KIN 473 CAP 4: Methods and Statistics
1. Please write your research question below
2. Assume you have 50 participants in each group who will be participating in your study. From here you have some creative freedom when describing your sample, but please keep things as scientifically rigorous as possible. Because you will be comparing two groups of participants, you will want mean values of your demographic characteristics that are closely matched between groups. Note: You may want to look ahead to the mock data in CAP 6, as it could influence some of your decision-making here (provided mock data should not be modified).
a. Age range: Example – 18-22 year olds
b. Sex: Example – 50 males and 50 females
c. Inclusion criteria: Example – Participants must be well-trained in resistance exercise
d. Exclusion criteria: Example – Participants must not consume other nutritional supplements
3. Describe your mock sampling method. How would you have recruited the participants in your study? Describe the strengths and weaknesses of your chosen approach.
4. Describe how you would protect the human subjects involved in your study. Explain procedures for participant safety and data protection/privacy.
5. Assume you will be following an experimental design with a pre-test and post-test of your participants. Describe the procedures you would follow to collect the necessary data on your participants.
6. Describe your procedural controls. What variables do you need to control in order to be able to answer your research question in the most accurate manner possible?
7. Describe the research instrument(s) to be used in collecting data. Identify the validity/reliability of your instrument(s) using previous research.
8. You will each be using a gain-score analysis to analyze your data (mock data will be provided in CAP 5). Explain what this analysis will identify (see p. 359-360 in your text).
9. Describe at least one ethical issue that could arise based on the methodology identified above, as well as how you plan to mitigate or eliminate it.
Participants were eighth-grade students sampled from a middle school in the southwestern United States. Participants (N = 63, 57 boys, 6 girls, mean age 13.7 +/- 0.5 years) were asked to provide written assent in conjunction with written consent from a parent or legal guardian. Participants were all apparently healthy as defined by their enrollment in PE class, and able to participate in regular exercise. No other inclusion or exclusion criteria was applied. The study was conducted in accordance with American College of Sports Medicine (ACSM) ethical guidelines and following the rules of the Declaration of Helsinki. Institutional Review Board approval was granted by the University of Utah (IRB_00061661) and the Salt Lake City School District. Comment by Andrew Harveson: This first paragraph could likely have the sub-heading “participants.” Note the description of demographic characteristics, inclusion criteria, and human subjects protection.
To test academic achievement, four 10-question math tests were conducted, with questions taken from the New York State Testing Program eighth-grade standardized exams . Similar tests have been used in previous research  and the tests used in the present study had been shown to be reliable and valid, containing internal consistency coefficients of r = 0.85. Reliability data were not available for mathematics tests in the state where data collection took place, thus, out-of-state exams were used. Eighth-grade mathematics teachers at the site of data collection were consulted to confirm that material on the proposed mathematics tests had been covered during the same school year. To prevent a practice effect, different questions were used for each test. Participants had to complete each 10-question test within five minutes to provide a realistic classroom setting. Cognition was measured using the Stroop Test (Victoria version). The Victoria version of the Stroop Test has been used to determine executive function and selective attention using three increasingly challenging tasks (Dot, Word, and Color tests) performed in quick succession , and is commonly used in research with participants ranging from children to adults. Participants were progressively required to name colored dots (Dot test), words printed in the same color as dots (Word test), and finally color words printed in non-corresponding colors (Color test). Each task contained 24 items and challenged participants to deal with an interference effect, which can slow reaction time. Comment by Andrew Harveson: Paragraph #2 is a description of the research instruments, their suitability for use in the study.
Participants were required to perform one familiarization session on the mathematics test, Stroop test, and exercise protocols during regularly scheduled PE classes. After a period of seven days, the students were separated into three experimental exercise sessions, aerobic exercise, resistance exercise, and non-exercise, which rotated each week for three weeks in a randomized crossover design. Experiment conditions were varied to avoid an order effect. Previous research has shown that the beneficial effects of exercise on executive function, as measured by event-related brain potential, peaks within 40 minutes , thus, the tests of mathematics and cognition were administered between 5 and 20 minutes after each exercise session. The authors also felt that such a time-span following acute exercise would best mimic what would be seen in authentic classroom settings where exercise might be used to boost academic performance. The primary author and trained research assistants collected data. Comment by Andrew Harveson: Paragraphs 3 and 4 describe the procedures and protocols that were followed to collect data. Note the use of previous research to support and strengthen the design.
