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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Control group receive activities on diabetes and obesity by Primary Care professionals on a care routine |
|
| Experimental group | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group session 1 | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months after the start of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid profile (HDL) | Lipid profile (HDL) measure by mg/dL | 12 months after the start of the study |
| Lipid profile (LDL) | Lipid profile (LDL) measure by mg/dL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Salobrar Labrador García, Medical | Contact | +34 925800921 | mslabrador@sescam.jccm.es | |
| Carmen Berenguer Jover, Medical | Contact | +34 925800921 | cberenguerj@sescam.jccm.es |
| Name | Affiliation | Role |
|---|---|---|
| Maria Salobrar Labrador García, Medical | Gerencia de Atención Integrada de Talavera de la Reina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gerencia de Atención Integrada de Talavera de la Reina Centro de Salud La Algodonera | Recruiting | Talavera de la Reina | Toledo | 45600 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27543006 | Background | Lecube A, Monereo S, Rubio MA, Martinez-de-Icaya P, Marti A, Salvador J, Masmiquel L, Goday A, Bellido D, Lurbe E, Garcia-Almeida JM, Tinahones FJ, Garcia-Luna PP, Palacio E, Gargallo M, Breton I, Morales-Conde S, Caixas A, Menendez E, Puig-Domingo M, Casanueva FF. Prevention, diagnosis, and treatment of obesity. 2016 position statement of the Spanish Society for the Study of Obesity. Endocrinol Diabetes Nutr. 2017 Mar;64 Suppl 1:15-22. doi: 10.1016/j.endonu.2016.07.002. Epub 2016 Aug 16. No abstract available. English, Spanish. | |
| Background | Diabetes [Internet]. Who.int. [citado el 8 de julio de 2023]. Disponible en: https://www.who.int/es/news-room/fact-sheets/detail/diabetes | ||
| Background | OECD (2019), The Heavy Burden of Obesity: The Economics of Prevention, OECD Health Policy Studies, OECD Publishing, Paris, https://doi.org/10.1787/67450d67-en. | ||
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 2, 2026 | |
| Reset | Jun 26, 2026 |
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| Group session 2 | Behavioral | 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. |
|
| Group session 3 | Behavioral | Its general objective is to motivate the change towards healthy eating. And the specific ones develop a weekly menu according to calorie needs. |
|
| Group session 4 | Behavioral | 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. |
|
| Group session 5 | Behavioral | 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. |
|
| Group session 6 | Behavioral | 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. |
|
| Group session 7 to 8 | Behavioral | The objective will be to maintain a healthy lifestyle and adjust menus and physical activity to current caloric needs, in addition to sharing experiences. |
|
| Group session 9 | Behavioral | 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. |
|
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| Control Intervention 1 | Behavioral | 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. |
|
| Control Intervention 2 | Behavioral | Your controls will be carried out according to the usual diabetes protocol established in the individual scheduled diabetes consultation reviews. |
|
| Control Intervention 3 | Behavioral | 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 |
|
| Control Intervention 4 | Behavioral | In addition to verbal recommendations. This document will be made after the act of assigning the control or experimental group. |
|
| 12 months after the start of the study |
| Triglycerides | Triglycerides measure by mg/dL | 12 months after the start of the study |
| Glomerular filtration rate | Measured glomerular filtration rate by ml/min | 12 months after the start of the study |
| Proteinuria | Measured renal function by mg/dL | 12 months after the start of the study |
| Weight | Body Weight (kg) | 12 months after the start of the study |
| Body Mass Index | Body Mass Index measure as body weight (kg) divided by height (m) squared | 12 months after the start of the study |
| Circumference weist | Circumference weist measure by cm | 12 months after the start of the study |
| IPAQ - International Physical Activity Questionnaire | Physical activity measure by IPAQ in metabolic equivalents of tasks (METs) | 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 | 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) | 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 | 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 | 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 | 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. | 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 | 12 months after the start of the study |
| Changes in Medication cholesterol | For the control of cholesterol Statins Fibrates Fibrates + statins | 12 months after the start of the study |
| Background |
| Ampudia-Blanco FJ, Mata M. Diabetes tipo 2 en Atención Primaria. Evidencia y práctica clínica. Euromedice Ed Médicas. 2015;39-45 |
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| 26879684 | Background | Leslie WS, Ford I, Sattar N, Hollingsworth KG, Adamson A, Sniehotta FF, McCombie L, Brosnahan N, Ross H, Mathers JC, Peters C, Thom G, Barnes A, Kean S, McIlvenna Y, Rodrigues A, Rehackova L, Zhyzhneuskaya S, Taylor R, Lean ME. The Diabetes Remission Clinical Trial (DiRECT): protocol for a cluster randomised trial. BMC Fam Pract. 2016 Feb 16;17:20. doi: 10.1186/s12875-016-0406-2. |
| 29221645 | Background | Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5. |
| 33406285 | Background | Brosnahan N, Leslie W, McCombie L, Barnes A, Thom G, McConnachie A, Messow CM, Sattar N, Taylor R, Lean MEJ. Brief formula low-energy-diet for relapse management during weight loss maintenance in the Diabetes Remission Clinical Trial (DiRECT). J Hum Nutr Diet. 2021 Jun;34(3):472-479. doi: 10.1111/jhn.12839. Epub 2021 Jan 6. |
| 24010754 | Background | Riobo Servan P. Obesity and diabetes. Nutr Hosp. 2013 Sep;28 Suppl 5:138-43. doi: 10.3305/nh.2013.28.sup5.6929. |
| 32933882 | Background | Ballesteros Pomar MD, Vilarrasa Garcia N, Rubio Herrera MA, Barahona MJ, Bueno M, Caixas A, Calanas Continente A, Ciudin A, Cordido F, de Hollanda A, Diaz MJ, Flores L, Garcia Luna PP, Garcia Perez-Sevillano F, Goday A, Lecube A, Lopez Gomez JJ, Minambres I, Morales Gorria MJ, Morinigo R, Nicolau J, Pellitero S, Salvador J, Valdes S, Breton Lesmes I. The SEEN comprehensive clinical survey of adult obesity: Executive summary. Endocrinol Diabetes Nutr (Engl Ed). 2021 Feb;68(2):130-136. doi: 10.1016/j.endinu.2020.05.003. Epub 2020 Sep 12. English, Spanish. |
| 30070890 | Background | De Cos AI, Gutierrez Medina S, Luca B, Galdon A, Simon Chacin J, De Mingo ML, Trifu D, Artola S, Egocheaga I, Soriano T, Vazquez C. [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. 2018 Aug 2;35(4):971-978. doi: 10.20960/nh.1646. Spanish. |
| Background | 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 |
| Background | Europa.eu. 2012 [citado el 31 de agosto de 2023]. Disponible en: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-prevention-diabetes-mellitus-revision_en.pdf |
| Background | FDA. [citado el 31 de agosto de 2023].Guidance for Industry. Type 2 diabetes mellitus: evaluating the safety of new drugs for improving glycemic control. Draft; March 2020. Disponible en: https://www.fda.gov/media/135936/download |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 2, 2026 | Jun 26, 2026 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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