1. Lesson 2-3: Developing Hypothesis and Study Questions Teacher Note: Module 2 Overview Content Area: Hypothesis-Testing: Cross-Sectional Study Essential Questions: How can I select groups of people and collect data/evidence from them that will test my hypothesis? If my causal hypothesis is correct, how would the exposure and outcome be distributed in these groups? Enduring Understanding: Causal hypotheses can be tested by conducting investigations of the exposures and outcomes of selected groups of people as they go about their lives. Information from these observational studies can be used to determine if an exposure and an outcome are associated. Because observational studies are complicated by factors not controlled by the observer, when an association is found, other explanations in addition to causality also must be considered. Core Concepts: Testing hypotheses Association Exposure/outcome Control group 2x2 table Observational studies Study design/study plan Study samples Prevalence rate Prevalence ratio Statement of effect Lessons: 2-1 Looking for Associations 2-2 Cross-Sectional Studies 2-3 Developing Hypothesis and Study Questions 2-4 Respect – Part II 2-5 Planning Study Conduct 2-6 Cross-Sectional Study - In Class 2-7 Cross-Sectional Study – In School 1Revised Sept 14, 2011

2. Lesson 2-3: Developing Hypothesis and Study Questions Teacher Note: Enduring Epidemiological Understandings for the Epidemiology and the Energy Balance Equation Curriculum 1.Health and disease are not distributed haphazardly in a population. There are patterns to their occurrence that can be identified through surveillance. Analysis of the patterns of health and disease distribution can provide clues for formulating hypotheses about their possible causes. 2.Causal hypotheses can be tested by conducting investigations of the exposures and outcomes of selected groups of people as they go about their lives. Information from these observational studies can be used to determine if an exposure and an outcome are associated. Because observational studies are complicated by factors not controlled by the observer, other explanations also must be considered. 2

3. Lesson 2-3: Developing Hypothesis and Study Questions Teacher Note: Authentic Assessment for Module 2 of the Epidemiology and the Energy Balance Equation Curriculum 3 Students will conduct, analyze, and interpret observational, cross- sectional studies among students in their class and then among students outside their class. Working in teams, students will have the opportunity to demonstrate their abilities to select a reasonable hypothesis of interest to them, design study questions about exposure and outcome, obtain informed consent, collect and manage data, calculate and compare prevalence rates, make accurate statements about whether their data support that hypothesis, and consider alternate explanations for what they observed. Reporting of results will be required, such as a written report, an item for the school newspaper, or an oral presentation or poster for students, teachers, and/or parents. Specific performance criteria will be used to help ensure that the experiences allow a genuine, realistic, and fair assessment of students’ comprehension of the Module 2 Enduring Epidemiological Understanding.

4. Lesson 2-3: Developing Hypothesis and Study Questions 4 Teacher Note: Photos of Worksheets for Lesson 2-3 2-3b 2-3a 2-3c 2-3d

5. Lesson 2-3: Developing Hypothesis and Study Questions Start of Lesson 2-3 (estimate 2 class periods) 5

6. Lesson 2-3: Developing Hypothesis and Study Questions 6 Big Ideas in Lesson 2-2 The cross-sectional design is an observational study of a natural experiment This design is relatively quick and simple, asking individuals about exposure and outcome at one point in time After the prevalence is calculated for the group with the exposure, the next question is “compared to what?” The “compared to what” consists of prevalence for the unexposed “controls” Dividing one prevalence by the other produces the prevalence ratio; it tells us if/how the exposure and outcome are associated Because exposure and outcome are measured at the same point in time, it is usually not possible to determine the time order of the exposure and the outcome (which came first) and as such, the association may not be interpretable Review

7. Lesson 2-3: Developing Hypothesis and Study Questions Overview of Lesson 2-3 7

8. Lesson 2-3: Developing Hypothesis and Study Questions 2-3a Checklist - Study Planning Components and Expectations 2-3 Study Hypothesis - Statement of a hypothesized association between an exposure and an outcome 2-3 Study Variables - Developing questions about exposure and outcome, and additional questions about participants 2-3 Questionnaire - Preparing a one-page sheet that study participants will fill out (typed and copies made) 2-4 Draft Informed Consent Script - Preparing a script to be read to possible study participants (typed and copies made) 2-5 Plans for Study Conduct – Having assignments for study day 8 Notebook Study

