DiabetesDiNESNCT00715585
Addressing The Role of Nutrition Education & Health Literacy in Diabetes Care
A study testing int arm 1 and int arm 3 in people with Diabetes, run by Vanderbilt University at 1 site in United States.
Trial summary
This study examines the impact of certified diabetes education, and the role of different educational approaches to medical nutrition therapy. in addition the role of patient health literacy level is assessed Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- int arm 1 and int arm 3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jun 2010
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Most recent a1c >7
- Type 2 diabetes
- Receiving primary care
- Not currently in the diabetes improvement program
- No plans to refer to diabetes improvement program in the next 6 mos
Who cannot join
- Significant dementia or psychosis
Trial locations and contacts
1 site in 1 country.
About this study
This study examines the impact of certified diabetes education, and the role of different educational approaches to medical nutrition therapy. in addition the role of patient health literacy level is assessed
Read the detailed description
150 patients with type 2 diabetes with most recent a1c>7% will be enrolled. patients are randomized to three arms: arm 1 includes 3 individualized visits with an rd-cde focused on a modified plate method for nutrition therapy, arm 2 includes 3 individualized visits with an rd-cde focused on carb counting for nutrition therapy, and arm 3 focuses on general diabetes education and health promotion. education sessions will be administered over a 4-6 week period. patients will be assessed at baseline, 3 and 6 month follow-up. primary outcome is a1c.
- Conditions
- Diabetes
- Being tested
- Active Control, int arm 1, int arm 3
- Keywords
- diabetes, education, health literacy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active ControlBehavioural
patients receive 3 individualized visits with a health educator focused on general diabetes education and health promotion
int arm 1Behavioural
VVpatients receive 3 individualized visits with an rd-cde for education focused on modified plate method
int arm 3Behavioural
patients receive 3 individualized visits with an rd-cde for education focused on carb counting
| Study group | Role | What they receive |
|---|---|---|
| Active Control | Active comparator | patients receive 3 individualized visits with a health educator for education on general diabetes and health promotion Receives: Behavioral: Active Control |
| Intervention 1 | Experimental | patients receive 3 individualized visits with an rd-cde for education focused on modified plate method Receives: Behavioral: int arm 1 |
| intervention 2 | Experimental | patients receive 3 individualized visits with an rd-cde for education focused on carb counting Receives: Behavioral: int arm 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
A1C
Measured: 6 months
Secondary outcomes (3)
self-efficacy
Measured: 3 and 6 months
satisfaction
Measured: 3 and 6 months
dietary behavior
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 posted15 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- American Association of Diabetes Educators
- Responsible party
- Principal investigator, Russell Rothman, Vanderbilt University
- Investigators
- Russell Rothman, MD MPP, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715585
- Sponsor's protocol ID
- 08335
- Acronym
- DiNES
- Status last verified
- Jun 2013
- First submitted
- 10 Jul 2008
- Last updated
- 13 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing The Role of Nutrition Education & Health Literacy in Diabetes Care
- ClinicalTrials.gov ID
- NCT00715585
- Acronym / sponsor ID
- DiNES / 08335
- Conditions
- Diabetes
- Keywords
- diabetes, education, health literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- American Association of Diabetes Educators
- Study start
- Jun 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 15 Jul 2008 (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.
This study examines the impact of certified diabetes education, and the role of different educational approaches to medical nutrition therapy. in addition the role of patient health literacy level is assessed
Detailed description
150 patients with type 2 diabetes with most recent a1c>7% will be enrolled. patients are randomized to three arms: arm 1 includes 3 individualized visits with an rd-cde focused on a modified plate method for nutrition therapy, arm 2 includes 3 individualized visits with an rd-cde focused on carb counting for nutrition therapy, and arm 3 focuses on general diabetes education and health promotion. education sessions will be administered over a 4-6 week period. patients will be assessed at baseline, 3 and 6 month follow-up. primary outcome is a1c.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Control | Active comparator | Behavioral: Active Controlpatients receive 3 individualized visits with a health educator for education on general diabetes and health promotion |
| Intervention 1 | Experimental | Behavioral: int arm 1patients receive 3 individualized visits with an rd-cde for education focused on modified plate method |
| intervention 2 | Experimental | Behavioral: int arm 3patients receive 3 individualized visits with an rd-cde for education focused on carb counting |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Most recent a1c >7
- Type 2 diabetes
- Receiving primary care
- Not currently in the diabetes improvement program
- No plans to refer to diabetes improvement program in the next 6 mos
Key exclusion criteria (1 listed)
- Significant dementia or psychosis
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 |
|---|---|---|
| Active Controlpatients receive 3 individualized visits with a health educator focused on general diabetes education and health promotion | Behavioural | Active Control |
| int arm 1VVpatients receive 3 individualized visits with an rd-cde for education focused on modified plate method | Behavioural | Intervention 1 |
| int arm 3patients receive 3 individualized visits with an rd-cde for education focused on carb counting | Behavioural | intervention 2 |
Primary outcome
A1C
Time frame: 6 months
3 secondary outcomes
self-efficacy
Time frame: 3 and 6 months
satisfaction
Time frame: 3 and 6 months
dietary behavior
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 13 Jun 2013.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Russell Rothman, MD MPP principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing int arm 1 and int arm 3 in people with Diabetes, run by Vanderbilt 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 5 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 13 Jun 2013. 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?
A1C (time frame: 6 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 13 Jun 2013; AzTrials last refreshed its copy on 8 Nov 2026.