Evidence-Based Nutrition Practice Guidelines of Toolkit a... | NCT04311853

Studies
Evidence-Based Nutrition Practice Guidelines of Toolkit and Preliminary Outcomes

NCT04311853

Sponsor

Academy of Nutrition and Dietetics

Status

Completed

Last Update Posted

Mar 17, 2020Actual

Enrollment

54Actual

Phase

Not provided

Conditions

Type 2 Diabetes Mellitus

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010Actual

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Mar 13, 2020

First Submission Date that Met QC Criteria

Mar 16, 2020

First Posted Date

Mar 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2020

Last Update Posted Date

Mar 17, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alison L Steiber, Chief Science Officier, Academy of Nutrition and DieteticsPrincipal Investigator

Lead Sponsor

Academy of Nutrition and DieteticsOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Label	Type	Description	Intervention Names
practitioner interviews		phone interviews conducted

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

practitioners working with patients who have heart failure

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Linda Snetselaar, PhD, RD, LD	University of Iowa	Principal Investigator
Esther F Myers, PhD, RD	Academy of Nutrition and Dietetics	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided