach with web-based technologies.

Behavioral:
• traditional approach
"traditional" face-to-face educational approach

Locations

Country	Name	City	State
Italy	Hospital "SS Annunziata"	Chieti

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Body Weight	Assessment of body weight (in kilograms) at baseline and after 3, 6, 9 and 12 months	Baseline, month 3, month 6, month 9 and month12
Secondary	Change from baseline in BMI	Assessment of BMI (kg/m^2) at baseline and after 3, 6, 9 and 12 months	Baseline, month 3, month 6, month 9 and month12
Secondary	Change from baseline in body circumferences	Assessment of body circumferences (in centimeters) at baseline and after 3, 6, 9 and 12 months	Baseline, month 3, month 6, month 9 and month12
Secondary	Change from baseline in Systolic and Diastolic blood pressure	Assessment of Systolic and Diastolic blood pressure (mm hg) at baseline and after 3, 6, 9 and 12 months	Baseline, month 3, month 6, month 9 and month12
Secondary	Change from baseline in fasting blood glucose	Assessment of fasting blood glucose (mg/dl) at baseline and after 3, 6, 9 and 12 months	Baseline, month 3, month 6, month 9 and month12
Secondary	Change from baseline in HbA1C	Assessment of HbA1C at baseline and after 3, 6, 9 and 12 months	Baseline, month 3, month 6, month 9 and month12
Secondary	Change from baseline in Dietary habits estimated by PREvencion con DIetaMEDiterranea questionnaire (PREDIMED questionnaire)	Assessment of Dietary habits at baseline and after 3, 6, 9 and 12 months. Changes in dietary habits will be estimated using a 14-item PREDIMED questionnaire which is a questionnaire to assess the adherence to the Mediterranean diet, 0 being the minimum total score and 14 the maximum total score. Higher values represent a higher adherence to the Mediterranean diet.	Baseline, month 3, month 6, month 9 and month12
Secondary	Change from baseline in physical activity level estimated by the International Physical Activity Questionnaire (IPAQ) - short form	Assessment of physical activity level at baseline and after 3, 6, 9 and 12 months. Changes in the level of physical exercise will be estimated by the International Physical Activity Questionnaire (IPAQ-short form) which is a questionnaire to assess the level of physical activity. Patients are asked to measure the average amount of time spent in sedentary behaviours and different intensity levels of physical activity. The questionnaire obtains three different intensity levels of physical activity: low, moderate and high.	Baseline, month 3, month 6, month 9 and month12
Secondary	Change from baseline in Quality of life by 36-item short form health survey (SF-36)	Assessment of Quality of life by SF-36 at baseline and after 3, 6, 9 and 12 months. The 36-Item Short Form Health Survey (SF-36) is a self-report generic quality of life measure. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH) with scores ranging from 0 to 100. Higher scores indicate greater self-reported quality of life.	Baseline, month 3, month 6, month 9 and month12