9. Lesson 2-3: Developing Hypothesis and Study Questions Part of 2-3a Expectations for Successful Completion of Activities in Lesson 2-3 9 Notebook Study #Study Plan Component Met Some- what Met Not Met 2-3 Study Hypothesis - Statement of a hypothesized association between an exposure and an outcome  1) Stated clearly; 2) makes sense at face value; and 3) is feasible to study in a school setting □□ □ 2-3 Study Variables - Developing questions about exposure and outcome  1) Clear questions that will mean the same thing to anyone who reads it;  2) a good description of what you are trying to measure; 3) a good understanding of challenges in measurement; and 4) an awareness of other information about study participants that will help in understanding study results 2-3 Questionnaire - Preparing a one-page sheet that study participants will fill out (typed and copies made)  Format of the survey that is user-friendly and clear in presenting questions and answer options and instructions

10. Lesson 2-3: Developing Hypothesis and Study Questions 10 An educated guess An unproven idea, based on observation or reasoning, that can be supported or refuted through investigation A tentative explanation Hypotheses

11. Lesson 2-3: Developing Hypothesis and Study Questions Hypotheses? 11

12. Lesson 2-3: Developing Hypothesis and Study Questions Hypotheses? 12

13. Lesson 2-3: Developing Hypothesis and Study Questions 13 Tips Your hypothesis statement should state the hypothesized relationship between an exposure variable and an outcome variable, including the direction expected. Make sure that the hypothesis you choose is of genuine interest to you, because you will be spending your time and energy exploring it. Your stated hypothesis MUST NOT require the collection of any information that might be considered embarrassing, sensitive, or illegal. The hypothesis needs to be related to nutrition and/or physical activity.

14. Lesson 2-3: Developing Hypothesis and Study Questions Eat school cafeteria food Regularly watch TV Have a sedentary lifestyle Have a high-fat diet Take multivitamins Eat breakfast Have perception of overweight Have good academic performance Regularly play computer games Eat junk food every day Examples of Variables to Use in a Hypothesis Have a low-fat diet Regularly exercise Participate in a team sport Eat fruits and vegetables Drink high calorie drinks Drink diet soda Walk to school Get a good night’s rest Other ? ? ? 14

15. Lesson 2-3: Developing Hypothesis and Study Questions Some variables can be an exposure or an outcome When is “eating more fruits and vegetables” an exposure? When is “eating more fruits and vegetables” an outcome? Examples of Hypotheses: - People who eat more fruits and vegetables take more multivitamins - People who rarely watch TV are more likely to eat fruits and vegetables When is “having more physical activity” an exposure? When is “having more physical activity” an outcome? Examples of Hypotheses: - Physical activity is associated with a longer night’s sleep - People with high academic performance are more likely to also have more physical activity 15

16. Lesson 2-3: Developing Hypothesis and Study Questions 16 2-3b Notebook Study Study Hypothesis Why is your study team interested in testing this hypothesis? Discuss the reason(s) your team thinks it will be possible to test this hypothesis in your class and school. “X is associated with Y” “People with X are more likely to have Y” “People with X have higher, or more Y” How do I state a hypothesis?

17. Lesson 2-3: Developing Hypothesis and Study Questions Eat school cafeteria food Regularly watch TV Have a sedentary lifestyle Have a high-fat diet Take multivitamins Eat breakfast Have perception of overweight Have good academic performance Regularly play computer games Eat junk food every day Have a low-fat diet Regularly exercise Participate in a team sport Eat fruits and vegetables Drink high calorie drinks Drink diet soda Walk to school Get a good night’s rest Other ? ? ? 17 2-3b Notebook Study Study Hypothesis

18. A few examples of hypotheses to test  Students who drink caffeinated drinks do more homework after school.  Students who drink caffeinated drinks get less sleep.  Healthy eating (at least 2 servings of fruit and vegetables a day) results in better grades (“doing well in school.  Students that regularly eat vegetables have fewer periods of illness (24 hours or more of flu/cold symptoms).  Students who eat breakfast have fewer colds and therefore have fewer absences from school.  A healthy breakfast is associated with playing in an organized sport.  Students who eat dinner with their family more often get better grades.  Students who skip lunch will eat more snacks.  People who eat more fruits and vegetables take more multivitamins.  Drinking more water is associated with eating more fruits and vegetables.  Students who drink more sweetened drinks are more likely to eat unhealthy snacks.  Drinking at least 2 cans or a 20 ounce bottle of non-diet soda per day leads to a crash (feeling tired). 18 OPTIONAL SLIDE TO SHOW STUDENTS

