Clinical trial NCT05222373: Community-based CBT and T2D in Latino Population
Official title: Community-based Cognitive Behavioral Lifestyle Therapy to Improve Diabetes-Related Health Outcomes in an Underserved Latino Population
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Type 2 Diabetes
Mental Health Issue
Quality of Life
Weight Loss
Keywords: Community health worker
Latinx/Hispanic
Mental health
Diabetes
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-02-03
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 26-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: 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 and at the end of the intervention (week 26).

Eligibility criteria: 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 27.0 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.

Primary outcomes:
measure: Change from Baseline HbA1c to 6 months
timeFrame: Baseline and at the end of the intervention, at month 6
Secondary outcomes:
measure: Change from Baseline Insulin Sensitivity to 6 months
timeFrame: Baseline and end of the intervention, at month 6
measure: Change from Baseline Fasting Glucose to 6 months
timeFrame: Baseline and end of the intervention, at month 6
measure: Change from Baseline Plasma Triglycerides to 6 months
timeFrame: Baseline and end of the intervention, at month 6
measure: Change from Baseline Systolic and Diastolic Blood Pressure to 12 months
timeFrame: Baseline and end of the intervention, at month 6
measure: Change from Baseline Depressive Symptoms to 6 months
timeFrame: Baseline and end of the intervention, at month 6
measure: Change from Baseline Perceived Stress to 6 months
timeFrame: Baseline and end of the intervention, at month 6
measure: Change from Baseline Quality of Life to 6 months
timeFrame: Baseline and end of the intervention, at month 6
Other outcomes:
measure: Intervention Implementation Fidelity
timeFrame: During and at the end of the intervention, day 1 to day 183
measure: Intervention Implementation Acceptability
timeFrame: During and at the end of the intervention, day 1 to day 183
measure: Intervention Implementation Feasibility
timeFrame: During and at the end of the intervention, day 1 to day 183
measure: Intervention Implementation Adaptability
timeFrame: During and at the end of the intervention, day 1 to day 183
Locations:
city: Santa Barbara
country: United States
facility: Sansum Diabetes Research Institute
state: California
Study officials:
affiliation: Washington University School of Medicine
name: Julia López, PhD, LCSW
role: PRINCIPAL_INVESTIGATOR
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citation: Arnett DK, Blumenthal RS, Albert MA, Buroker AB, Goldberger ZD, Hahn EJ, Himmelfarb CD, Khera A, Lloyd-Jones D, McEvoy JW, Michos ED, Miedema MD, Munoz D, Smith SC Jr, Virani SS, Williams KA Sr, Yeboah J, Ziaeian B. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Sep 10;140(11):e596-e646. doi: 10.1161/CIR.0000000000000678. Epub 2019 Mar 17. No abstract available.