Diabetes Mellitus, Type 2CALMS-DNCT01578096
Stress Management Among Latinos With Type 2 Diabetes
A study testing stress management in people with Diabetes Mellitus, Type 2, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- stress management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stress Management Among Latinos With Type 2 Diabetes Mellitus
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- stress management
- Keywords
- Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stress managementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes education | No intervention | Group-based diabetes education delivered to participants through community health workers |
| Diabetes education plus stress management | Experimental | Group-based diabetes education plus stress management delivered to participants through community health workers Receives: Behavioral: stress management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Blood will be drawn from participants and hemoglobin A1c levels will be measured
Measured: Baseline
Hemoglobin A1c
Blood will be drawn from participants and hemoglobin A1c levels will be measured
Measured: 9 weeks
Hemoglobin A1c
Blood will be drawn from participants and hemoglobin A1c levels will be measured
Measured: 6 months
Secondary outcomes (3)
Diabetes specific distress
Participants will be asked questions assessing their perspective of emotional distress from living with diabetes
Measured: Baseline
Diabetes specific distress
Participants will be asked questions assessing their perspective of emotional distress from living with diabetes
Measured: 9 weeks
Diabetes specific distress
Participants will be asked questions assessing their perspective of emotional distress from living with diabetes
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Hartford Hospital, UConn Health, Hispanic Health Council, Inc., National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Rafael Pérez-Escamilla, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578096
- Sponsor's protocol ID
- R01MD005879
- Other IDs
- R01MD005879
- Acronym
- CALMS-D
- Status last verified
- Mar 2020
- First submitted
- 12 Apr 2012
- Last updated
- 1 Apr 2020
- Results posted
- No
Publications
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.
PubMed 35534102Wagner 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.
PubMed 32494976Bermudez-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.
PubMed 31006809Bermudez-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.
PubMed 27489004
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Management Among Latinos With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01578096
- Acronym / sponsor ID
- CALMS-D / R01MD005879
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Hartford Hospital, UConn Health, Hispanic Health Council, Inc., National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- May 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 16 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes education | No intervention | –Group-based diabetes education delivered to participants through community health workers |
| Diabetes education plus stress management | Experimental | Behavioral: stress managementGroup-based diabetes education plus stress management delivered to participants through community health workers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stress managementThe 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. | Behavioural | Diabetes education plus stress management |
Primary outcome
Hemoglobin A1c
Time frame: Baseline
Blood will be drawn from participants and hemoglobin A1c levels will be measured
Hemoglobin A1c
Time frame: 9 weeks
Blood will be drawn from participants and hemoglobin A1c levels will be measured
Hemoglobin A1c
Time frame: 6 months
Blood will be drawn from participants and hemoglobin A1c levels will be measured
3 secondary outcomes
Diabetes specific distress
Time frame: Baseline
Diabetes specific distress
Time frame: 9 weeks
Diabetes specific distress
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Derived from this study: PubMed 35534102Bermudez-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.
- Derived from this study: PubMed 32494976Wagner 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.
- Derived from this study: PubMed 31006809Bermudez-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.
- Derived from this study: PubMed 27489004Bermudez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael Pérez-Escamilla, Ph.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stress management in people with Diabetes Mellitus, Type 2, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01578096, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2020.