Type 2 DiabetesPhase 2NCT00848315
Diabetes Management in Low-Income Hispanic Patients
A Phase 2 study testing Cognitive Behavioral Intervention in people with Type 2 Diabetes and Glycemic Control, run by University of Massachusetts, Worcester at 5 sites in United States.
Trial summary
The overall goal of this randomized clinical trial (RCT) is to test the efficacy of a culturally- and literacy-tailored cognitive-behavioral intervention designed to enhance adherence to diabetes self-management behaviors and improve glycemic control among low-income Hispanic individuals with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Glycemic Control
- What is being tested?
- Cognitive Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2004to Jul 2008
- Phase
- Phase 2
- 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
- Diagnosed with T2DM (documented in the medical chart);
- HbA1c level > 7.5;
- Currently treated with diet, oral hypoglycemics or insulin. If currently on insulin, must have a history of prior therapy with diet alone or oral hypoglycemic agents;
- Hispanic origin;
- > 18 years old;
- Telephone in home or easy access to one;
Show all 10Show fewer
- Able to understand and participate in the study protocol;
- Functionally capable of meeting the activity goals;
- Understands and can provide informed consent (English or Spanish; for illiterate pts we will require that a representative of the pt also understands and signs the consent form on behalf of the pt);
- Physician approval to participate in the study.
Who cannot join
- History of diabetic ketoacidosis
- Gestational diabetes
- Unable or unwilling to provide informed consent;
- Plans to move out of the area within the 12-month study period;
- Required intermittent glucocorticoid therapy within the past 3 months;
- Experienced an acute coronary event (myocardial infarction or unstable angina) within the previous 6 mos
- Has a medical condition that precludes adherence to study dietary recommendations (e.g., Crohn's disease, ulcerative colitis, end-stage renal disease);
- Has a medical or psychiatric illness (i.e., dementia, psychiatric hospitalization or suicidality within past 5 years or takes an atypical neuroleptic medication). We will not exclude individuals with a diagnosis of depression or pts taking anti-depressants.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Northgate Medical Center
Springfield, Massachusetts, 01103
Brightwood Health Center
Springfield, Massachusetts, 01107
High Street Health Center
Springfield, Massachusetts, 01199
Plumley Village
Worcester, Massachusetts, 01608
Family Health Center
Worcester, Massachusetts, 01610
About this study
The overall goal of this randomized clinical trial (RCT) is to test the efficacy of a culturally- and literacy-tailored cognitive-behavioral intervention designed to enhance adherence to diabetes self-management behaviors and improve glycemic control among low-income Hispanic individuals with type 2 diabetes mellitus.
Read the detailed description
Patients are randomly assigned to a Usual Care condition or to the Cognitive Behavioral Intervention condition. The unit of randomization and analysis is the patient. The intervention is implemented by a nutritionist, a nurse diabetes educator and an assistant, and patients are encouraged to bring a family member or friend living in the same household to facilitate home-based support for the intervention. The intervention emphasizes patients' ethnic preferences and traditions (e.g., adapting ethnic recipes to meet dietary goals) and the use of available community resources (e.g., available areas for exercise), and is delivered utilizing strategies and materials appropriate for low-literate/illiterate pts.
- Conditions
- Type 2 Diabetes, Glycemic Control
- Being tested
- Cognitive Behavioral Intervention
- Keywords
- cognitive behavioral intervention, low literate/illiterate Hispanic patients
- 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.
Cognitive Behavioral InterventionBehavioural
Also called Diabetes Self-Management
The intervention emphasizes patients' ethnic preferences and traditions (e.g., adapting ethnic recipes to meet dietary goals) and the use of available community resources (e.g., available areas for exercise), and is delivered utilizing strategies and materials appropriate for low-literate/illiterate patients.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Usual Care that the Type 2 Diabetes Patients usually receive at the health centers. |
| 2 | Experimental | Cognitive Behavioral Intervention Receives: Behavioral: Cognitive Behavioral Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is improvement in metabolic control (HbA1c).
Measured: The primary outcome was evaluated at 4- and 12-months following randomization.
Secondary outcomes (1)
Efficacy of the intervention
Measured: 4- and 12-months following the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2009 (estimated)
- Study startJul 2004
- Primary completionJun 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Milagros C Rosal, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848315
- Sponsor's protocol ID
- 1R18DK065985
- Status last verified
- Sep 2023
- First submitted
- 19 Feb 2009
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang ML, Gellar L, Nathanson BH, Pbert L, Ma Y, Ockene I, Rosal MC. Decrease in Glycemic Index Associated with Improved Glycemic Control among Latinos with Type 2 Diabetes. J Acad Nutr Diet. 2015 Jun;115(6):898-906. doi: 10.1016/j.jand.2014.10.012. Epub 2014 Dec 26.
