Community-based CBT and T2D in Latino Population

NCT05222373 | Withdrawn DMC

• 2 other identifiers: 202110125P30DK056341
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Mental Health Issue; Quality of Life; Weight Loss

Keywords

Community health worker; Latinx/Hispanic; Mental health; Diabetes

Outcome Measures

Primary Outcomes (1)

• Change from Baseline HbA1c to 6 months

  To assess glycemic control

  Baseline and at the end of the intervention, at month 6

Secondary Outcomes (7)

• Change from Baseline Insulin Sensitivity to 6 months

  Baseline and end of the intervention, at month 6

• Change from Baseline Fasting Glucose to 6 months

  Baseline and end of the intervention, at month 6

• Change from Baseline Plasma Triglycerides to 6 months

  Baseline and end of the intervention, at month 6

• Change from Baseline Systolic and Diastolic Blood Pressure to 12 months

  Baseline and end of the intervention, at month 6

• Change from Baseline Depressive Symptoms to 6 months

  Baseline and end of the intervention, at month 6

Other Outcomes (4)

• Intervention Implementation Fidelity

  During and at the end of the intervention, day 1 to day 183

• Intervention Implementation Acceptability

  During and at the end of the intervention, day 1 to day 183

• Intervention Implementation Feasibility

  During and at the end of the intervention, day 1 to day 183

Study Arms (2)

Standard care

NO 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 group

ACTIVE COMPARATOR

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

Interventions

CBT-based lifestyle intervention BEHAVIORAL

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.

CBT-based lifestyle intervention group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• i) HbA1c ≥ 6.5% 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

Related Publications (9)

• Rodriguez JE, Campbell KM. Racial and Ethnic Disparities in Prevalence and Care of Patients With Type 2 Diabetes. Clin Diabetes. 2017 Jan;35(1):66-70. doi: 10.2337/cd15-0048. No abstract available.

  PMID: 28144049 BACKGROUND

• Aguayo-Mazzucato C, Diaque P, Hernandez S, Rosas S, Kostic A, Caballero AE. Understanding the growing epidemic of type 2 diabetes in the Hispanic population living in the United States. Diabetes Metab Res Rev. 2019 Feb;35(2):e3097. doi: 10.1002/dmrr.3097. Epub 2018 Dec 4.

  PMID: 30445663 BACKGROUND

• Stacciarini JM, Shattell MM, Coady M, Wiens B. Review: Community-based participatory research approach to address mental health in minority populations. Community Ment Health J. 2011 Oct;47(5):489-97. doi: 10.1007/s10597-010-9319-z. Epub 2010 May 13.

  PMID: 20464489 BACKGROUND

• Shah M, Kaselitz E, Heisler M. The role of community health workers in diabetes: update on current literature. Curr Diab Rep. 2013 Apr;13(2):163-71. doi: 10.1007/s11892-012-0359-3.

  PMID: 23345198 BACKGROUND

• Yang X, Li Z, Sun J. Effects of Cognitive Behavioral Therapy-Based Intervention on Improving Glycaemic, Psychological, and Physiological Outcomes in Adult Patients With Diabetes Mellitus: A Meta-Analysis of Randomized Controlled Trials. Front Psychiatry. 2020 Jul 28;11:711. doi: 10.3389/fpsyt.2020.00711. eCollection 2020.

  PMID: 32848906 BACKGROUND

• Walker RJ, Strom Williams J, Egede LE. Influence of Race, Ethnicity and Social Determinants of Health on Diabetes Outcomes. Am J Med Sci. 2016 Apr;351(4):366-73. doi: 10.1016/j.amjms.2016.01.008.

  PMID: 27079342 BACKGROUND

• Schwab T, Meyer J, Merrell R. Measuring attitudes and health beliefs among Mexican Americans with diabetes. Diabetes Educ. 1994 May-Jun;20(3):221-7. doi: 10.1177/014572179402000308.

  PMID: 7851237 BACKGROUND

• Fain JA. The Diabetes Educator (TDE): Successes, Opportunities, and Future Changes. Diabetes Educ. 2020 Dec;46(6):512-513. doi: 10.1177/0145721720976349. No abstract available.

  PMID: 33353512 BACKGROUND

• 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.

  PMID: 30879355 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Weight Loss; Psychological Well-Being; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Study Officials

• Julia López, PhD, LCSW

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Medicine

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: February 3, 2022
• Study Start: December 7, 2023
• Primary Completion: April 9, 2024
• Study Completion: April 9, 2024
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)