Case Report Form Instructions

Phone ScreenPhone Screen
Phone Screen Verbal consent given by respondent: If “No,” thank the participant for their time and end the phone conversation. If “Yes,” complete all phone screen questions.
Medical History Check “No,” “Yes,” based on volunteer-reported history of the condition. If “Yes,” provide additional known information such as: when diagnosed, symptoms, family history, type of disease, and length of treatment.
Heart attack, heart-related chest pain, or other heart condition: Refers to known heart attacks, evidence or knowledge of symptoms described as chest pain or pressure, jaw pain, arm pain, or other equivalent discomfort suggestive of cardiac ischemia. Includes other conditions such as high cholesterol (hyperlipidemia), coronary artery disease, and valvular disease. Abnormal heart rhythm: Includes acute or chronic atrial fibrillation, flutter, bradyarrhythmias, supraventricular tachycardia, ventricular tachycardia or fibrillation. If “Yes,” describe type. Cancer: Refers to all solid and hematologic malignancies, except non-metastatic skin cancer, ever diagnosed or treated. Shortness of breath or other breathing problem: Refers to nonasthma episodes of shortness of breath or breathing problems. Diabetes (meds): Refers to any history of diabetes, need for antidiabetic agents, diet-controlled, or high blood sugar. If “Yes,” describe if type 1 or 2. High blood pressure (> 140/90): Refers to any known diagnosis of high blood pressure (> 140 mm Hg systolic or 90 mm Hg diastolic). Anemia or other blood condition: Iron deficiency, blood loss, or other blood disorders. Thyroid or other metabolic disorders: Refers to hyperthyroidism, hypothyroidism, or any enzyme-deficiency disorders, such as phenylketonuria. Stomach or digestive disorders: Examples include celiac disease, hemorrhoids, constipation, diarrhea, gastroesophageal reflux disease (GERD), inflammatory bowel disease, irritable bowel syndrome, pancreatitis, and peptic ulcers. Active liver disease and/or gallstones: Refers to active hepatitis, cirrhosis, or gallstones. Kidney or urologic disorders: Examples include renal insufficiency, acute or chronic kidney failure, and urinary incontinence. Weight loss or gain of > 3 kg over the past 6 months: Check “Yes” if participant reports losing or gaining more than 6 ½ pounds in the last 6 months. Anaphylaxis, severe allergies, or asthma: Includes allergic food, drug, and seasonal reactions, rashes (including hives), and skin swelling. Also includes lung and airway disorders, such as asthma, bronchospasm, exercise-induced asthma.
Retain at site. Do not fax to DCRI.
Final CALERIE PH2 CRF v5.0_30AUG2007 CRF, page 1
Phone Screen
Medications If “Yes,” to questions 1, 2, or 6, specify the medication (generic or brand) name.
Women 3 Do you use some form of birth control? If “Yes,” specify oral contraceptives, barrier, IUD,
etc. Physical Activity/Lifestyle 1 Regular program of physical fitness involving heavy physical activity more than 5
times per week? If “Yes,” specify the type of exercise and how often. For example, running 3 miles/3 x week and weight lifting for 30 minutes/2 x week.
2 Have you used drugs recreationally within the past two years? Check “Yes” for abuse of any controlled substance within the past two years.
3 Have you smoked within the past twelve months? Check "Yes" if the participant is currently smoking or has smoked within the past twelve months. This refers to tobacco cigarettes only, not cigars, pipe smoking, chewing tobacco, or marijuana cigarettes.
4 Have you given blood in the last 30 days? Check “Yes” if the participant has donated blood within the last 30 days. This refers to donated blood only and does not include blood taken as part of laboratory testing.
5 Are you currently participating in another interventional trial? Check "Yes" if the participant is currently involved in another a clinical trial investigating a medication, device, or procedure.
6 Are you currently practicing a vegan lifestyle? Check “Yes,” if the participant does not consume animal products, including meat, fish, poultry, eggs, and dairy.
7 Do you anticipate difficulties adhering to special diets and clinical visits over a two year period? After careful consideration of all that is involved in the study, ask the participant to respond “Yes” or “No” to this question.
Eligibility Information To be completed by the interviewer
After reviewing the participant’s responses with the exclusion criteria, check the appropriate response. If “No,” specify reason why the participant is not eligible. If the participant meets eligibility criteria, confirm that he or she is interested. If participation is on hold, specify reason and record date the participant will be contacted to resume screening.
Orientation (screening visit 1) scheduled: Record date of scheduled clinic visit for screening visit 1. Comments: Provide any pertinent comments regarding the participant’s eligibility.
Screening Visit 1 Checklist
Screening Visit 1 Checklist Date of initial clinic visit for Screening Visit 1: Record the date of screening visit 1 clinic visit.
Check completed items: Informed consent: The informed consent must be signed prior to initiation of any screening procedures or study activities with the participant. 3–17 Check item once activity completed. 18 Is the participant expected to return for Screening Visit 2? If “No,” check all reasons that
apply. If “Other,” describe reason. If “Yes,” record date of scheduled clinic visit for screening visit 2.
