Type 2 Diabetes MellitusNCT04311853
Evidence-Based Nutrition Practice Guidelines of Toolkit and Preliminary Outcomes
An observational study of Type 2 Diabetes Mellitus, run by Academy of Nutrition and Dietetics.
Trial summary
The goal of this study is to field test ADA's Type 2 Diabetes Evidence-Based nutrition Practice Guidelines (EBNPG) for Adults in 2008 as a tool for registered dietitians (RDs) for their patients with with type 2 diabetes who have no evidence of organ damage. Read more about this study
- Who is it for?
- Ages 19 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Dec 2012
- Phase
- Observational
- 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 19 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: practitioners working with patients who have heart failure
Who may be able to join
- over 19 years
- no documented claims for the treatment of TD over the past 7 years
- no MNT claims submitted within the past 12 months
- not under RD care
- able to make visits to the clinic per guidelines
Who cannot join
- not in end-stage renal disease or renal insufficiency; history of Cardiovascular Disease,Chronic Athrosclerotic Disease, or Myocardial Infection; Chronic Obstructive Pulmonary Disease, untreated depression, severe psychiatric illness; cancer diagnosis in previous two years or on-going radiation or chemotherapy treatment; Congestive Heart Failure.
- pregnant or lactating at time of study
- presence of cognitive limitations that preclude making lifestyle or dietary changes as assessed by the RD during the initial interview
About this study
Official title: Pilot Study of Type 2 Diabetes Evidence-Based Nutrition Practice Guidelines--Field Test of Toolkit and Preliminary Outcomes
The goal of this study is to field test ADA's Type 2 Diabetes Evidence-Based nutrition Practice Guidelines (EBNPG) for Adults in 2008 as a tool for registered dietitians (RDs) for their patients with with type 2 diabetes who have no evidence of organ damage. A six month pilot study will be conducted to determine the feasibility of training RDs in documenting the outcomes of implementing Medical Nutrition Therapy (MNT) using ADA's evidence-based GL for T2D.
- Conditions
- Type 2 Diabetes Mellitus
- 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.
| Study group | Role | What they receive |
|---|---|---|
| practitioner interviews | phone interviews conducted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation of new evidence-based nutrition practice guidelines
RDs and RDs with CDE credential, will have reached the target professional goals in successful implementation of new evidence-based nutrition practice guidelines in daily clinical practice.
Measured: six months
Secondary outcomes (1)
Improved health outcomes
Patients counseled by either an RD, or an RD with CDE credential, will exhibit improvements in critical health outcomes, relative to baseline levels.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study startFeb 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academy of Nutrition and Dietetics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alison L Steiber, Academy of Nutrition and Dietetics
- Investigators
- Linda Snetselaar, PhD, RD, LD, Principal investigator, University of IowaEsther F Myers, PhD, RD, Principal investigator, Academy of Nutrition and Dietetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311853
- Sponsor's protocol ID
- not determined yet
- Status last verified
- Mar 2020
- First submitted
- 13 Mar 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Type 2 Diabetes Evidence-Based Nutrition Practice Guidelines--Field Test of Toolkit and Preliminary Outcomes
- ClinicalTrials.gov ID
- NCT04311853
- Acronym / sponsor ID
- not determined yet
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Academy of Nutrition and DieteticsUniversity, hospital or other
- Study start
- Feb 2010 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Mar 2020 (actual)
- 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 goal of this study is to field test ADA's Type 2 Diabetes Evidence-Based nutrition Practice Guidelines (EBNPG) for Adults in 2008 as a tool for registered dietitians (RDs) for their patients with with type 2 diabetes who have no evidence of organ damage. A six month pilot study will be conducted to determine the feasibility of training RDs in documenting the outcomes of implementing Medical Nutrition Therapy (MNT) using ADA's evidence-based GL for T2D.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| practitioner interviews | – | –phone interviews conducted |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- practitioners working with patients who have heart failure
Key inclusion criteria (5 listed)
- over 19 years
- no documented claims for the treatment of TD over the past 7 years
- no MNT claims submitted within the past 12 months
- not under RD care
- able to make visits to the clinic per guidelines
Key exclusion criteria (3 listed)
- not in end-stage renal disease or renal insufficiency; history of Cardiovascular Disease,Chronic Athrosclerotic Disease, or Myocardial Infection; Chronic Obstructive Pulmonary Disease, untreated depression, severe psychiatric illness; cancer diagnosis in previous two years or on-going radiation or chemotherapy treatment; Congestive Heart Failure.
- pregnant or lactating at time of study
- presence of cognitive limitations that preclude making lifestyle or dietary changes as assessed by the RD during the initial interview
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Implementation of new evidence-based nutrition practice guidelines
Time frame: six months
RDs and RDs with CDE credential, will have reached the target professional goals in successful implementation of new evidence-based nutrition practice guidelines in daily clinical practice.
1 secondary outcome
Improved health outcomes
Time frame: six 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 17 Mar 2020.
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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.
Linda Snetselaar, PhD, RD, LD principal investigator
University of Iowa
Esther F Myers, PhD, RD principal investigator
Academy of Nutrition and Dietetics
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by Academy of Nutrition and Dietetics.
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 3 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 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Implementation of new evidence-based nutrition practice guidelines (time frame: six 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 17 Mar 2020.