Preventing Postpartum Depression: Exercise as Medicine
Phase: NA
Conditions: Postpartum Depression
Sponsor: Kaiser Permanente

 
 
Pr e v e nti n g P o st p art u m D e pr e s si o n: E x er ci s e i s M e di ci n e  
N C T 0 4 4 1 4 6 9 6  
O ct o b er 2 1, 2 0 2 0  
 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
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I N S T R U C TI O N S:  
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Please e ns ure y o u are usi n g t he m ost rece nt versi o n a vaila ble i n I R B Net.  
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If y o u are c o n d ucti n g  a data-o nl y st u d y wit h n o pr os pecti ve or i nter ve nti o nal c o m p o ne nts, use t he Data 
O nl y Pr ot oc ol Te m plate i nstea d . 
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T his Pr ot oc ol Te m plate is t o be use d i n c o nj u ncti o n wit h t he S M A R T  K P I R B C ore Data F or m.  
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E nter y o ur res p o nses t o eac h q uesti o n directl y bel o w t he B L U E te xt i n t he filla ble fiel d. 
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W he n c o m pleti n g t his Pr ot oc ol Te m plate, if a secti o n d oes n ot a p pl y t o y o ur st u d y t he n e nter “ N/ A.”  
 
1.  Pr ot oc ol  
Pr ot oc ol Title  
 
Pr e v e nti n g P o st p art u m D e pr e s si o n: E x er ci s e a s M e di ci n e  
 
Pri nci pal I n vesti gat or  
 
L y n d s a y A v al o s, P h D, M P H  
 
Versi o n Date  
 
1 0/ 2 1/ 2 0 2 0  
 
F or m A ut h or  
 
Cr y st al H si a o  
 
2.  O bjecti ves  
Descri be i n plai n la n g ua ge t he p ur p ose, s pecific ai ms, or o bjecti ves a n d i n dicate t he pri mar y g oal(s) of t he 
st u d y (e. g. safet y, t olera bilit y, effecti ve ness, feasi bilit y, pil ot st u d y, etc.).  State t he h y p ot heses t o be 
teste d. State pri mar y a n d a n y sec o n dar y st u d y e n d p oi nts. 
 
T h e p ur p o s e of t hi s st u d y i s t o a d dr e s s a hi g h pri orit y ar e a of t h e K P -N B A E x er ci s e a s M e di ci n e 
i niti ati v e a n d t h e criti c al n e e d f or e vi d e n c e-b a s e d i nt er v e nti o n s f or i n cr e a si n g p h y si c al a cti vit y  
( P A) a n d pr e v e nti n g p o st p art u m d e pr e s si o n  ( P P D) t h at d o n ot i n v ol v e i nt e n s e h e alt h c ar e 
s y st e m r e s o ur c e s  t hr o u g h t h e ai m s b el o w.  T hi s st u d y will al s o i d e ntif y a cti o n a bl e a v e n u e s f or 
i m pl e m e nt ati o n of t hi s e H e alt h P A i nt er v e nti o n at K P N C a n d p ot e nti all y ot h er K P r e gi o n s i n t h e 
f ut ur e. 
 
Ai m 1. C o n d u ct a n eff e cti v e n e s s tri al of M o m Zi n g, a n e H e alt h P A i nt er v e nti o n, i n w o m e n at 
i n cr e a s e d ri s k of p o st p art u m d e pr e s si o n ( P P D) f or a) i n cr e a si n g P A a n d b) d e cr e a si n g 
d e pr e s si v e s y m pt o m s . 
 
Ai m 2 . E v al u at e pr o c e d ur e s f or i m pl e m e nt ati o n of M o m Zi n g  at K P N C.   W e will u s e t h e R E -AI M 
fr a m e w or k (R e a c h, E ff e cti v e n e s s, A d o pti o n, Im pl e m e nt ati o n, M ai nt e n a n c e) t o e v al u at e 
pr o c e d ur e s f or i m pl e m e nt ati o n of M o m Zi n g i n cl u di n g d o c u m e nt ati o n of w e b a c c e s s t o M o m Zi n g 
e x er ci s e vi d e o s ( w e b sit e a n al yti c s), pr o c e s s m e a s ur e s ( p arti ci p a nt s ati sf a cti o n  wit h t h e 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
3  
i nt er v e nti o n), a n d q u alit ati v e i nt er vi e w s wit h K P N C cli ni c al st aff ( b arri er s t o 
a d o pti o n/ m ai nt e n a n c e).  
 
E x pl or at o r y Ai m 1: A s s e s s t h e i m p a ct of M o m Zi n g o n  i m pr o vi n g m at er n al o ut c o m e s ( e. g. 
p o st p art u m d e pr e s si o n di a g n o s e s, a n xi et y, str e s s, sl e e p, m e di c al c o n diti o n s, s u b st a n c e u s e, 
h e alt h c ar e utili z ati o n) a n d i nf a nt o ut c o m e s ( e. g. gr o wt h a n d d e v el o p m e nt, h e alt h c ar e 
utili z ati o n).  D e s cri b e m at er n al a n d i nf a nt c h ar a ct eri sti c s a s s o ci at e d wit h gr e at er l e v el s of 
e n g a g e m e nt/ u s e of t h e M o m Zi n g i nt er v e nti o n.  
 
E x pl or at or y Ai m 2:  I d e ntif y m e di at or s a n d m o d er at or s  ( e. g. pr e vi o u s p h y si c al a cti vit y, m at er n al 
i nf a nt b o n di n g, p er c ei v e d b arri er s t o p h y si c al a cti vit y, s o ci al s u p p ort) i n t h e r el ati o n s hi p b et w e e n 
M o m Zi n g a n d m at er n al a n d i nf a nt o ut c o m e s ( a s li st e d a b o v e).  
 
E x pl or at or y Ai m 3 : A s s e s s r el ati o n s hi p s b et w e e n e x er ci s e a n d ot h er h e alt h b e h a vi or s (e. g. 
sl e e p, sitti n g, s u b st a n c e u s e, s m o ki n g) a n d m at er n al a n d i nf a nt o ut c o m e s.  
 
3.  B ac k gr o u n d  
a. Scie ntific Bac k gr o u n d  
Pr o vi de t he scie ntific or sc h olarl y bac k gr o u n d f or, rati o nale f or, a n d si g nifica nce of t he researc h base d o n 
t he e xisti n g literat ure a n d h o w will it a d d t o e xisti n g k n o wle d ge. A list of refere nces or bi bli o gra p h y m ust 
be i ncl u de d as part of t his d oc u me nt o r u pl oa de d se paratel y. 
 
N e arl y 2 0 % of p o st p art u m w o m e n s uff er fr o m p o st p art u m d e pr e s si o n ( P P D), a lif e -t hr e at e ni n g, 
d e bilit ati n g a n d c o stl y m o o d di s or d er t h at e m er g e s wit hi n a y e ar of d eli v er y. 4 0 -4 2  P P D  h a s a 
s u b st a nti al i m p a ct o n t h e h e alt h of m ot h er a n d c hil d i n cl u di n g n e g ati v e m at er n al -i nf a nt 
i nt er a cti o n,4 3  l o w er li k eli h o o d of br e a stf e e di n g,4 4, 4 5  a n d c o m pl eti n g r e c o m m e n d e d 
i m m u ni z ati o n s.4 5  P P D i s al s o a s s o ci at e d wit h c hil d b e h a vi or al pr o bl e m s 7, 4 5  a n d p o or er c o g niti v e 
d e v el o p m e nt. 4 6 -4 8  Th e n ati o n al h e alt h c ar e c o st s a s s o ci at e d wit h P P D i n 2 0 1 7 w er e e sti m at e d at 
$ 2. 9 billi o n f or m ot h er s a n d $ 4. 9 billi o n f or t h eir c hil dr e n. 1 3  I m p ort a ntl y, t h e U S Pr e v e nti v e 
S er vi c e s T a s k F or c e  r e c o g ni z e d t h at P P D i s pr e v e nt a bl e a n d i s s u e d a r e c o m m e n d ati o n t o r ef er 
w o m e n at i n cr e a s e d ri s k of P P D (t h o s e wit h a hi st or y of d e pr e s si o n pri or t o pr e g n a n c y or at 
l e a st m o d er at e p o st p art u m d e pr e s si v e s y m pt o m s t h at d o n ot m e et t h e di a g n o sti c t hr e s h ol d f or 
P P D) t o c o u n s eli n g s er vi c e s. 1 6  O ur t e a m r e s p o n d e d i n a J A M A P e di atri c s E dit ori al 1 7  hi g hli g hti n g 
t h e ur g e nt n e e d t o i d e ntif y ot h er e vi d e n c e-b a s e d pr e v e nti v e i nt er v e nti o n s, s u c h a s P A 
i nt er v e nti o n s, t h at m a y n ot i n v ol v e i nt e n s e h e alt h c ar e s y st e m r e s o ur c e s. 
 
