Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
107 participants
INTERVENTIONAL
2012-05-31
2015-06-30
Brief Summary
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1. Tailor a diabetes stress management intervention for delivery by community health workers (CHWs) serving an urban Latino population.
2. Investigate the efficacy of the stress management intervention on glycemic control.
Secondary aims of this study are to:
3. Investigate the efficacy of the stress management intervention on stress hormones, psychosocial functioning, and stress-glucose reactivity.
Study hypothesis:
A CHW-led group-based diabetes education model enhanced with stress management education will improve glycemic control more than CHW-led group-based diabetes education alone.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Diabetes education
Group-based diabetes education delivered to participants through community health workers
No interventions assigned to this group
Diabetes education plus stress management
Group-based diabetes education plus stress management delivered to participants through community health workers
stress management
The study is a randomized, controlled,single-site, parallel group clinical trial comparing the effectiveness of CHW led diabetes education with CHW led diabetes education plus CHW led stress management in Latinos with Type 2 Diabetes.
Interventions
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stress management
The study is a randomized, controlled,single-site, parallel group clinical trial comparing the effectiveness of CHW led diabetes education with CHW led diabetes education plus CHW led stress management in Latinos with Type 2 Diabetes.
Eligibility Criteria
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Inclusion Criteria
* Spanish speaking
* Diagnosed with type 2 diabetes for at least 1 year
* Hemoglobin A1c levels greater than 7.0
Exclusion Criteria
* Diagnoses of bipolar disorder or thought disorder (or taking medications prescribed for either); current substance abuse or dependence disorder
* Current suicidality or history of suicide attempt
* History of psychiatric hospitalization
* Taking antidepressant medications prescribed for the treatment of depression accompanied by either a) changes to the antidepressant regimen within previous 6 weeks, or b) anticipated changes to the regimen during period of study. Such patients will be deferred and re-evaluated for eligibility after 6 months
18 Years
ALL
No
Sponsors
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Hartford Hospital
OTHER
UConn Health
OTHER
Hispanic Health Council, Inc.
OTHER
National Institute on Minority Health and Health Disparities (NIMHD)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Rafael Pérez-Escamilla, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale University
New Haven, Connecticut, United States
Countries
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References
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Bermudez-Millan A, Perez-Escamilla R, Lampert R, Feinn R, Damio G, Segura-Perez S, Chhabra J, Kanc K, Wagner JA. Night Eating Among Latinos With Diabetes: Exploring Associations With Heart Rate Variability, Eating Patterns, and Sleep. J Nutr Educ Behav. 2022 May;54(5):449-454. doi: 10.1016/j.jneb.2022.02.006.
Wagner J, Armeli S, Tennen H, Bermudez-Millan A, Wolpert H, Perez-Escamilla R. A daily study of stressors, continuously measured glucose, and diabetes symptoms in latinos with type 2 diabetes. J Behav Med. 2021 Feb;44(1):94-103. doi: 10.1007/s10865-020-00162-1. Epub 2020 Jun 3.
Bermudez-Millan A, Wagner JA, Feinn RS, Segura-Perez S, Damio G, Chhabra J, Perez-Escamilla R. Inflammation and Stress Biomarkers Mediate the Association between Household Food Insecurity and Insulin Resistance among Latinos with Type 2 Diabetes. J Nutr. 2019 Jun 1;149(6):982-988. doi: 10.1093/jn/nxz021.
Bermudez-Millan A, Perez-Escamilla R, Segura-Perez S, Damio G, Chhabra J, Osborn CY, Wagner J. Psychological Distress Mediates the Association between Food Insecurity and Suboptimal Sleep Quality in Latinos with Type 2 Diabetes Mellitus. J Nutr. 2016 Oct;146(10):2051-2057. doi: 10.3945/jn.116.231365. Epub 2016 Aug 3.
Other Identifiers
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