Community-based CBT and T2D in Latinx

Community-based Cognitive Behavioral Lifestyle Therapy to Improve Diabetes-Related Health Outcomes in an Underserved Latinx Population

This project will develop and test the acceptance and efficacy of a cognitive behavioral therapy (CBT)-based lifestyle intervention, to help manage obesity and diabetes-related health outcomes (glycemic control, blood pressure, lipid profile, depressive symptoms, stress, and quality of life), provided through community health workers (CHWs) in Latinx adults with type 2 diabetes (T2D). The collaboration is with Mil Familias, a community-based program, to develop, train and implement a culturally sensitive curriculum for the CHWs. The specific aims are: 1) to develop a CBT-based lifestyle intervention focused on diet, activity, depressive symptoms, stress, quality of life, and provide training for three CHWs to implement this intervention; 2) conduct a 16-week randomized controlled trial in 50 Latinx adults with T2D to evaluate the efficacy of the CBT-based lifestyle intervention to improve weight- and diabetes- related health outcomes; 3) evaluate the acceptance and delivery of the intervention in CHWs and participants.

The investigators will implement a CBT-based lifestyle intervention program, among Latinx adults with T2D, that targets appropriate body weight, glycemic control, blood pressure, plasma triglyceride, and emphasizes techniques to help reduce depressive symptoms, stress, and improve quality of life through the collaborative partnership with a community partner, Sansum Diabetes Research Insitutute (SDRI). Latinx adults with T2D who meet eligibility requirements will be recruited for the study, and subjects will be randomized to one of two conditions: 1) Standard care: will include the Mil Familias CHW curriculum focused on diabetes education and connecting individuals to appropriate resources in the community; or 2) CBT- based lifestyle intervention: standard care plus a theoretically-based, diet, activity, and mental health lifestyle intervention integrated within a culturally sensitive curriculum (materials in Spanish and English). Trained CHWs will promote CBT-based lifestyle-change aims and assist in goal setting with participants to reach the primary goal of appropriate glycemic control (fasting blood glucose and HbA1c) and weight reduction, in addition to decrease depressive symptoms and stress. Participants' body weight, body composition, metabolic measures, and mental health outcomes will be obtained at enrollment and at the end of the intervention.

Standard care: will include the CHW curriculum focused on diabetes education and connecting individuals to appropriate resources in the community (materials in Spanish and English).

CBT-based lifestyle intervention: standard care plus a theoretically-based, diet, activity, and mental health lifestyle intervention integrated within a culturally sensitive curriculum (materials in Spanish and English).

The standard care plus a theoretically-based, diet, activity, and mental health lifestyle intervention integrated within a culturally sensitive curriculum (materials in Spanish and English). Trained CHWs will promote CBT-based lifestyle-change aims and assist in goal setting with participants to reach the primary goal of appropriate glycemic control (fasting blood glucose and HbA1c) and weight reduction, in addition to decrease in depressive symptoms and stress and an increase in quality of life. Participants' body weight, body composition, metabolic measures, and mental health outcomes will be obtained at enrollment and at the end of the intervention.

Baseline, halfway through the intervention, at month 6 and at the end of the intervention, at month 12

Insulin sensitivity assessed as HOMA-IR. The higher the score the more likely to be insulin resistant (less than 1.0 means insulin sensitivity, above 1.9 indicates early insulin resistance, above 2.9 indicates significant insulin resistance.

Normal - Less than 150 milligrams per deciliter (mg/dL), or less than 1.7 millimoles per liter (mmol/L) Borderline high - 150 to 199 mg/dL (1.8 to 2.2 mmol/L) High - 200 to 499 mg/dL (2.3 to 5.6 mmol/L) Very high - 500 mg/dL or above (5.7 mmol/L or above)

To assess blood pressure changes. Normal is systolic: less than 120 mm Hg and diastolic: less than 80 mm Hg; At Risk (prehypertension) is systolic: 120-139 mm Hg and diastolic: 80-89 mm Hg; High Blood Pressure (hypertension) issystolic: 140 mm Hg or higher and diastolic: 90 mm Hg or higher

Depressive symptoms assessed by using the Patient Health Questionaire-9 (PHQ-9). The scale is from 0 to 27 with a higher score indicating worse depressive symptoms.

Stress assessed by using Perceived Stress Scale (PSS-4). The scale is from 0 to 16 with a higher score indicating more stress.

Quality of life assessed by using the Health Survey Short Form (SF-12).Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.

Fidelity to the delivery of the intervention will be quantified from a checklist of objectives the CHWs completes for each visit. The specific measure (e.g., the percent of content that was covered) will be verified by listening to audiotapes. The outcome variables for the participants include the participation in >80% of the sessions and the CHWs will note attendance of all participants in the study.

Acceptability will be assessed using a newly formed 10-item questionnaire specific to the intervention for community health workers. For participants, a curated self-reported satisfaction survey will be developed.

Feasibility will be assessed using a newly formed 10-item questionnaire specific to the intervention for community health workers. For participants, a curated self-reported satisfaction survey will be developed.

Adaptability will be assessed by the community health workers annotating changes in their delivery of the intervention at every session.

Inclusion Criteria: Type 2 diabetes (T2D) 35 to 65 years old Self-reported Hispanic and/or Latino/a/x heritage Overweight ≥ 25 kg/m2 to 29.9 kg/m2 BMI Obese (Class 1 and 2) ≥ 30.0 kg/m2 to 39.9 kg/m2 BMI HbA1c ≥ 7% and ≤ 10% Stable medication for the past three months; and viii) stable weight for the past two months. Exclusion Criteria: No previous diagnosis of T2D Type 1 diabetes Severe cardiovascular disease within the 6 months prior to enrollment, defined as: previous stroke, decompensated heart failure New York Heart Association class III or IV, myocardial infarction, unstable angina pectoris, or coronary arterial bypass graft or angioplasty Active substance abuse with alcohol or drugs by self-report Treatment with non-diabetes medications (e.g., corticosteroids, anti-psychotics) known to have metabolic/body weight effects that could affect the outcome measures; and vi) any person that the is unable to provide informed consent or unwilling to complete the study.

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