ObesityDiabesityNCT06222775
Multicomponent Intervention on Lifestyle, Anthropometric Measurements, Glycemic Control and Quality of Life in Patients Obese People With Type II Diabetes
A study testing Group session 1, Group session 2 and Group session 3 in people with Obesity and Diabetes Mellitus, Type 2, run by Castilla-La Mancha Health Service at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Obesity, Diabetes Mellitus, Type 2
- What is being tested?
- Group session 1, Group session 2 and Group session 3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 4 Dec 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Gerencia de Atención Integrada de Talavera de la Reina Centro de Salud La Algodonera
Talavera de la Reina, Toledo, 45600
María Salobrar Labrador García, Medical, +34 925900921, mslabrador@sescam.jccm.es
Carmen Berenguer Jover, Medical, +34 925900921, cberenguerj@sescam.jccm.es
About this study
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.
Read the 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.
- Conditions
- Obesity, Diabetes Mellitus, Type 2
- Being tested
- Group session 1, Group session 2, Group session 3, Group session 4, Group session 5
- Keywords
- prevention, clinical trial, obesity, Diabetes Mellitus, Type 2, Healthy Lifestyle
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group session 1Behavioural
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.
Group session 2Behavioural
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 3Behavioural
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 4Behavioural
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 5Behavioural
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 6Behavioural
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 8Behavioural
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 9Behavioural
Also called Final session
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.
Control Intervention 1Behavioural
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 2Behavioural
Your controls will be carried out according to the usual diabetes protocol established in the individual scheduled diabetes consultation reviews.
Control Intervention 3Behavioural
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 4Behavioural
In addition to verbal recommendations. This document will be made after the act of assigning the control or experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Control group receive activities on diabetes and obesity by Primary Care professionals on a care routine Receives: Behavioral: Control Intervention 1; Behavioral: Control Intervention 2; Behavioral: Control Intervention 3; Behavioral: Control Intervention 4 |
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after the start of the study
Secondary outcomes (17)
Lipid profile (HDL)
Lipid profile (HDL) measure by mg/dL
Measured: 12 months after the start of the study
Lipid profile (LDL)
Lipid profile (LDL) measure by mg/dL
Measured: 12 months after the start of the study
Triglycerides
Triglycerides measure by mg/dL
Measured: 12 months after the start of the study
Glomerular filtration rate
Measured glomerular filtration rate by ml/min
Measured: 12 months after the start of the study
Proteinuria
Measured renal function by mg/dL
Measured: 12 months after the start of the study
Weight
Body Weight (kg)
Measured: 12 months after the start of the study
Body Mass Index
Body Mass Index measure as body weight (kg) divided by height (m) squared
Measured: 12 months after the start of the study
Circumference weist
Circumference weist measure by cm
Measured: 12 months after the start of the study
IPAQ - International Physical Activity Questionnaire
Physical activity measure by IPAQ in metabolic equivalents of tasks (METs)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 12 months after the start of the study
Changes in Medication cholesterol
For the control of cholesterol Statins Fibrates Fibrates + statins
Measured: 12 months after the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start4 Dec 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Castilla-La Mancha Health Service
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Salobrar Labrador García, Medical, Principal investigator, Gerencia de Atención Integrada de Talavera de la Reina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222775
- Sponsor's protocol ID
- 39/2023
- Acronym
- Diabesity
- Status last verified
- Feb 2024
- First submitted
- 21 Dec 2023
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27543006Diabetes [Internet]. Who.int. [citado el 8 de julio de 2023]. Disponible en: https://www.who.int/es/news-room/fact-sheets/detail/diabetes
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.
Ampudia-Blanco FJ, Mata M. Diabetes tipo 2 en Atención Primaria. Evidencia y práctica clínica. Euromedice Ed Médicas. 2015;39-45
Soriguer F, Goday A, Bosch-Comas A, Bordiu E, Calle-Pascual A, Carmena R, Casamitjana R, Castano L, Castell C, Catala M, Delgado E, Franch J, Gaztambide S, Girbes J, Gomis R, Gutierrez G, Lopez-Alba A, Martinez-Larrad MT, Menendez E, Mora-Peces I, Ortega E, Pascual-Manich G, Rojo-Martinez G, Serrano-Rios M, Valdes S, Vazquez JA, Vendrell J. Prevalence of diabetes mellitus and impaired glucose regulation in Spain: the Di@bet.es Study. Diabetologia. 2012 Jan;55(1):88-93. doi: 10.1007/s00125-011-2336-9. Epub 2011 Oct 11.
