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

NCT06222775 | Recruiting

• 1 other identifier: 39/2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Diabetes Mellitus, Type 2

Keywords

prevention; clinical trial; obesity; Diabetes Mellitus, Type 2; Healthy Lifestyle

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Lipid profile (HDL)

  12 months after the start of the study

• Lipid profile (LDL)

  12 months after the start of the study

• Triglycerides

  12 months after the start of the study

• Glomerular filtration rate

  12 months after the start of the study

• Proteinuria

  12 months after the start of the study

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

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

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

Interventions

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.

Experimental group

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.

Experimental group

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.

Experimental group

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.

Experimental 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.

Experimental group

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.

Experimental group

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.

Experimental group

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.

Also known as: Final session

Experimental group

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 group

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 group

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 group

Control Intervention 4 BEHAVIORAL

In addition to verbal recommendations. This document will be made after the act of assigning the control or experimental group.

Control group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Castilla-La Mancha Health Service: lead

Study Sites (1)

Gerencia de Atención Integrada de Talavera de la Reina Centro de Salud La Algodonera

Talavera de la Reina, Toledo, 45600, Spain

RECRUITING

Related Publications (37)

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MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Maria Salobrar Labrador García, Medical

  Gerencia de Atención Integrada de Talavera de la Reina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Salobrar Labrador García, Medical

CONTACT

+34 925800921; mslabrador@sescam.jccm.es

Carmen Berenguer Jover, Medical

CONTACT

+34 925800921; cberenguerj@sescam.jccm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 25, 2024
• Study Start: December 4, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)