Laboratory Management and Statistical Analysis Plans for Clinical Nutrition Studies (Best Practices for Human RCTs Collection)

Human nutrition randomized controlled trials (RCTs) have unique considerations and conducting them with the highest scientific rigor is essential to the development of evidence-based dietary guidance for promoting optimal health and advancing health care. Diet-related interventions can include diet and/or behavioral manipulation, provision of foods or entire meals, or delivery of dietary components in individual food items or supplements.

Join an esteemed faculty for a training on the design and conduct of human nutrition RCTs, documentation and reporting of all aspects of clinical trial management, and data analysis and reporting of results. Course content is based on a series of articles published in Advances in Nutrition; see reading assignments below.

Reading Assignments as Preparation for Course Attendance

This course is included in the Best Practices for Human RCTs Collection.

 

Learning Objectives

  • Describe how to develop a data analysis plan 
  • Explain best practices for laboratory management 
  • Use core principles to complete a statistical analysis and report results 

Target Audience

  • Faculty in graduate nutrition/obesity and related programs
  • NIH-funded Nutrition Obesity Research Center members
  • Graduate students and early career professionals
  • Contract research organizations staff
  • International nutrition societies members
  • Industry scientists
  • Funding agencies personnel
  • Clinical research oversight committee members and auditors

Performance Indicators for Registered Dietitians

  • ​​4.2.8 Evaluates the effectiveness of plans and decisions, and make adjustments when needed.
  • 6.1.4 Defines and establishes appropriate research methodology approaches (e.g. quantitative and qualitative methods).
  • 6.2.1 Identifies and applies appropriate research methods when collecting and retrieving data.
  • 6.2.2 Selects and uses appropriate tools and skills to collect and interpret research data. 
Course summary
Available credit: 
  • 3.50 Attendance

    Learners are eligible to download a Certificate of Attendance upon activity completion. A Certificate of Attendance confirms the learner has completed the activity and does not confer any continuing education credit to the learner from ASN.

  • 3.50 CPE for Registered Dietitians

    ASN (Provider #NS010) is accredited and approved by the Commission on Dietetic Registration (CDR) as a provider of Continuing Professional Education (CPE) programs for Registered Dietitians.

    ASN designates this activity for a maximum of 3.50 CPE credits.

Course opens: 
04/14/2023
Course expires: 
03/31/2024
Cost:
$30.00
Part of: 
Best Practices for Human RCTs Collection
Rating: 
0

This activity includes the following presentations:

Laboratory Management and Statistical Analysis Plans for Clinical Nutrition Studies

Welcome and Introductions

Penny M. Kris-Etherton, PhD, RDN,FAHA, FNLA, FASN, CLS – Pennsylvania State University

Session 1: Laboratory Management and Statistical Analysis Plans for Clinical Nutrition Studies Part 1 / Elements and Purpose of a Statistical Analysis Plan 

Kristina S. Petersen, PhD, APD, FAHA – Texas Tech University

Preparing a Statistical Analysis Plan

George P. McCabe, PhD – Purdue University

Session 1 Panel Discussion

Kathryn Barger, PhD – JM USDA HNRCA at Tufts University
George P. McCabe, PhD – Purdue University
Joshua W. Miller, PhD – Department of Nutritional Sciences, Rutgers University
Connie M. Weaver, PhD – San Diego State University

Laboratory Considerations 

Joshua W. Miller, PhD – Department of Nutritional Sciences, Rutgers University

Completing Statistical Analyses and Reporting Results

Kathryn Barger, PhD – JM USDA HNRCA at Tufts University

Data Management Planning and Execution

Kevin C. Maki, PhD – Midwest Biomedical Research, Addison, IL and Indiana University, Department of Applied Health Science, School of Public Health

Session 2 Panel Discussion

Kathryn Barger, PhD – JM USDA HNRCA at Tufts University
Kevin C. Maki, PhD – Midwest Biomedical Research, Addison, IL and Indiana University, Department of Applied Health Science, School of Public Health
George P. McCabe, PhD – Purdue University
Joshua W. Miller, PhD – Department of Nutritional Sciences, Rutgers University
Connie M. Weaver, PhD – San Diego State University

Highlights 

Kevin C. Maki, PhD – Midwest Biomedical Research, Addison, IL and Indiana University, Department of Applied Health Science, School of Public Health

Disclosure Policy

The American Society for Nutrition supports fair and unbiased participation of individuals in its education activities. Any real or potential conflicts of interest must be identified and managed. All relevant financial relationships with commercial interests that directly impact and/or might conflict with ASN activities must be disclosed, or disclosure that no relevant financial relationships exist must be documented. Other relationships that could cause private interests to conflict with professional interests must also be disclosed. This policy is intended to openly identify any potential conflict so that participants in an education activity are able to form their own judgments about the presentation. In addition, disclosure must be made of presentations on drugs or devices or uses of drugs or devices that have not been approved by the Food and Drug Administration. 