Str o n g e vi d e n c e s u g g e st s p o st p art u m P A i s eff e cti v e i n pr e v e nti n g P P D; 1 8 -2 1, 4 9, 5 0  h o w e v er, 
s e v er al b arri er s t o P A k e e p p o st p art u m w o m e n fr o m b ei n g p h y si c all y a cti v e.  T h e P A G ui d eli n e s 
f or A m eri c a n s,2 4  t h e A m eri c a n C oll e g e of S p ort s M e di ci n e,5 1  a n d t h e A m eri c a n C oll e g e of 
O b st etri ci a n s a n d G y n e c ol o gi st s 2 3  r e c o m m e n d p arti ci p ati o n i n r e g ul ar P A ( at l e a st 1 5 0 mi n ut e s 
of m o d er at e t o vi g or o u s i nt e n sit y p er w e e k) f or p o st p art u m w o m e n. D e s pit e t h e s e 
r e c o m m e n d ati o n s, P A l e v el s i n p o st p art u m w o m e n r e m ai n l o w: o nl y o n e t hir d of p o st p art u m 
w o m e n r e p ort b ei n g r e g ul arl y p h y si c all y a cti v e i n t h e y e ar aft er d eli v er y. 2 8 -3 0  L o w p o st p art u m 
r at e s of P A c o ntri b ut e t o p o st p art u m w ei g ht r et e nti o n, o v er w ei g ht, a n d o b e sit y.5 2, 5 3  W e 
c o n d u ct e d f o c u s gr o u p s a m o n g K P N C m e m b er s wit h P P D a n d f o u n d si mil ar b arri er s t o P A 
d uri n g t h e p o st p art u m p eri o d a s h a s b e e n r e p ort e d b y ot h er s: l a c k of ti m e a n d pri oriti z ati o n of 
ot h er r e s p o n si biliti e s, diffi c ult y fi n di n g a c c e s si bl e a n d aff or d a bl e P A pr o gr a m s a n d cl a s s e s, l a c k 
of c hil d c ar e, a n d l a c k of m oti v ati o n a n d s o ci al s u p p ort. 5 4 -5 7  M o st pr e vi o u s P A i nt er v e nti o n s i n 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
4  
p o st p art u m w o m e n h a v e r eli e d o n i n -p er s o n e x er ci s e gr o u p s al o n e or i n c o m bi n ati o n wit h 
i n di vi d u al i n-p er s o n or t el e p h o n e -b a s e d h e alt h c o a c hi n g. 1 8, 1 9  T h e s e a p pr o a c h e s d o n ot a d dr e s s 
t h e b arri er s t o b ei n g p h y si c all y a cti v e i d e ntifi e d i n p o st p art u m w o m e n. 
 
T e c h n ol o g y -b a s e d ( e H e alt h) i nt er v e nti o n s ar e a pr o mi si n g a p pr o a c h t o i n cr e a si n g P A l e v el s t h at 
a d dr e s s b arri er s r ai s e d b y p o st p art u m w o m e n. N e w m ot h er s ar e fr e q u e nt u s er s of t e c h n ol o g y 
a n d w el c o m e e H e alt h i nt er v e nti o n s. 5 8, 5 9  e H e alt h P A i nt er v e nti o n s h a v e d e m o n str at e d 
eff e cti v e n e s s i n i n cr e a si n g P A i n g e n er al p o p ul ati o n s. 3 1, 3 2  I n a d diti o n, M o m Zi n g, a n e H e alt h 
i nt er v e nti o n t ail or e d t o p o st p art u m w o m e n, w a s eff e cti v e i n i n cr e a si n g t h e pr o p orti o n of 
p o st p art u m w o m e n m e eti n g n ati o n al P A g ui d eli n e s. 3 3  M o m Zi n g w a s  d e v el o p e d b y e x er ci s e 
p h y si ol o gi st s a n d b e h a vi or al m e di ci n e s p e ci ali st s a n d a d dr e s s e s a c c e s si bilit y, aff or d a bilit y, ti m e 
c o n str ai nt s, a n d c hil d c ar e c o n c er n s.  
 
R E F E R E N C E S  
 
1.  
H or o wit z J A, G o o d m a n J. A l o n git u di n al st u d y of m at er n al p o st p art u m d e pr e s si o n s y m pt o m s. 
R e s T h e or y N ur s Pr a ct. 2 0 0 4; 1 8( 2 -3): 1 4 9 -1 6 3.  
2.  
K u m ar R, R o b s o n K M. A pr o s p e cti v e st u d y of e m oti o n al di s or d er s i n c hil d b e ari n g w o m e n. Br J 
P s y c hi atr y. 1 9 8 4; 1 4 4: 3 5 -4 7.  
3.  
D a vi d s o n J, R o b ert s o n E. A f oll o w -u p st u d y of p o st p art u m ill n e s s, 1 9 4 6 -1 9 7 8. A ct a P s y c hi atr 
S c a n d. 1 9 8 5; 7 1( 5): 4 5 1 -4 5 7.  
4.  
C o o p er P J, M urr a y L. C o ur s e a n d r e c urr e n c e of p o st n at al d e pr e s si o n. E vi d e n c e f or t h e 
s p e cifi cit y of t h e di a g n o sti c c o n c e pt. Br J P s y c hi atr y. 1 9 9 5; 1 6 6( 2): 1 9 1 -1 9 5.  
5.  
U d d e n b er g N, E n gl e s s o n I. Pr o g n o si s of p o st p art u m m e nt al di st ur b a n c e. A pr o s p e cti v e st u d y of 
pri mi p ar o u s w o m e n a n d t h eir 4 1/ 2 -y e ar -ol d c hil dr e n. A ct a P s y c hi atr S c a n d. 1 9 7 8; 5 8( 3): 2 0 1 -
2 1 2.  
6.  
St ei n A, G at h D H, B u c h er J, B o n d A, D a y A, C o o p er P J. T h e r el ati o n s hi p b et w e e n p o st -n at al 
d e pr e s si o n a n d m ot h er -c hil d i nt er a cti o n. Br J P s y c hi atr y. 1 9 9 1; 1 5 8: 4 6 -5 2.  
7.  
M urr a y L. T h e i m p a ct of p o st n at al d e pr e s si o n o n i nf a nt d e v el o p m e nt. J o ur n al of c hil d 
p s y c h ol o g y a n d p s y c hi atr y, a n d alli e d di s ci pli n e s. 1 9 9 2; 3 3( 3): 5 4 3 -5 6 1.  
8.  
St ei n A, M al m b er g L E, S yl v a K, B ar n e s J, L e a c h P, t e a m** F. T h e i nfl u e n c e of m at er n al 
d e pr e s si o n, c ar e gi vi n g, a n d s o ci o e c o n o mi c st at u s i n t h e p o st -n at al y e ar o n c hil dr e n' s l a n g u a g e 
d e v el o p m e nt. C hil d C ar e H e alt h D e v. 2 0 0 8; 3 4( 5): 6 0 3 -6 1 2.  
9.  
H a y D F, P a wl b y S, S h ar p D, A st e n P, Mill s A, K u m ar R. I nt ell e ct u al pr o bl e m s s h o w n b y 1 1 -
y e ar -ol d c hil dr e n w h o s e m ot h er s h a d p o st n at al d e pr e s si o n. J C hil d P s y c h ol P s y c hi atr y. 
2 0 0 1; 4 2( 7): 8 7 1 -8 8 9.  
1 0.  
Gr a c e S L, E vi n d ar A, St e w art D E. T h e eff e ct of p o st p art u m d e pr e s si o n o n c hil d c o g niti v e 
d e v el o p m e nt a n d b e h a vi or: a r e vi e w a n d criti c al a n al y si s of t h e lit er at ur e. Ar c h W o m e n s M e nt 
H e alt h. 2 0 0 3; 6( 4): 2 6 3 -2 7 4.  
1 1.  
F ari a s -A nt u n e z S, X a vi er M O, S a nt o s I S. Eff e ct of m at er n al p o st p art u m d e pr e s si o n o n 
off s pri n g' s gr o wt h. J Aff e ct Di s or d. 2 0 1 8; 2 2 8: 1 4 3 -1 5 2.  
1 2.  
B al bi er z A, B o d n ar -D er e n S, W a n g J J, H o w ell E A. M at er n al d e pr e s si v e s y m pt o m s a n d 
p ar e nti n g pr a cti c e s 3 -m o nt h s p o st p art u m. M at er n C hil d H e alt h J. 2 0 1 5; 1 9( 6): 1 2 1 2 -1 2 1 9.  
1 3.  
L u c a D L, G arl o w N, St a at z C, M ar gi ott a C, Zi vi n K. S o ci et al C o st s of U ntr e at e d P eri n at al M o o d 
a n d A n xi et y Di s or d er s i n t h e U nit e d St at e s. M at h e m ati c a P oli c y R e s e ar c h. 2 0 1 9.  
1 4.  
L ei g h B, Mil gr o m J. Ri s k f a ct or s f or a nt e n at al d e pr e s si o n, p o st n at al d e pr e s si o n a n d p ar e nti n g 
str e s s. B M C P s y c hi atr y. 2 0 0 8; 8: 2 4.  

