- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04311853
Evidence-Based Nutrition Practice Guidelines of Toolkit and Preliminary Outcomes
March 16, 2020 updated by: Alison L Steiber, Academy of Nutrition and Dietetics
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
54
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
practitioners working with patients who have heart failure
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
practitioner interviews
phone interviews conducted
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improved health outcomes
Time Frame: six months
|
Patients counseled by either an RD, or an RD with CDE credential, will exhibit improvements in critical health outcomes, relative to baseline levels.
|
six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Linda Snetselaar, PhD, RD, LD, University of Iowa
- Principal Investigator: Esther F Myers, PhD, RD, Academy of Nutrition and Dietetics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2010
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
March 13, 2020
First Submitted That Met QC Criteria
March 16, 2020
First Posted (Actual)
March 17, 2020
Study Record Updates
Last Update Posted (Actual)
March 17, 2020
Last Update Submitted That Met QC Criteria
March 16, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- not determined yet
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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