19.  Students who have one or more cats or dogs are more physically active.  Students who have one or more cats or dogs have more school absences due to colds.  Receiving a daily, weekly, or monthly allowance is related to eating junk food/unhealthy food more than twice a day.  Students who chew gum eat fewer snacks.  Students who listen to an IPOD are more likely to participate in physical activity.  Students who text more are less physically active.  Watching more TV is associated with having lower stress levels.  Students who watch TV eat more snacks.  Students who regularly play video games eat more snacks.  Students who play regular video games (not active) eat more junk food.  Playing active video games is related to getting better grades.  Student athletes, on average, get more sleep than students who do not participate in a sport. 19 OPTIONAL SLIDE TO SHOW STUDENTS A few examples of hypotheses to test

20.  Students who participate in sports are more satisfied with their lives  Physical activity is associated with eating less junk food.  People who participate in a team sport are more likely to eat fruits and vegetables.  Physically active students place greater weight on the importance of a healthy lifestyle.  Regular exercise is related to higher academic performance.  Students who get 8 or more hours of sleep on average have higher academic performance.  Students who sleep <8 hours a night eat more often than those who get at least 8 hours of sleep.  Students who have less parental supervision are more likely to watch TV.  Students who have less parental supervision eat more junk food for after school snacks.  High academic performance is associated with more physical activity.  High academic performance is associated with a healthy diet. 20 OPTIONAL SLIDE TO SHOW STUDENTS A few examples of hypotheses to test

21. Lesson 2-3: Developing Hypothesis and Study Questions 21 Possible break point between class periods

22. Lesson 2-3: Developing Hypothesis and Study Questions More Information about CHIS Study Theresa A. Hastert, Susan H. Babey. School lunch source and adolescent dietary behavior. Prevention of Chronic Diseases 2009, Vol 6 (4). http://www.cdc.gov/pcd/issues/2009/oct/08_0182.htm 22

23. Lesson 2-3: Developing Hypothesis and Study Questions Review: “Criteria for a Good Question” It should be clear and unambiguous, written so that its intended audience understands it. It should mean the same thing to everyone who reads it. The answer options must categorize and cover the entire range of possible behavior (from complete absence of the behavior to a maximum amount of the behavior). The time period to consider when answering a particular question must be appropriate (long or short enough) to capture the frequency of behavior desired (depending on the information desired and the type of behavior). 23

24. Lesson 2-3: Developing Hypothesis and Study Questions 24 Exposure Question During the school year, about how many times a week do you usually bring your own lunch to school from home? 0 1 2 3 4 5

25. Lesson 2-3: Developing Hypothesis and Study Questions 25 Outcome Questions TOPICQUESTION Fruit? Vegetables? Fast food? Soda? Fried potatoes? High-sugar foods?

26. Lesson 2-3: Developing Hypothesis and Study Questions 26 TOPICQUESTION FruitYesterday, how many servings of fruit, such as an apple or a banana, did you eat? Vegetables? Fast food? Soda? Fried potatoes? High-sugar foods? Outcome Questions

27. Lesson 2-3: Developing Hypothesis and Study Questions 27 TOPICQUESTION FruitYesterday, how many servings of fruit, such as an apple or a banana, did you eat? VegetablesYesterday, how many servings of vegetables, like corn, green beans, green salad or other vegetables did you eat? Fast food? Soda? Fried potatoes? High-sugar foods? Outcome Questions

28. Lesson 2-3: Developing Hypothesis and Study Questions 28 TOPICQUESTION FruitYesterday, how many servings of fruit, such as an apple or a banana, did you eat? VegetablesYesterday, how many servings of vegetables, like corn, green beans, green salad or other vegetables did you eat? Fast foodYesterday, how many times did you eat fast food? Soda? Fried potatoes? High-sugar foods? Outcome Questions

29. Lesson 2-3: Developing Hypothesis and Study Questions 29 TOPICQUESTION FruitYesterday, how many servings of fruit, such as an apple or a banana, did you eat? VegetablesYesterday, how many servings of vegetables, like corn, green beans, green salad or other vegetables did you eat? Fast foodYesterday, how many times did you eat fast food? SodaYesterday, how many glasses or cans of soda, such as Coke, or other sweetened drinks, such as fruit punch or Sunny Delight did you drink? Do not count diet drinks. Fried potatoes? High-sugar foods? Outcome Questions

30. Lesson 2-3: Developing Hypothesis and Study Questions 30 TOPICQUESTION FruitYesterday, how many servings of fruit, such as an apple or a banana, did you eat? VegetablesYesterday, how many servings of vegetables, like corn, green beans, green salad or other vegetables did you eat? Fast foodYesterday, how many times did you eat fast food? SodaYesterday, how many glasses or cans of soda, such as Coke, or other sweetened drinks, such as fruit punch or Sunny Delight did you drink? Do not count diet drinks. Fried potatoesYesterday, how many servings of French fries, home fries, or hash browns did you eat? High-sugar foods? Outcome Questions