Fax completed form to DCRI Forms Management at 919-668-7100
Screening
Clinic Weight Weight date and time: Record the date and time the weight was obtained, or if not done, specify reason, using the Not Done Codelist. Staff initials: Record the initials of the staff person obtaining the measurement. Clinic weight: Record 2 weight measurements. Obtain a 3rd measurement if the 2 measurements are > 0.1 kg apart. Obtain and record gown weight. Height Height: Record 2 height measurements. Obtain a 3rd measurement if the 2 measurements are > 0.1 cm apart.
Not Done Codelist 1 Participant refused 4 Instrument failure 2 Clinician unable to obtain 5 Not required 3 Insufficient time
Screening
Demographic Questionnaire Print this form and complete with the participant. Do not submit this form to DCRI. File the completed form in the participant’s file for reference throughout the study.
Screening
Demographics
3 Ethnicity (check only one): Check 1 category as reported by the participant. Hispanic or Latino: Refers to a person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture of origin, regardless of race. Not Hispanic or Latino: Check if participant does not report ethnicity in the above category, “Hispanic or Latino.” Unknown: Check if participant does not know or want to answer.
4 Race (check only one): Check 1 category as reported by the participant. American Indian or Alaska Native: Originating from any of the original peoples of North, Central, or South America. Asian: Originating from any of the original peoples of the Indian subcontinent, Far East, or Southeast Asia including Bangladesh, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, Philippine Islands, Thailand, and Vietnam. Native Hawaiian or other Pacific Islander: Originating from any of the original peoples of Hawaii, Samoa, Guam, or other Pacific Island. Black or African American: Originating from any of the original black racial groups of Africa. White: Originating from any of the original peoples of Europe, North Africa, the Middle East, or Russia. More than one race: Combination of any of the above. Unknown: Check if participant does not know or want to answer.
5 Marital status (check only one): Check only one response to indicate participant’s current marital status.
6 Living situation: Where do you live (check only one): Check only one response to indicate participant’s current living situation. If “Other,” please specify.
7 Education: What is the highest level of formal education that you have completed (check only one)? Check only one response that best represents participant’s highest level of formal education.
8 Family income: What is the total annual income of your household (check only one): Check one response that best reflects total (from all sources) household income.
Screening
Questionnaires
Stanford Brief Physical Activity Survey Eating Inventory Multiaxial Assessment of Eating Disorder Symptoms (MAEDS) Structured Clinical Interview for DSM-IV (SCID-II) BDI-II
For each questionnaire:
Record the date completed. Participant must initial each page. Refer to instructions provided with the test. Additional instructions are not
provided in this document.
Screening Visit 2 Checklist 1 Did participant return for Screening Visit 2? If “No,” skip checklist and complete question
number 15. If “Yes,” record date of visit.
2–14 Check item once activity completed. 15 Is the participant expected to return for Screening Visit 3?
If “No,” check all reasons that apply. If “Other,” describe reason. If “Yes,” record date of scheduled clinic visit for screening visit 3.
Baseline Submission 1 Screening
Date completed: Record date medical history completed.
Screening Medical History For each body system, check “No” or “Yes” to indicate a clinically significant pre-existing condition. If “Yes,” specify diagnosis, using concise medical terminology.
15 Other (including contraception methods, females only): If “Yes,” specify oral contraceptives, barrier, IUD, etc.
Physician’s Signature Information on this page must be reviewed, signed, and dated by a study physician.
Baseline Submission 1 Screening
Date completed: Record date medication history completed. Medication History Record medications taken from 6 months prior to screening through the screening period. Record generic or brand name and include over-the-counter and prescription drugs, vitamins, supplements, and herbal medications. Include any steroid use within the last 5 years.
Record the start and stop date, or check “Continuing” if participant is taking medication at the end of the screening period. Indication: Record the primary reason for medication use. Page Numbering: Number this page 24.1. Number any additional pages in sequential order, i.e., 24.2, 24.3, etc.
Final CALERIE PH2 CRF v5.0_30AUG2007 CRF, page 24.__
Screening
Physical Examination Date of examination: Record date of examination or if not performed, specify reason, using the Not Done Codelist. Assessments:
1–10: Check “Not Done,” “Abnormal,” or “Normal” for each body system.
11–12: Check “Not Done” if systems not examined or participant referred to primary care physician for exam.
If Abnormal or Not Done: Explain: If “Abnormal” or “Not Done” is checked for any body system, provide an explanation.
Screening Visit 3 Checklist 1 Did participant return for Screening Visit 3? If “No,” skip checklist and complete question
number 5. If “Yes,” record date of visit.
2–4 Check item once activity completed. 5 Has the participant been contacted and agreed to additional visit (check only one)?
If “No,” check all reasons that apply. If “Other,” describe reason. If “Yes,” check appropriate type of the next scheduled visit—screening visit 4 or baseline visit.
Screening Visit 4 Checklist Optional—Submit form only if Screening Visit 4 was scheduled
1 Did participant return for Screening Visit 4? If “No,” skip checklist and complete question number 4. If “Yes,” record date of visit.
2–3 Check item once activity completed. 4 Has the participant been contacted and agreed to proceed with a baseline visit (check
only one)? If “No,” check all reasons that apply. If “Other,” describe reason. If “Yes,” record date of scheduled baseline visit.
Baseline Submission 1 Visit 1
Informed Consent 1 Did participant present for baseline visit? If no, check one reason why visit was not
performed. If “Other,” specify reason in space available.
2 Date and time study baseline informed consent signed: Record the date and time the participant signed the informed consent.
