Clinical trial NCT04386200: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Overweight and Obesity
Nutritional and Metabolic Diseases
Keywords: Web technologies
Nutrition
Lead sponsor: Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Change from baseline in Body Weight
timeFrame: Baseline, month 3, month 6, month 9 and month12
Secondary outcomes:
measure: Change from baseline in BMI
timeFrame: Baseline, month 3, month 6, month 9 and month12
measure: Change from baseline in body circumferences
timeFrame: Baseline, month 3, month 6, month 9 and month12
measure: Change from baseline in Systolic and Diastolic blood pressure
timeFrame: Baseline, month 3, month 6, month 9 and month12
measure: Change from baseline in fasting blood glucose
timeFrame: Baseline, month 3, month 6, month 9 and month12
measure: Change from baseline in HbA1C
timeFrame: Baseline, month 3, month 6, month 9 and month12
measure: Change from baseline in Dietary habits estimated by PREvencion con DIetaMEDiterranea questionnaire (PREDIMED questionnaire)
timeFrame: Baseline, month 3, month 6, month 9 and month12
measure: Change from baseline in physical activity level estimated by the International Physical Activity Questionnaire (IPAQ) - short form
timeFrame: Baseline, month 3, month 6, month 9 and month12
measure: Change from baseline in Quality of life by 36-item short form health survey (SF-36)
timeFrame: Baseline, month 3, month 6, month 9 and month12
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: Hospital "SS Annunziata"
Study officials:
References:
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.