PubMed 21987347Astrup A, Finer N. Redefining type 2 diabetes: 'diabesity' or 'obesity dependent diabetes mellitus'? Obes Rev. 2000 Oct;1(2):57-9. doi: 10.1046/j.1467-789x.2000.00013.x.
PubMed 12119987Brunton SA. Diabesity. Clin Diabetes. 2022 Fall;40(4):392-393. doi: 10.2337/cd22-0088. No abstract available.
PubMed 36385971Costo-Muriel C, Martín-Carmona J, Pérez-Belmonte LM. Complicaciones macrovasculares de la diabetes. Medicine [Internet]. 2020;13(16):891-9. Disponible en: http://dx.doi.org/10.1016/j.med.2020.09.011
Evert AB, Dennison M, Gardner CD, Garvey WT, Lau KHK, MacLeod J, Mitri J, Pereira RF, Rawlings K, Robinson S, Saslow L, Uelmen S, Urbanski PB, Yancy WS Jr. Nutrition Therapy for Adults With Diabetes or Prediabetes: A Consensus Report. Diabetes Care. 2019 May;42(5):731-754. doi: 10.2337/dci19-0014. Epub 2019 Apr 18. No abstract available.
PubMed 31000505Pérez-Rodrigo C, Hervás Bárbara G, Gianzo Citores M, Aranceta-Bartrina J. Prevalencia de obesidad y factores de riesgo cardiovascular asociados en la población general española: estudio ENPE. Rev Esp Cardiol [Internet]. 2022;75(3):232-41. Disponible en: http://dx.doi.org/10.1016/j.recesp.2020.12.013
Thom G, Messow CM, Leslie WS, Barnes AC, Brosnahan N, McCombie L, Al-Mrabeh A, Zhyzhneuskaya S, Welsh P, Sattar N, Taylor R, Lean MEJ. Predictors of type 2 diabetes remission in the Diabetes Remission Clinical Trial (DiRECT). Diabet Med. 2021 Aug;38(8):e14395. doi: 10.1111/dme.14395. Epub 2020 Sep 27.
PubMed 32870520Leslie 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.
PubMed 26879684Lean 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.
PubMed 29221645Brosnahan 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.
PubMed 33406285Riobo Servan P. Obesity and diabetes. Nutr Hosp. 2013 Sep;28 Suppl 5:138-43. doi: 10.3305/nh.2013.28.sup5.6929.
PubMed 24010754
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicomponent Intervention on Lifestyle, Anthropometric Measurements, Glycemic Control and Quality of Life in Patients Obese People With Type II Diabetes
- ClinicalTrials.gov ID
- NCT06222775
- Acronym / sponsor ID
- Diabesity / 39/2023
- Conditions
- Obesity, Diabetes Mellitus, Type 2
- Keywords
- prevention, clinical trial, obesity, Diabetes Mellitus, Type 2, Healthy Lifestyle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Castilla-La Mancha Health ServiceUniversity, hospital or other
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: Control Intervention 1, Behavioral: Control Intervention 2, Behavioral: Control Intervention 3, Behavioral: Control Intervention 4Control group receive activities on diabetes and obesity by Primary Care professionals on a care routine |
| Experimental group | Experimental | 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 9Experimental 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 |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group session 1This 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. | Behavioural | Experimental group |
| Group session 2The 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. | Behavioural | Experimental group |
| Group session 3Its general objective is to motivate the change towards healthy eating. And the specific ones develop a weekly menu according to calorie needs. | Behavioural | Experimental group |
| Group session 4Its 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. | Behavioural | Experimental group |
| Group session 5Its 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. | Behavioural | Experimental group |
| Group session 6Its 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. | Behavioural | Experimental group |
| Group session 7 to 8The objective will be to maintain a healthy lifestyle and adjust menus and physical activity to current caloric needs, in addition to sharing experiences. | Behavioural | Experimental group |
| Group session 9Also: Final sessionIn 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. | Behavioural | Experimental group |
| Control Intervention 1They 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. | Behavioural | Control group |
| Control Intervention 2Your controls will be carried out according to the usual diabetes protocol established in the individual scheduled diabetes consultation reviews. | Behavioural | Control group |
| Control Intervention 3These 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 | Behavioural | Control group |
| Control Intervention 4In addition to verbal recommendations. This document will be made after the act of assigning the control or experimental group. | Behavioural | Control group |
Primary outcome
Glycated hemoglobin
Time frame: 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.