Speakers

Laboratory Management and Statistical Analysis Plans for Clinical Nutrition Studies

Kathryn Barger, PhD, JM USDA HNRCA at Tufts University 
No relevant financial relationship(s) with ineligible companies to disclose. 

Penny Kris-Etherton, PhD, RDN,FAHA, FNLA, FASN, CLS, Pennsylvania State University
Disclosures: Grant/Research Support: American Pecan Council, American Pistachio Growers, Hass Avocado Board, McCormick Spice Institute; Advisory Committee/Board Member: Heali, HumanN, Seafood Nutrition Partnership 

Kevin Maki, PhD, President and Chief Scientist, Midwest Biomedical Research, Addison, IL and Indiana University, Department of Applied Health Science, School of Public Health 
Disclosures: Consultant: Acasti Pharma Inc, Beren Therapeutics, Eli Lilly and Co., Naturmega, New Amsterdam Pharma, NorthSea Therapeutics, Novo Nordisk Pharma Inc.; Grant/Research Support: Pharmavite 

George McCabe, PhD, Purdue University 
No relevant financial relationship(s) with ineligible companies to disclose. 

Joshua Miller, PhD, Rutgers University
Disclosure(s): Consultant: Church & Dwight Co.; Independent Contractor: Church & Dwight Co. 

Kristina Petersen, PhD, APD, FAHA, Texas Tech University
Disclosure(s): Advisory Committee/Board Member: McCormick Science Institute; Grant/Research Support: McCormick Science Institute 

Connie Weaver, PhD, San Diego State University
No relevant financial relationship(s) with ineligible companies to disclose. 

Staff 

Michelle Crispino, American Society for Nutrition 
No relevant financial relationship(s) with ineligible companies to disclose. 

Gwen Twillman, American Society for Nutrition 
No relevant financial relationship(s) with ineligible companies to disclose. 

Accreditation Statement

ASN (Provider #NS010) is accredited and approved by the Commission on Dietetic Registration (CDR) as a provider of Continuing Professional Education (CPE) programs for Registered Dietitians.

Credit Designation

Dietitians/Dietetic Technicians
ASN (Provider #NS010) is accredited and approved by the Commission on Dietetic Registration (CDR) as a provider of Continuing Professional Education (CPE) programs for Registered Dietitians. ASN designates this activity for a maximum of 1.5 CPE credits.

Activity Type: Recorded pre-approved CPE Activity: 175 Lectures/Webinars
Activity Number: 171551

CPE Level 2

Performance Indicators/Learning Objectives

  • 4.2.8 Evaluates the effectiveness of plans and decisions, and make adjustments when needed.
  • 6.1.4 Defines and establishes appropriate research methodology approaches (e.g. quantitative and qualitative methods).
  • 6.2.1 Identifies and applies appropriate research methods when collecting and retrieving data.
  • 6.2.2 Selects and uses appropriate tools and skills to collect and interpret research data. 

Other Learners
Learners who take this course will receive a Certificate of Attendance. This certificate does not confer continuing education credit and indicates the course has been completed.

Available Credit

  • 3.50 Attendance

    Learners are eligible to download a Certificate of Attendance upon activity completion. A Certificate of Attendance confirms the learner has completed the activity and does not confer any continuing education credit to the learner from ASN.

  • 3.50 CPE for Registered Dietitians

    ASN (Provider #NS010) is accredited and approved by the Commission on Dietetic Registration (CDR) as a provider of Continuing Professional Education (CPE) programs for Registered Dietitians.

    ASN designates this activity for a maximum of 3.50 CPE credits.

Price

Cost:
$30.00
Please login or register to take this course.

This course is included in the Best Practices for Human RCTs Collection.