Integrative Group Program for Type 2 Diabetes Mellitus (T2DM)

NCT ID: NCT05888454

Last Updated: 2024-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-24

Study Completion Date

2024-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental Group

Conventional treatment for T2DM + Integrative Group Program

Group Type EXPERIMENTAL

Integrative Group Program

Intervention Type OTHER

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.

Conventional treatment for T2DM

Intervention Type OTHER

Conventional medical treatment for T2DM

Control Group

Conventional treatment for T2DM

Group Type ACTIVE_COMPARATOR

Conventional treatment for T2DM

Intervention Type OTHER

Conventional medical treatment for T2DM

Interventions

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Integrative Group Program

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.

Intervention Type OTHER

Conventional treatment for T2DM

Conventional medical treatment for T2DM

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TecSalud

UNKNOWN

Sponsor Role collaborator

Fundación Santos y de la Garza Evia I.B.P

UNKNOWN

Sponsor Role collaborator

TecSalud Investigación Clínica

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tania Zertuche, MD

Role: PRINCIPAL_INVESTIGATOR

Director de Instituto de Bienestar y Prevención

Locations

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Centro Médico Zambrano Hellion, Fundación Santos y de la Garza Evia I.B.P, TecSalud

San Pedro Garza García, Nuevo León, Mexico

Site Status RECRUITING

Centro de Salud Integral, Fundación Santos y de la Garza Evia I.B.P, TecSalud

Santa Catarina, Nuevo León, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Regina Moreno, MD

Role: CONTACT

+52 33 367 668 77

Facility Contacts

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Regina Moreno, MD

Role: primary

+52 33 367 668 77

Regina Moreno, MD

Role: primary

+52 33 367 668 77

Other Identifiers

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Dando pasos juntos

Identifier Type: -

Identifier Source: org_study_id

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