Page 320 of CRF Annotated - Calerie |

WEIGHT (TYPE 4)

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DATEHDR (TYPE 4)

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CALERIE PHASE2 ANNOTATION V3.0 31AUG2007

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FORM/BLOCK = MONTH 9

SAFETYLB (TYPE 4)

ECG (TYPE 4) DATEHDR (TYPE 4)

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CALERIE PHASE2 ANNOTATION V8.0 24FEB2012

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OUTCME2 (TYPE 4)

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BDIQ (TYPE 4)



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BDIQ (TYPE 4)


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BDIQ (TYPE 4)


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POMS (TYPE 4)PS

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PSQI1(TYPE 4)


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DISFEM3 (TYPE 4)PS



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DISMALE1 (TYPE 4)PS

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DISMALE1 (TYPE 4)PS

DISMALE2 (TYPE 4)PS

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DISMALE3 (TYPE 4)PS


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FCQSTATE (TYPE 4)PS

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DATEHDR (TYPE 4)

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CRAVE (TYPE 4)PS


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TFEQA (TYPE 4)PS


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MAEDS (TYPE 4)PS


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BSQ (TYPE 4)PS


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HEPA<XYES> HEPVAC<TUHVAC>

HEPSPEC V:30

HEPLOT V:20 TD<XYES>

TETVAC<TUTVAC>

TETSPEC V:30

TETLOT V:20 PV<XYES>

PNEUVAC<TUPVAC>

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HEPDOS<TUHDOS>

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ADD CARTID TO RMR PANEL

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CALERIE PHASEE2 ANNOTATION V8.0 24FEB2012

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CALERIE PHASE2 ANNOTATION V3.0 31AUG2007

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CALERIE PHASEE2 ANNOTATION V8.0

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BDIQ (TYPE 4)

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PSS (TYPE 4)


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TIM

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TUTMPT Codelist

1 = Baseline 1

2 = Baseline 2

3 = Month 1

4 = Month 3

5 = Month 6

6 = Month 9

7 = Month 12

8 = Month 18

9 = Month 24


PAGEID = 281


TIMEPT<TUTMPT> include on CONMED2 panel

CONMED1 (TYPE 4)PS

CONMED2 (TYPE 4)R

SUPSTRDT SUPSTPDT

CMED<V:110>

CMSTRDT

CMPSTDY<XYES>

CMSTPDT

CMEDCONT<XYES>

MEDIND<V:110>

WHODRUG_ATC_B2

ATCTERM<V:110>

ATCCODE<V:40>

WORKFLO2<V:5>

CODETM2 <DATETIME>

CONFLVL2<V:2>

MATCHES2<V:4>

CODER2<V:20>

WHODRUG_B2

WHONAME<V:80>

WHOCODE <V:32>

WORKFLOW <V:5>

CODER <V:20>

CODETM<DATETIME>

CONFLVL <V:2>

MATCHES <V:4>

FORM/BLOCK = CONMED LOG

=

=

CMEDNUM<I:2>

Derivation for CONMED1 WHOTERM WHOCODE

Vitamins 90005301001

Calcium 00751501001

STUDYSUP<TUMED>

SEE PAGE 281A

THIS IS A REPEATING PAGE

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CONMED2 (TYPE 4)R

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SUPSTPDT

SUPSTRDT

STUDYSUP<TUMED>

3 =

PAGEID = 281

FORM/BLOCK = CONMED LOG

SAME AS PAGE 281

Derivation for CONMED1 WHOTERM WHOCODE

Calcium 00751501001


PAGEID = 282


SAEFORM (TYPE 4)R SAEDIAG<V:100>

SAESTRDT

SAESTPDT

DEATH ALL <XYES>

LIFETHRT DISINCAP

PRLGHOSP

CONGDEF

OTHRSIG

SAECAUS<TUCAUS>

SAEINTEN<TUTEN>

SAEOTCME<TUOCME>

ACNONE ACTEMPD ACMEDREQ ACPERMD

ACOTHR ACOTHSP <V:50>

SAETYPE<TURPTP>

ADDITIONAL PANEL ITEM ON PAGE

284._

FORM/BLOCK = ADVERSE EVENTS

MEDRA

MEDRTEXT<V:100>

MEDRCODE<V:8>

WORKFLOW<V:5>

CODETM<DATETIME>

CONFLVL<V:2>

MATCHES<V:4>

CODER<V:20>

DEATHDT


THIS PAGE NOT ENTERED


SAESUMRY<V:150>

CONTINUED FROM PAGE 282

NOT DATABASED


PAGEID = 285


REPORTDT

THRESDT

HEIGHT

WEIGHT1

CALBMI1

CALBMI2

WEIGHT2

FLWUPDT

TMPDIS<XYESNO>

EXPLAIN<V:50>

PERMDIS<XYESNO>

PERMRSN<TUBMI> EXPLNOTH<V:50>

WGHTLOSS (TYPE 4)