Note: Baseline informed consent must be signed prior to the start of any baseline study procedures.
Clinic Weight Weight date and time: Record the date and time the weight was obtained. If measurement not obtained, specify reason using the Not Done Codelist.
Staff initials: Record the initials of the staff person obtaining the measurement. Clinic weight: Record 2 weight measurements. Obtain a 3rd measurement if the 2 measurements are > 0.1 kg apart. Obtain and record gown weight. Vital Signs Assessment date and time: Record the date and time assessment completed. Staff initials: Record the initials of the staff person obtaining the measurement. Not done: If any measurement or test not obtained, specify reason using the Not Done Codelist. 1 Natural waist circumference: Record 2 measurements. Obtain a 3rd measurement if the 2
measurements are > 1.0 cm apart. 2 Umbilical point waist measurement: Record 2 measurements. Obtain a 3rd measurement
if the 2 measurements are > 1.0 cm apart. 3 Pulse: Record measurement after obtaining at rest for a full minute. 4 Temperature: Record oral temperature in centigrade only. 5 Respirations: Record measurement after obtaining at rest for a full minute. 6 Blood pressure: Specify which arm was used to obtain measurement. If measurement not
obtained, do not record any information in 6a-6c.Specify reason, using the Not Done Codelist.
Not Done Codelist
1 Participant refused 4 Instrument failure 2 Clinician unable to obtain 5 Not required 3 Insufficient time
12-Lead ECG Date and time: Record date and time the ECG performed or if not done, specify reason using the Not Done Codelist.
Findings: Check one finding as assessed by the study physician, not as described by the computerized ECG analysis. Clinically significant abnormalities should be recorded on the AE page. Staff Initials: Record the initials of the staff person performing the measurement. Safety Labs Date and time of last meal: Record date and time of last meal prior to sample collection. Date and time of sample collection: Record the date and time of obtaining the blood and urine samples. Sample Complete? For each sample, check “Yes” if collection complete and “No” for partial collections. If Not Done, Reason: If sample not obtained, specify reason using the Not Done Codelist. Staff Initials: Record the initials of the staff person obtaining the samples.
Date completed: Record date the abbreviated medical history was completed. Abbreviated Medical History Check “No Change” if no significant changes have occurred since the screening medical history. If a significant change has occurred, check “Yes” and specify diagnosis.
Physical Examination Date of examination: Record date of examination or if not performed, specify reason, using the Not Done Codelist.
Assessments:
1–10: Check “Not Done,” “Abnormal,” or “Normal” for each body system assessment.
11–12: Check “Not Done” if systems not examined or participant referred to primary care physician for exam.
If Abnormal or Not Done: Explain: If “Abnormal” or “Not Done” is checked for any body system, provide an explanation.
Clinic Weight Weight date and time: Record the date and time the weight was obtained or if not done, specify reason, using the “Not Done Codelist.”
Staff initials: Record the initials of the staff person obtaining the measurement. Clinic weight: Record 2 weight measurements. Obtain a 3rd measurement if the 2 measurements are > 0.1 kg apart. Obtain and record gown weight.
Pregnancy Test Complete this section for female participants only.
Does participant have reproductive potential? Select “No” if participant is surgically sterile or postmenopausal (no menstrual cycle for ≥ 12 months). If “Yes,” record the date of the local urine pregnancy test.
Results: Check 1 box to indicate results. If “Positive,” record the pregnancy on the Signs, Symptoms and Adverse Events log.
Doubly Labeled Water (DLW) 1 Date and time of DLW dosing: Record the date and time dosing took place. If dosing not
done, specify reason using the Not Done Codelist.
Staff initials: Record the initials of the staff person obtaining the measurement. 2 DLW dose mixture ID and bottle number: Record lot and bottle numbers as found on the
mixture bottle. 3 Exact weight of DLW mixture: Record the exact weight of the DLW mixture to the nearest
0.01 gm. 4 Urine samples: The date and time collected refers to the set of urine samples collected over
the 14-day DLW period and includes 2 separate urine samples for each time point. Record the date and time of each sample collection. Record all urine samples for Baseline Submission 1 on this page.
5 CRF page label(s): Adhere the corresponding label identified as “CRF page.”
DXA Scan 1 Has the participant taken a calcium supplement today? If “No,” proceed with test. If
“Yes,” the scan can be done, however document supplement on the Subject Scan Log. Calcium supplements may interfere with the results and the scan may need to be repeated. Inform participants, prior to the scheduled visit, not to take a supplement within 24 hours prior to the DXA scan.
2 Were any studies involving barium or radioisotopes performed within 4 weeks prior to the scheduled DXA exam? Check “No” or “Yes.” Subject should not be exposed to barium or radioisotopes within 4 weeks of DXA exam.
Record date of DXA scan and DXA rescan, if applicable. Check all areas scanned. If an area not scanned, specify reason using the Not Done Codelist.
Questionnaires Rand SF-36 BDI-II Profile of Mood States Perceived Stress Scale (PSS) Pittsburgh Sleep Quality Index (PSQI) Derogatis Interview for Sexual Function (DISF-SR)
(F) Female Version (M) Male Version
Food Cravings Questionnaire—Trait Food Cravings Questionnaire—State (FCQ-S) Food Craving Inventory (FCI-II) Eating Inventory Weight Efficacy Lifestyle Questionnaire (WEL) Multiaxial Assessment of Eating Disorder Symptoms (MAEDS) Body Shape Questionnaire (BSQ)
Record the date completed or if not done, specify the reason using the Not Done Codelist.
