NCT04311853

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2010

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

2.8 years

First QC Date

March 13, 2020

Last Update Submit

March 16, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Improved health outcomes

    six months

Study Arms (1)

practitioner interviews

phone interviews conducted

Eligibility Criteria

Age19 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

practitioners working with patients who have heart failure

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Linda Snetselaar, PhD, RD, LD

    University of Iowa

    PRINCIPAL INVESTIGATOR
  • Esther F Myers, PhD, RD

    Academy of Nutrition and Dietetics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Science Officier

Study Record Dates

First Submitted

March 13, 2020

First Posted

March 17, 2020

Study Start

February 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 17, 2020

Record last verified: 2020-03