FORM/BLOCK = SURVEILLANCE

All measurements

<F:9:3>

NOT DATABASED


PAGEID = 287


TMPDIS<XYESNO>

EXPLAIN<V:50>

TMPRSN<TUBDI>

REPORTDT

INELEVDT

INITBDI <I:3>

REPBDI <I:3>

REPBDIDT

FLWUPDT

FLWUPBDI<I:3> ADDITIONAL PANEL ITEMS NEXT

PAGE

DEPRESS (TYPE 4)

NOT DATABASED


PERMDIS<XYESNO>

PERMRSN<TUDEPR>

EXPLAIN2<V:50>


NOT DATABASED


PAGEID = 289


EDISORD (TYPE 4)

REPORTDT

BINEAT

RESEAT

FEARFAT

PURGE

AVOID

DEPRESN

ALL<I:3>

CBSSCALE

IBSSCALE

EBSSCALE

ALL 3 <XYESNO> CBSCORE

IBSCORE

ALL <XYESNO>

ANERVOSA

BNERVOSA

BINGE

SUBTHRES

ADDITIONAL PANEL ITEMS NEXT

PAGE

ALL<I:3>

NOT DATABASED



PERMDIS<XYESNO>

PERMRSN<TUDISO>

EXPLAIN<V:50>

NOT DATABASED


PAGEID = 291


ELEVATEK (TYPE 4) REPORTDT

INELEVDT

KLEVEL1

CONFRMDT

KLEVEL2

TMPDIS<XYESNO>

EXPLAIN<V:50>

TMPRSN<TUELPM>

FLWUPDT

KLEVEL3

ADDITIONAL PANEL ITEMS NEXT

PAGE

All measurements

<F:9:3>

NOT DATABASED



PERMDIS<XYESNO>

PERMRSN<TUELVN>

EXPLAIN2<V:50>

NOT DATABASED


PAGEID = 293


ANEMIA1 (TYPE 4)

REPORTDT

LABDT

ALL<XYESNO>

GLOBLLN1

CRITLLN1

RBCLLN1

IRONLLN1

HGLOB1

HCRIT1

RBC1

IRON1

ALL<XYESNO>

GLOBLLN2

CRITLLN2

RBCLLN2

IRONLLN2

HGLOB2

HCRIT2

RBC2

IRON2

BLCRITDT

FUCRITDT

BLCRIT

FLUPCRIT

DECREASE

REPTLBDT

All measurements

<F:9:3> NOT DATABASED

NOT DATABASED

PAGEID = 294


ALL<XYESNO>

GLOBLLN3

CRITLLN3

RBCLLN3

IRONLLN3

HGLOB3

HCRIT3

RBC3

IRON3

MEDHELP<XYESNO>

HELPRSN<TUHELP>

HLPOTHSP<V:50>

ANEMIA2 (TYPE 4)

TMPDIS<XYESNO>

EXPLAIN<V:50>

TMPRSN<TUANEP>


All measurements

<F:9:3>

FUMTH1DT

PAGEID = 295


ANEMIA3 (TYPE 4)

ALL<XYESNO>

GLOBLLN4

CRITLLN4

RBCLLN4

IRONLLN4

HGLOB4

HCRIT4

RBC4

IRON4

FUMTH2DT

PERMDIS<XYESNO>

PERMRSN<TUANEQ>

EXPLAIN2<V:50>


All measurements

<F:9:3>

NOT DATABASED


PAGEID = 296


ISCHEMIA (TYPE 4)

REPORTDT

VOMAXDT

TMPDIS<XYESNO>

EXPLAIN<V:50>

PERMDIS<XYESNO>

PERMRSN<TUVENT>

EXPLAIN2<V:150>

STRESSDT

ISCHEMIA<XYESNO>

NOT DATABASED


PAGEID = 298


TEMPDISC (TYPE 4) TMPDISDT

DISCTYPE<TURPTP>

TEMPRSN<TUTEMP>

PERSONAL<V:50>

TEMPOTHR<V:50>

ADDITIONAL PANEL ITEM NEXT

PAGE

FORM/BLOCK = DISCONTINUATION



RESUMEDT

NOT DATABASED

PAGEID = 300


PERMDISC (TYPE 1) PRMDISDT

PERMRSN<TUPERM>

PERSONAL<V:50>

PERMOTHR<V:50>

NOT DATABASED

CALERIE PHASE2 ANNOTATION V4.012JUN2008


PAGEID = 302


STDYCOMP (TYPE 1)