Previous work by Alves et al.  laid the groundwork for the aerobic and resistance exercise protocols used in this study, which were designed to elicit moderate intensity activity levels. The resistance exercise protocol involved six exercises, and participants completed two sets of 15 repetitions in each of the following: squat, lunge, pushup, band pull down, band row, and overhead press. Weight was reduced or exercises were modified if participants were unable to complete 15 repetitions per set . The complete resistance exercise session was 20 minutes long, with one-minute rest breaks between sets. The aerobic exercise intervention was likewise composed of 20 minutes of walking or jogging around an indoor track at approximately 50-60% of the participants’ age-predicted heart rate maximum. The non-exercise control group consisted of participants viewing a sports-related DVD for 20 minutes. To ensure that participants remained inactive, seated, and did not fall asleep, students were monitored by the primary author, trained research assistants, and classroom teachers, in accordance with prior research protocols . Exercise intensity was monitored immediately following each set of resistance exercise and at five minute intervals during the aerobic exercise intervention, using Borg’s original Rating of Perceived Exertion (RPE) scale .
Repeated measures analysis of variance (ANOVA) was used to determine whether differences existed among the treatments. An alpha of 0.05 was used to determine statistical significance. All analysis was completed using SPSS 22.0. Comment by Andrew Harveson: The final paragraph describes the statistical analysis that will be performed in order to determine results.
Protocol Design – Inclusion and Exclusion Criteria
Investigators must include in their protocols a thorough description of the study population. The first priority is that the subject population have the attributes that will make it possible to accomplish the purpose of the research. The investigator must specify inclusion and exclusion criteria for participation in a study. Inclusion criteria are characteristics that the prospective subjects must have if they are to be included in the study. Exclusion criteria are those characteristics that disqualify prospective subjects from inclusion in the study. Inclusion and exclusion criteria may include factors such as age, gender, race, ethnicity, type and stage of disease, the subject’s previous treatment history, and the presence or absence (as in the case of the “healthy” or “control” subject) of other medical, psychosocial, or emotional conditions. Healthy, or control, subjects may be defined as those individuals who are free of certain specified attributes of non-health. Additional information on screening potential subjects for attributes of non-health is available in the Specific Guidance on Special Issues section of this module . Defining inclusion and exclusion criteria increases the likelihood of producing reliable and reproducible results, minimizes the likelihood of harm to the subjects, and guards against exploitation of vulnerable persons.
An example of inclusion criteria for a study of chemotherapy of breast cancer subjects might be postmenopausal women between the ages of 45 and 75 who have been diagnosed with Stage II breast cancer. An exclusion criterion for this study might be abnormal renal function tests, if the combination of study drugs includes one or more that is nephrotoxic. In this case it would be required to specify which tests of renal function are to be performed to evaluate renal function and the threshold values that would disqualify the prospective subject (e.g., serum creatinine above 1.9 mg/dl). Social science research generally does not have defined exclusion criteria. Rather, ethnographic research usually defines the community of interest and seeks to include the broadest sampling of individuals who meet the inclusion criteria. For example, in an ethnographic study of Amazonian communities and their use of forest products, individuals living near the Amazonian forest would be included. Within these communities everyone would be eligible to participate.
Furthermore, the investigator must be prepared to provide a rationale in case one or more of the inclusion or exclusion criteria is questioned. The investigator should review the inclusion and exclusion criteria and decide if any group(s) is inappropriately excluded. If the justification for the exclusion of this group is not reasonable with regard to the risks, benefits, and purpose of the research, then this group should be included. In the breast cancer study example discussed above, there would be no justification for the exclusion of minority women, but there is justification for the exclusion of men (based upon the target population of the research.) As noted in this example, the requirement that groups not be excluded without adequate justification does not mean that it is never appropriate for exclusion criteria to be based on race, gender, or age. For example, some ethnographic research, by definition, may be limited to a certain ethnic group. To assess the rationale for selecting certain subject groups, the investigator needs to review information on the distribution of the health condition in the general population. Research that has the potential to benefit men, women, and children or different races should target a population of subjects that is diverse enough to distinguish differing effects, risks, and benefits. No group or individual subject should be excluded without a scientifically sound reason or a requirement of the regulations to do so.
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