Community-based CBT and T2D in Latino Population

Study Overview
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Brief Summary
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The purpose of this project is to develop and test the acceptance and clinical efficacy of a cognitive behavioral therapy (CBT)-based lifestyle intervention, to help manage obesity and diabetes-related health outcomes, provided through community health workers (CHWs) in Latino adults with type 2 diabetes (T2D). A collaboration with an established community-based organization named Sansum Diabetes Research Institute (SDRI), will provide an opportunity to develop, train and implement a culturally sensitive curricula for the CHWs that focuses on body weight and mental health (depressive symptoms and stress) among participants disproportionately impacted by T2D due to social, economic and community factors. Cultural sensitivity focuses on delivering health information based on norms, values, beliefs, environmental factors, and historical context that is unique to a racial/ethnic population. Therefore, for our curricula to be culturally sensitive it will include the following aspects: being primarily delivered in the Spanish language with English as needed, actively incorporate culturally relevant eating and physical activity recommendations, and encompass the foundational importance of familial and social relationships as part of the mental health component of the intervention. For this proposal, the specific aims of this project are: 1) develop a CBT-based lifestyle intervention that focuses on diet, activity, depressive symptoms, stress, and quality of life in collaboration with CHWs and participants from SDRI, and provide training for three CHWs to implement this intervention; 2) conduct a 52-week randomized controlled trial in 50 Latino adults with T2D in the SDRI organization to evaluate the efficacy of the CBT-based lifestyle intervention to improve weight- and diabetes- related health outcomes (body weight, glycemic control, blood pressure, lipid profile, depressive symptoms, stress, and quality of life); 3) evaluate the acceptance and delivery of the CBT-based lifestyle intervention in CHWs and participants with T2D. If successful, this study will establish the structure and content of a culturally sensitive, effective CBT-lifestyle, community-based treatment.

Detailed Description
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We will implement a CBT-based lifestyle intervention program, among Latino 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 SDRI. Latino 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 SDRI 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 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, mid intervention (week 24), and at the end of the intervention (week 52).

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

Conditions
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Quality of Life, Weight Loss, Type 2 Diabetes, Mental Health Issue

Intervention / Treatment
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* Behavioral: CBT-based lifestyle intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: i) HbA1c ≥ 7% and ≤ 10% at screening; ii) 35 to 65 years old; iii) self-reported Hispanic and/or Latino/a/x heritage; iv) Able to speak and read Spanish; v) obese, defined as BMI 30.0 kg/m2 to 45.0 kg/m2; vi) no change in medications for the past three months; and vii) stable weight (defined as <4% change in body weight) for the past two months. Exclusion Criteria: i) treatment with basal insulin >0.5units/kg/day; ii) treatment with rapid acting (prandial) insulin iii) Type 1 diabetes; iv) severe cardiovascular disease 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; v) severe pulmonary, renal, or liver disease; vi) active substance abuse with alcohol or drugs by self-report; vii) active tobacco use (>8 cigarettes/day); viii) excessive alcohol consumption (>14 drinks per week for women or 21 drinks per week for men); ix) treatment with non-diabetes medications (e.g., corticosteroids, anti-psychotics) known to have metabolic/body weight effects that could affect the outcome measures or increase the risk of study procedures; x) history of bariatric surgery; xi) poorly controlled hypertension (SBP ≥160 mmHg or DBP ≥110 mmHg); xii) structured exercise >120 minutes/week; xiii) pregnant, lactating, not using effective birth control if premenopausal, or planning to become pregnant within the 12-month study period; xiv) unstable weight (>4% change in the last 2 months); xv) anemia (hemoglobin <10 g/dL); xvi) has a continuous glucose monitor (CGM) or plans to have a CGM in the next 12 months; xvii) major psychiatric illness that would interefer with study participation; and xviii) any person that is unable to provide informed consent or unwilling to complete the study or who, for any reason, the research team considers an inappropriate candidate for the study.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br>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). | |
| Active Comparator: CBT-based lifestyle intervention group<br>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). | Behavioral: CBT-based lifestyle intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline HbA1c to 12 months | To assess glycemic control | Baseline, halfway through the intervention, at month 6 and at the end of the intervention, at month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Insulin Sensitivity to 12 months | 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. | Baseline and end of the intervention, at month 12 | 
| Change from Baseline Fasting Glucose to 12 months | Fasting glucose for those with T2D is below 131 mg/dL is optimal. | Baseline and end of the intervention, at month 12 | 
| Change from Baseline Plasma Triglycerides to 12 months | 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) | Baseline and end of the intervention, at month 12 | 
| Change from Baseline Systolic and Diastolic Blood Pressure to 12 months | 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 | Baseline and end of the intervention, at month 12 | 
| Change from Baseline Depressive Symptoms to 12 months | 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. | Baseline and end of the intervention, at month 12 | 
| Change from Baseline Perceived Stress to 12 months | Stress assessed by using Perceived Stress Scale (PSS-4). The scale is from 0 to 16 with a higher score indicating more stress. | Baseline and end of the intervention, at month 12 | 
| Change from Baseline Quality of Life to 12 months | 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. | Baseline and end of the intervention, at month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Community health worker, Latinx/Hispanic, Mental health, Diabetes