Community-based CBT and T2D in Latinx
Primary Purpose
Type 2 Diabetes, Mental Health Issue, Quality of Life
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CBT-based lifestyle intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Type 2 Diabetes focused on measuring Community health worker, Latinx/Hispanic, Mental health, Diabetes
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetes (T2D)
- 35 to 65 years old
- Self-reported Hispanic and/or Latino/a/x heritage
- Overweight ≥ 25 kg/m2 to 29.9 kg/m2 BMI
- Obese (Class 1 and 2) ≥ 30.0 kg/m2 to 39.9 kg/m2 BMI
- HbA1c ≥ 7% and ≤ 10%
- Stable medication for the past three months; and viii) stable weight for the past two months.
Exclusion Criteria:
- No previous diagnosis of T2D
- Type 1 diabetes
- Severe cardiovascular disease within the 6 months prior to enrollment, 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
- Active substance abuse with alcohol or drugs by self-report
- Treatment with non-diabetes medications (e.g., corticosteroids, anti-psychotics) known to have metabolic/body weight effects that could affect the outcome measures; and vi) any person that the is unable to provide informed consent or unwilling to complete the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Standard care
CBT-based lifestyle intervention group
Arm Description
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: standard care plus a theoretically-based, diet, activity, and mental health lifestyle intervention integrated within a culturally sensitive curriculum (materials in Spanish and English).
Outcomes
Primary Outcome Measures
Change from Baseline HbA1c to 12 months
To assess glycemic control
Secondary Outcome Measures
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.
Change from Baseline Fasting Glucose to 12 months
Fasting glucose for those with T2D is below 131 mg/dL is optimal.
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)
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
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.
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.
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.
Full Information
NCT ID
NCT05222373
First Posted
December 22, 2021
Last Updated
April 26, 2023
Sponsor
Washington University School of Medicine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT05222373
Brief Title
Community-based CBT and T2D in Latinx
Official Title
Community-based Cognitive Behavioral Lifestyle Therapy to Improve Diabetes-Related Health Outcomes in an Underserved Latinx Population
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This project will develop and test the acceptance and efficacy of a cognitive behavioral therapy (CBT)-based lifestyle intervention, to help manage obesity and diabetes-related health outcomes (glycemic control, blood pressure, lipid profile, depressive symptoms, stress, and quality of life), provided through community health workers (CHWs) in Latinx adults with type 2 diabetes (T2D). The collaboration is with Mil Familias, a community-based program, to develop, train and implement a culturally sensitive curriculum for the CHWs. The specific aims are: 1) to develop a CBT-based lifestyle intervention focused on diet, activity, depressive symptoms, stress, quality of life, and provide training for three CHWs to implement this intervention; 2) conduct a 16-week randomized controlled trial in 50 Latinx adults with T2D to evaluate the efficacy of the CBT-based lifestyle intervention to improve weight- and diabetes- related health outcomes; 3) evaluate the acceptance and delivery of the intervention in CHWs and participants.
Detailed Description
The investigators will implement a CBT-based lifestyle intervention program, among Latinx 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 a community partner, Sansum Diabetes Research Insitutute (SDRI).
Latinx 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 Mil Familias 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 depressive symptoms and stress. Participants' body weight, body composition, metabolic measures, and mental health outcomes will be obtained at enrollment and at the end of the intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Mental Health Issue, Quality of Life, Weight Loss
Keywords
Community health worker, Latinx/Hispanic, Mental health, Diabetes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
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).
Arm Title
CBT-based lifestyle intervention group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
CBT-based lifestyle intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline HbA1c to 12 months
Description
To assess glycemic control
Time Frame
Baseline, halfway through the intervention, at month 6 and at the end of the intervention, at month 12
Secondary Outcome Measure Information:
Title
Change from Baseline Insulin Sensitivity to 12 months
Description
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.
Time Frame
Baseline and end of the intervention, at month 12
Title
Change from Baseline Fasting Glucose to 12 months
Description
Fasting glucose for those with T2D is below 131 mg/dL is optimal.
