Designing and Conducting Human Nutrition RCTs (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

  • Use core principles to design and conduct controlled feeding studies 
  • Prepare documentation and reporting requirements for clinical trial management 

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: 
  • 3.00 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.

  • 3.00 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 3.00 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:

Designing and Conducting Human Nutrition RCTs

Welcome and Introductions 

Martha A. Belury, PhD, RDN – The Ohio State University
Connie M. Weaver, PhD – San Diego State University

Session 1: Designing and Conducting Human Nutrition RCTs 

Cheryl Anderson, MPH, PhD – University of California, San Diego

Design and Conduct of a Randomized, Crossover, Controlled Feeding Study: Example from the Soy vs Animal Protein Study +/- Soy Derived Isoflavones

Alice H. Lichtenstein, DSc – Jean Mayer USDA HNRCA at Tufts University

Design and Conduct of a Randomized, Crossover, Controlled Feeding Study: Example from the Carbohydrates and Related Biomarkers (CARB) Study 

Johanna W. Lampe, PhD – Fred Hutchinson Cancer Research Center

Translation of Findings from the DASH Feeding Study: Design and Conduct of PREMIER, a Behavioral Intervention Trial 

Lawrence J. Appel, MD, MPH – Johns Hopkins University School of Medicine, Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research

Session 1 Panel Discussion

Lawrence J. Appel, MD, MPH – Johns Hopkins University School of Medicine, Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research
Johanna W. Lampe, PhD – Fred Hutchinson Cancer Research Center
Alice H. Lichtenstein, DSc – Jean Mayer USDA HNRCA at Tufts University
Connie M. Weaver, PhD – San Diego State University

Session 2: Documentation and Regulation for Human Nutrition RCTs / Importance of Documentation

Connie M. Weaver, PhD – San Diego State University

Documentation of Dietary Interventions in a Controlled Feeding Study and a Tolerance Study

DeAnn Liska, PhD – Texas A&M AgriLife

Regulatory OVERSIGHT in Clinical Trials: WHI & WHIMS

Linda Snetselaar, PhD, RD – University of Iowa

Development of SOPs and Staff Training in Clinical Trials: OWLE

Sue A. Shapses, PhD – Rutgers University

Session 2 Panel Discussion

DeAnn Liska, PhD – Texas A&M AgriLife
Richard Mattes, MPH, PhD, R.D. – Purdue University
Sue A. Shapses, PhD – Rutgers University
Linda Snetselaar, PhD, RD – University of Iowa

Highlights 

Cheryl Anderson, MPH, PhD – University of California, San Diego

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

Designing and Conducting Human Nutrition RCTs

Cheryl Anderson, MPH, PhD, University of California, San Diego 
No relevant financial relationship(s) with ineligible companies to disclose.

Lawrence Appel, MD, MPH, Johns Hopkins University School of Medicine, Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research 
No relevant financial relationship(s) with ineligible companies to disclose. 

Martha Belury, PhD, RDN, The Ohio State University
No relevant financial relationship(s) with ineligible companies to disclose. 

Johanna Lampe, PhD, Fred Hutchinson Cancer Research Center 
No relevant financial relationship(s) with ineligible companies to disclose. 

Alice Lichtenstein, DSc, Jean Mayer USDA HNRCA at Tufts University 
No relevant financial relationship(s) with ineligible companies to disclose. 

DeAnn Liska, PhD, Texas A&M AgriLife 
No relevant financial relationship(s) with ineligible companies to disclose. 

Richard Mattes, MPH, PhD, R.D., Purdue University
Disclosures: Advisory Committee/Board Member: Grain Food Foundation, Mars Wrigley; Grant/Research Support: Almond Board of California 

Sue Shapses, PhD, Rutgers University
No relevant financial relationship(s) with ineligible companies to disclose. 

Linda Snetselaar, PhD, RD, University of Iowa
No relevant financial relationship(s) with ineligible companies to disclose. 

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: 171514

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

  • 3.00 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.

  • 3.00 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 3.00 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.