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
5  
1 5.  
N a ki c R a d o s S, H er m a n R, T a di n a c M. I s t h e Pr e di ct a bilit y of N e w -O n s et P o st p art u m 
D e pr e s si o n B ett er D uri n g Pr e g n a n c y or i n t h e E arl y P o st p art u m P eri o d ? A Pr o s p e cti v e St u d y i n 
Cr o ati a n W o m e n. H e alt h C ar e W o m e n I nt. 2 0 1 6; 3 7( 1): 2 3 -4 4.  
1 6.  
C urr y S J, Kri st A H, O w e n s D K, et al. I nt er v e nti o n s t o Pr e v e nt P eri n at al D e pr e s si o n: U S 
Pr e v e nti v e S er vi c e s T a s k F or c e R e c o m m e n d ati o n St at e m e nt. J a m a. 2 0 1 9; 3 2 1( 6): 5 8 0 -5 8 7.  
1 7.  
A v al o s L A, Fl a n a g a n T, Li D K. Pr e v e nti n g P eri n at al D e pr e s si o n t o I m pr o v e M at er n al a n d C hil d 
H e alt h -a H e alt h C ar e I m p er ati v e. J A M A P e di atr. 2 0 1 9.  
1 8.  
T e y c h e n n e M, Y or k R. P h y si c al a cti vit y, s e d e nt ar y b e h a vi or, a n d p o st n at al d e pr e s si v e 
s y m pt o m s: a r e vi e w. A m eri c a n j o ur n al of pr e v e nti v e m e di ci n e. 2 0 1 3; 4 5( 2): 2 1 7 -2 2 7.  
1 9.  
M c C ur d y A P, B o ul e N G, Si v a k A, D a v e n p ort M H. Eff e ct s of E x er ci s e o n Mil d -t o-M o d er at e 
D e pr e s si v e S y m pt o m s i n t h e P o st p art u m P eri o d: A M et a -a n al y si s. O b st etri c s a n d g y n e c ol o g y. 
2 0 1 7; 1 2 9( 6): 1 0 8 7 -1 0 9 7.  
2 0.  
P o y at o s -L e o n R, G ar ci a -H er m o s o A, S a n a bri a -M arti n e z G, Al v ar e z -B u e n o C, C a v er o -R e d o n d o 
I, M arti n e z-Vi z c ai n o V. Eff e ct s of e x er ci s e -b a s e d i nt er v e nti o n s o n p o st p art u m d e pr e s si o n: A 
m et a -a n al y si s of r a n d o mi z e d c o ntr oll e d tri al s. Birt h ( B er k el e y, C alif). 2 0 1 7; 4 4( 3): 2 0 0 -2 0 8.  
2 1.  
P h y si c al A cti vit y G ui d eli n e s A d vi s or y C o m mitt e e. S e cti o n F, C h a pt er 8. W o m e n W h o ar e 
Pr e g n a nt or P o st p art u m. W a s hi n gt o n, D. C: U. S. D e p art m e nt of H e alt h a n d H u m a n 
S er vi c e s; 2 0 1 8.  
2 2.  
M a m m e n G, F a ul k n er G. P h y si c al a cti vit y a n d t h e pr e v e nti o n of d e pr e s si o n: a s y st e m ati c r e vi e w 
of pr o s p e cti v e st u di e s. A m eri c a n j o ur n al of pr e v e nti v e m e di ci n e. 2 0 1 3; 4 5( 5): 6 4 9 -6 5 7.  
2 3.  
C o m mitt e e o n O b st etri c Pr a cti c e. A C O G c o m mitt e e o pi ni o n. E x er ci s e d uri n g pr e g n a n c y a n d t h e 
p o st p art u m p eri o d. N u m b er 2 6 7, J a n u ar y 2 0 0 2. A m eri c a n C oll e g e of O b st etri ci a n s a n d 
G y n e c ol o gi st s. I nt J G y n a e c ol O b st et. 2 0 0 2; 7 7( 1): 7 9 -8 1.  
2 4.  
U. S. P h y si c al A cti vit y G ui d eli n e s f or A m eri c a n s, 2 n d e diti o n.  W a s hi n gt o n, D C: U. S. D e p art m e nt 
of H e alt h a n d H u m a n S er vi c e s; 2 0 1 8.  
2 5.  
B or o d uli n K, E v e n s o n K R, H erri n g A H. P h y si c al a cti vit y p att er n s d uri n g pr e g n a n c y t hr o u g h 
p o st p art u m. B M C w o m e n' s h e alt h. 2 0 0 9; 9: 3 2.  
2 6.  
E v e n s o n K R, H erri n g A H, W e n F. S elf -R e p ort e d a n d o bj e cti v el y m e a s ur e d p h y si c al a cti vit y 
a m o n g a c o h ort of p o st p art u m w o m e n: t h e PI N P o st p art u m St u d y. J o ur n al of p h y si c al a cti vit y & 
h e alt h. 2 0 1 2; 9( 1): 5 -2 0.  
2 7.  
Ol s o n C M, Str a w d er m a n M S, Hi nt o n P S, P e ar s o n T A. G e st ati o n al w ei g ht g ai n a n d p o st p art u m 
b e h a vi or s a s s o ci at e d wit h w ei g ht c h a n g e fr o m e arl y pr e g n a n c y t o 1 y p o st p art u m. I nt er n ati o n al 
j o ur n al of o b e sit y a n d r el at e d m et a b oli c di s or d er s : j o ur n al of t h e I nt er n ati o n al A s s o ci ati o n f or 
t h e St u d y of O b e sit y. 2 0 0 3; 2 7( 1): 1 1 7 -1 2 7.  
2 8.  
H ull E E, R of e y D L, R o b ert s o n R J, N a gl e E F, Ott o A D, A ar o n D J. I nfl u e n c e of m arri a g e a n d 
p ar e nt h o o d o n p h y si c al a cti vit y: a 2 -y e ar pr o s p e cti v e a n al y si s. J o ur n al of p h y si c al a cti vit y & 
h e alt h. 2 0 1 0; 7( 5): 5 7 7 -5 8 3.  
2 9.  
Al bri g ht C, M a d d o c k J E, Ni g g C R. P h y si c al a cti vit y b ef or e pr e g n a n c y a n d f oll o wi n g c hil d birt h i n 
a m ulti et h ni c s a m pl e of h e alt h y w o m e n i n H a w aii. W o m e n & h e alt h. 2 0 0 5; 4 2( 3): 9 5 -1 1 0.  
3 0.  
P er eir a M A, Rif a s -S hi m a n S L, Kl ei n m a n K P, Ri c h -E d w ar d s J W, P et er s o n K E, Gill m a n M W. 
Pr e di ct or s of c h a n g e i n p h y si c al a cti vit y d uri n g a n d aft er pr e g n a n c y: Pr oj e ct Vi v a. A m eri c a n 
j o ur n al of pr e v e nti v e m e di ci n e. 2 0 0 7; 3 2( 4): 3 1 2 -3 1 9.  
3 1.  
C oti e L M, Pri n c e S A, Elli ott C G, et al. T h e eff e cti v e n e s s of e H e alt h i nt er v e nti o n s o n p h y si c al 
a cti vit y a n d m e a s ur e s of o b e sit y a m o n g w or ki n g -a g e w o m e n: a s y st e m ati c r e vi e w a n d m et a -
a n al y si s. O b e sit y r e vi e w s : a n offi ci al j o ur n al of t h e I nt er n ati o n al A s s o ci ati o n f or t h e St u d y of 
O b e sit y. 2 0 1 8; 1 9( 1 0): 1 3 4 0 -1 3 5 8.  
3 2.  
H a k al a S, Ri nt al a A, I m m o n e n J, K ar v a n e n J, H ei n o n e n A, Sj o gr e n T. Eff e cti v e n e s s of p h y si c al 
a cti vit y pr o m oti n g t e c h n ol o g y -b a s e d di st a n c e i nt er v e nti o n s c o m p ar e d t o u s u al c ar e. S y st e m ati c 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
6  
r e vi e w, m et a-a n al y si s a n d m et a -r e gr e s si o n. E ur o p e a n j o ur n al of p h y si c al a n d r e h a bilit ati o n 
m e di ci n e. 2 0 1 7; 5 3( 6): 9 5 3 -9 6 7.  
3 3.  
Al bri g ht C, Wil k e n s L, S ai ki K, T o m e A, M arti n R, D u n n A. I n cr e a si n g p h y si c al a cti vit y i n n e w 
m ot h er s vi a c u st o mi z a bl e o nli n e e x er ci s e vi d e o s: M o m Zi n g R e s ult s. A n n al s of B e h a vi or al 
M e di ci n e. 2 0 1 5; 4 9( S u p pl): S 8 9.  
3 4.  
Al bri g ht C, Wil k e n s L, S ai ki K, W hit e K, St eff e n A. M e di at or s of a 1 2 -m o nt h c h a n g e i n p h y si c al 
a cti vit y i n et h ni c all y di v er s e s a m pl e of p o st p art u m w o m e n. Tr a n sl ati o n al J o ur n al of t h e 
A m eri c a n C oll e g e of S p ort s M e di ci n e. I n pr e s s. 
3 5.  
Mi c hi e S, J o h n st o n M, A br a h a m C, L a wt o n R, P ar k er D, W al k er A. M a ki n g p s y c h ol o gi c al t h e or y 
u s ef ul f or i m pl e m e nti n g e vi d e n c e b a s e d pr a cti c e: a c o n s e n s u s a p pr o a c h. Q u alit y a n d S af et y i n 
H e alt h C ar e. 2 0 0 5; 1 4( 1): 2 6 -3 3.  
3 6.  
Mi c hi e S, At ki n s L, W e st R. T h e b e h a vi o ur c h a n g e w h e el: A g ui d e t o d e si g ni n g i nt er v e nti o n s.  
L o n d o n: Sil v er b a c k P u bli s hi n g; 2 0 1 4.  
3 7.  
C a n e J, O' C o n n or D, Mi c hi e S. V ali d ati o n of t h e t h e or eti c al d o m ai n s fr a m e w or k f or u s e i n 
b e h a vi o ur c h a n g e a n d i m pl e m e nt ati o n r e s e ar c h. I m pl e m e nt ati o n S ci e n c e. 2 0 1 2; 7: 3 7.  
3 8.  
Fl a n a g a n T, A v al o s L A. P eri n at al O b st etri c Offi c e D e pr e s si o n S cr e e ni n g a n d Tr e at m e nt: 
I m pl e m e nt ati o n i n a H e alt h C ar e S y st e m. O b st etri c s a n d g y n e c ol o g y. 2 0 1 6; 1 2 7( 5): 9 1 1 -9 1 5.  
3 9.  
A v al o s L A, R ai n e -B e n n ett T, C h e n H, A d a m s A S, Fl a n a g a n T. I m pr o v e d P eri n at al D e pr e s si o n 
S cr e e ni n g, Tr e at m e nt, a n d O ut c o m e s Wit h a U ni v er s al O b st etri c Pr o gr a m. O b st etri c s a n d 
g y n e c ol o g y. 2 0 1 6; 1 2 7( 5): 9 1 7 -9 2 5.  
4 0.  
A C O G C o m mitt e e O pi ni o n N o. 6 3 0: S cr e e ni n g f or p eri n at al d e pr e s si o n. O b st etri c s a n d 
G y n e c ol o g y. 2 0 1 5; 1 2 5( 5): 1 2 6 8 -1 2 7 1.  
4 1.  
G a vi n NI, G a y n e s B N, L o hr K N, M elt z er -Br o d y S, G artl e h n er G, S wi n s o n T. P eri n at al 
d e pr e s si o n: a s y st e m ati c r e vi e w of pr e v al e n c e a n d i n ci d e n c e. O b st etri c s a n d g y n e c ol o g y. 
2 0 0 5; 1 0 6( 5 Pt 1): 1 0 7 1 -1 0 8 3.  
4 2.  
G a y n e s B N, G a vi n N, M elt z er -Br o d y S, et al. P eri n at al d e pr e s si o n: pr e v al e n c e, s cr e e ni n g 
a c c ur a c y, a n d s cr e e ni n g o ut c o m e s. E vi d R e p T e c h n ol A s s e s s ( S u m m). 2 0 0 5( 1 1 9): 1 -8.  
4 3.  
B e c k C T. T h e eff e ct s of p o st p art u m d e pr e s si o n o n m at er n al -i nf a nt i nt er a cti o n: a m et a-a n al y si s. 
N ur si n g r e s e ar c h. 1 9 9 5; 4 4( 5): 2 9 8 -3 0 4.  
4 4.  
Gri g ori a di s S, V o n d er P ort e n E H, M a mi s a s h vili L, et al. T h e i m p a ct of m at er n al d e pr e s si o n 
d uri n g pr e g n a n c y o n p eri n at al o ut c o m e s: a s y st e m ati c r e vi e w a n d m et a -a n al y si s. T h e J o ur n al of 
cli ni c al p s y c hi atr y. 2 0 1 3; 7 4( 4): e 3 2 1 -3 4 1.  
4 5.  
O' H ar a M W, M c C a b e J E. P o st p art u m d e pr e s si o n: c urr e nt st at u s a n d f ut ur e dir e cti o n s. A n n u al 
r e vi e w of cli ni c al p s y c h ol o g y. 2 0 1 3; 9: 3 7 9 -4 0 7.  
4 6.  
Y o n k er s K A, Wi s n er K L, St e w art D E, et al. T h e m a n a g e m e nt of d e pr e s si o n d uri n g pr e g n a n c y: a 
r e p ort fr o m t h e A m eri c a n P s y c hi atri c A s s o ci ati o n a n d t h e A m eri c a n C oll e g e of O b st etri ci a n s a n d 
G y n e c ol o gi st s. O b st etri c s a n d g y n e c ol o g y. 2 0 0 9; 1 1 4( 3): 7 0 3 -7 1 3.  
4 7.  
Q u e v e d o L A, Sil v a R A, G o d o y R, et al. T h e i m p a ct of m at er n al p o st -p art u m d e pr e s si o n o n t h e 
l a n g u a g e d e v el o p m e nt of c hil dr e n at 1 2 m o nt h s. C hil d: c ar e, h e alt h a n d d e v el o p m e nt. 
2 0 1 2; 3 8( 3): 4 2 0 -4 2 4.  
4 8.  
M urr a y L, C o o p er P J. P o st p art u m d e pr e s si o n a n d c hil d d e v el o p m e nt. P s y c h ol o gi c al m e di ci n e. 
1 9 9 7; 2 7( 2): 2 5 3 -2 6 0.  
4 9.  
Prit c h ett R V, D al e y A J, J oll y K. D o e s a er o bi c e x er ci s e r e d u c e p o st p art u m d e pr e s si v e 
s y m pt o m s ? a s y st e m ati c r e vi e w a n d m et a -a n al y si s. T h e Briti s h j o ur n al of g e n er al pr a cti c e : t h e 
j o ur n al of t h e R o y al C oll e g e of G e n er al Pr a ctiti o n er s. 2 0 1 7; 6 7( 6 6 3): e 6 8 4 -e 6 9 1.  
5 0.  
D a v e n p ort M H, M c C ur d y A P, M ott ol a M F, et al. I m p a ct of pr e n at al e x er ci s e o n b ot h pr e n at al 
a n d p o st n at al a n xi et y a n d d e pr e s si v e s y m pt o m s: a s y st e m ati c r e vi e w a n d m et a -a n al y si s. Br J 
S p ort s M e d. 2 0 1 8; 5 2( 2 1): 1 3 7 6 -1 3 8 5.  

