Lifestyle Intervention for Type 2 Diabetes in Primary Care (CREDOenAP)

NCT ID: NCT07207980

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-11
• Study Completion Date: 2028-01-11

Brief Summary

The purpose of this clinical trial is to determine whether an intensive lifestyle intervention can achieve remission of type 2 diabetes mellitus (T2DM) in adult patients treated in primary care. The main questions the study seeks to answer are:

• What proportion of participants achieve diabetes remission after 6 months of intervention?
• How many participants maintain remission 12 months after completing the program (18 months total)?

Participants will:

• Follow a personalized dietary plan with carbohydrate restriction.
• Engage in moderate, accessible physical activity.
• Implement strategies to improve circadian rhythm regularity.
• Receive psychological counseling and support.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

The program consists of biweekly in-person and telephone visits, focused on implementing a personalized dietary plan with carbohydrate restriction, based on the American Diabetes Association recommendations; moderate and accessible physical activity; circadian rhythm regularization; and psychological counseling and support.

Group Type: EXPERIMENTAL

CREDOenAP intervention

Intervention Type: BEHAVIORAL

Intervention program with intensive lifestyle counseling, added to standard pharmacological treatment subsequently adjusted according to clinical needs and outcomes. The intervention will last 6 months and consists of biweekly in-person and telephone visits. Patients will follow a personalized dietary plan with carbohydrate restriction, based on the recommendations of the American Diabetes Association; engage in moderate and accessible physical activity; implement circadian rhythm regularization; and receive psychological counseling and support.

Control group

They will receive the standard clinical treatment for diabetes

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CREDOenAP intervention

Intervention program with intensive lifestyle counseling, added to standard pharmacological treatment subsequently adjusted according to clinical needs and outcomes. The intervention will last 6 months and consists of biweekly in-person and telephone visits. Patients will follow a personalized dietary plan with carbohydrate restriction, based on the recommendations of the American Diabetes Association; engage in moderate and accessible physical activity; implement circadian rhythm regularization; and receive psychological counseling and support.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent.

2. Men and women aged 18-80 years, inclusive.

3. Confirmed diagnosis of T2DM according to recognized diagnostic criteria

4. Most recent recorded hemoglobin A1c (HbA1c) > 6.5%.

5. Body Mass Index (BMI) greater than 27 kg/m².

Exclusion Criteria

1. Failure to meet the diagnostic criteria for T2DM in the screening laboratory tests.

2. Being dependent for basic activities of daily living (Barthel score ≤ 90 points).

3. Lack of willingness to cooperate with the follow-up of the lifestyle intervention plan.

4. Presence of serious or terminal comorbidities significantly worsening short- to medium-term prognosis (active cancer, terminal chronic diseases, myocardial infarction within the last 6 months, acute heart failure or NYHA stage ≥ III, etc.).

5. History of ketoacidosis.

6. Presence of criteria or potential autoimmune insulinopenia (abnormal C-peptide, anti-GAD+ antibodies, pattern of basal and/or glucose-stimulated hypoinsulinemia).

7. Cognitive impairment.

8. Weight loss exceeding 5 kg in the past 6 months.

9. Significant changes in physical activity and/or dietary patterns in the past 6 months.

10. History of eating disorders.

11. History of substance abuse.

12. History of severe psychiatric disorders.

13. Pregnancy or intention to become pregnant within the study period.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parc Sanitari Pere Virgili

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandre Ternianov

Role: PRINCIPAL_INVESTIGATOR

Parc Sanitari Pere Virgili

Locations

Parc Sanitari Pere Virgili

Barcelona, , Spain

Countries

Spain

Central Contacts

Alexandre Ternianov Principal investigator

Role: CONTACT

aternianov@perevirgili.cat

+34 932 21 37 85

Facility Contacts

Neus Carrilero Primary and Community Care Research Coordinator

Role: primary

ncarrilero@perevirgili.cat

+ 34 659 77 29 79

Aida Veras Primary and Community Care Researcher

Role: backup

averas@perevirgili.cat

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

CREDOenAP

Identifier Type: -

Identifier Source: org_study_id