Web-based Approach in Nutrition and Diabetes

Not Applicable

• Conditions: Type 2 Diabetes Mellitus; Overweight and Obesity; Nutritional and Metabolic Diseases
• Interventions: Other: web-based thecnologies; Behavioral: traditional approach

• Registration Number: NCT04386200
• Lead Sponsor: Università degli Studi 'G. d'Annunzio' Chieti e Pescara

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-13
• Status Verified: 2020-05
• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-08
• Study First Posted: 2020-05-13
• Last Update Submitted: 2020-05-13
• Last Update Posted: 2020-05-15
• Primary Completion: 2020-10
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WEB GROUP	web-based thecnologies	Traditional approach integrated with web-based technologies.
TRADITIONAL GROUP	traditional approach	Traditional educational approach

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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 HbA1C	Baseline, month 3, month 6, month 9 and month12	Assessment of HbA1C 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 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

Trial Locations

Locations (1)

Hospital "SS Annunziata"; 🇮🇹 Chieti, Italy