Educational Approach, Clinical Nutrition and Type 2 Diabetes: Traditional Strategies and Innovative Technologies
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Università degli Studi 'G. d'Annunzio' Chieti e Pescara
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change from baseline in Body Weight
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Ester Vitacolonna
Professor
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Change from baseline in Body Weight
Time Frame: Baseline, month 3, month 6, month 9 and month12
Assessment of body weight (in kilograms) at baseline and after 3, 6, 9 and 12 months
Secondary Outcomes
- Change from baseline in body circumferences(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(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)(Baseline, month 3, month 6, month 9 and month12)
- Change from baseline in BMI(Baseline, month 3, month 6, month 9 and month12)
- Change from baseline in HbA1C(Baseline, month 3, month 6, month 9 and month12)
- Change from baseline in Dietary habits estimated by PREvencion con DIetaMEDiterranea questionnaire (PREDIMED questionnaire)(Baseline, month 3, month 6, month 9 and month12)
- Change from baseline in Systolic and Diastolic blood pressure(Baseline, month 3, month 6, month 9 and month12)
- Change from baseline in fasting blood glucose(Baseline, month 3, month 6, month 9 and month12)