NCT06222775

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Castilla-La Mancha Health Service · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-12-04
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-01-25
• Last updated: 2024-02-14

Locations

1 site across 1 country: Spain