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

February 13, 2024 updated by: Castilla-La Mancha Health Service
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Toledo
      • Talavera De La Reina, Toledo, Spain, 45600
        • Recruiting
        • Gerencia de Atención Integrada de Talavera de la Reina Centro de Salud La Algodonera
        • Contact:
        • Contact:
        • Principal Investigator:
          • María Salobrar Labrador García, Medical
        • Sub-Investigator:
          • Concepción Monterrubio Pérez, Medical
        • Sub-Investigator:
          • Sara Costa del Amo, Medical
        • Sub-Investigator:
          • Gerardine Carolina Armas Sequera, Medical
        • Sub-Investigator:
          • Carmen Berenguer Jover, Medical
        • Sub-Investigator:
          • Aurea Berná Escarabajal, Nurse
        • Sub-Investigator:
          • Aura Mercedes Benitez Gutierrez, Medical
        • Sub-Investigator:
          • Lirios Villaplana Miró, Nurse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Control group receive activities on diabetes and obesity by Primary Care professionals on a care routine
Behavioral: 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.
Behavioral: Control Intervention 2
Your controls will be carried out according to the usual diabetes protocol established in the individual scheduled diabetes consultation reviews.
Behavioral: 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
Behavioral: Control Intervention 4
In addition to verbal recommendations. This document will be made after the act of assigning the control or experimental group.
Experimental: Experimental group

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

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.

Behavioral: 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.

Behavioral: 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.
Behavioral: 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.
Behavioral: 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.
Behavioral: 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.
Behavioral: 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.
Behavioral: 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.

Other Names:
  • Final session

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months after the start of the study

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Castilla-La Mancha Health Service

Investigators

  • Principal Investigator: Maria Salobrar Labrador García, Medical, Gerencia de Atención Integrada de Talavera de la Reina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 21, 2023

First Submitted That Met QC Criteria

January 15, 2024

First Posted (Actual)

January 25, 2024

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 39/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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