Stress Management Among Latinos With Type 2 Diabetes
CALMS-D
1 other identifier
interventional
107
1 country
1
Brief Summary
The primary aims of this study are to:
- 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.
- 3.Investigate the efficacy of the stress management intervention on stress hormones, psychosocial functioning, and stress-glucose reactivity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus-type-2
Started May 2012
Longer than P75 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2012
CompletedFirst Posted
Study publicly available on registry
April 16, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedApril 1, 2020
March 1, 2020
2.6 years
April 12, 2012
March 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Hemoglobin A1c
Blood will be drawn from participants and hemoglobin A1c levels will be measured
Baseline
Hemoglobin A1c
Blood will be drawn from participants and hemoglobin A1c levels will be measured
9 weeks
Hemoglobin A1c
Blood will be drawn from participants and hemoglobin A1c levels will be measured
6 months
Secondary Outcomes (3)
Diabetes specific distress
Baseline
Diabetes specific distress
9 weeks
Diabetes specific distress
6 months
Study Arms (2)
Diabetes education
NO INTERVENTIONGroup-based diabetes education delivered to participants through community health workers
Diabetes education plus stress management
EXPERIMENTALGroup-based diabetes education plus stress management delivered to participants through community health workers
Interventions
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
You may qualify if:
- Latinos age 18 or older that are ambulatory
- Spanish speaking
- Diagnosed with type 2 diabetes for at least 1 year
- Hemoglobin A1c levels greater than 7.0
You may not qualify if:
- Medical instability or medical treatment requiring inpatient care
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- Hartford Hospitalcollaborator
- UConn Healthcollaborator
- Hispanic Health Council, Inc.collaborator
- National Institute on Minority Health and Health Disparities (NIMHD)collaborator
Study Sites (1)
Yale University
New Haven, Connecticut, United States
Related Publications (4)
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.
PMID: 35534102DERIVEDWagner 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.
PMID: 32494976DERIVEDBermudez-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.
PMID: 31006809DERIVEDBermudez-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.
PMID: 27489004DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rafael Pérez-Escamilla, Ph.D.
Yale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2012
First Posted
April 16, 2012
Study Start
May 1, 2012
Primary Completion
December 1, 2014
Study Completion
June 1, 2015
Last Updated
April 1, 2020
Record last verified: 2020-03