Multicomponent Intervention on Lifestyle, Anthropometric Measurements, Glycemic Control and Quality of Life in Patients Obese People With Type II Diabetes (Diabesity)

Castilla-La Mancha Health Service

Status: Enrolling

Conditions: Obesity; Diabetes Mellitus, Type 2

Treatments: Behavioral: Group session 7 to 8; Behavioral: Group session 2; Behavioral: Group session 9; Behavioral: Control Intervention 2; Behavioral: Group session 3; Behavioral: Group session 5; Behavioral: Group session 4; Behavioral: Group session 6; Behavioral: Control Intervention 3; Behavioral: Control Intervention 1; Behavioral: Control Intervention 4; Behavioral: Group session 1

Study type: Interventional

Funder types: Other

Identifiers

NCT06222775

39/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Control group

Active Comparator group

Description:

Control group receive activities on diabetes and obesity by Primary Care professionals on a care routine

Treatment:

Behavioral: Control Intervention 1

Behavioral: Control Intervention 4

Behavioral: Control Intervention 3

Behavioral: Control Intervention 2

Experimental group

Experimental group

Description:

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

Treatment:

Behavioral: Group session 3

Behavioral: Group session 5

Behavioral: Group session 7 to 8

Behavioral: Group session 6

Behavioral: Group session 1

Behavioral: Group session 9

Behavioral: Group session 2

Behavioral: Group session 4