Back to resultsPromotion of Healthy Eating Behaviors in Type 2 Diabetes Patients
Primary Purpose
Healthy Lifestyle, Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Healthy eating
Sponsored by
About this trial
This is an interventional prevention trial for Healthy Lifestyle
Eligibility Criteria
Inclusion Criteria: Age Type 2 diabetes Poor dietary habits Exclusion Criteria: Micro and macro-vascular complications Poor glycemic control Food allergy
Sites / Locations
- University hospital valenciaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Outcomes
Primary Outcome Measures
Change in plasma triglycerides
Plasma triglycerides (mmol/L) assessed using chemistry kits on an analyzer platform
Change in blood glucose
Plasma blood glucose (mmol/L) assessed using chemistry kits on an analyzer platform
Secondary Outcome Measures
Change in waist circumference
Waist circumference in cm assessed using steel tape
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05714852
Brief Title
Promotion of Healthy Eating Behaviors in Type 2 Diabetes Patients
Official Title
Promotion of Healthy Eating Behaviors in Type 2 Diabetes Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
February 10, 2025 (Anticipated)
Study Completion Date
February 10, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Valencia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Intervention designed to promote healthy eating in patients with type 2 diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Lifestyle, Diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Healthy eating
Intervention Description
Promotion of healthy eating
Primary Outcome Measure Information:
Title
Change in plasma triglycerides
Description
Plasma triglycerides (mmol/L) assessed using chemistry kits on an analyzer platform
Time Frame
Before - 16 weeks
Title
Change in blood glucose
Description
Plasma blood glucose (mmol/L) assessed using chemistry kits on an analyzer platform
Time Frame
Before - 16 weeks
Secondary Outcome Measure Information:
Title
Change in waist circumference
Description
Waist circumference in cm assessed using steel tape
Time Frame
Before - 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age
Type 2 diabetes
Poor dietary habits
Exclusion Criteria:
Micro and macro-vascular complications
Poor glycemic control
Food allergy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Cano
Phone
0034 629308479
Email
antonio.cano@uv.es
Facility Information:
Facility Name
University hospital valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio cano sanchez
Phone
629308479
Email
antonio.cano@uv.es
12. IPD Sharing Statement
Learn more about this trial
Promotion of Healthy Eating Behaviors in Type 2 Diabetes Patients
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