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
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5 1.  
A m eri c a n C oll e g e of S p ort s M e di ci n e. A C S M' s G ui d eli n e s f or E x er ci s e T e sti n g a n d Pr e s cri pti o n.  
1 0 e d. P hil a d el p hi a: W olt er s Kl u w er; 2 0 1 8.  
5 2.  
Mi ni g L, Tri m bl e E L, S ar s otti C, S e b a sti a ni M M, S p o n g C Y. B uil di n g t h e e vi d e n c e b a s e f or 
p o st o p er ati v e a n d p o st p art u m a d vi c e. O b st etri c s a n d g y n e c ol o g y. 2 0 0 9; 1 1 4( 4): 8 9 2 -9 0 0.  
5 3.  
O' T o ol e M L, S a wi c ki M A, Art al R. Str u ct ur e d di et a n d p h y si c al a cti vit y pr e v e nt p o st p art u m 
w ei g ht r et e nti o n. J o ur n al of w o m e n' s h e alt h ( 2 0 0 2). 2 0 0 3; 1 2( 1 0): 9 9 1 -9 9 8.  
5 4.  
L eif er m a n J, S wi b a s T, K oi n e s s K, M ar s h all J A, D u n n A L. M y b a b y, m y m o v e: e x a mi n ati o n of 
p er c ei v e d b arri er s a n d m oti v ati n g f a ct or s r el at e d t o a nt e n at al p h y si c al a cti vit y. J o ur n al of 
mi d wif er y & w o m e n' s h e alt h. 2 0 1 1; 5 6( 1): 3 3 -4 0.  
5 5.  
Al bri g ht C L, S ai ki K, St eff e n A D, W o e k el E. W h at b arri er s t h w art p o st p art u m w o m e n' s p h y si c al 
a cti vit y g o al s d uri n g a 1 2 -m o nt h i nt er v e nti o n ? A pr o c e s s e v al u ati o n of t h e N a Mi ki mi ki Pr oj e ct. 
W o m e n & h e alt h. 2 0 1 5; 5 5( 1): 1 -2 1.  
5 6.  
E v e n s o n K R, A yt ur S A, B or o d uli n K. P h y si c al a cti vit y b eli ef s, b arri er s, a n d e n a bl er s a m o n g 
p o st p art u m w o m e n. J o ur n al of w o m e n' s h e alt h ( 2 0 0 2). 2 0 0 9; 1 8( 1 2): 1 9 2 5 -1 9 3 4.  
5 7.  
S ali g h e h M, M c N a m ar a B, R o o n e y R. P er c ei v e d b arri er s a n d e n a bl er s of p h y si c al a cti vit y i n 
p o st p art u m w o m e n: a q u alit ati v e a p pr o a c h. B M C pr e g n a n c y a n d c hil d birt h. 2 0 1 6; 1 6( 1): 1 3 1.  
5 8.  
F er n a n d e z N, C o p e n h a v er D J, V a w dr e y D K, K ot c h o u b e y H, St o c k w ell M S. S m art p h o n e U s e 
A m o n g P o st p art u m W o m e n a n d I m pli c ati o n s f or P er s o n al H e alt h R e c or d Utili z ati o n. Cli ni c al 
p e di atri c s. 2 0 1 7; 5 6( 4): 3 7 6 -3 8 1.  
5 9.  
H o g u e J, B e n e zr a K. T h e Di git al Li v e s of P o w er M o m s. 2 0 0 9.  
6 0.  
Gili n s k y A S, D al e H, R o bi n s o n C, H u g h e s A R, M cI n n e s R, L a v all e e D. Effi c a c y of p h y si c al 
a cti vit y i nt er v e nti o n s i n p o st -n at al p o p ul ati o n s: s y st e m ati c r e vi e w, m et a -a n al y si s a n d c o nt e nt 
c o di n g of b e h a vi o ur c h a n g e t e c h ni q u e s. H e alt h p s y c h ol o g y r e vi e w. 2 0 1 5; 9( 2): 2 4 4 -2 6 3.  
6 1.  
D a vi s R, C a m p b ell R, Hil d o n Z, H o b b s L, Mi c hi e S. T h e ori e s of b e h a vi o ur a n d b e h a vi o ur 
c h a n g e a cr o s s t h e s o ci al a n d b e h a vi o ur al s ci e n c e s: a s c o pi n g r e vi e w. H e alt h p s y c h ol o g y 
r e vi e w. 2 0 1 5; 9( 3): 3 2 3 -3 4 4.  
6 2.  
Gr e a n e y M L, P ul e o E, S pr u n c k -H arril d K, H ai n e s J, H o u g ht o n S C, E m m o n s K M. S o ci al S u p p ort 
f or C h a n gi n g M ulti pl e B e h a vi or s: F a ct or s A s s o ci at e d Wit h S e e ki n g S u p p ort a n d t h e I m p a ct of 
Off er e d S u p p ort. H e alt h e d u c ati o n & b e h a vi or : t h e offi ci al p u bli c ati o n of t h e S o ci et y f or P u bli c 
H e alt h E d u c ati o n. 2 0 1 8; 4 5( 2): 1 9 8 -2 0 6.  
6 3.  
C o ur n e y a K S, Pl ot ni k off R, H ot z S, Bir k ett N. S o ci al s u p p ort a n d t h e t h e or y of pl a n n e d b e h a vi or 
i n t h e e x er ci s e d o m ai n. A m eri c a n J o ur n al of H e alt h B e h a vi or. 2 0 0 0; 2 4( 4): 3 0 0 -3 0 8.  
6 4.  
S h a w L H, G a nt L M. I n d ef e n s e of t h e i nt er n et: t h e r el ati o n s hi p b et w e e n I nt er n et c o m m u ni c ati o n 
a n d d e pr e s si o n, l o n eli n e s s, s elf -e st e e m, a n d p er c ei v e d s o ci al s u p p ort. C y b er p s y c h ol o g y & 
b e h a vi or : t h e i m p a ct of t h e I nt er n et, m ulti m e di a a n d virt u al r e alit y o n b e h a vi or a n d s o ci et y. 
2 0 0 2; 5( 2): 1 5 7 -1 7 1.  
6 5.  
C ol e D A, Ni c k E A, Z el k o wit z R L, R o e d er K M, S pi n elli T. O nli n e S o ci al S u p p ort f or Y o u n g 
P e o pl e: D o e s It R e c a pit ul at e I n -p er s o n S o ci al S u p p ort; C a n It H el p ? C o m p ut er s i n h u m a n 
b e h a vi or. 2 0 1 7; 6 8: 4 5 6 -4 6 4.  
6 6.  
R o v ni a k L S, S alli s J F, Kr a s c h n e w s ki J L, et al. E n gi n e eri n g o nli n e a n d i n -p er s o n s o ci al n et w or k s 
t o s u st ai n p h y si c al a cti vit y: a p pli c ati o n of a c o n c e pt u al m o d el. B M C p u bli c h e alt h. 2 0 1 3; 1 3: 7 5 3.  
6 7.   
V al er o-Eli z o n d o J, S al a mi J A, O s o n d u C U, et al. E c o n o mi c I m p a ct of M o d er at e -Vi g or o u s 
P h y si c al A cti vit y A m o n g T h o s e Wit h a n d Wit h o ut E st a bli s h e d C ar di o v a s c ul ar Di s e a s e: 2 0 1 2 
M e di c al E x p e n dit ur e P a n el S ur v e y. J o ur n al of t h e A m eri c a n H e art A s s o ci ati o n. 2 0 1 6; 5( 9).  
6 8.  
Gl a s g o w R E, V o gt T M, B ol e s S M. E v al u ati n g t h e p u bli c h e alt h i m p a ct of h e alt h pr o m oti o n 
i nt er v e nti o n s: t h e R E-AI M fr a m e w or k. A m eri c a n j o ur n al of p u bli c h e alt h. 1 9 9 9; 8 9( 9): 1 3 2 2 -1 3 2 7.  