Participant must initial each page. Refer to instructions provided with the test. Additional instructions are not
2 Clinician unable to obtain 5 Not required
3 Insufficient time
Record all Adverse Events on the Signs, Symptoms and Adverse Events Log. Record all medication changes on the Concomitant Medications Log.
Seven-Day Physical Activity Recall (PAR) Record today’s date and check 1 box to indicate the day of the week. If not done, specify reason using the Not Done Codelist. Interviewer initials: Record the initials of the test administrator (study coordinator or designated backup). 1 Employed in the last seven days? If “No,” skip to question 3. 2 If Yes: Which days: Check all boxes that apply to indicate days worked in the last
seven days. 3 Which two days do you consider the weekend, or nonwork days? Check boxes to indicate weekend or nonwork days. Starting with yesterday, record the following:
• Day of Week • Date • Sleep Time: “In Bed” is the time the participant went to bed following the day’s
activities. “Up” is the time the participant gets out of bed following sleep. Use a 24-hour clock from 00:00 (midnight) to 23:59 (11:59 PM). Do not record 24:00.
• Work Time: Record start and stop time using a 24-hour clock from 00:00 (midnight) to 23:59 (11:59 PM). Do not record 24:00.
• Physical activity: Record minutes spent in moderate, hard, or very hard activities. Do not record physical activities that are considered light, such as desk work, standing light housework, driving, grocery shopping. See below for examples.
On the job At home Sport or Recreation
Moderate Lifting or carrying objects up to 5 lbs, painting exterior of a house
Sweeping, mopping, vacuuming, clipping hedges, raking, mowing lawn with power mower, cleaning windows, pushing stroller with child
Brisk walking on level ground, shooting baskets, throwing frisbee, cycling leisurely on level ground, swimming laps (easy effort), weightlifting
Hard Construction work, lifting or carrying objects 5–15 lbs, climbing ladder or stairs
Scrubbing floors, shoveling dirt, coal, etc., mowing lawn with a nonpower mower, carrying child (5–15 lbs)
Brisk walking (uphill), backpacking on level ground, brisk cycling on level ground without losing breath, tennis (doubles), downhill skiing, swimming laps (moderate effort)
Very Hard Carrying heavy loads such as bricks or lumber, carrying objects (16–40 lbs) upstairs
Digging ditches, chopping or splitting wood, gardening with heavy tools
Jogging, basketball (game), soccer (game), backpacking uphill, cycling uphill or racing, tennis (singles), cross-country skiing, swimming laps (hard effort), aerobic dancing, circuit training
Midnight 00:00 7:00 PM 1900 9:00 AM 0900 8:00 PM 2000 11:00 AM 1100 9:00 PM 2100 12:00 PM 1200 10:00 PM 2200 1:00 PM 1300 11:00 PM 2300 6:00 PM 1800 11:30 PM 2330
Seven-Day Physical Activity Recall (PAR) (continued) 4 Compared to your physical activity over the past three months, was last week’s
physical activity more, less, or about the same? Check only one box.
Interviewer to complete this section. Record additional comments in the source record.
6-day Food Record If food record not completed for days 1–6, specify reason using the Not Done Codelist.
Staff initials: Record the initials of the staff person reviewing the record. Date of Record: Record date corresponding to the day of DLW (doubly labeled water). Record of Quality: Check 1 box describing quality of food record.
Reliable: Information consistently recorded and data deemed reliable. Unreliable: Information inconsistently recorded and data deemed unreliable. Missing: Incomplete record.
Record data for Day 8–13 for replacement days if needed.
Clinic Weight Weight date and time: Record the date and time the weight was obtained or if not done, specify using the Not Done Codelist.
• Day of the week • Date • Sleep Time: “In Bed” is the time the participant went to bed following the day’s
• Work time: Record start and stop time using a 24-hour clock from 00:00 (midnight) to 23:59 (11:59). Do not record 24:00.
physical activity more, less, or about the same? Check only one box. Interviewer to complete this section. Record any additional comments in the source record.
Handgrip Strength Date and time of assessment: Record date and time assessment completed or if not done, specify reason using the Not Done Codelist.
Staff initials: Record the initials of the staff person obtaining the measurement. 1 Dynometer handle position: Enter the position of the handle. Note that the handle should be positioned so that the proximal interphalangeal joints (i.e., the joints just distal to where a ring is worn) are flexed at 90 degrees. For follow-up tests, the handle should be placed in the same position as at baseline. 2 Dominant hand: Check 1 box to indicate what participant reports as being their dominant
hand or “Ambidextrous” if they use both hands equally. 3 Handgrip strength: For each hand and test, record the force value in kg.
Isometric/Isokinetic Knee Extension and Flexion Date and time of assessment: Record date and time assessment completed or if not completed, specify reason using the Not Done codelist.
Staff initials: Record the initials of the staff person obtaining the measurement. 1 Recent injury or pain—right knee? Check “No” or “Yes.” 2 Recent injury or pain—left knee? Check “No” or “Yes.” Record test results for each leg. If any test is not performed, specify reason using the Not Done Codelist.
