Web-based Approach in Nutrition and Diabetes

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Other: web-based thecnologies
* Behavioral: traditional approach


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WEB GROUP<br>Traditional approach integrated with web-based technologies. | Other: web-based thecnologies<br>* Integration of traditional face-to-face educational approach with web-based technologies.<br>|
| Other: TRADITIONAL GROUP<br>Traditional educational approach | Behavioral: traditional approach<br>* traditional face-to-face educational approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Web technologies, Nutrition