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
8  
6 9.  
Al bri g ht C L, D u n n A L, E d w ar d s E, K a d o w a ki J, M arti n R. D e si g ni n g m ulti m e di a i nt er n et -b a s e d 
t e c h n ol o g y t o i n cr e a s e p h y si c al a cti vit y i n n e w m ot h er s: T h e M o m Zi n g Pr o gr a m. O b e sit y R e v. 
2 0 1 0; 1 1( S u p pl 1): 4 5 0.  
7 0.  
C u m mi n s J, D u n n A L, M arti n R, Al bri g ht C L, S ai ki K, S h a n e J. D e si g ni n g a n eff e cti v e p h y si c al 
a cti vit y i nt er v e nti o n u si n g t h e G o o gl e T V -p utti n g u s er i n p ut at t h e f or efr o nt. . J S ci M e d S p ort. 
2 0 1 2; 1 5( 6): 3 3 8.  
7 1.  
S a m d al G B, Ei d e G E, B art h T, Willi a m s G, M el a n d E. Eff e cti v e b e h a vi o ur c h a n g e t e c h ni q u e s f or 
p h y si c al a cti vit y a n d h e alt h y e ati n g i n o v er w ei g ht a n d o b e s e a d ult s; s y st e m ati c r e vi e w a n d 
m et a -r e gr e s si o n a n al y s e s. I nt J B e h a v N utr P h y s A ct. 2 0 1 7; 1 4( 1): 4 2.  
7 2.  
Br o w n S D, H e d d er s o n M M, E hrli c h S F, et al. G e st ati o n al w ei g ht g ai n a n d o pti m al w ell n e s s 
( G L O W): r ati o n al e a n d m et h o d s f or a r a n d o mi z e d c o ntr oll e d tri al of a lif e st yl e i nt er v e nti o n 
a m o n g pr e g n a nt w o m e n wit h o v er w ei g ht or o b e sit y. B M C pr e g n a n c y a n d c hil d birt h. 
2 0 1 9; 1 9( 1): 1 4 5.  
7 3.  
C o n w a y M R, M ar s h all M R, S c hl aff R A, Pf eiff er K A, Pi v ar ni k J M. P h y si c al A cti vit y D e vi c e 
R eli a bilit y a n d V ali dit y d uri n g Pr e g n a n c y a n d P o st p art u m. M e di ci n e a n d s ci e n c e i n s p ort s a n d 
e x er ci s e. 2 0 1 8; 5 0( 3): 6 1 7 -6 2 3.  
7 4.  
V a n d e s o m p el e J, D e Pr et er K, P att y n F, et al. A c c ur at e n or m ali z ati o n of r e al -ti m e q u a ntit ati v e 
R T -P C R d at a b y g e o m etri c a v er a gi n g of m ulti pl e i nt er n al c o ntr ol g e n e s. G e n o m e bi ol o g y. 
2 0 0 2; 3( 7): R e s e ar c h 0 0 3 4.  
7 5.  
C h oi L, W ar d S C, S c h n ell e J F, B u c h o w s ki M S. A s s e s s m e nt of w e ar/ n o n w e ar ti m e cl a s sifi c ati o n 
al g orit h m s f or tri a xi al a c c el er o m et er. M e di ci n e a n d s ci e n c e i n s p ort s a n d e x er ci s e. 
2 0 1 2; 4 4( 1 0): 2 0 0 9 -2 0 1 6.  
7 6.  
C h oi L, Li u Z, M att h e w s C E, B u c h o w s ki M S. V ali d ati o n of a c c el er o m et er w e ar a n d n o n w e ar 
ti m e cl a s sifi c ati o n al g orit h m. M e di ci n e a n d s ci e n c e i n s p ort s a n d e x er ci s e. 2 0 1 1; 4 3( 2): 3 5 7 -3 6 4.  
7 7.  
Tr oi a n o R P, B erri g a n D, D o d d K W, M a s s e L C, Til ert T, M c D o w ell M. P h y si c al a cti vit y i n t h e 
U nit e d St at e s m e a s ur e d b y a c c el er o m et er. M e di ci n e a n d s ci e n c e i n s p ort s a n d e x er ci s e. 
2 0 0 8; 4 0( 1): 1 8 1 -1 8 8.  
7 8.  
S a s a ki J E, J o h n D, Fr e e d s o n P S. V ali d ati o n a n d c o m p ari s o n of A cti Gr a p h a cti vit y m o nit or s. 
J o ur n al of s ci e n c e a n d m e di ci n e i n s p ort / S p ort s M e di ci n e A u str ali a. 2 0 1 1; 1 4( 5): 4 1 1 -4 1 6.  
7 9.  
Cr ai g C L, M ar s h all A L, Sj o str o m M, et al. I nt er n ati o n al p h y si c al a cti vit y q u e sti o n n air e: 1 2 -
c o u ntr y r eli a bilit y a n d v ali dit y. M e di ci n e a n d s ci e n c e i n s p ort s a n d e x er ci s e. 2 0 0 3; 3 5( 8): 1 3 8 1 -
1 3 9 5.  
8 0.  
G ui d eli n e s f or D at a Pr o c e s si n g a n d A n al y si s of t h e I nt er n ati o n al P h y si c al A cti vit y Q u e sti o n n air e 
(I P A Q). 2 0 0 5.  
8 1.  
Kr o e n k e K, S pit z er R L, Willi a m s J B. T h e P H Q -9: v ali dit y of a bri ef d e pr e s si o n s e v erit y m e a s ur e. 
J o ur n al of g e n er al i nt er n al m e di ci n e. 2 0 0 1; 1 6( 9): 6 0 6 -6 1 3.  
8 2.  
S pit z er R L, Willi a m s J B, Kr o e n k e K, H or n y a k R, M c M urr a y J. V ali dit y a n d utilit y of t h e P RI M E -
M D p ati e nt h e alt h q u e sti o n n air e i n a s s e s s m e nt of 3 0 0 0 o b st etri c -g y n e c ol o gi c p ati e nt s: t h e 
P RI M E -M D P ati e nt H e alt h Q u e sti o n n air e O b st etri c s -G y n e c ol o g y St u d y. A m eri c a n j o ur n al of 
o b st etri c s a n d g y n e c ol o g y. 2 0 0 0; 1 8 3( 3): 7 5 9 -7 6 9.  
8 3.  
S pit z er R L, Kr o e n k e K, Willi a m s J B. V ali d ati o n a n d utilit y of a s elf -r e p ort v er si o n of P RI M E-M D: 
t h e P H Q pri m ar y c ar e st u d y. Pri m ar y C ar e E v al u ati o n of M e nt al Di s or d er s. P ati e nt H e alt h 
Q u e sti o n n air e. J a m a. 1 9 9 9; 2 8 2( 1 8): 1 7 3 7 -1 7 4 4.  
8 4.  
Gil b o d y S, Ri c h ar d s D, Br e al e y S, H e witt C. S cr e e ni n g f or d e pr e s si o n i n m e di c al s etti n g s wit h 
t h e P ati e nt H e alt h Q u e sti o n n air e ( P H Q): a di a g n o sti c m et a-a n al y si s. J G e n I nt er n M e d. 
2 0 0 7; 2 2( 1 1): 1 5 9 6 -1 6 0 2.  

