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CBT-based lifestyle intervention group for Type 2 Diabetes

N/A

Recruiting

Led By Julia López, PhD, LCSW

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Obese (Class 1 and 2) ≥ 30.0 kg/m2 to 39.9 kg/m2 BMI

35 to 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and end of the intervention, at month 6

Awards & highlights

Study Summary

This trial will develop/test a culturally sensitive CBT-based lifestyle intervention to help manage obesity/diabetes-related health outcomes for Latino adults with type 2 diabetes, via community health workers.

Who is the study for?

This trial is for Latino adults aged 35-65 with type 2 diabetes, an HbA1c level between 7% and 10%, and a BMI indicating they are overweight or obese. Participants must have been on stable medication for the last three months and maintained a stable weight for the past two months.Check my eligibility

What is being tested?

The study tests a cognitive behavioral therapy (CBT)-based lifestyle intervention aimed at managing obesity and improving mental health in Latinos with type 2 diabetes. It involves community health workers delivering culturally sensitive training focused on diet, physical activity, stress reduction, and quality of life over one year.See study design

What are the potential side effects?

As this is a non-drug intervention focusing on lifestyle changes through CBT, side effects may include discomfort from new dietary or exercise routines but are generally expected to be minimal compared to medicinal treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is between 30.0 and 39.9.

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I am between 35 and 65 years old.

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I have type 2 diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and end of the intervention, at month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and end of the intervention, at month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and end of the intervention, at month 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline HbA1c to 6 months

Secondary outcome measures

Change from Baseline Depressive Symptoms to 6 months

Change from Baseline Fasting Glucose to 6 months

Change from Baseline Insulin Sensitivity to 6 months

+4 more

Other outcome measures

Intervention Implementation Acceptability

Intervention Implementation Adaptability

Intervention Implementation Feasibility

+1 more

Trial Design

2Treatment groups

Active Control

Group I: Standard careActive Control1 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).

Group II: CBT-based lifestyle intervention groupActive Control1 Intervention

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).

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,937 Previous Clinical Trials

2,299,652 Total Patients Enrolled

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

2,359 Previous Clinical Trials

4,314,542 Total Patients Enrolled

Julia López, PhD, LCSWPrincipal InvestigatorWashington University School of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the research accommodate people of more advanced age?

"For this medical study, individuals aged 35 to 65 are suitable candidates for recruitment."

Answered by AI

To what extent has this clinical trial been populated?

"Affirmative. Records on clinicaltrials.gov demonstrate that the enrollment process for this experiment is active. It was initially announced in December of 2023 and updated two weeks ago, with a goal to recruit 50 individuals from one medical center."

Answered by AI

Are there any open enrollment opportunities for this research endeavor?

"Affirmative. Clinicaltrials.gov states that this clinical trial, which was initially published on December 7th 2023, is actively enrolling participants. They are looking for 50 volunteers to join from one site of research."

Answered by AI

Am I eligible to enroll in this research experiment?

"This clinical trial seeks to enlist 50 participants who meet the following criteria: diagnosis of Type 2 diabetes (T2D), age between 35 and 65, Hispanic or Latino/a/x heritage, Overweight BMI ≥ 25 kg/m2 to 29.9 kg/m2 , Obese (Class 1 & 2) BMI ≥ 30.0 kg/m2 to 39.9 kg/m2 , HbA1c range from 7% - 10%,s tabled medication for three months prior, and stable weight over the past two months."

Answered by AI

Recent research and studies

Diabetes/Metabolism Research and ReviewsJournal

Understanding the Growing Epidemic of Type 2 Diabetes in the Hispanic Population Living in the United States

Aguayo-Mazzucato, Cristina, Paula Diaque, Sonia Hernandez, Silvia Rosas, Aleksandar Kostic, and Augusto Enrique Caballero. 2018. “Understanding the Growing Epidemic of Type 2 Diabetes in the Hispanic Population Living in the United States”. Diabetes/metabolism Research and Reviews. Wiley. doi:10.1002/dmrr.3097.

clinicaltrials.govStudy

Community-based CBT and T2D in Latino Population

Julia López 2023. "Community-based CBT and T2D in Latino Population". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05222373.

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