STENDDT

STDCOMP<XYESNO>

LSTCONDT

REASON<TUEND>

DEATHDT

NOCOMPSP<V:50>

FORM/BLOCK = STUDY COMPLETION

TH

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HW

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GD

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HW

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HT

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FO

RM

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CK

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E W

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HT

LO

G

NO

T D

AT

AB

AS

ED


PAGEID = 304


TIMEPT<TUTMPT>

PDEVIATE (TYPE 4)R

DEVDT

DEVEXPLN<V:150>

CONSENT

INEXCL

RANDOM

CONMED

STUDYLAB LABEXPLN<V:50>

NONFAST

SAFETY SAFEXPLN<V:50>

OTHER OTHEREXP<V:50>

ALL<XYES>

FORM/BLOCK = PROTOCOL DEVIATION

Center Number __ __ Participant Number __ __ __ __

End of CR Survey

I was helped in following my CR

prescription by...

Strongly Agree

Agree Agree

Somewhat

Neither Agree Nor

Disagree

Disagree Somewhat

Disagree Strongly Disagree

Not Applicable

1. ...feeling prepared by

what I was told about the

intervention requirements

before I started the study.

2. …being provided my meals during the in-feeding

period

3. …trying the Mediterranean diet during the

in-feeding period.

4. …trying the Low Glycemic diet during the

in-feeding period.

5. …trying the Low-fat High

fiber diet during the in-feeding

period.

6. …being trained on

portion sizes during the first

few weeks of the study.

7. … using a system (like

HMR) to memorize estimated calories.

CALSRVY (TYPE 1)

ALL<TUTOOL>

PREREQ

MEALS

MEDDIET

LOWGLYC

LOWFAT

PORTION

HMRSYS

PROTOCOL = CALERIE_PHASE2

STUDYBOOK = END OF CR SURVEY

FORM = SURVEY




prescription by...

Strongly Agree

Agree Agree

Somewhat

Neither Agree Nor

Disagree

Disagree Somewhat


Not Applicable

8. …being provided

recipes by the staff.

9. …being provided meal

plans by the staff.

10. …changing which food

groups I include in my meals and

snacks.

11. …changing my eating

patterns (how many times I eat

a day).

12. …trying to use a

Volumetrics approach (i.e.,

eating low-calorie foods of high volume), in

order to feel fuller on my

calorie prescription.

13. …weighing in at my sessions.

14. …weighing myself at home.

RECIPES

STAFMEA

FOODCHG

EATPATT

VOLUMET

WEIGHIN

HOMEWGT




prescription by...

Strongly Agree

Agree Agree

Somewhat

Neither Agree Nor

Disagree

Disagree Somewhat


Not Applicable

15. …using the weight zone

graph.

16. …self-monitoring my calorie intake using a PDA.

17. …self-monitoring my calorie intake

using a computer program.

18. …self-monitoring my calorie intake using a paper

record.

19. ...individual sessions with

my counselors.

20. …written materials and

handouts I received during

individual sessions.

21. …having extra contacts by phone with my counselors.

22. …having extra contacts by email with

my counselors.

WGTGRPH

USEPDA

COMPUTR

PAPEREC

COUNSLR

HANDOUT

XTRPHON

XTREMAI




prescription by...

Strongly Agree

Agree Agree

Somewhat

Neither Agree Nor

Disagree

Disagree Somewhat


Not Applicable

23. … having extra contacts in-person with my counselors.

24. …attending group sessions.

25. …written materials and

handouts I received at

group sessions.

26. …using behavioral

contracts with my counselors.

27. …seeking social support

of family or friends.

28. …being provided meal replacements.

29. …decreasing the frequency of

eating out.

30. …increasing fiber in my diet.

INPRSON

GRPSESS

GRPHAND

BEHAVE

SOCSUPP

REPLACE

EATOUT

HIGHFIB




prescription by...

Strongly Agree

Agree Agree

Somewhat

Neither Agree Nor

Disagree

Disagree Somewhat


Not Applicable

31. …returning to in-feeding later in the

study (after the first in-feeding)

32. ...having

flexible options and strategies to assist my CR (instead of one

structured program for everyone).

33. ...being given some of my

results during the 2 years,

such as my total calories

expended and how it related to

my CR goal.

INFEED

FLEXOPT

CRGOAL



Now that you have finished the CALERIE trial, you may or may not choose to continue to follow a CR diet on your own.

Based on how you feel now, please answer these questions about your diet behavior after you finish CALERIE.

Strongly

Agree Agree

Agree Somewhat

Neither Agree Nor Disagree

Disagree Somewhat


34. After leaving CALERIE, I will

continue to follow a CR diet.

To A Great

Extent

Somewhat

Undecided

Very Little

Not At All

35. I plan to continue to follow my current level of

CR …

POSTCR

CRLEVEL<TULEV>


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