Multicomponent Intervention on Lifestyle, Anthropometric Measurements, Glycemic Control and Quality of Life in Patients Obese People With Type II Diabetes
- Conditions
- Diabetes Mellitus, Type 2Obesity
- Interventions
- Behavioral: Control Intervention 1Behavioral: Group session 1Behavioral: Control Intervention 2Behavioral: Group session 2Behavioral: Control Intervention 3Behavioral: Group session 3Behavioral: Group session 4Behavioral: Control Intervention 4Behavioral: Group session 5Behavioral: Group session 6Behavioral: Group session 7 to 8Behavioral: Group session 9
- Registration Number
- NCT06222775
- Lead Sponsor
- Castilla-La Mancha Health Service
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Control Intervention 3 Control group receive activities on diabetes and obesity by Primary Care professionals on a care routine Experimental group Group session 5 Experimental group receive multicomponent intervention based on: De Cos AI, Gutiérrez Medina S, Luca B, Galdón A, Simon Chacín J, De Mingo ML, et al. Recommendations for clinical practice in diabetes and obesity. The Madrid Agreements. Document agreed by the working groups of the scientific societies: SENDIMAD, SOMAMFYC, SEMG Madrid, SEMERGEN Madrid and RedGDPS. Nutr Hosp \[Internet\]. 2018;35(4):971-8. Disponible en: http://dx.doi.org/10.20960/nh.1646 Kojdamanian Favetto V. Guía NICE 2022: actualización en el manejo de la diabetes mellitus tipo 2 en personas adultas. Evid actual pract ambul \[Internet\]. 2022;25(2):e007015. Disponible en: http://dx.doi.org/10.51987/evidencia.v25i3.7015 Control group Control Intervention 2 Control group receive activities on diabetes and obesity by Primary Care professionals on a care routine Experimental group Group session 2 Experimental group receive multicomponent intervention based on: De Cos AI, Gutiérrez Medina S, Luca B, Galdón A, Simon Chacín J, De Mingo ML, et al. Recommendations for clinical practice in diabetes and obesity. The Madrid Agreements. Document agreed by the working groups of the scientific societies: SENDIMAD, SOMAMFYC, SEMG Madrid, SEMERGEN Madrid and RedGDPS. Nutr Hosp \[Internet\]. 2018;35(4):971-8. Disponible en: http://dx.doi.org/10.20960/nh.1646 Kojdamanian Favetto V. Guía NICE 2022: actualización en el manejo de la diabetes mellitus tipo 2 en personas adultas. Evid actual pract ambul \[Internet\]. 2022;25(2):e007015. Disponible en: http://dx.doi.org/10.51987/evidencia.v25i3.7015 Experimental group Group session 4 Experimental group receive multicomponent intervention based on: De Cos AI, Gutiérrez Medina S, Luca B, Galdón A, Simon Chacín J, De Mingo ML, et al. Recommendations for clinical practice in diabetes and obesity. The Madrid Agreements. Document agreed by the working groups of the scientific societies: SENDIMAD, SOMAMFYC, SEMG Madrid, SEMERGEN Madrid and RedGDPS. Nutr Hosp \[Internet\]. 2018;35(4):971-8. Disponible en: http://dx.doi.org/10.20960/nh.1646 Kojdamanian Favetto V. Guía NICE 2022: actualización en el manejo de la diabetes mellitus tipo 2 en personas adultas. Evid actual pract ambul \[Internet\]. 2022;25(2):e007015. Disponible en: http://dx.doi.org/10.51987/evidencia.v25i3.7015 Control group Control Intervention 1 Control group receive activities on diabetes and obesity by Primary Care professionals on a care routine Experimental group Group session 1 Experimental group receive multicomponent intervention based on: De Cos AI, Gutiérrez Medina S, Luca B, Galdón A, Simon Chacín J, De Mingo ML, et al. Recommendations for clinical practice in diabetes and obesity. The Madrid Agreements. Document agreed by the working groups of the scientific societies: SENDIMAD, SOMAMFYC, SEMG Madrid, SEMERGEN Madrid and RedGDPS. Nutr Hosp \[Internet\]. 2018;35(4):971-8. Disponible en: http://dx.doi.org/10.20960/nh.1646 Kojdamanian Favetto V. Guía NICE 2022: actualización en el manejo de la diabetes mellitus tipo 2 en personas adultas. Evid actual pract ambul \[Internet\]. 2022;25(2):e007015. Disponible en: http://dx.doi.org/10.51987/evidencia.v25i3.7015 Experimental group Group session 3 Experimental group receive multicomponent intervention based on: De Cos AI, Gutiérrez Medina S, Luca B, Galdón A, Simon Chacín J, De Mingo ML, et al. Recommendations for clinical practice in diabetes and obesity. The Madrid Agreements. Document agreed by the working groups of the scientific societies: SENDIMAD, SOMAMFYC, SEMG Madrid, SEMERGEN Madrid and RedGDPS. Nutr Hosp \[Internet\]. 2018;35(4):971-8. Disponible en: http://dx.doi.org/10.20960/nh.1646 Kojdamanian Favetto V. Guía NICE 2022: actualización en el manejo de la diabetes mellitus tipo 2 en personas adultas. Evid actual pract ambul \[Internet\]. 2022;25(2):e007015. Disponible en: http://dx.doi.org/10.51987/evidencia.v25i3.7015 Experimental group Group session 6 Experimental group receive multicomponent intervention based on: De Cos AI, Gutiérrez Medina S, Luca B, Galdón A, Simon Chacín J, De Mingo ML, et al. Recommendations for clinical practice in diabetes and obesity. The Madrid Agreements. Document agreed by the working groups of the scientific societies: SENDIMAD, SOMAMFYC, SEMG Madrid, SEMERGEN Madrid and RedGDPS. Nutr Hosp \[Internet\]. 