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Completed

NCT Number: NCT04311853

Evidence-Based Nutrition Practice Guidelines 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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Academy of Nutrition and Dietetics

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 17, 2020
Registry last updated
Mar 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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