Group program to improve health for people with Type 2 Diabetes
Dando Pasos Juntos: An Integrative Group Program for Type 2 Diabetes Mellitus
This study is testing a group program that combines health coaching and education to see if it helps people with Type 2 Diabetes feel better and manage their condition more effectively.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | TecSalud Investigación Clínica Academic / other |
| Locations | 2 sites (San Pedro Garza Garcia, Nuevo León and 1 other locations) |
| Trial ID | NCT05888454 on ClinicalTrials.gov |
What this trial studies
This open, randomized, controlled trial aims to evaluate the effects of an integrative group program on metabolic control and the perception of wellbeing in patients with Type 2 Diabetes Mellitus (T2DM). The program includes six in-person sessions led by a health coach, occurring bi-weekly, along with six asynchronous educational sessions over a 12-week period. Participants will receive both the integrative program and conventional treatment for T2DM to assess the combined impact on their health outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with a recent diagnosis of Type 2 Diabetes and residing in Nuevo León, México.
Not a fit: Patients currently on insulin treatment or with a diagnosis of Type 2 Diabetes for more than five years may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could enhance metabolic control and improve the overall wellbeing of patients with Type 2 Diabetes.
How similar studies have performed: Previous studies have shown positive outcomes with integrative approaches for managing Type 2 Diabetes, suggesting potential success for this program.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Pedro Garza Garcia, Nuevo León and 1 other locations
- Centro Médico Zambrano Hellion, Fundación Santos y de la Garza Evia I.B.P, TecSalud — San Pedro Garza Garcia, Nuevo León, Mexico (Recruiting)
- Centro de Salud Integral, Fundación Santos y de la Garza Evia I.B.P, TecSalud — Santa Catarina, Nuevo León, Mexico (Recruiting)
Study contacts
- Principal investigator: Tania Zertuche, MD — Director de Instituto de Bienestar y Prevención
- Study coordinator: Regina Moreno, MD
- Email: regina.moreno@tecsalud.mx
- Phone: +52 33 367 668 77
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.