2018;35(4):971-8. Disponible en: http://dx.doi.org/10.20960/nh.1646 Kojdamanian Favetto V. Guía NICE 2022: actualización en el manejo de la diabetes mellitus tipo 2 en personas adultas. Evid actual pract ambul \[Internet\]. 2022;25(2):e007015. Disponible en: http://dx.doi.org/10.51987/evidencia.v25i3.7015 Control group Control Intervention 4 Control group receive activities on diabetes and obesity by Primary Care professionals on a care routine Experimental group Group session 7 to 8 Experimental group receive multicomponent intervention based on: De Cos AI, Gutiérrez Medina S, Luca B, Galdón A, Simon Chacín J, De Mingo ML, et al. Recommendations for clinical practice in diabetes and obesity. The Madrid Agreements. Document agreed by the working groups of the scientific societies: SENDIMAD, SOMAMFYC, SEMG Madrid, SEMERGEN Madrid and RedGDPS. Nutr Hosp \[Internet\]. 2018;35(4):971-8. Disponible en: http://dx.doi.org/10.20960/nh.1646 Kojdamanian Favetto V. Guía NICE 2022: actualización en el manejo de la diabetes mellitus tipo 2 en personas adultas. Evid actual pract ambul \[Internet\]. 2022;25(2):e007015. Disponible en: http://dx.doi.org/10.51987/evidencia.v25i3.7015 Experimental group Group session 9 Experimental group receive multicomponent intervention based on: De Cos AI, Gutiérrez Medina S, Luca B, Galdón A, Simon Chacín J, De Mingo ML, et al. Recommendations for clinical practice in diabetes and obesity. The Madrid Agreements. Document agreed by the working groups of the scientific societies: SENDIMAD, SOMAMFYC, SEMG Madrid, SEMERGEN Madrid and RedGDPS. Nutr Hosp \[Internet\]. 2018;35(4):971-8. Disponible en: http://dx.doi.org/10.20960/nh.1646 Kojdamanian Favetto V. Guía NICE 2022: actualización en el manejo de la diabetes mellitus tipo 2 en personas adultas. Evid actual pract ambul \[Internet\]. 2022;25(2):e007015. Disponible en: http://dx.doi.org/10.51987/evidencia.v25i3.7015
- Primary Outcome Measures
Name Time Method Glycated hemoglobin 12 months after the start of the study We expect a difference in the mean glycated hemoglobin between the control group and the experimental group of 0.6 units 12 months after starting participation in the study.
- Secondary Outcome Measures
Name Time Method Triglycerides 12 months after the start of the study Triglycerides measure by mg/dL
Lipid profile (LDL) 12 months after the start of the study Lipid profile (LDL) measure by mg/dL
Glomerular filtration rate 12 months after the start of the study Measured glomerular filtration rate by ml/min
Body Mass Index 12 months after the start of the study Body Mass Index measure as body weight (kg) divided by height (m) squared
Changes in Medication cholesterol 12 months after the start of the study For the control of cholesterol Statins Fibrates Fibrates + statins
Lipid profile (HDL) 12 months after the start of the study Lipid profile (HDL) measure by mg/dL
Proteinuria 12 months after the start of the study Measured renal function by mg/dL
Weight 12 months after the start of the study Body Weight (kg)
Circumference weist 12 months after the start of the study Circumference weist measure by cm
SDSCA - Summary of Diabetes Self-Care Activities measure 12 months after the start of the study Measures levels of behavior related to self-care and compliance with activities recommended by the doctor in the last 7 days in 5 areas (diet, exercise, blood glucose control, foot care and smoking) whose average score ranges from 0 and 7 (higher scores indicate better results)
Quality of life - Euroqol-5D 12 months after the start of the study Evaluate the impact on the quality of life in people who participate in this project
IPAQ - International Physical Activity Questionnaire 12 months after the start of the study Physical activity measure by IPAQ in metabolic equivalents of tasks (METs)
PREDIMED - Prevention with Mediterranean diet 12 months after the start of the study PREDIMED questionnaire to assess the adherence to the Mediterranean diet. 0 being the minimum total score and 14 the maximum total score. Higher values represent a higher adherence to the Mediterranean diet
Mortality of related to cardiovascular events 12 months after the start of the study Heart failure, ischemic heart disease, stroke, kidney failure collected as such in patients electronic medical record
Morbility of related to cardiovascular events 12 months after the start of the study Heart failure, ischemic heart disease, stroke, peripheral arterial disease, kidney failure, diabetic retinopathy, diabetic neuropathy collected as such in patients electronic medical record
Changes in medication diabetes 12 months after the start of the study For the control of diabetes Glinids. Sulfonylureas. IDPP4. GLP1. Basal Insuline Mix insuline ISGLT2. Acarbose. Metformine.
Changes in Medication high blood pressure 12 months after the start of the study For the control of high blood pressure IECAS. ARAII. Beta blockers Calcium antagonists Alpha blockers Diuretics
Trial Locations
- Locations (1)
Gerencia de Atención Integrada de Talavera de la Reina Centro de Salud La Algodonera
🇪🇸Talavera De La Reina, Toledo, Spain