17 secondary outcomes
Lipid profile (HDL)
Time frame: 12 months after the start of the study
Lipid profile (LDL)
Time frame: 12 months after the start of the study
Triglycerides
Time frame: 12 months after the start of the study
Glomerular filtration rate
Time frame: 12 months after the start of the study
Proteinuria
Time frame: 12 months after the start of the study
Weight
Time frame: 12 months after the start of the study
Body Mass Index
Time frame: 12 months after the start of the study
Circumference weist
Time frame: 12 months after the start of the study
IPAQ - International Physical Activity Questionnaire
Time frame: 12 months after the start of the study
PREDIMED - Prevention with Mediterranean diet
Time frame: 12 months after the start of the study
SDSCA - Summary of Diabetes Self-Care Activities measure
Time frame: 12 months after the start of the study
Quality of life - Euroqol-5D
Time frame: 12 months after the start of the study
Mortality of related to cardiovascular events
Time frame: 12 months after the start of the study
Morbility of related to cardiovascular events
Time frame: 12 months after the start of the study
Changes in medication diabetes
Time frame: 12 months after the start of the study
Changes in Medication high blood pressure
Time frame: 12 months after the start of the study
Changes in Medication cholesterol
Time frame: 12 months after the start of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Background: PubMed 27543006Lecube 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.
- BackgroundDiabetes [Internet]. Who.int. [citado el 8 de julio de 2023]. Disponible en: https://www.who.int/es/news-room/fact-sheets/detail/diabetes
- BackgroundOECD (2019), The Heavy Burden of Obesity: The Economics of Prevention, OECD Health Policy Studies, OECD Publishing, Paris, https://doi.org/10.1787/67450d67-en.
- BackgroundAmpudia-Blanco FJ, Mata M. Diabetes tipo 2 en Atención Primaria. Evidencia y práctica clínica. Euromedice Ed Médicas. 2015;39-45
- Background: PubMed 21987347Soriguer F, Goday A, Bosch-Comas A, Bordiu E, Calle-Pascual A, Carmena R, Casamitjana R, Castano L, Castell C, Catala M, Delgado E, Franch J, Gaztambide S, Girbes J, Gomis R, Gutierrez G, Lopez-Alba A, Martinez-Larrad MT, Menendez E, Mora-Peces I, Ortega E, Pascual-Manich G, Rojo-Martinez G, Serrano-Rios M, Valdes S, Vazquez JA, Vendrell J. Prevalence of diabetes mellitus and impaired glucose regulation in Spain: the Di@bet.es Study. Diabetologia. 2012 Jan;55(1):88-93. doi: 10.1007/s00125-011-2336-9. Epub 2011 Oct 11.
- Background: PubMed 12119987Astrup A, Finer N. Redefining type 2 diabetes: 'diabesity' or 'obesity dependent diabetes mellitus'? Obes Rev. 2000 Oct;1(2):57-9. doi: 10.1046/j.1467-789x.2000.00013.x.
- Background: PubMed 36385971Brunton SA. Diabesity. Clin Diabetes. 2022 Fall;40(4):392-393. doi: 10.2337/cd22-0088. No abstract available.
- BackgroundCosto-Muriel C, Martín-Carmona J, Pérez-Belmonte LM. Complicaciones macrovasculares de la diabetes. Medicine [Internet]. 2020;13(16):891-9. Disponible en: http://dx.doi.org/10.1016/j.med.2020.09.011
- Background: PubMed 31000505Evert AB, Dennison M, Gardner CD, Garvey WT, Lau KHK, MacLeod J, Mitri J, Pereira RF, Rawlings K, Robinson S, Saslow L, Uelmen S, Urbanski PB, Yancy WS Jr. Nutrition Therapy for Adults With Diabetes or Prediabetes: A Consensus Report. Diabetes Care. 2019 May;42(5):731-754. doi: 10.2337/dci19-0014. Epub 2019 Apr 18. No abstract available.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Salobrar Labrador García, Medical principal investigator
Gerencia de Atención Integrada de Talavera de la Reina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group session 1, Group session 2 and Group session 3 in people with Obesity and Diabetes Mellitus, Type 2, run by Castilla-La Mancha Health Service at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Salobrar Labrador García, Medical (+34 925800921, mslabrador@sescam.jccm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated hemoglobin (time frame: 12 months after the start of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06222775, which also lists 37 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.