PubMed 25547339Rosal MC, White MJ, Restrepo A, Olendzki B, Scavron J, Sinagra E, Ockene IS, Thompson M, Lemon SC, Candib LM, Reed G. Design and methods for a randomized clinical trial of a diabetes self-management intervention for low-income Latinos: Latinos en Control. BMC Med Res Methodol. 2009 Dec 9;9:81. doi: 10.1186/1471-2288-9-81.
PubMed 20003208
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Management in Low-Income Hispanic Patients
- ClinicalTrials.gov ID
- NCT00848315
- Acronym / sponsor ID
- 1R18DK065985
- Conditions
- Type 2 Diabetes, Glycemic Control
- Keywords
- cognitive behavioral intervention, low literate/illiterate Hispanic patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Jul 2004
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 20 Feb 2009 (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 overall goal of this randomized clinical trial (RCT) is to test the efficacy of a culturally- and literacy-tailored cognitive-behavioral intervention designed to enhance adherence to diabetes self-management behaviors and improve glycemic control among low-income Hispanic individuals with type 2 diabetes mellitus.
Detailed description
Patients are randomly assigned to a Usual Care condition or to the Cognitive Behavioral Intervention condition. The unit of randomization and analysis is the patient. The intervention is implemented by a nutritionist, a nurse diabetes educator and an assistant, and patients are encouraged to bring a family member or friend living in the same household to facilitate home-based support for the intervention. The intervention emphasizes patients' ethnic preferences and traditions (e.g., adapting ethnic recipes to meet dietary goals) and the use of available community resources (e.g., available areas for exercise), and is delivered utilizing strategies and materials appropriate for low-literate/illiterate pts.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Usual Care that the Type 2 Diabetes Patients usually receive at the health centers. |
| 2 | Experimental | Behavioral: Cognitive Behavioral InterventionCognitive Behavioral Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosed with T2DM (documented in the medical chart);
- HbA1c level > 7.5;
- Currently treated with diet, oral hypoglycemics or insulin. If currently on insulin, must have a history of prior therapy with diet alone or oral hypoglycemic agents;
- Hispanic origin;
- > 18 years old;
Key exclusion criteria (8 listed)
- History of diabetic ketoacidosis
- Gestational diabetes
- Unable or unwilling to provide informed consent;
- Plans to move out of the area within the 12-month study period;
- Required intermittent glucocorticoid therapy within the past 3 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 |
|---|---|---|
| Cognitive Behavioral InterventionAlso: Diabetes Self-ManagementThe intervention emphasizes patients' ethnic preferences and traditions (e.g., adapting ethnic recipes to meet dietary goals) and the use of available community resources (e.g., available areas for exercise), and is delivered utilizing strategies and materials appropriate for low-literate/illiterate patients. | Behavioural | 2 |
Primary outcome
The primary outcome is improvement in metabolic control (HbA1c).
Time frame: The primary outcome was evaluated at 4- and 12-months following randomization.
1 secondary outcome
Efficacy of the intervention
Time frame: 4- and 12-months following the intervention
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 13 Sep 2023.
- Derived from this study: PubMed 25547339Wang ML, Gellar L, Nathanson BH, Pbert L, Ma Y, Ockene I, Rosal MC. Decrease in Glycemic Index Associated with Improved Glycemic Control among Latinos with Type 2 Diabetes. J Acad Nutr Diet. 2015 Jun;115(6):898-906. doi: 10.1016/j.jand.2014.10.012. Epub 2014 Dec 26.
- Derived from this study: PubMed 20003208Rosal MC, White MJ, Restrepo A, Olendzki B, Scavron J, Sinagra E, Ockene IS, Thompson M, Lemon SC, Candib LM, Reed G. Design and methods for a randomized clinical trial of a diabetes self-management intervention for low-income Latinos: Latinos en Control. BMC Med Res Methodol. 2009 Dec 9;9:81. doi: 10.1186/1471-2288-9-81.
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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.
Milagros C Rosal, PhD principal investigator
University of Massachusetts, Worcester
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cognitive Behavioral Intervention in people with Type 2 Diabetes and Glycemic Control, run by University of Massachusetts, Worcester at 5 sites 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 10 inclusion and 8 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 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary outcome is improvement in metabolic control (HbA1c). (time frame: The primary outcome was evaluated at 4- and 12-months following randomization.). 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 NCT00848315, which also lists 2 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 13 Sep 2023.