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

March 30, 2020 updated by: Yale University

Stress Management Among Latinos With Type 2 Diabetes Mellitus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States
        • Yale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Diabetes education
Group-based diabetes education delivered to participants through community health workers
Experimental: Diabetes education plus stress management
Group-based diabetes education plus stress management delivered to participants through community health workers
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c
Time Frame: Baseline
Blood will be drawn from participants and hemoglobin A1c levels will be measured
Baseline
Hemoglobin A1c
Time Frame: 9 weeks
Blood will be drawn from participants and hemoglobin A1c levels will be measured
9 weeks
Hemoglobin A1c
Time Frame: 6 months
Blood will be drawn from participants and hemoglobin A1c levels will be measured
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes specific distress
Time Frame: Baseline
Participants will be asked questions assessing their perspective of emotional distress from living with diabetes
Baseline
Diabetes specific distress
Time Frame: 9 weeks
Participants will be asked questions assessing their perspective of emotional distress from living with diabetes
9 weeks
Diabetes specific distress
Time Frame: 6 months
Participants will be asked questions assessing their perspective of emotional distress from living with diabetes
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

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

Investigators

  • Principal Investigator: Rafael Pérez-Escamilla, Ph.D., Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

April 12, 2012

First Submitted That Met QC Criteria

April 12, 2012

First Posted (Estimate)

April 16, 2012

Study Record Updates

Last Update Posted (Actual)

April 1, 2020

Last Update Submitted That Met QC Criteria

March 30, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MD005879 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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