Clinical trial NCT06222775: Multicomponent Intervention on Lifestyle, Anthropometric Measurements, Glycemic Control and Quality of Life in Patients Obese People With Type II Diabetes
Official title: Multicomponent Intervention on Lifestyle, Anthropometric Measurements, Glycemic Control and Quality of Life in Patients Obese People With Type II Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Diabetes Mellitus, Type 2
Keywords: prevention
clinical trial
obesity
Diabetes Mellitus, Type 2
Healthy Lifestyle
Lead sponsor: Castilla-La Mancha Health Service
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main objective of this study will be to evaluate the effectiveness of a multicomponent intervention on nutritional recommendations and physical activity on glycemic control in obese patients with Type II Diabetes (DM2) in three places at the Algodonera Health Center of the Care Management Integrated in Talavera de la Reina.

Detailed description: Diabetes Mellitus (DM) is a chronic process that is not only important for its incidence and prevalence, but also for its complications. DM is responsible for cardiovascular complications that have high and premature mortality and a significant impact on quality of life. Diet control is one of the most effective therapeutic measures at all stages of diabetes management. It is important to promote healthy eating patterns that increase the consumption of foods with high nutritional value, in appropriate proportions, to improve overall health.

The objective of this study will be to evaluate the effectiveness of a multicomponent intervention on nutritional recommendations and physical activity on glycemic control in obese patients with Type II Diabetes (DM2) in three places at the Algodonera Health Center of the Integrated Care Management. from Talavera de la Reina.

For this purpose, a clinical trial will be carried out with two parallel arms, random assignment and blind evaluation by third parties. The study will be carried out on obese patients with DM2 between 40 and 75 years old at the "Algodonera" Health Center of the Integrated Care Management of Talavera de la Reina over a period of 1 year, from the subject's admission to the hospital. study until the last follow-up evaluation at one year. Selected patients must have a Barthel index \> 90 and must travel to the health center independently.

Eligibility 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.

Primary outcomes:
measure: Glycated hemoglobin
timeFrame: 12 months after the start of the study
Secondary outcomes:
measure: Lipid profile (HDL)
timeFrame: 12 months after the start of the study
measure: Lipid profile (LDL)
timeFrame: 12 months after the start of the study
measure: Triglycerides
timeFrame: 12 months after the start of the study
measure: Glomerular filtration rate
timeFrame: 12 months after the start of the study
measure: Proteinuria
timeFrame: 12 months after the start of the study
measure: Weight
timeFrame: 12 months after the start of the study
measure: Body Mass Index
timeFrame: 12 months after the start of the study
measure: Circumference weist
timeFrame: 12 months after the start of the study
measure: IPAQ - International Physical Activity Questionnaire
timeFrame: 12 months after the start of the study
measure: PREDIMED - Prevention with Mediterranean diet
timeFrame: 12 months after the start of the study
measure: SDSCA - Summary of Diabetes Self-Care Activities measure
timeFrame: 12 months after the start of the study
measure: Quality of life - Euroqol-5D
timeFrame: 12 months after the start of the study
measure: Mortality of related to cardiovascular events
timeFrame: 12 months after the start of the study
measure: Morbility of related to cardiovascular events
timeFrame: 12 months after the start of the study
measure: Changes in medication diabetes
timeFrame: 12 months after the start of the study
measure: Changes in Medication high blood pressure
timeFrame: 12 months after the start of the study
measure: Changes in Medication cholesterol
timeFrame: 12 months after the start of the study
Other outcomes:
Locations:
city: Talavera De La Reina
country: Spain
facility: Gerencia de Atención Integrada de Talavera de la Reina Centro de Salud La Algodonera
state: Toledo
Study officials:
affiliation: Gerencia de Atención Integrada de Talavera de la Reina
name: Maria Salobrar Labrador García, Medical
role: PRINCIPAL_INVESTIGATOR
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