Promotion of Healthy Eating Behaviors in Type 2 Diabetes Patients

• Sponsor: University of Valencia (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05714852
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

Intervention designed to promote healthy eating in patients with type 2 diabetes.

Condition or Disease	Intervention/Treatment	Phase
Healthy Lifestyle; Diabetes	Behavioral: Healthy eating	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Promotion of Healthy Eating Behaviors in Type 2 Diabetes Patients
• Anticipated Study Start Date: Feb 10, 2023
• Anticipated Primary Completion Date: Feb 10, 2025
• Anticipated Study Completion Date: Feb 10, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention	Behavioral: Healthy eating; Promotion of healthy eating
No Intervention: Control

Outcome Measures

Primary Outcome Measures

1. Change in plasma triglycerides [Before - 16 weeks]

   Plasma triglycerides (mmol/L) assessed using chemistry kits on an analyzer platform

2. Change in blood glucose [Before - 16 weeks]

   Plasma blood glucose (mmol/L) assessed using chemistry kits on an analyzer platform

Secondary Outcome Measures

1. Change in waist circumference [Before - 16 weeks]

   Waist circumference in cm assessed using steel tape

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age

• Type 2 diabetes

• Poor dietary habits

Exclusion Criteria:

• Micro and macro-vascular complications

• Poor glycemic control

• Food allergy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University hospital valencia	Valencia		Spain	46010

Sponsors and Collaborators

• University of Valencia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Valencia
• ClinicalTrials.gov Identifier: NCT05714852
• Other Study ID Numbers: Valencia Hospital Clínico
• First Posted: Feb 6, 2023
• Last Update Posted: Feb 6, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus

Study Results

No Results Posted as of Feb 6, 2023