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
9  
8 5.  
Witt k a m pf K A, N a eij e L, S c h e n e A H, H u y s er J, v a n W e ert H C. Di a g n o sti c a c c ur a c y of t h e m o o d 
m o d ul e of t h e P ati e nt H e alt h Q u e sti o n n air e: a s y st e m ati c r e vi e w. G e n er al h o s pit al p s y c hi atr y. 
2 0 0 7; 2 9( 5): 3 8 8 -3 9 5.  
8 6.  
L o w e B, U n ut z er J, C all a h a n C M, P er ki n s A J, Kr o e n k e K. M o nit ori n g d e pr e s si o n tr e at m e nt 
o ut c o m e s wit h t h e p ati e nt h e alt h q u e sti o n n air e -9. M e d C ar e. 2 0 0 4; 4 2( 1 2): 1 1 9 4 -1 2 0 1.  
8 7.  
R o o z e n b e e k B, M a a s AI, Li n g s m a H F, et al. B a s eli n e c h ar a ct eri sti c s a n d st ati sti c al p o w er i n 
r a n d o mi z e d c o ntr oll e d tri al s: s el e cti o n, pr o g n o sti c t ar g eti n g, or c o v ari at e a dj u st m e nt ? Crit C ar e 
M e d. 2 0 0 9; 3 7( 1 0): 2 6 8 3 -2 6 9 0.  
8 8.  
H er n a n d e z A V, St e y er b er g E W, H a b b e m a J D. C o v ari at e a dj u st m e nt i n r a n d o mi z e d c o ntr oll e d 
tri al s wit h di c h ot o m o u s o ut c o m e s i n cr e a s e s st ati sti c al p o w er a n d r e d u c e s s a m pl e si z e 
r e q uir e m e nt s. J Cli n E pi d e mi ol. 2 0 0 4; 5 7( 5): 4 5 4 -4 6 0.  
8 9.  
C e nt er s f or Di s e a s e C o ntr ol a n d Pr e v e nti o n, N ati o n al C e nt er f or H e alt h St ati sti c s: Vit al a n d 
H e alt h St ati sti c s. T a bl e 5 7. P arti ci p ati o n i n l ei s ur e -ti m e a er o bi c a n d m u s cl e-str e n gt h e ni n g 
a cti viti e s t h at m e et t h e f e d er al 2 0 0 8 P h y si c al A cti vit y G ui d eli n e s f or A m eri c a n s a m o n g a d ult s 
a g e d 1 8 a n d o v er, b y s el e ct e d c h ar a ct eri sti c s: U nit e d St at e s, s el e ct e d y e ar s 1 9 9 8 – 2 0 1 6. 2 0 1 7.  
9 0.  
K u b o A, K urt o vi c h E, A g h a e e S, N k e m er e L, A v al o s L A. m H e alt h mi n df ul n e s s i nt er v e nti o n f or 
w o m e n wit h p eri n at al d e pr e s si o n: a pil ot st u d y wit hi n a n i nt e gr at e d h e alt h c ar e s y st e m P a p er 
pr e s e nt e d at: 8t h W orl d C o n gr e s s of I nt er n ati o n al A s s o ci ati o n f or W o m e n' s M e nt al H e alt h 
(I A W M H); M ar 5 - 8, 2 0 1 9  2 0 1 9; P ari s, Fr a n c e.  
9 1.  
C o h e n J. St ati sti c al P o w er A n al y si s f or t h e B e h a vi or al S ci e n c e s.  Hill s d al e, N e w J er s e y: 
L a wr e n c e Erl b a u m A s s o ci at e s; 1 9 8 8.  
9 2.  
St ati st a. N u m b er of s m art p h o n e u s er s i n t h e U. S. fr o m 2 0 1 0 t o 2 0 1 8 (i n milli o n s). 2 0 1 5; 
htt p:// w w w. st ati st a. c o m/ st ati sti c s/ 2 0 1 1 8 2/f or e c a st -of -s m art p h o n e -u s er s -i n-t h e-u s/. A c c e s s e d 
M ar c h 1 8, 2 0 1 5, 2 0 1 5.  
9 3.  
K ai s er F a mil y F o u n d ati o n. M e nt al H e alt h C ar e H e alt h Pr of e s si o n al S h ort a g e Ar e a s  ( H P S A s). I n: 
K a si er F a mil y F o u n d ati o n; 2 0 1 8 . 
 
 
b.  Preli mi nar y Data  
Descri be a n y rele va nt preli mi nar y data.  
 
Str o n g e vi d e n c e s u g g e st s p h y si c al a cti vit y ( P A) c a n  r e d u c e d e pr e s si o n ri s k b y h alf.1 8 -2 2  W hil e 
n ati o n al g ui d eli n e s a n d pr of e s si o n al or g a ni z ati o n s, i n cl u di n g t h e A m eri c a n C oll e g e of 
O b st etri ci a n s a n d G y n e c ol o gi st s, r e c o m m e n d at l e a st 1 5 0 mi n ut e s p er w e e k of m o d er at e t o 
vi g or o u s i nt e n sit y P A f or p o st p art u m w o m e n, 2 3, 2 4  7 0 % of p o st p art u m w o m e n d o n ot m e et t h e s e 
g ui d eli n e s. 2 5 -3 0  T e c h n ol o g y -b a s e d ( e H e alt h) i nt er v e nti o n s h a v e b e e n s h o w n t o eff e cti v el y 
i n cr e a s e P A i n t h e g e n er al p o p ul ati o n.3 1, 3 2  F e w e H e alt h P A i nt er v e nti o n s ar e a v ail a bl e 
s p e cifi c all y f or p o st p art u m w o m e n, b ut a r e c e nt e H e alt h pr o gr a m ( M o m Zi n g) h a s b e e n 
s u c c e s sf ul i n i n cr e a si n g P A t o m or e t h a n t hr e e ti m e s b a s eli n e l e v el s i n t hi s p o p ul ati o n. 3 3  W hil e 
t h e M o m Zi n g st u d y f o u n d l o w er d e pr e s si v e s y m pt o m s i n w o m e n w h o m et n ati o n al P A 
g ui d eli n e s aft er 3 m o nt h s of i nt er v e nti o n, n o e H e alt h P A i nt er v e nti o n s (i n cl u di n g M o m Zi n g) h a v e 
b e e n t e st e d i n w o m e n at i n cr e a s e d ri s k of P P D, a p o p ul ati o n t h at m a y n e e d a d diti o n al 
m oti v ati o n a n d s o ci al s u p p ort. S o ci al s u p p ort i s t h e str o n g e st c o ntri b ut or t o P A b e h a vi or c h a n g e 
i n p o st p art u m w o m e n.3 4   T h e pr o p o s e d e H e alt h P A i nt er v e nti o n ( M o m Zi n g) i s an i nt er v e nti o n 
t h at t ar g et s e a c h of t h e t hr e e c o m p o n e nt s n e c e s s ar y f or b e h a vi or c h a n g e a c c or di n g t o t h e 
C O M -B m o d el: “ C a p a bilit y” ( e. g., k n o wl e d g e a n d s kill s), “ O p p ort u nit y” ( e. g., ti m e), a n d 
“M oti v ati o n” t o e n g a g e i n P A B e h a vi or c h a n g e. 3 5 -3 7   
 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
1 0  
4.  St u d y Desi g n  
Descri be t he o verall a p pr oac h of t he st u d y (e. g. pr os pecti ve, i nter ve nti o nal, o bser vati o nal, retr os pecti ve, 
etc.).  If y o ur st u d y i ncl u des m ore t ha n o ne gr o u p, ar m, or s u bject p o p ulati o n, descri be t hat here (f or 
e xa m ple, a st u d y of b ot h s u bjects a n d t heir care gi vers, or a st u d y wit h b ot h a pr os pecti ve i nter ve nti o nal 
ar m a n d a retr os pecti ve c hart re vie w ar m).  
 
T hi s i s a h y bri d eff e cti v e n e s s -i m pl e m e nt ati o n st u d y i n cl u di n g 1) a r a n d o mi z e d c o ntr oll e d tri al t o 
t e st t h e eff e cti v e n e s s of M o m Zi n g t o i n cr e a s e P A a n d r e d u c e p o st p art u m d e pr e s si v e s y m pt o m s 
i n w o m e n at i n cr e a s e d ri s k of P P D a n d 2) e v al u ati o n of i m pl e m e nt ati o n of M o m Zi n g wit hi n t h e 
K P N C h e alt h c ar e d eli v er y s y st e m.  
 
Assess w het h er t his st u d y i n v ol ves a cli nical trial. Cli nical trial mea ns a researc h st u d y i n w hic h o ne or 
m ore h u ma n s u bjects are pr os pecti vel y assi g ne d t o o ne or m ore i nter ve nti o ns ( w hic h ma y i ncl u de place b o 
or ot her c o ntr ol) t o e val uate t he effects of t he i nter ve nti o ns o n bi o me dical or be ha vi oral healt h -relate d 
o utc o mes.  
 
Y e s, t hi s st u d y i n v ol v e s a cli ni c al tri al.  It i s a r a n d o mi z e d c o ntr ol tri al of a b e h a vi or al 
i nt er v e nti o n w h er e parti ci p a nt s will b e r a n d o mi z e d i nt o 1 of 2 ar m s: ( 1) M o m Zi n g (i nt er v e nti o n, 
n = 1 0 0) or  ( 2) U s u al c ar e ( c o ntr ol, n = 1 0 0).  
 
Descri be w het her t he st u d y i n v ol ves e d ucati o nal tests, s ur ve y pr oce d ures, or i nter vie w pr oce d ures.  
 
Y e s, t h e st u d y i n v ol v e s s ur v e y s .  All eli gi bl e w o m e n will b e a s k e d t o 1) c o m pl et e a b a s eli n e 
s ur v e y w hi c h i n cl u d e s  s elf -r e p ort of P A a n d 2) w e ar a r e s e ar c h-gr a d e a c c el er o m et er f or 7 d a y s 
t o a s s e s s b a s eli n e P A.  W o m e n will t h e n b e r a n d o mi z e d i nt o 1 of 2 ar m s: ( 1) M o m Zi n g 
(i nt er v e nti o n, n = 1 0 0) or ( 2) U s u al c ar e ( c o ntr ol, n = 1 0 0).  T h e y will c o m pl et e s ur v e y s a g ai n at  3 
m o nt h s ( T 1) a n d  6 m o nt h s ( T 2) aft er b a s eli n e.   T h er e will b e o n e fi n al s ur v e y w h e n t h e 
p arti ci p a nt’ s c hil d i s a p pr o xi m at el y 1 2 m o nt h s ol d  t o a s s e s s c hil d d e v el o p m e nt.  D e p e n di n g o n 
t h e a g e of t h e i nf a nt at e nr oll m e nt , t hi s m a y o c c ur at T 2. 
 
