1. Research Proposal Data collection Components of the study
Baseline – what, where, when and how
Follow-up – what, where, when and how
Questionnaire, interview, venipuncture, physical measurements, medical record review
Develop a figure that depicts data collection for each participant.

2. Research Proposal Enroll 600 women Prenatal Examination GCRC
Figure 3. Study Components
Enrollment (n=50)
Bariatric Patients
Pre-surgery
Full Exam GCRC
Surgery
Liver Biopsy OR
3,6,9-month Post-OP
Brief Exam GCRC
12-month Post-OP
4-week Post-OP
Figure 5.1. Components of the proposed study
Prenatal Examination GCRC
Medical Record Abstraction
Enroll 600 women
Telephone
Interview
2 week
3 month
6 month
9 month
Delivery Cord Blood
6-week Examination GCRC
Mother and Child Components
1-year Examination GCRC

3. Research Proposal Data collection Main Exposure and Outcome Variables
Details on what will be collected for these variables
Questionnaires
Developed for this study?
Has it been validated?
Has it been validated in race/ethnic, age, gender?
What language will be used?
If you are studying acculturation how will it impact your study if questionnaires are only available in English
Scale or a score, need to provide information on the range of values, how it is scored and interpreted, what type of variable is the output (continuous, discrete, ordinal, nominal)

4. Research Proposal Data collection Main Exposure and Outcome Variables
Details on what will be collected for these variables
Laboratory assays
Variation
How standardized are the measurements.
Are there different analytical techniques?
Does it matter which one you use?
Batch variation – is this a problem
Biologic variation – is this a problem
Upper and lower bounds
Reliability coefficient, same person different days, same sample different times
Where will the assays be completed. Will samples be stored and measured all at once or will they be sent as acquired.

5. Research Proposal Data collection Main Exposure and Outcome Variables
Details on what will be collected for these variables
Standardized measurements
Blood pressure, ultrasound, MRI
Need a standardized protocol for how you will measure it
Clinical protocol is not good enough
Good starting spot
Need a standardized protocol for how you will read it
May need repeatability studies for scanning/reading
Blinded

6. Research Proposal Data collection
What is the final information that will be obtained
DXA – percent body fat
MRI – visceral adiposity, amount of fat in kg
Carotid ultrasound – intima media thickness
The focus of your study – may be a lot of information available but what is central to your study.

7. Research Proposal Data collection Main Exposure and Outcome Variables
Details on what will be collected for these variables
Case definitions
Define exposure, outcome or study population
Clinical definition – not ideal
Standard criteria
What information are needed to make the diagnosis
How will you get that information: Abstract medical record or measure required variables to obtain all required information
Develop algorithm to define disease - missing data

8. Research Proposal Data collection Confounders -- covariates
Identify potential confounders
Comorbidities
Age, sex, race, SES
Observational study – these can make or break
Less information on measurement of these variables

9. Research Proposal Data analysis
For each hypothesis write out your exposure and outcome.
Indicate variable to be used in analysis for both the exposure and outcome.
Continuous, categorical, nominal or ordinal
Power calculation for that hypothesis

10. Research Proposal Theoretical model Exposure  Outcome
Covariates – where do they enter in

11. Research Proposal Diet/ Physical Activity Obesity ↕ Visceral Adiposity
Hepatocyte Metabolism
Microbiome
Hepatic Steatosis
Diabetes
Incretin/Satiety
Insulin Resistance
Impaired Insulin Secretion
Figure 4. Aim 1 Conceptual Framework; Proposed etiology of diabetes and hepatic steatosis in morbidly obese patients prior to gastric bypass surgery.

12. Research Proposal Problems, Pitfalls and limitations
Keep a running list of problems with your study