Nutritional and Metabolic Diseases, Overweight and Obesity, Type 2 Diabetes Mellitus
Conditions
Keywords
Web technologies, Nutrition
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.
Interventions
OTHERweb-based thecnologies
Integration of traditional face-to-face educational approach with web-based technologies.
BEHAVIORALtraditional approach
traditional face-to-face educational approach
Sponsors
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Body Weight | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in body circumferences | Baseline, month 3, month 6, month 9 and month12 | Assessment of body circumferences (in centimeters) at baseline and after 3, 6, 9 and 12 months |
| Change from baseline in Systolic and Diastolic blood pressure | Baseline, month 3, month 6, month 9 and month12 | Assessment of Systolic and Diastolic blood pressure (mm hg) at baseline and after 3, 6, 9 and 12 months |
| Change from baseline in fasting blood glucose | Baseline, month 3, month 6, month 9 and month12 | Assessment of fasting blood glucose (mg/dl) at baseline and after 3, 6, 9 and 12 months |
| Change from baseline in BMI | Baseline, month 3, month 6, month 9 and month12 | Assessment of BMI (kg/m\^2) at baseline and after 3, 6, 9 and 12 months |
| Change from baseline in Dietary habits estimated by PREvencion con DIetaMEDiterranea questionnaire (PREDIMED questionnaire) | Baseline, month 3, month 6, month 9 and month12 | 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. |
| 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 | 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. |
| 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 | 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. |
| Change from baseline in HbA1C | Baseline, month 3, month 6, month 9 and month12 | Assessment of HbA1C at baseline and after 3, 6, 9 and 12 months |
Countries
Italy
Outcome results
None listed