Type 2 DiabetesNCT01284465
Type 2 Diabetes Self-management Intervention for Low-income Women
A study testing Education and patient liaison combination in people with Type 2 Diabetes, run by Meharry Medical College at 1 site in United States.
Trial summary
The purpose of this study is to assess the extent to which a culturally appropriate, self-management intervention that combines patient education with a patient outreach liaison strategy improves outcomes associated with type-2 diabetes among low-income diabetic women. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Education and patient liaison combination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Dec 2014
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Low-income women ages 21 and older; With type 2 diabetes ( fasting plasma glucose > 126 mg/dl);
- At risk of developing diabetes related complications (treatments goals from The American Diabetes Association Standards of medical care) as defined by:
- HbA1c >8.0 %
- Any of the metabolic clusters such as Pre-prandial plasma glucose > 130 mg/dl; Obesity (BMI >25 kg/m2, or waist circumference >88 cm (>35 in); Hypertension (Systolic >130 and Diastolic > 80 mmHg); Hyperlipidemia (Triglycerides >150 mg/dL; HDL<50 mg/dL; LDL >100 mg/dL)
Who cannot join
- Participants will be excluded if they are currently pregnant, have conditions (i.e., end stage diagnosis) or behaviors likely to affect conduct of the trial, and unwilling to accept treatment assignment by randomization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comprehensive Approach to Type 2 Diabetes Self-management for Low-income Women
The purpose of this study is to assess the extent to which a culturally appropriate, self-management intervention that combines patient education with a patient outreach liaison strategy improves outcomes associated with type-2 diabetes among low-income diabetic women.
Read the detailed description
In recent years, the prevalence of diabetes has significantly increased among women and because of the expected fast growth rate of minority populations, the number of women in these groups who will be diagnosed with diabetes is also expected to increase significantly over the coming years. Among women from minority groups diabetes is the fourth leading cause of death while it is the seventh among non-Hispanic White females. Non-compliance to diabetes self-care is a major concern for type 2 diabetic women of racial/ethnic groups because of the existing socio-economic and environmental barriers. Often, these women live in poverty; have less than a high school education as well as language barriers and inadequate health literacy, which further place them at risk for complications, and the daily activities of diabetes self-care are implemented within the context of family responsibilities and patient's priorities.
This study is a 12-month randomized controlled trial designed to compare a lifestyle intervention group (combination group) and a control group (education only group). Participants assigned to either group will receive three group education sessions (baseline, 3 and 6 months) with an emphasis on self-management.
- Conditions
- Type 2 Diabetes
- Being tested
- Education and patient liaison combination, Control group
- Keywords
- Type 2 diabetes self-management, Minority women, Barriers to diabetes self-management
- 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.
Education and patient liaison combinationBehavioural
Also called Type 2 diabetes self-management, Low-income women, Barriers to diabetes self-care
Group education sessions with Patient liaison using ecological momentary assessment principles
Control groupBehavioural
Also called Type 2 diabetes self-management, Low-income women, Barriers to diabetes self-care
Group education sessions at baseline, 3 and 6 months
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Education and patient liaison combination Receives: Behavioral: Education and patient liaison combination |
| Control group | Experimental | Education only Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
glycosylated hemoglobin
Measured: baseline, 6 and 12 months
Secondary outcomes (1)
Risk factors for co-morbidity and daily self-management behaviors
- -Risk factors for co-morbidity:
- -Daily self-management behaviors
Measured: baseline, 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meharry Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Responsible party
- Principal investigator, Sylvie Akohoue, Meharry Medical College
- Investigators
- Sylvie A Akohoue, PhD, Principal investigator, Meharry Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284465
- Sponsor's protocol ID
- 081204AAH231 26
- Other IDs
- U54RR026140-01
- Status last verified
- Apr 2015
- First submitted
- 25 Jan 2011
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Approach to Type 2 Diabetes Self-management for Low-income Women
- ClinicalTrials.gov ID
- NCT01284465
- Acronym / sponsor ID
- 081204AAH231 26
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes self-management, Minority women, Barriers to diabetes self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Meharry Medical CollegeUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 Jan 2011 (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 purpose of this study is to assess the extent to which a culturally appropriate, self-management intervention that combines patient education with a patient outreach liaison strategy improves outcomes associated with type-2 diabetes among low-income diabetic women.
Detailed description
In recent years, the prevalence of diabetes has significantly increased among women and because of the expected fast growth rate of minority populations, the number of women in these groups who will be diagnosed with diabetes is also expected to increase significantly over the coming years. Among women from minority groups diabetes is the fourth leading cause of death while it is the seventh among non-Hispanic White females. Non-compliance to diabetes self-care is a major concern for type 2 diabetic women of racial/ethnic groups because of the existing socio-economic and environmental barriers. Often, these women live in poverty; have less than a high school education as well as language barriers and inadequate health literacy, which further place them at risk for complications, and the daily activities of diabetes self-care are implemented within the context of family responsibilities and patient's priorities.
This study is a 12-month randomized controlled trial designed to compare a lifestyle intervention group (combination group) and a control group (education only group). Participants assigned to either group will receive three group education sessions (baseline, 3 and 6 months) with an emphasis on self-management.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Education and patient liaison combinationEducation and patient liaison combination |
| Control group | Experimental | Behavioral: Control groupEducation only |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Low-income women ages 21 and older; With type 2 diabetes ( fasting plasma glucose > 126 mg/dl);
- At risk of developing diabetes related complications (treatments goals from The American Diabetes Association Standards of medical care) as defined by:
Key exclusion criteria (1 listed)
- Participants will be excluded if they are currently pregnant, have conditions (i.e., end stage diagnosis) or behaviors likely to affect conduct of the trial, and unwilling to accept treatment assignment by randomization.
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 |
|---|---|---|
| Education and patient liaison combinationAlso: Type 2 diabetes self-management, Low-income women, Barriers to diabetes self-careGroup education sessions with Patient liaison using ecological momentary assessment principles | Behavioural | Intervention group |
| Control groupAlso: Type 2 diabetes self-management, Low-income women, Barriers to diabetes self-careGroup education sessions at baseline, 3 and 6 months | Behavioural | Control group |
Primary outcome
HbA1c
Time frame: baseline, 6 and 12 months
glycosylated hemoglobin
1 secondary outcome
Risk factors for co-morbidity and daily self-management behaviors
Time frame: baseline, 3, 6, 9 and 12 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 7 Apr 2015.
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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.
Sylvie A Akohoue, PhD principal investigator
Meharry Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and patient liaison combination in people with Type 2 Diabetes, run by Meharry Medical College 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 1 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 7 Apr 2015. 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?
HbA1c (time frame: baseline, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2015.