Obesity Clinical Trial - Multicomponent Intervention on Lifestyle,

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06222775
Study type	Interventional
Source	Castilla-La Mancha Health Service
Contact	Maria Salobrar Labrador García, Medical
Phone	+34 925800921
Email	mslabrador@sescam.jccm.es
Status	Recruiting
Phase	N/A
Start date	December 4, 2023
Completion date	December 31, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms