Web-based Approach in Nutrition and Diabetes

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

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes Mellitus; Overweight and Obesity; Nutritional and Metabolic Diseases
• Intervention / Treatment: Other: web-based thecnologies; Behavioral: traditional approach

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Chieti, Italy, 66100
    • Hospital "SS Annunziata"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Publications and helpful links

General Publications

• Fraticelli F, Nicola MD, Vitacolonna E. A nutritional web-based approach in obesity and diabetes before and during the COVID-19 lockdown. J Telemed Telecare. 2023 Feb;29(2):91-102. doi: 10.1177/1357633X20966933. Epub 2020 Oct 21.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2019
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 8, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): May 15, 2020
• Last Update Submitted That Met QC Criteria: May 13, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Nutrition; Web technologies
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Endocrine System Diseases; Body Weight; Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight; Metabolic Diseases
• Other Study ID Numbers: VITA02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No