Doubly Labeled Water (DLW) 1 Date and time of DLW dosing: Record the date and time dosing took place, or if not done,
specify reason using the Not Done Codelist. Staff initials: Record the initials of the staff person obtaining the measurement.
2 DLW dose mixture ID and bottle number: Record lot and bottle numbers as found on the mixture bottle.
3 Exact weight of DLW mixture: Record the exact weight of the DLW mixture to the nearest 0.01 gm.
4 Urine samples: The date and time collected refers to the set of urine samples collected over the 14-day DLW period and includes 2 separate urine samples for each time point. Record the date and time of each sample collection. Record all urine samples for Baseline Submission 2 on this page.
Clinic Weight Weight date and time: Record the date and time the weight was obtained.
Staff initials: Record the initials of the staff person obtaining the measurement. Clinic weight: Record 2 weight measurements. Obtain a 3rd measurement if the 2 measurements are > 0.1 kg apart. If measurement not obtained, specify reason using the Not Done Codelist. Obtain and record gown weight.
VO2 Max 1 Date and time of test: Record the date and time the test was performed or if not done, specify
reason using the Not Done Codelist.
Staff initials: Record the initials of the staff person obtaining the measurement. 2 At what time was the participant’s last meal/snack eaten? Record start time of most recent
food intake. 3 Rest ECG:
Rhythm (check only one): Check “Other” if rhythm is not “Sinus” or “Atrial fibrillation.” Ventricular conduction (check only one): LBBB=left bundle branch block; RBBB=right bundle branch block.
4 Heart rate (HR) data: Resting heart rate: Record heart rate measured at rest, without mouthpiece, and after the participant has been sitting for 5 minutes. Age predicted heart rate: HRmax = 208−(0.7 x age) Heart rate (max): Record heart rate obtained at maximum exercise level.
5 Reason(s) for termination of testing (check all that apply): Symptom limited: Check if test stopped for dyspnea, fatigue, lightheadness Angina/ischemia: If test stopped for angina or ischemia, record heart rate when true angina and when ischemic ECG changes occurred, if applicable. Serious arrhythmias (VT or SVT): Check if test stopped for ventricular tachycardia, ventricular fibrillation, or supraventricular tachycardia. Changes in blood pressure: Check if test stopped for significant drop (20 mm Hg) of systolic or failure of the systolic blood pressure to rise. Excessive rise in BP: systolic BP > 250 mm Hg or diastolic BP > 120 mm Hg. Ventricular ischemia: Check if test stopped due to evidence of ventricular ischemia. Schedule stress test and complete Ventricular Ischemia Episode Report CRF page. Orthopedic/extremity complaints: Check if test stopped for pains or cramps Other: Check if test stopped for a reason not listed above. Specify reason.
6 Did frequent ventricular ectopy occur (e.g., ≥ 7 PVCs/min, bi/tri-geminy, NVST (≥ 3 beats)? If Yes: When did it occur? Check all that apply—if ectopy occurred during exercise and/or in recovery.
7 Peak VO2: Record the highest VO2 determinations over any 15-second period. 8 Did the participant meet 2 or 3 of the VO2 max criteria (see listed criteria)? 9 Exercise time: Record the total time in minutes and seconds that the participant exercised. 10 Blood pressure at VO2 peak/ VO2max: Record blood pressure obtained at maximum exercise
level. 11 Borg RPE score at VO2 peak/ VO2max: Record score obtained at maximum exercise level. 12 Peak RER: Record the respiratory exchange ratio (RER) obtained at maximum exercise level. 13 VE at VO2 peak/ VO2max: Record in liters per minute. 14 VE/VO2 at VO2 peak/ VO2max: Record in liters per minute.
Seven-Day Physical Activity Recall (PAR) Record today’s date and check 1 box to indicate the day of the week. If not done, specify reason using the Not Done Codelist.
Interviewer initials: Record the initials of the test administrator (study coordinator or designated backup). 1 Employed in the last seven days? If “No,” skip to question 3. 2 If Yes: Which days: Check all boxes that apply to indicate days worked in the last
Seven-Day Physical Activity Recall (PAR) (continued) 4 Compared to your physical activity over the past three months, was last week’s physical activity more, less, or about the same? Check only one box.
Interviewer to complete this section. Record any comments in the source record
Delayed-type Hypersensitivity (DTH) 1 Was the DTH worksheet completed?
If Yes: Were any Exclusion criteria met? If “Yes” do not administer test.
5 DTH results: For each antigen, record the diameter in millimeters (mm) of A and B at Visit 7 and Visit 8. The person reading the results must initial results.
4 Arm injected: Check box to indicate the test arm. 3 Injection by: Record the initials of the staff person administering the test.
2 Date of injection: Record the date of the injection, or if not performed, specify reason using the Not Done Codelist.
Clinic Weight Weight date and time: Record the date and time the weight was obtained.
Staff initials: Record the initials of the staff person obtaining the measurement. Clinic weight: Record 2 weight measurements. Obtain a 3rd measurement if the 2 measurements are > 0.1 kg apart. If measurement not obtained, specify reason using the Not Done Codelist. Obtain and record gown weight. Vital Signs Assessment date and time: Record the date and time assessment completed.
Staff initials: Record the initials of the staff person obtaining the measurement. Not done: If any measurement or test not obtained, specify reason using the Not Done Codelist. 1 Natural waist circumference: Record 2 measurements. Obtain a 3rd measurement if the 2
Pregnancy Test Complete only for female participants.
