Remission of Type 2 Diabetes With Mediterranean Diet, Physical Activity and Psychological Support: a Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to achieve diabetes type 2 (DM2) remission using intensive lifestyle intervention. The main questions it aims to answer are: * Does intensive lifestyle intervention (including Mediterranean diet with a caloric deficit, daily physical activity, increase in stress resilience and group support) lead to DM2 remission (HbA1c\<6.5%, without medications) * Can intensive lifestyle intervention (including Mediterranean diet with a caloric deficit, daily physical activity, increase in stress resilience and group support) result to weight loss of \>15 kg * Does intensive lifestyle intervention result in any side effects (secondary outcome) Researchers will compare intensive lifestyle intervention to the usual clinical care (control group). Participants in the experimental group will: * eat Mediterranean diet with a caloric deficit * perform daily physical activity * increase their stress resilience with psychosocial support of the group * enroll weekly in individual and group counseling and workshops for 6 months, following with 1.5 years of follow-up

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 69
Healthy Volunteers: f
View:

• type 2 diabetes diagnosis

• incident cases or diagnosed not more than 7 years ago

• body mass index of 27-45 kg/m²

Locations
Other Locations
Croatia
University of Split School of Medicine
RECRUITING
Split
Contact Information
Primary
Ivana Kolčić, Professor
ikolcic@mefst.hr
+38515762263
Backup
Lana Barać, PhD
lana.barac@mefst.hr
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2027-12-17
Participants
Target number of participants: 120
Treatments
Experimental: Lifestyle intervention group
The intervention will consist of the following elements:~1. Mediterranean diet - personalized nutritional recommendation based on the modern pyramid of the Mediterranean diet (44), additionally adjusted based on the current nutritional status of the subjects (tested through anthropometric and body composition parameters), and considering the level of physical activity during free time and professional requirements~2. Physical activity - emphasis on reducing sedentary behavior and including a daily regime of aerobic exercises, and exercises for muscle strength and endurance 2 times a week~3. Psychological support and intervention - group and individual counselling of subjects on effective ways of coping with stress~4. Positive and supportive interpersonal relationships - implementation of the intervention in small groups, which will be formed primarily as support groups (12 subjects per group) - weekly meetings, counselling and workshops, group exercise (walking)
No_intervention: Control group
Subjects in the control group will receive a short brochure that will be created for the purposes of this project on the importance of healthy lifestyle habits in people diagnosed with DM2, as well as advice and recommendations from a specialists for practicing healthy eating and physical activity. Furthermore, the subjects of the control group will receive regular clinical care within the framework of the health care system. At the same time intervals as the subjects of the experimental group, these subjects will be invited for a clinical examination, carrying out all measurements and tests, filling out questionnaires and providing biological samples (fasting blood and urine).
Related Therapeutic Areas
Sponsors
Collaborators: Croatian Science Foundation
Leads: University of Split, School of Medicine

This content was sourced from clinicaltrials.gov

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