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

Obesity Clinical Trial

— Diabesity  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06222775
• Other study ID #: 39/2023
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Castilla-La Mancha Health Service
• Contact: Maria Salobrar Labrador García, Medical
• Phone: +34 925800921
• Email: mslabrador[@]sescam.jccm.es
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity

Intervention

Behavioral:
• Group session 1
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 2
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
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
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
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
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
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
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 1
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
Your controls will be carried out according to the usual diabetes protocol established in the individual scheduled diabetes consultation reviews.
• Control Intervention 3
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
In addition to verbal recommendations. This document will be made after the act of assigning the control or experimental group.

Locations

Country	Name	City	State
Spain	Gerencia de Atención Integrada de Talavera de la Reina Centro de Salud La Algodonera	Talavera De La Reina	Toledo

Sponsors (1)

Lead Sponsor	Collaborator
Castilla-La Mancha Health Service

Country where clinical trial is conducted

Spain, 

References & Publications (37)

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Lipid profile (HDL)	Lipid profile (HDL) measure by mg/dL	12 months after the start of the study
Secondary	Lipid profile (LDL)	Lipid profile (LDL) measure by mg/dL	12 months after the start of the study
Secondary	Triglycerides	Triglycerides measure by mg/dL	12 months after the start of the study
Secondary	Glomerular filtration rate	Measured glomerular filtration rate by ml/min	12 months after the start of the study
Secondary	Proteinuria	Measured renal function by mg/dL	12 months after the start of the study
Secondary	Weight	Body Weight (kg)	12 months after the start of the study
Secondary	Body Mass Index	Body Mass Index measure as body weight (kg) divided by height (m) squared	12 months after the start of the study
Secondary	Circumference weist	Circumference weist measure by cm	12 months after the start of the study
Secondary	IPAQ - International Physical Activity Questionnaire	Physical activity measure by IPAQ in metabolic equivalents of tasks (METs)	12 months after the start of the study
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in Medication cholesterol	For the control of cholesterol Statins Fibrates Fibrates + statins	12 months after the start of the study