Integrative Group Program for Type 2 Diabetes Mellitus (T2DM)

February 27, 2024 updated by: Hospital San Jose Tec de Monterrey

Dando Pasos Juntos: An Integrative Group Program for Type 2 Diabetes Mellitus

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

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 Locations

  • Mexico
    • Nuevo León
      • San Pedro Garza Garcia, Nuevo León, Mexico, 66278
        • Recruiting
        • Centro Médico Zambrano Hellion, Fundación Santos y de la Garza Evia I.B.P, TecSalud
        • Contact:
        • Principal Investigator:
          • Tania Zertuche, MD
      • Santa Catarina, Nuevo León, Mexico, 66369
        • Recruiting
        • Centro de Salud Integral, Fundación Santos y de la Garza Evia I.B.P, TecSalud
        • Contact:
        • Principal Investigator:
          • Tania Zertuche, MD

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:

  • 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

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Conventional treatment for T2DM + Integrative Group Program
Other: 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.
Other: Conventional treatment for T2DM
Conventional medical treatment for T2DM
Active Comparator: Control Group
Conventional treatment for T2DM
Other: Conventional treatment for T2DM
Conventional medical treatment for T2DM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c levels (%)
Time Frame: Baseline to 12 weeks
Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c levels (%)
Time Frame: Baseline to 12 weeks and 36 weeks
Baseline to 12 weeks and 36 weeks
Fasting insulin (mU/mL)
Time Frame: Baseline to 12 weeks and 36 weeks
Baseline to 12 weeks and 36 weeks
Fasting glucose (mg/dL)
Time Frame: Baseline to 12 weeks and 36 weeks
Baseline to 12 weeks and 36 weeks
Homeostatic Model Assessment (HOMA index)
Time Frame: Baseline to 12 weeks and 36 weeks
Baseline to 12 weeks and 36 weeks
High-sensitivity C-reactive protein (hs-CRP, mg/dL)
Time Frame: Baseline to 12 weeks and 36 weeks
Baseline to 12 weeks and 36 weeks
Change in lifestyle instrument
Time Frame: Baseline to 12 weeks and 36 weeks
Instrument to measure diabetic lifestyles (IMEVID) total score
Baseline to 12 weeks and 36 weeks
Subjective sense of wellbeing instrument
Time Frame: Baseline to 12 weeks and 36 weeks
Positive emotion, Engagement, Relationships, Meaning, and Accomplishment (PERMA-profiler) score
Baseline to 12 weeks and 36 weeks
Adherence to pharmacological interventions for T2DM
Time Frame: Baseline to 12 weeks and 36 weeks
Adherence to Refill and Medication Scale (ARMS) score
Baseline to 12 weeks and 36 weeks
Change in dose of pharmacological interventions for T2DM
Time Frame: Baseline to 12 weeks and 36 weeks
Baseline to 12 weeks and 36 weeks

Collaborators and Investigators

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

Sponsor

Hospital San Jose Tec de Monterrey

Collaborators

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

Investigators

  • Principal Investigator: Tania Zertuche, MD, Director de Instituto de Bienestar y Prevención

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)

July 24, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

May 15, 2023

First Submitted That Met QC Criteria

May 25, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dando pasos juntos

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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