Integrative Group Program for Type 2 Diabetes Mellitus (T2DM)

Study Overview
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Integrative Group Program
* Other: Conventional treatment for T2DM


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Conventional treatment for T2DM + Integrative Group Program | Other: Integrative Group Program<br>* 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.<br>Other: Conventional treatment for T2DM<br>* Conventional medical treatment for T2DM<br>|
| Active Comparator: Control Group<br>Conventional treatment for T2DM | Other: Conventional treatment for T2DM<br>* Conventional medical treatment for T2DM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c levels (%) |  | Baseline to 12 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Integrative Medicine, Diabetes Mellitus Type 2