Community-based CBT and T2D in Latino Population

NCT05222373 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-07-10

No results posted yet for this study

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

Interventions

BEHAVIORAL

CBT-based lifestyle intervention

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.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH
  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Julia López, PhD, LCSW · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-07
Primary Completion
2024-04-09
Completion
2024-04-09

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05222373 on ClinicalTrials.gov