Integrative Group Program for Type 2 Diabetes Mellitus (T2DM)

• Sponsor: Hospital San Jose Tec de Monterrey (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05888454
• Collaborator: TecSalud (Other), Fundación Santos y de la Garza Evia I.B.P (Other)
• Enrollment: 120
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 6
• Patients Per Site: 60
• Patients Per Site Per Month: 10

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Other: Integrative Group Program; Other: Conventional treatment for T2DM	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Dando Pasos Juntos: An Integrative Group Program for Type 2 Diabetes Mellitus
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. HbA1c levels (%) [Baseline to 12 weeks]

Secondary Outcome Measures

1. HbA1c levels (%) [Baseline to 12 weeks and 36 weeks]

2. Fasting insulin (mU/mL) [Baseline to 12 weeks and 36 weeks]

3. Fasting glucose (mg/dL) [Baseline to 12 weeks and 36 weeks]

4. Homeostatic Model Assessment (HOMA index) [Baseline to 12 weeks and 36 weeks]

5. High-sensitivity C-reactive protein (hs-CRP, mg/dL) [Baseline to 12 weeks and 36 weeks]

6. Change in lifestyle instrument [Baseline to 12 weeks and 36 weeks]

   Instrument to measure diabetic lifestyles (IMEVID) total score

7. Subjective sense of wellbeing instrument [Baseline to 12 weeks and 36 weeks]

   Positive emotion, Engagement, Relationships, Meaning, and Accomplishment (PERMA-profiler) score

8. Adherence to pharmacological interventions for T2DM [Baseline to 12 weeks and 36 weeks]

   Adherence to Refill and Medication Scale (ARMS) score

9. Change in dose of pharmacological interventions for T2DM [Baseline to 12 weeks and 36 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro Médico Zambrano Hellion, Fundación Santos y de la Garza Evia I.B.P, TecSalud	San Pedro Garza Garcia	Nuevo León	Mexico	66278
2	Centro de Salud Integral, Fundación Santos y de la Garza Evia I.B.P, TecSalud	Santa Catarina	Nuevo León	Mexico	66369

Sponsors and Collaborators

• Hospital San Jose Tec de Monterrey
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospital San Jose Tec de Monterrey
• ClinicalTrials.gov Identifier: NCT05888454
• Other Study ID Numbers: Dando pasos juntos
• First Posted: Jun 5, 2023
• Last Update Posted: Jun 5, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hospital San Jose Tec de Monterrey: Integrative Medicine; Diabetes Mellitus Type 2
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jun 5, 2023