Web-based Approach in Nutrition and Diabetes
Primary Purpose
Type 2 Diabetes Mellitus, Overweight and Obesity, Nutritional and Metabolic Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
web-based thecnologies
traditional approach
Sponsored by
About this trial
This is an interventional prevention trial for Type 2 Diabetes Mellitus focused on measuring Web technologies, Nutrition
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.
Sites / Locations
- Hospital "SS Annunziata"
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
WEB GROUP
TRADITIONAL GROUP
Arm Description
Traditional approach integrated with web-based technologies.
Traditional educational approach
Outcomes
Primary Outcome Measures
Change from baseline in Body Weight
Assessment of body weight (in kilograms) at baseline and after 3, 6, 9 and 12 months
Secondary Outcome Measures
Change from baseline in BMI
Assessment of BMI (kg/m^2) at baseline and after 3, 6, 9 and 12 months
Change from baseline in body circumferences
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
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
Assessment of fasting blood glucose (mg/dl) at baseline and after 3, 6, 9 and 12 months
Change from baseline in HbA1C
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)
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
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)
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.
Full Information
NCT ID
NCT04386200
First Posted
May 5, 2020
Last Updated
May 13, 2020
Sponsor
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
1. Study Identification
Unique Protocol Identification Number
NCT04386200
Brief Title
Web-based Approach in Nutrition and Diabetes
Official Title
Educational Approach, Clinical Nutrition and Type 2 Diabetes: Traditional Strategies and Innovative Technologies
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 13, 2019 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Overweight and Obesity, Nutritional and Metabolic Diseases
Keywords
Web technologies, Nutrition
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
WEB GROUP
Arm Type
Experimental
Arm Description
Traditional approach integrated with web-based technologies.
Arm Title
TRADITIONAL GROUP
Arm Type
Other
Arm Description
Traditional educational approach
Intervention Type
Other
Intervention Name(s)
web-based thecnologies
Intervention Description
Integration of "traditional" face-to-face educational approach with web-based technologies.
Intervention Type
Behavioral
Intervention Name(s)
traditional approach
Intervention Description
"traditional" face-to-face educational approach
Primary Outcome Measure Information:
Title
Change from baseline in Body Weight
Description
Assessment of body weight (in kilograms) at baseline and after 3, 6, 9 and 12 months
Time Frame
Baseline, month 3, month 6, month 9 and month12
Secondary Outcome Measure Information:
Title
Change from baseline in BMI
Description
Assessment of BMI (kg/m^2) at baseline and after 3, 6, 9 and 12 months
Time Frame
Baseline, month 3, month 6, month 9 and month12
Title
Change from baseline in body circumferences
Description
Assessment of body circumferences (in centimeters) at baseline and after 3, 6, 9 and 12 months
Time Frame
Baseline, month 3, month 6, month 9 and month12
Title
Change from baseline in Systolic and Diastolic blood pressure
Description
Assessment of Systolic and Diastolic blood pressure (mm hg) at baseline and after 3, 6, 9 and 12 months
Time Frame
Baseline, month 3, month 6, month 9 and month12
Title
Change from baseline in fasting blood glucose
Description
Assessment of fasting blood glucose (mg/dl) at baseline and after 3, 6, 9 and 12 months
Time Frame
Baseline, month 3, month 6, month 9 and month12
Title
Change from baseline in HbA1C
Description
Assessment of HbA1C at baseline and after 3, 6, 9 and 12 months
Time Frame
Baseline, month 3, month 6, month 9 and month12
Title
Change from baseline in Dietary habits estimated by PREvencion con DIetaMEDiterranea questionnaire (PREDIMED questionnaire)
Description
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.
Time Frame
Baseline, month 3, month 6, month 9 and month12
Title
Change from baseline in physical activity level estimated by the International Physical Activity Questionnaire (IPAQ) - short form
Description
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.
Time Frame
Baseline, month 3, month 6, month 9 and month12
Title
Change from baseline in Quality of life by 36-item short form health survey (SF-36)
Description
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.
Time Frame
Baseline, month 3, month 6, month 9 and month12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hospital "SS Annunziata"
City
Chieti
ZIP/Postal Code
66100
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
33081596
Citation
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.
Results Reference
derived
Learn more about this trial
Web-based Approach in Nutrition and Diabetes
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