An interventional study of Group session 1 and Group session 2 in Obesity and Diabetes Mellitus, Type 2, sponsored by Castilla-La Mancha Health Service. Recruiting at 1 site in Spain. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-02-14.
Sponsored by Castilla-La Mancha Health Service · Not applicable, Interventional, and Prevention
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.
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.
Exclusion Criteria:
Control group receive activities on diabetes and obesity by Primary Care professionals on a care routine
Behavioral: Control Intervention 1 · Behavioral: Control Intervention 2 · Behavioral: Control Intervention 3 · Behavioral: Control Intervention 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
Behavioral: Group session 1 · Behavioral: Group session 2 · Behavioral: Group session 3 · Behavioral: Group session 4 · Behavioral: Group session 5 · Behavioral: Group session 6 · Behavioral: Group session 7 to 8 · Behavioral: Group session 9
This session will have 3 editions in which the 50 participants of the experimental group will be distributed, with about 16 to 17 participants per edition. Its objective is to know the group and their expectations, in addition to providing basic knowledge about diabetes and a healthy lifestyle.
The sessions for the 5 groups will take place within 2 weeks. Two weeks after the 1st session, the 2nd session-workshop will be scheduled with no more than 10 participants. For this, 5 groups will be made. An attempt will be made to ensure that the participants in the groups remain stable. Its objective is to pave the way for the change to a healthy eating lifestyle and provide patients with sufficient knowledge so that with theory they can prepare a daily group menu according to the caloric needs of each of the participants.
Its general objective is to motivate the change towards healthy eating. And the specific ones develop a weekly menu according to calorie needs.
Its general objective is to reinforce a healthy lifestyle-eating, and the specific ones are to learn to read labels, preparing a weekly menu in a group.
Its general objective is to reinforce lifestyle-physical activity. And the specific objectives are to recognize that it is a moderate physical activity and the goal to achieve of recommended physical activity per week and plan a week of physical activity.
Its general objective is to reinforce a lifestyle-healthy eating and physical activity. And the specific ones are to reinforce the concept of physical activity in diabetes, what to do with hypoglycemia and adjust diet and exercise to current weight and needs.
The objective will be to maintain a healthy lifestyle and adjust menus and physical activity to current caloric needs, in addition to sharing experiences.
In the final session, a certificate of adherence to healthy living will be delivered, reminding you to continue with the acquired habits and attend scheduled consultations and tests. The days of the sessions are indicative, but they must be held in the week when the specified period of time between session and session is met.
Also known as: Final session
They will be given written information about the convenience of moderate physical activity and they will be informed of the importance of following an appropriate diet for diabetes and we will encourage weight loss.
Your controls will be carried out according to the usual diabetes protocol established in the individual scheduled diabetes consultation reviews.
These patients will also be given a written document about living with diabetes, advice on physical activity, and a pre-established diet will be given according to the number of calories needed previously calculated
In addition to verbal recommendations. This document will be made after the act of assigning the control or experimental group.
Glycated hemoglobin
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.
Time frame: 12 months after the start of the study
Lipid profile (HDL)
Lipid profile (HDL) measure by mg/dL
Time frame: 12 months after the start of the study
Lipid profile (LDL)
Lipid profile (LDL) measure by mg/dL
Time frame: 12 months after the start of the study
Triglycerides
Triglycerides measure by mg/dL
Time frame: 12 months after the start of the study
Glomerular filtration rate
Measured glomerular filtration rate by ml/min
Time frame: 12 months after the start of the study
Proteinuria
Measured renal function by mg/dL
Time frame: 12 months after the start of the study
Weight
Body Weight (kg)
Time frame: 12 months after the start of the study
Body Mass Index
Body Mass Index measure as body weight (kg) divided by height (m) squared
Time frame: 12 months after the start of the study
Circumference weist
Circumference weist measure by cm
Time frame: 12 months after the start of the study
IPAQ - International Physical Activity Questionnaire
Physical activity measure by IPAQ in metabolic equivalents of tasks (METs)
Time frame: 12 months after the start of the study
PREDIMED - Prevention with Mediterranean diet
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
Time frame: 12 months after the start of the study
SDSCA - Summary of Diabetes Self-Care Activities measure
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)
Time frame: 12 months after the start of the study
Quality of life - Euroqol-5D
Evaluate the impact on the quality of life in people who participate in this project
Time frame: 12 months after the start of the study
Mortality of related to cardiovascular events
Heart failure, ischemic heart disease, stroke, kidney failure collected as such in patients electronic medical record
Time frame: 12 months after the start of the study
Morbility of related to cardiovascular events
Heart failure, ischemic heart disease, stroke, peripheral arterial disease, kidney failure, diabetic retinopathy, diabetic neuropathy collected as such in patients electronic medical record
Time frame: 12 months after the start of the study
Changes in medication diabetes
For the control of diabetes Glinids. Sulfonylureas. IDPP4. GLP1. Basal Insuline Mix insuline ISGLT2. Acarbose. Metformine.
Time frame: 12 months after the start of the study
Changes in Medication high blood pressure
For the control of high blood pressure IECAS. ARAII. Beta blockers Calcium antagonists Alpha blockers Diuretics
Time frame: 12 months after the start of the study
Changes in Medication cholesterol
For the control of cholesterol Statins Fibrates Fibrates + statins
Time frame: 12 months after the start of the study
Plan to share: No
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Castilla-La Mancha Health Service