Multicomponent intervention for obesity and diabetes management
Multicomponent Intervention on Lifestyle, Anthropometric Measurements, Glycemic Control and Quality of Life in Patients Obese People With Type II Diabetes
NA · Castilla-La Mancha Health Service · NCT06222775
This study is testing a new program that combines healthy eating and exercise to see if it helps people with obesity and Type II Diabetes improve their blood sugar control and overall health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Castilla-La Mancha Health Service (other) |
| Locations | 1 site (Talavera De La Reina, Toledo) |
| Trial ID | NCT06222775 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a multicomponent intervention focusing on nutritional recommendations and physical activity to improve glycemic control in obese patients with Type II Diabetes. Conducted at the Algodonera Health Center in Talavera de la Reina, the trial involves two parallel arms with random assignment and blind evaluation by third parties. Participants will be followed for one year, during which their dietary habits, physical activity levels, and health outcomes will be assessed. The study aims to promote healthy eating patterns and physical activity to enhance overall health and quality of life.
Who should consider this trial
Good fit: Ideal candidates are obese individuals aged 40 to 75 with a diagnosis of Type II Diabetes and a Barthel index greater than 90.
Not a fit: Patients with Type I Diabetes, severe cognitive impairments, or those unable to perform physical exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve glycemic control and quality of life for obese patients with Type II Diabetes.
How similar studies have performed: Other studies have shown success with similar multicomponent lifestyle interventions for managing obesity and diabetes, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with a known diagnosis of DM2. * Obese patients with a BMI \> 30. * Patients with Barthel index \> 90 * Possibility of walking to the Health Center. * Know how to read and write * That they agree to participate in the study and sign the informed consent. Exclusion Criteria: * Patients with Type I DM. * Inability to perform physical exercise, defined as such, that appears in your current medical history or that your PCP considers. * Patients with complete deafness. * Patients with blindness. * Moderate or severe cognitive impairment. * Participation in another clinical trial. * Pregnant or breastfeeding women * Any condition, laboratory parameter or concomitant therapy that, in the opinion of the investigator, may be a risk to the potential participant or that participation in the study is not in the best interest of the patient.
Where this trial is running
Talavera De La Reina, Toledo
- Gerencia de Atención Integrada de Talavera de la Reina Centro de Salud La Algodonera — Talavera De La Reina, Toledo, Spain (RECRUITING)
Study contacts
- Principal investigator: Maria Salobrar Labrador García, Medical — Gerencia de Atención Integrada de Talavera de la Reina
- Study coordinator: Maria Salobrar Labrador García, Medical
- Email: mslabrador@sescam.jccm.es
- Phone: +34 925800921
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity, Diabetes Mellitus, Type 2, prevention, clinical trial, obesity, Healthy Lifestyle