Web-based Approach in Nutrition and Diabetes
Educational Approach, Clinical Nutrition and Type 2 Diabetes: Traditional Strategies and Innovative Technologies
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable type-2-diabetes-mellitus
Started Feb 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 13, 2019
CompletedFirst Submitted
Initial submission to the registry
May 5, 2020
CompletedFirst Posted
Study publicly available on registry
May 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedMay 15, 2020
May 1, 2020
1.6 years
May 5, 2020
May 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Change from baseline in BMI
Baseline, month 3, month 6, month 9 and month12
Change from baseline in body circumferences
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
Change from baseline in HbA1C
Baseline, month 3, month 6, month 9 and month12
- +3 more secondary outcomes
Study Arms (2)
WEB GROUP
EXPERIMENTALTraditional approach integrated with web-based technologies.
TRADITIONAL GROUP
OTHERTraditional educational approach
Interventions
Integration of "traditional" face-to-face educational approach with web-based technologies.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Conditions that could interfere with the execution and completion of the project or failure adherence to the protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital "SS Annunziata"
Chieti, 66100, Italy
Related Publications (1)
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.
PMID: 33081596DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 5, 2020
First Posted
May 13, 2020
Study Start
February 13, 2019
Primary Completion
October 1, 2020
Study Completion
October 1, 2020
Last Updated
May 15, 2020
Record last verified: 2020-05