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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
120
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 medical treatment for T2DM
Centro Médico Zambrano Hellion, Fundación Santos y de la Garza Evia I.B.P, TecSalud
San Pedro Garza García, Nuevo León, Mexico
RECRUITINGCentro de Salud Integral, Fundación Santos y de la Garza Evia I.B.P, TecSalud
Santa Catarina, Nuevo León, Mexico
RECRUITINGHbA1c levels (%)
Time frame: Baseline to 12 weeks
HbA1c levels (%)
Time frame: Baseline to 12 weeks and 36 weeks
Fasting insulin (mU/mL)
Time frame: Baseline to 12 weeks and 36 weeks
Fasting glucose (mg/dL)
Time frame: Baseline to 12 weeks and 36 weeks
Homeostatic Model Assessment (HOMA index)
Time frame: 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
Change in lifestyle instrument
Instrument to measure diabetic lifestyles (IMEVID) total score
Time frame: Baseline to 12 weeks and 36 weeks
Subjective sense of wellbeing instrument
Positive emotion, Engagement, Relationships, Meaning, and Accomplishment (PERMA-profiler) score
Time frame: Baseline to 12 weeks and 36 weeks
Adherence to pharmacological interventions for T2DM
Adherence to Refill and Medication Scale (ARMS) score
Time frame: Baseline to 12 weeks and 36 weeks
Change in dose of pharmacological interventions for T2DM
Time frame: Baseline to 12 weeks and 36 weeks
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