Time Frame
Baseline and end of the intervention, at month 12
Title
Change from Baseline Plasma Triglycerides to 12 months
Description
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)
Time Frame
Baseline and end of the intervention, at month 12
Title
Change from Baseline Systolic and Diastolic Blood Pressure to 12 months
Description
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
Time Frame
Baseline and end of the intervention, at month 12
Title
Change from Baseline Depressive Symptoms to 12 months
Description
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.
Time Frame
Baseline and end of the intervention, at month 12
Title
Change from Baseline Perceived Stress to 12 months
Description
Stress assessed by using Perceived Stress Scale (PSS-4). The scale is from 0 to 16 with a higher score indicating more stress.
Time Frame
Baseline and end of the intervention, at month 12
Title
Change from Baseline Quality of Life to 12 months
Description
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.
Time Frame
Baseline and end of the intervention, at month 12
Other Pre-specified Outcome Measures:
Title
Intervention Implementation Fidelity
Description
Fidelity to the delivery of the intervention will be quantified from a checklist of objectives the CHWs completes for each visit. The specific measure (e.g., the percent of content that was covered) will be verified by listening to audiotapes. The outcome variables for the participants include the participation in >80% of the sessions and the CHWs will note attendance of all participants in the study.
Time Frame
During and at the end of the intervention, day 1 to day 365
Title
Intervention Implementation Acceptability
Description
Acceptability will be assessed using a newly formed 10-item questionnaire specific to the intervention for community health workers. For participants, a curated self-reported satisfaction survey will be developed.
Time Frame
During and at the end of the intervention, day 1 to day 365
Title
Intervention Implementation Feasibility
Description
Feasibility will be assessed using a newly formed 10-item questionnaire specific to the intervention for community health workers. For participants, a curated self-reported satisfaction survey will be developed.
Time Frame
During and at the end of the intervention, day 1 to day 365
Title
Intervention Implementation Adaptability
Description
Adaptability will be assessed by the community health workers annotating changes in their delivery of the intervention at every session.
Time Frame
During and at the end of the intervention, day 1 to day 365
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes (T2D)
35 to 65 years old
Self-reported Hispanic and/or Latino/a/x heritage
Overweight ≥ 25 kg/m2 to 29.9 kg/m2 BMI
Obese (Class 1 and 2) ≥ 30.0 kg/m2 to 39.9 kg/m2 BMI
HbA1c ≥ 7% and ≤ 10%
Stable medication for the past three months; and viii) stable weight for the past two months.
Exclusion Criteria:
No previous diagnosis of T2D
Type 1 diabetes
Severe cardiovascular disease within the 6 months prior to enrollment, 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
Active substance abuse with alcohol or drugs by self-report
Treatment with non-diabetes medications (e.g., corticosteroids, anti-psychotics) known to have metabolic/body weight effects that could affect the outcome measures; and vi) any person that the is unable to provide informed consent or unwilling to complete the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julia López, PhD, LCSW
Phone
314-454-8249
Email
Julialopez@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Raul Bastarrachea, MD
Phone
210-218-8256
Email
Rbasta@sansum.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia López, PhD, LCSW
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28144049
Citation
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.
Results Reference
background
PubMed Identifier
30445663
Citation
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.
Results Reference
background
PubMed Identifier
20464489
Citation
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.
Results Reference
background
PubMed Identifier
23345198
Citation
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. Erratum In: Curr Diab Rep. 2013 Aug;13(4):600.
Results Reference
background
PubMed Identifier
32848906
Citation
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.
Results Reference
background
PubMed Identifier
27079342
Citation
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.
Results Reference
background
PubMed Identifier
7851237
Citation
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.
Results Reference
background
PubMed Identifier
33353512
Citation
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.
Results Reference
background
PubMed Identifier
30879355
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. Erratum In: Circulation. 2019 Sep 10;140(11):e649-e650. Circulation. 2020 Jan 28;141(4):e60. Circulation. 2020 Apr 21;141(16):e774.
Results Reference
background
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Community-based CBT and T2D in Latinx
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