Nutritional Strategy for Glycemic Control in Patients With Type 2 Diabetes Mellitus (NUGLIC)
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|ClinicalTrials.gov Identifier: NCT03793855|
Recruitment Status : Recruiting
First Posted : January 4, 2019
Last Update Posted : May 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Behavioral: Nutritional Strategy Behavioral: Dietary Prescription||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||370 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effectiveness of a Nutritional Strategy for Glycemic Control in Patients With Type 2 Diabetes Mellitus Users of a Public Health System: NUGLIC Study|
|Actual Study Start Date :||May 6, 2019|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Nutritional Strategy
Nutritional counseling based on the quality of the diet, the Food Guide for the Brazilian Population and concepts of mindfulness and mindful eating; dietary guidance based on feasible goals built together (patient and nutritionist).
Behavioral: Nutritional Strategy
Counseling based on dietary goals and mindfulness techniques.
Active Comparator: Dietary Prescription
Individualized dietary prescription according to the guidelines of the Brazilian Society of Diabetes.
Behavioral: Dietary Prescription
Dietary prescription according to guidelines.
- HbA1C [ Time Frame: 1 year ]Glycated hemoglobin, in %
- B-PAID [ Time Frame: 1 year ]Quality of life evaluated by the Brazilian version of the Problem Areas in Diabetes Scale
- DSCA [ Time Frame: 1 year ]Self-care evaluated by the Brazilian version of the Diabetes Self-Care Activities
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03793855
|Contact: Aline Marcadenti, PhD||(+55)11 30536611 ext firstname.lastname@example.org|
|Contact: Alexandre Cavalcanti, PhD||(+55)11 30536611 ext email@example.com|
|Hospital do Coracao||Recruiting|
|São Paulo, Brazil, 04004-030|
|Contact: Aline Marcadenti, PhD|
|Principal Investigator:||Aline Marcadenti, PhD||Hospital do Coracao|