Integrative Group Program for Type 2 Diabetes Mellitus (T2DM)

Hospital San Jose Tec de Monterrey

Status: Enrolling

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: Integrative Group Program; Other: Conventional treatment for T2DM

Study type: Interventional

Funder types: Other

Identifiers

NCT05888454

Dando pasos juntos

Details and patient eligibility

About

This is an open, randomized, controlled trial to determine the impact of an integrative group program on metabolic control and wellbeing perception of patients with T2DM. The integrative group program consists of 6 in-person sessions directed by a health coach and occurring every other week, and 6 asynchronous educative sessions during a period of 12 weeks.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• T2DM diagnosis of less than 5 years
• Age 18 to 80 years
• Current residence in Nuevo León, México
• Availability to attend in-person sessions
• Provides written informed consent
• Able to read and write

Exclusion criteria

• Currently under insulin treatment
• T2DM diagnosis more than 5 years ago
• Comorbidities such as active cancer, acquired immunodeficiency (HIV+, AIDS), liver, cardiovascular, renal, pulmonary or thyroid disease.
• History of severe neurologic or psychiatric disease (current or past diagnosis)
• Currently pregnant or intention of pregnancy in the following 3 months
• Males that consume more than 4 alcoholic beverages daily or 14 weekly
• Females that consume more than 3 alcoholic beverages daily or 7 weekly
• Consumption of any illicit drug

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Experimental Group

Experimental group

Description:

Conventional treatment for T2DM + Integrative Group Program

Treatment:

Other: Integrative Group Program

Other: Conventional treatment for T2DM

Control Group

Active Comparator group

Description:

Conventional treatment for T2DM

Treatment:

Other: Conventional treatment for T2DM