Does participant have reproductive potential? If “Yes,” record the date of the local urine pregnancy test.
Core Temperature Staff initials: Record the initials of the staff person obtaining the measurement.
Date and Time of Sample Collection/Procedure: Record start and stop dates and times. If temperature not obtained, specify reason using the Not Done Codelist.
Inpatient Admission and Discharge 1 Inpatient admission date and time: Record date and time of admission.
2 Inpatient discharge date and time: Record date and time of discharge.
Seven-Day Physical Activity Recall (PAR) (continued)
Interviewer to complete this section. Record any comments in the source record.
4 Compared to your physical activity over the past three months, was last week’s physical activity more, less, or about the same? Check only one box.
Outcomes Labs Date and time of last meal: Record date and time using a 24-hour clock from 00:00 (midnight) to 23:59 (11:59). Do not record 24:00.
Date and time sample collection started: Record date and time using a 24-hour clock from 00:00 (midnight) to 23:59 (11:59). Do not record 24:00. For each sample, check “Yes” if collection complete and “No” for partial collections. If not done, specify reason using the Not Done Codelist. Record staff initials of person obtaining the sample. Biopsy Labs For each biopsy, record the date of the collection and the staff initials of the person obtaining the sample. If not done, specify reason using the Not Done Codelist.
24-hour Urine Collection Record the total volume collected, dates and times of the collection, and the staff initials of the person obtaining the sample. If not done, specify reason using the Not Done Codelist.
Sex Hormone Note: For female participants, the blood draws need to occur during the mid-luteal phase (days 19-21, day one being the start of menses). It may be necessary to fill this page out at an earlier visit or at a later visit than the rest of scheduled study procedures at Baseline v7, 12 Month v4 and 24 Month v4 dates. If not done, specify reason using the Not Done Codelist. Contraception method (females only): Check “None” or all that apply. If “Oral contraceptive” checked, specify name and record on this page and the Concomitant Medications page. If “Other” checked, specify type on this page. Day 1 of menses (females only): Enter day 1 of menses, which is prior to the hormone-level blood draw. Date and time of last meal: Enter date and time of last meal. Hormone-level blood draw 1: Enter date and time of blood draw and the staff initials of the person obtaining the sample. If not done, specify reason using the Not Done Codelist. Hormone-level blood draw 2 (females only) Progesterone level: Enter date and time of blood draw and the staff initials of the person obtaining the sample. Day 2
Date and time of last meal: Enter date and time of last meal. Hormone-level blood draw 3 (females only) Progesterone level: Enter date and time of blood draw and the staff initials of the person obtaining the sample. If not done, specify reason using the Not Done Codelist.
2 Were any studies involving barium or radioisotopes performed within 4 weeks prior to the scheduled DXA exam? Check “Yes” or “No.” Subject should not be exposed to barium or radioisotopes within 4 weeks of DXA exam.
Record date of scan and rescan, if applicable. Check all areas scanned. If an area is not scanned, specify reason using the Not Done Codelist.
Final CALERIE PH2 CRF v5.0_30AUG2007 CRF, page 90A
Metabolic Rate Record the dates of the resting metabolic rate (RMR) obtained at Visits 7 and 8.
If Not Done, Reason: Specify reason using the Not Done Codelist.
Staff initials: Record the initials of the staff person obtaining the measurement.
Cart ID: Select the assigned cart ID that was used to administer the test.
Baseline Submission 2 Randomization
Randomization Date of randomization: Record the date of randomization.
Treatment Group To which treatment group was the participant assigned (check only one)? Check 1 box.
Intervention Did participant start intervention? If “No,” Complete the Study Completion/Early Discontinuation of Study Evaluation form.
If “Yes,” record the date the intervention started using the following information:
CR—calorie restricted: Record the date the participant ate their first prescribed intervention meal. AL—ab libitum (control): Record the date of the day following randomization.
Staff Signature Sign and date by the person who randomized the participant. Do not share this page with other study staff to avoid unblinding them.
Month 1 Submission CR Visit Study Week 2
Findings: Check one finding as assessed by the study physician, not as described by the computerized ECG analysis. Clinically significant abnormalities should be recorded on the AE page.
Staff Initials: Record the initials of the staff person performing the measurement.
Safety Labs (Potassium Surveillance) Date and time of sample collection: Record the date and time of obtaining the blood sample.
If Not Done, Reason: If sample not obtained, specify reason using the Not Done Codelist.
Staff Initials: Record the initials of the staff person obtaining the samples.
Month 1 Submission
Not Done Codelist
Month 1 Submission
Findings: Check one finding as assessed by the study physician, not as described by the computerized ECG analysis. Clinically significant abnormalities should be recorded on the AE page. Staff Initials: Record the initials of the staff person performing the measurement. Safety Labs Date and time of last meal: Record date and time of last meal prior to sample collection. Date and time of sample collection: Record the date and time of obtaining the blood and urine samples. If Not Done, Reason: If sample not obtained, specify reason using the Not Done Codelist. Staff Initials: Record the initials of the staff person obtaining the samples.
Month 1 Submission
Questionnaire
BDI-II
For each questionnaire: Record the date completed or if not done, specify the reason using the Not
Done Codelist. Participant must initial each page. Refer to instructions provided with the test. Additional instructions are not
3 Insufficient time
Final CALERIE PH2 CRF v5.0_30AUG2007 CRF, pages 96-98
Safety Labs (Potassium Surveillance)
Date and time of sample collection: Record the date and time of obtaining the blood sample.
