HNH-32006 Design and Interpretation of Nutrition Intervention Studies

Course

Credits 6.00

Teaching methodContact hours
Individual Paper6
Lecture12
Group work12
Course coordinator(s)dr. ir. NM de Roos
dr. ir. RM Winkels
Lecturer(s)dr. ir. RM Winkels
dr. ir. NM de Roos
Examiner(s)dr. ir. NM de Roos

Language of instruction:

EN

Assumed knowledge on:

Basics of study design, statistics, and retrieving and reading scientific papers in the filed of human nutrition. 

Contents:

This course covers the whole process of designing intervention studies and interpreting their results for clinical or public health practice. The design part of the course involves the writing of a research protocol according to the Medical Research Involving Human Subjects Act (WMO). All parts of a research protocol, including the choice of study design and subjects, intervention, sample size estimations, data analysis and ethics are discussed. The interpretation part involves discussing the quality of scientific papers, using quality assessment tools such as the JADAD and Heyland score, and being able to apply this in various situations. Lectures provide background in nutritional assessment in specific groups such as patients and under- or overweight people.  

Learning outcomes:

After successful completion of this course students are expected to be able to:
- understand the background and objectives of nutrition intervention studies in healthy volunteers and patients;
- understand he pros and cons of specific types of study design, such as the n-1 trials and historical controls. 
- evaluate the design and performance of a medical-scientific study in human research subjects;
- create a research proposal for a human nutrition intervention study according to the Medical Research Involving Human Subjects Act (WMO).


Activities:

Activities involve group work, individual assignments, and plenary lectures. 
Group work: In groups of 5-6 students students work on a research protocol for a dietary study in healthy research subjects or patients. As a format, we use the CCMO protocol. The different chapters of the protocol will be explained in lectures. Each week, questions of the group will be discussed with a supervisor and PhD student. Every week, the supervisors will have group discussions with their own groups, with 45-min slots for each group. In these weekly discussions, the different chapters of the CCMO protocol will be followed. The result of the group work will be a protocol and a poster that presents the study design. In the third week of the course, all protocols will be presented in 10-minute pitches. The protocols will be handed in at the end of week 4. The supervisors will grade these protocols and provide written feedback. The feedback can be discussed with the supervisors and used to revise the protocol into a final version. Revisions may be awarded by an extra 0.5 points. The posters will be presented in the last week. The poster that best presents the study design will receive a poster prize.
Individual assignment: students will review and rate prominent research papers in the field of human nutrition.  
Plenary lectures: lectures will cover the different chapters of the research protocol, estimating sample size, special study designs (such as n-1 trials and pseudo-randomized trials), and nutritional assessment in special groups. 

Examination:

This course does not have an exam. The assessment consists of:
- report of the protocol writing per group (50%);
- written critical comments on selected research paper(s) per student (50%).
Each component needs a minimum mark of 5.5 to pass.

Literature:

Will be announced in the course guide.

ProgrammePhaseSpecializationPeriod
Compulsory for: MNHNutrition and HealthMScB: Spec. B - Nutritional Physiology and Health Status2AF
MNHNutrition and HealthMScF: Spec. F - Food Digestion and Health2AF
Restricted Optional for: MNHNutrition and HealthMScC: Spec. C - Molecular Nutrition and Toxicology2AF
MNHNutrition and HealthMScA: Spec. A - Nutritional and Public Health Epidemiology2AF
MNHNutrition and HealthMScD: Spec. D - Sensory Science2AF