31. Lesson 2-3: Developing Hypothesis and Study Questions 31 TOPICQUESTION FruitYesterday, how many servings of fruit, such as an apple or a banana, did you eat? VegetablesYesterday, how many servings of vegetables, like corn, green beans, green salad or other vegetables did you eat? Fast foodYesterday, how many times did you eat fast food? SodaYesterday, how many glasses or cans of soda, such as Coke, or other sweetened drinks, such as fruit punch or Sunny Delight did you drink? Do not count diet drinks. Fried potatoesYesterday, how many servings of French fries, home fries, or hash browns did you eat? High-sugar foodsYesterday, how many servings of high-sugar foods, such as cookies, candy, doughnuts, pastries, cake or popsicles did you eat? Outcome Questions

32. Lesson 2-3: Developing Hypothesis and Study Questions Questions for your Cross-Sectional Studies One question must obtain information about the exposure in your hypothesis and the other question must obtain information about the outcome in your hypothesis. The study information on exposure and outcome must fit into a 2x2 table. A “yes/no” question will fit and is recommended. If using a multiple choice question, you will need a predetermined “cut point” so there is a “higher/lower” range to fit into the 2x2 table. 32

33. Lesson 2-3: Developing Hypothesis and Study Questions Yes Exposure Total No Exposure ab cd Yes Outcome No Outcome The 2x2 table Exposure and Outcome Distributions Among Individuals in a Study Population Optional: Use as needed for review of 2x2 tables and necessity for a question about exposure and a question about outcome 33

34. Lesson 2-3: Developing Hypothesis and Study Questions 2-3c Study Variables: Questions About Exposure and Outcome and Additional Questions 34 Notebook Study How should we ask about eating a healthy breakfast?

35. Lesson 2-3: Developing Hypothesis and Study Questions “Criteria for a Good Question” It should be clear and unambiguous, written so that its intended audience understands it. It should mean the same thing to everyone who reads it. The answer options must categorize and cover the entire range of possible behavior (from complete absence of the behavior to a maximum amount of the behavior). The time period to consider when answering a particular question must be appropriate (long or short enough) to capture the frequency of behavior desired (depending on the information desired and the type of behavior). 35

36. Lesson 2-3: Developing Hypothesis and Study Questions 2-3c Item 5 - Labeling a 2x2 Table 36 Notebook Study 2x2 Table Fill in the two boxes in the table below, to show how your exposure and outcome variables will be analyzed in a contingency table in order to test your hypothesis. (Note: if you plan to use multiple choice questions for your exposure and/or outcome, determine cut points for the data so that you can fill in the contingency table below.)

37. Lesson 2-3: Developing Hypothesis and Study Questions 37 2-3c Item 6 – Additional Questions Notebook Study Think about what other information about students in your study would be interesting to know, in terms of your hypothesis. (Hint: perhaps gender would be one of these) In the space below, write any additional questions for your questionnaire that will gather information about these other characteristics of your study subjects.. Should we ask about gender? Questions to Gather Additional Information on Participants

38. Lesson 2-3: Developing Hypothesis and Study Questions Break Between Classes 38

39. Lesson 2-3: Developing Hypothesis and Study Questions 39 2-3d Sample Questionnaire for for Cross-Sectional Study Notebook Study Thank you for your participation in this survey. Please answer the questions below by circling one choice for each question. When you are finished, fold this paper in half and follow instructions for handing in your questionnaire. Remember: Do not write your name anywhere on this paper. Study Questions: (Circle one answer for each question) 1. During the past month, did you usually eat 2 or more servings of fruits/vegetables per day? Yes No 2. In the last semester that you have completed, did you have a grade average of A or B? Yes No 3. What is your gender? Male Female 4. What grade are you in? 6th grade 7th grade 8th grade

40. Lesson 2-3: Developing Hypothesis and Study Questions 40 Type your questionnaire Make enough copies for all potential study participants

41. Lesson 2-3: Developing Hypothesis and Study Questions 41 Big Ideas in Lesson 2-3 A good study plan includes careful thought about choice of exposure and outcome variables and high-quality questions to measure them Additional questions about other characteristics of participants can be asked in order to better understand study results A well-planned study has a user-friendly questionnaire to administer to participants Re-Cap