Safety Labs (Potassium Surveillance) Date and time of sample collection: Record the date and time of obtaining the blood sample.
Month 3 Submission
Not Done Codelist
Month 3 Submission
Findings: Check one finding as assessed by the study physician, not as described by the computerized ECG analysis. Clinically significant abnormalities should be recorded on the AE page. Staff Initials: Record the initials of the staff person performing the measurement. Safety Labs Date and time of last meal: Record date and time of last meal prior to sample collection. Date and time of sample collection: Record the date and time of obtaining the blood and urine samples. If Not Done, Reason: Specify reason using the Not Done Codelist. Staff Initials: Record the initials of the staff person obtaining the samples.
Date and time sample collection started: Record date and time using a 24-hour clock from 00:00 (midnight) to 23:59 (11:59). Do not record 24:00. Sample Complete? For each sample, check “Yes” if collection complete and “No” for partial collections. If Not Done, Reason: Specify reason using the Not Done Codelist. Staff Initials: Record the initials of the staff person obtaining the samples.
Month 3 Submission
3 Insufficient time
Month 6 Submission CR Visit Month 4
Findings: Check one finding as assessed by the study physician, not as described by the computerized ECG analysis. Clinically significant abnormalities should be recorded on the AE page. Staff Initials: Record the initials of the staff person performing the measurement. Safety Labs (Potassium Surveillance) Date and time of sample collection: Record the date and time of obtaining the blood sample.
Month 6 Submission CR Visit Month 5
Findings: Check one finding as assessed by the study physician, not as described by the computerized ECG analysis. Clinically significant abnormalities should be recorded on the AE page. Staff Initials: Record the initials of the staff person performing the measurement. Safety Labs (Potassium Surveillance) Date and time of sample collection: Record the date and time of obtaining the blood sample.
Month 6 Submission CR Visit 1/Control Visit 2
Staff initials: Record the initials of the staff person obtaining the measurement. Clinic weight: Record 2 weight measurements. Obtain a 3rd measurement if the 2 measurements are > 0.1 kg apart. Obtain and record gown weight. Vital Signs Assessment date and time: Record the date and time assessment completed. Staff initials: Record the initials of the staff person obtaining the measurement. Not done: If any measurement or test not obtained, specify reason using the Not Done Codelist.
3 Pulse: Record measurement after obtaining at rest for a full minute.
2 Umbilical point waist measurement: Record 2 measurements. Obtain a 3rd measurement if the 2 measurements are > 1.0 cm apart.
1 Natural waist circumference: Record 2 measurements. Obtain a 3rd measurement if the 2 measurements are > 1.0 cm apart.
6 Blood pressure: Specify which arm was used to obtain measurement. If measurement not obtained, do not record any information in 6a-6c.Specify reason, using the Not Done Codelist.
5 Respirations: Record measurement after obtaining at rest for a full minute. 4 Temperature: Record oral temperature in centigrade only.
Findings: Check one finding as assessed by the study physician, not as described by the computerized ECG analysis. Clinically significant abnormalities should be recorded on the AE page. Staff Initials: Record the initials of the staff person performing the measurement. Safety Labs Date and time of last meal: Record date and time of last meal prior to sample collection. Date and time of sample collection: Record the date and time of obtaining the blood and urine samples. Sample Complete? For each sample, check “Yes” if collection complete and “No” for partial collections. If Not Done, Reason: If sample not obtained, specify reason using the Not Done Codelist. Staff Initials: Record the initials of the staff person obtaining the samples. Not Done Codelist
Month 6 Submission CR Visit 2
Staff initials: Record the initials of the staff person obtaining the measurement. Clinic weight: Record 2 weight measurements. Obtain a 3rd measurement if the 2 measurements are > 0.1 kg apart. Obtain and record gown weight. Pregnancy Test Complete this section for female participants only.
Record date of DXA scan and DXA rescan, if applicable. Check all areas scanned. If an area not scanned, specify reason using the Not Done Codelist.
Doubly Labeled Water (DLW) 1 Date and time of DLW dosing: Record the date and time dosing took place. If dosing not
done, specify reason using the Not Done Codelist.
mixture bottle. 3 Exact weight of DLW mixture: Record the exact weight of the DLW mixture to the nearest
0.01 gm. 4 Urine samples: The date and time collected refers to the set of urine samples collected over
the 14-day DLW period and includes 2 separate urine samples for each time point. Record the date and time of each sample collection. Record all urine samples for Month 6 submission on this page.
Questionnaires
Rand SF-36 BDI-II Profile of Mood States Perceived Stress Scale (PSS) Pittsburgh Sleep Quality Index (PSQI) Derogatis Interview for Sexual Function (DISF-SR)
(F) Female Version (M) Male Version
Food Cravings Questionnaire—State (FCQ-S) Food Craving Inventory (FCI-II) Eating Inventory Weight Efficacy Lifestyle Questionnaire (WEL) Multiaxial Assessment of Eating Disorder Symptoms (MAEDS) Body Shape Questionnaire (BSQ)
3 Insufficient time
seven days. 3 Which days do you consider the weekend, or nonwork days? Check boxes to indicate weekend or nonwork days. Starting with yesterday, record the following:
physical activity more, less, or about the same? Check only one box.
