Promotion of Healthy Eating Behaviors in Type 2 Diabetes... | NCT05714852

Studies
Promotion of Healthy Eating Behaviors in Type 2 Diabetes Patients

NCT05714852

Sponsor

University of Valencia

Status

Unknown status

Last Update Posted

May 16, 2023Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Healthy Lifestyle
Diabetes

Interventions

Healthy eating

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2023Actual

Primary Completion Date

Feb 10, 2025Estimated

Completion Date

Feb 10, 2026Estimated

First Submitted Date

Jan 26, 2023

First Submission Date that Met QC Criteria

Jan 26, 2023

First Posted Date

Feb 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2023

Last Update Posted Date

May 16, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental		Behavioral: Healthy eating
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Healthy eating	Behavioral	Promotion of healthy eating	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in plasma triglycerides	Plasma triglycerides (mmol/L) assessed using chemistry kits on an analyzer platform	Before - 16 weeks
Change in blood glucose	Plasma blood glucose (mmol/L) assessed using chemistry kits on an analyzer platform	Before - 16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in waist circumference	Waist circumference in cm assessed using steel tape	Before - 16 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age
Type 2 diabetes
Poor dietary habits

Exclusion Criteria:

Micro and macro-vascular complications
Poor glycemic control
Food allergy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Antonio Cano	Contact	0034 629308479		antonio.cano@uv.es

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University hospital valencia	Recruiting	Valencia		46010	Spain

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000072001	Diet, Healthy

Ancestor Terms

ID	Term
D004032	Diet
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided