Status:
COMPLETED
HOME COOKING: Health Empowerment Strategy in People With Type II Diabetes Mellitus
Lead Sponsor:
Basque Culinary Center Fundazioa
Collaborating Sponsors:
University of Navarra
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Currently, one of the health challenges in the field of public health is to improve the quality of life of people with metabolic diseases, using new strategies that allow to promote healthy eating hab...
Detailed Description
One of the main factors influencing health is nutrition. Therefore, lifestyle and more specifically healthy eating habits, are key elements for the promotion of healthy lifestyle in society. Eating ha...
Eligibility Criteria
Inclusion
- Patients with type 2 Diabetes Mellitus without treatment with insulin, sulfonylureas and glinides.
- Overweight or obesity (BMI between 25 and 40 kg/m2).
- Stable treatment with oral antidiabetics, other than sulfonylureas or glinides, at least for 3 months.
Exclusion
- Treatment with insulin, sulfonylureas or glinides
- Glycosylated hemoglobin (HbA1c) concentration greater than 10%
- Weight loss exceeding 5 kg in the past three months
- Pregnant or breastfeeding women
- Serious medical condition that impedes from conducting the dietary intervention or that limits the survival to less than one year
- Consumption of illegal drugs, chronic alcoholism or alcohol total consumption above 80 g/day
- Participation in other clinical trial with drugs or nutritional intervention during the previous year to inclusion
- Major difficulties or inconveniences in changing dietary habits and following the Mediterranean Diet (allergies, intolerances)
- Difficulties for regular home cooking and/or eating out more than 2 days per week
- Current diagnosis of an eating disorder, schizophrenia, other psychotic disorder or bipolar disorder
- Hospitalization for any mental illness in the previous year
- History of bariatric surgery or extensive bowel resection
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2021
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04449120
Start Date
June 1 2020
End Date
March 30 2021
Last Update
June 1 2021
Active Locations (1)
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1
Basque Culinary Center
Donostia / San Sebastian, Guipuzcoa, Spain, 20009