Evidence-Based Nutrition Practice Guidelines of Toolkit and Preliminary Outcomes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Pilot Study of Type 2 Diabetes Evidence-Based Nutrition Practice Guidelines--Field Test of Toolkit and Preliminary Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04311853
• Other study ID #: not determined yet
• Status: Completed
• Start date: February 2010
• Est. completion date: December 2012

Study information

• Verified date: March 2020
• Source: Academy of Nutrition and Dietetics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Academy of Nutrition and Dietetics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	six months
Secondary	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.	six months