Clinical trial NCT01578096: Stress Management Among Latinos With Type 2 Diabetes
Official title: Stress Management Among Latinos With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 Diabetes
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Hartford Hospital
name: UConn Health
name: Hispanic Health Council, Inc.
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2012-04-16
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

   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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: Baseline
measure: Hemoglobin A1c
timeFrame: 9 weeks
measure: Hemoglobin A1c
timeFrame: 6 months
Secondary outcomes:
measure: Diabetes specific distress
timeFrame: Baseline
measure: Diabetes specific distress
timeFrame: 9 weeks
measure: Diabetes specific distress
timeFrame: 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Rafael Pérez-Escamilla, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.