Date and time sample collection started: Record date and time using a 24-hour clock from 00:00 (midnight) to 23:59 (11:59). Do not record 24:00. Sample Complete? For each sample, check “Yes” if collection complete and “No” for partial collections. If Not Done, Reason: If sample not obtained, specify reason using the Not Done Codelist. Staff Initials: Record the initials of the staff person obtaining the samples. Core Temperature Staff initials: Record the initials of the staff person obtaining the measurement.
Date and Time of Sample Collection/Procedure: Record start and stop dates and times. If Not Done, Reason: If sample not obtained, specify reason using the Not Done Codelist.
Inpatient Admission and Discharge 1 Inpatient admission date and time: Record date and time of admission.
2 Inpatient discharge date and time: Record date and time of discharge.
Staff initials: Record the initials of the staff person obtaining the measurement. Clinic weight: Record 2 weight measurements. Obtain a 3rd measurement if the 2 measurements are > 0.1 kg apart. Obtain and record gown weight. Pregnancy Test Complete this section for female participants only.
Record date of DXA scan and DXA rescan, if applicable. Check all areas scanned. If an area is not scanned, specify reason using the Not Done Codelist. Metabolic Rate Date of Collection: Record date of resting metabolic rate measurement.
If Not Done, Reason: Specify reason using the Not Done Codelist.
Staff initials: Record the initials of the staff person obtaining the measurement.
Cart ID: Select the assigned cart ID that was used to administer the test.
Not Done Codelist
Seven-Day Physical Activity Recall (PAR) Record today’s date and check 1 box to indicate the day of the week. If not done, specify reason using the Not Done Codelist. Interviewer initials: Record the initials of the test administrator (study coordinator or designated backup). 1 Were you employed in the last seven days? If “No,” skip to question 3. 2 If Yes: Which days: Check all boxes that apply to indicate days worked in the last
seven days. 3 Which days do you consider your weekend, or non-work days? Check boxes to indicate weekend or non-work days. Starting with yesterday, record the following:
Seven-Day Physical Activity Recall (PAR) (continued) 4 Compared to your physical activity over the past three months, was last week’s physical
activity more, less, or about the same? Check only one box.
Month 9 Submission
measurements are > 1.0 cm apart. 2 Umbilical point waist measurement: Record 2 measurements. Obtain a 3rd measurement if the
2 measurements are > 1.0 cm apart. 3 Pulse: Record measurement after obtaining at rest for a full minute. 4 Temperature: Record oral temperature in centigrade only. 5 Respirations: Record measurement after obtaining at rest for a full minute. 6 Blood pressure: Specify which arm was used to obtain measurement. If measurement not
obtained, do not record any information in 6a-6c.Specify reason, using the Not Done Codelist. Not Done Codelist
Month 9 Submission
Findings: Check one finding as assessed by the study physician, not as described by the computerized ECG analysis. Clinically significant abnormalities should be recorded on the AE page. Staff Initials: Record the initials of the staff person performing the measurement. Safety Labs Date and time of last meal: Record date and time of last meal prior to sample collection. Date and time of sample collection: Record the date and time of obtaining the blood and urine samples. Sample Complete? For each sample, check “Yes” if collection complete and “No” for partial collections. If Not Done, Reason: If sample not obtained, specify reason using the Not Done Codelist. Staff Initials: Record the initials of the staff person obtaining the samples.
Month 9 Submission
Questionnaire
BDI-II
For each questionnaire: Record the date completed or if not done, specify the reason using the Not
Done Codelist. Participant must initial each page. Refer to instructions provided with the test. Additional instructions are not
3 Insufficient time
Month 12 Submission Visit 1
measurements are > 1.0 cm apart. 2 Umbilical point waist measurement: Record 2 measurements. Obtain a 3rd measurement if the
2 measurements are > 1.0 cm apart. 3 Pulse: Record measurement after obtaining at rest for a full minute. 4 Temperature: Record oral temperature in centigrade only. 5 Respirations: Record measurement after obtaining at rest for a full minute. 6 Blood pressure: Specify which arm was used to obtain measurement. If measurement not
obtained, do not record any information in 6a-6c.Specify reason, using the Not Done Codelist. Not Done Codelist
Findings: Check one finding as assessed by the study physician, not as described by the computerized ECG analysis. Clinically significant abnormalities should be recorded on the AE page. Staff Initials: Record the initials of the staff person performing the measurement. Safety Labs Date and time of last meal: Record date and time of last meal prior to sample collection. Date and time of sample collection: Record the date and time of obtaining the blood and urine samples. Sample Complete? For each sample, check “Yes” if collection complete and “No” for partial collections. If Not Done, Reason: If sample not obtained, specify reason using the Not Done Codelist. Staff Initials: Record the initials of the staff person obtaining the samples. Not Done Codelist
Pregnancy Test Complete this section for female participants only.
Doubly Labeled Water (DLW) 1 Date and time of DLW dosing: Record the date and time dosing took place. If dosing not done,
specify reason using the Not Done Codelist.
mixture bottle. 3 Exact weight of DLW mixture: Record the exact weight of the DLW mixture to the nearest 0.01
gm. 4 Urine samples: The date and time collected refers to the set of urine samples collected over the

Documents

Case Report Form Instructions