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Stress Management Among Latinos With Type 2 Diabetes (CALMS-D)

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

stress management

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Yale University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Diabetes education

Diabetes education plus stress management

Arm Description

Group-based diabetes education delivered to participants through community health workers

Group-based diabetes education plus stress management delivered to participants through community health workers

Outcomes

Primary Outcome Measures

Hemoglobin A1c

Blood will be drawn from participants and hemoglobin A1c levels will be measured

Hemoglobin A1c

Blood will be drawn from participants and hemoglobin A1c levels will be measured

Hemoglobin A1c

Blood will be drawn from participants and hemoglobin A1c levels will be measured

Secondary Outcome Measures

Diabetes specific distress

Participants will be asked questions assessing their perspective of emotional distress from living with diabetes

Diabetes specific distress

Participants will be asked questions assessing their perspective of emotional distress from living with diabetes

Diabetes specific distress

Participants will be asked questions assessing their perspective of emotional distress from living with diabetes

Full Information

NCT ID

NCT01578096

First Posted

April 12, 2012

Last Updated

March 30, 2020

Sponsor

Yale University

Collaborators

Hartford Hospital, UConn Health, Hispanic Health Council, Inc., National Institute on Minority Health and Health Disparities (NIMHD)

1. Study Identification

Unique Protocol Identification Number

NCT01578096

Brief Title

Stress Management Among Latinos With Type 2 Diabetes

Acronym

CALMS-D

Official Title

Stress Management Among Latinos With Type 2 Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

Hartford Hospital, UConn Health, Hispanic Health Council, Inc., National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

5. Study Description

Brief Summary

The primary aims of this study are to: Tailor a diabetes stress management intervention for delivery by community health workers (CHWs) serving an urban Latino population. Investigate the efficacy of the stress management intervention on glycemic control. Secondary aims of this study are to: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

Type 2 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

107 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diabetes education

Arm Type

No Intervention

Arm Description

Group-based diabetes education delivered to participants through community health workers

Arm Title

Diabetes education plus stress management

Arm Type

Experimental

Arm Description

Group-based diabetes education plus stress management delivered to participants through community health workers

Intervention Type

Behavioral

Intervention Name(s)

stress management

Intervention Description

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.

Primary Outcome Measure Information:

Title

Hemoglobin A1c

Description

Blood will be drawn from participants and hemoglobin A1c levels will be measured

Time Frame

Baseline

Title

Hemoglobin A1c

Description

Blood will be drawn from participants and hemoglobin A1c levels will be measured

Time Frame

9 weeks

Title

Hemoglobin A1c

Description

Blood will be drawn from participants and hemoglobin A1c levels will be measured

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Diabetes specific distress

Description

Participants will be asked questions assessing their perspective of emotional distress from living with diabetes

Time Frame

Baseline

Title

Diabetes specific distress

Description

Participants will be asked questions assessing their perspective of emotional distress from living with diabetes

Time Frame

9 weeks

Title

Diabetes specific distress

Description

Participants will be asked questions assessing their perspective of emotional distress from living with diabetes

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rafael Pérez-Escamilla, Ph.D.

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale University

City

New Haven

State/Province

Connecticut

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

35534102

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. Erratum In: J Nutr Educ Behav. 2022 Jul;54(7):704.

Results Reference

derived

PubMed Identifier

32494976

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.

Results Reference

derived

PubMed Identifier

31006809

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.

Results Reference

derived

PubMed Identifier

27489004

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.

Results Reference

derived

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Stress Management Among Latinos With Type 2 Diabetes

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