W e will c o n d u ct k e y st a k e h ol d er i nt er vi e w s wit h cli ni ci a n s a n d cli ni c al  l e a d er s, i d e ntifi e d t hr o u g h 
t h e O B G Y N P eri p art u m D e pr e s si o n C h a m pi o n s  C o m mitt e e, w hi c h c o n si st s of a d e pr e s si o n 
c h a m pi o n cli ni ci a n fr o m diff er e nt K P N C f a ciliti e s, t o a d dr e s s a n d i d e ntify a v e n u e s f or a d o pti o n  
of M o m Zi n g a n d b arri er s t o i m pl e m e nt ati o n a n d m ai nt e n a n c e  wit hi n cli ni c al pr a cti c e at K P N C.  
 
Descri be w het her t he researc h i n v ol ves be ni g n be ha vi oral i nter ve nti o ns o n a d ult  s u bjects. N ote: Be ni g n 
be ha vi oral i nter ve nti o ns are brief i n d urati o n, har mless, pai nless, n ot p h ysicall y i n vasi ve, n ot li kel y t o 
ha ve a si g nifica nt a d verse lasti n g i m pact o n t he s u bjects, a n d n ot offe nsi ve or e m barrassi n g t o t he 
s u bjects. E xa m ples i ncl u de ha vi n g s ubjects pla y o nli ne ga mes or s ol vi n g p uzzles u n der vari o us n oise 
c o n diti o ns. 
 
A s d e s cri b e d a b o v e, all eli gi bl e w o m e n will b e a s k e d t o w e ar a r e s e ar c h -gr a d e a c c el er o m et er 
f or 7 d a y s t o a s s e s s b a s eli n e P A a n d  t h e n r a n d o mi z e d i nt o M o m Zi n g (i nt er v e nti o n) or  U s u al 
c ar e ( c o ntr ol ).  T h e y will w e ar t h e a c c el er o m et er a g ai n f or 7 d a y s at 3 m o nt h s p o st -b a s eli n e a n d 
6 m o nt h s p o st -b a s eli n e.  
 
M o m Zi n g i nt er v e nti o n: t h e M o m Zi n g o nli n e e x er ci s e  a p pli c ati o n ( w w w. m o m zi n g. c o m ) w a s 
d e v el o p e d b a s e d o n m ot h er s’ pr ef er e n c e s f or e x er ci s e vi d e o s t h at: 1) i n str u ct e d m ot h er s h o w t o 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
1 1  
e x er ci s e s af el y wit h t h eir b a b y b a s e d o n t h e i nf a nt’ s w ei g ht a n d d e v el o p m e nt al st a g e; 2) di d n ot 
r e q uir e e x er ci s e e q ui p m e nt or a s u b st a nti al ti m e c o m mit m e nt p er vi d e o ( e. g., m a xi m u m ti m e p er 
vi d e o 1 0 mi n ut e s); 3) pr o vi d e d diff er e nt t y p e s of p h y si c al a cti viti e s ( e. g., y o g a, str e n gt h e ni n g, 
c ar di o) a n d i nt e n sit y l e v el s (li g ht, m o d er at e, h ar d); a n d fi n all y, 4) f e at ur e d w o m e n i n t h e 
e x er ci s e d e m o n str ati o n s w h o w er e “r e al” m ot h er s ( n ot fit n e s s i n str u ct or s) e x er ci si n g wit h t h eir 
o w n i nf a nt.  U s er s c a n eit h er s el e ct u p t o t hr e e 1 0 -mi n ut e vi d e o s t o cr e at e a 1 0 t o 3 0 -mi n ut e 
w or k o ut or c h o o s e a ‘ R e a d y M a d e’ w or k o ut t h at i s eit h er 1 0, 2 0, or 3 0 -mi n ut e s l o n g.   
 
If t he st u d y i n v ol ves eit her e d ucati o n al tests, s ur ve y pr oce d ures, i nter vie w pr oce d ures,  or be ni g n 
be ha vi oral i nter ve nti o ns ( o n a d ults), s pecif y w het her o ne o f t he f oll o wi n g criteria is met: 
 
(i) 
T he i nf or mati o n o btai ne d is rec or de d b y t he i n vesti gat or i n s uc h a ma n ner t hat t he  
ide ntit y of t he h u ma n s u bjects ca n n ot rea dil y be ascertai ne d, directl y or t hr o u g h i de ntifiers  
li n ke d t o t he s u bjects 
 
N/ A    
 
(ii) 
A n y discl os ure of t he h u ma n s u bjects’ res p o nses o utsi de t he researc h w o ul d n ot  
reas o na bl y place t he s u bjects at ris k of cri mi nal or ci vil lia bilit y or be da ma gi n g t o t he  su bjects’ 
fi na ncial sta n di n g, e m pl o ya bilit y, e d ucati o nal a d va nce me nt, or re p utati o n 
 
N/ A  
 
(iii) 
T he i nf or mati o n o btai ne d is rec or de d b y t he i n vesti gat or i n s uc h a ma n ner t hat t he  ide ntit y of t he 
h u ma n s u bjects ca n rea dil y be ascertai ne d, directl y or t hr o u g h i de ntifiers  li n ke d t o t he s u bjects, 
a n d a n I R B c o n d ucts a li mite d I R B re vie w t o ma ke t he deter mi nati o n  
 
C o nfir m e d.   
 
 
5.  St u d y P o p ul ati o n  
a. N u m ber of S u bjects  
State t he n u m ber of s u bjects y o u pla n t o i ncl u de at  t he K P re gi o n t o w hic h t his st u d y is bei n g s u b mitte d. 
If a p plica ble, disti n g uis h bet wee n t he n u m ber of s u bjects w h o are e x pecte d t o be e nr olle d/scree ne d a n d 
t he n u m ber of s u bjects nee de d t o c o m plete t he researc h pr oce d ures (e. g. n u m ber of s u bjects e xcl u din g 
scree n fail ures).  
 
W e will i d e ntif y a p pr o xi m at el y  13 2 , 0 0 0 p o st p art u m w o m e n at t h e K P N C r e gi o n f or p ot e nti al 
p arti ci p ati o n u si n g el e ctr o ni c h e alt h r e c or d s d at a, i n cl u di n g t h eir d e pr e s si o n s cr e e ni n g at t h eir 4 -
6 w e e k s p o st p art u m vi sit r e c ei v e d a s p art of t h e K P u ni v er s al p eri n at al d e pr e s si o n s cr e e n 
pr o gr a m, t o a s s e s s eli gi bilit y.  
 
T o pil ot t e st t h e i m pl e m e nt ati o n of t h e i nt er v e nti o n a n d m a xi mi z e t h e r e cr uit m e nt r at e o v er t h e 
st u d y p eri o d w e will i d e ntif y a n d r e cr uit w o m e n t hr o u g h t w o m et h o d s: 1) Cli ni ci a n r ef err al s  a n d 
2) E H R i d e ntifi c ati o n .  W e will r a n d o mi z e 2 0 0 w o m e n i nt o 1 of 2 ar m s: 1) I nt er v e nti o n 
( M o m Zi n g, n = 1 0 0) or 2) C o ntr ol ( U s u al c ar e, n = 1 0 0) u si n g a r e stri ct e d r a n d o mi z ati o n s c h e m e t o 
e n s ur e a n a c c e pt a bl e l e v el of b et w e e n -ar m b al a n c e i n t h e di stri b uti o n of i m p ort a nt c o v ari at e s 
( e. g. K P cli ni c, r a c e/ et h ni cit y, a g e, p arit y, m arit al st at u s, a n d e d u c ati o n ).   

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
1 2  
 
W e will al s o i n cl u d e t h e c hil dr e n of p arti ci p a nt s i n t h e st u d y b y a c c e s si n g a n d li n ki n g r e c or d s f or 
e a c h e nr oll e d m ot h er/ b a b y t o e xtr a ct d at a r e g ar di n g t h e pr e g n a n c y a n d ot h er h e alt h f a ct or s 
i n cl u di n g c hil d d e v el o p m e nt a n d b e h a vi or al pr o bl e m s, m at er n al-i nf a nt i nt er a cti o n, a n d 
br e a stf e e di n g.  
 
T o e v al u at e pr o c e d u r e s f or i m pl e me nt ati o n of M o m Zi n g at K P N C, w e wil l c o n d u ct q u alit ati v e 
i nt er vi e w s wit h a p pr o xi m at el y 2 0 cli ni ci a n s a n d cli ni c al  l e a d er s, i d e ntifi e d t hr o u g h t h e O B G Y N 
P eri p art u m D e pr e s si o n C h a m pi o n s C o m mitt e e . 
 
As a p pr o priate,  differe ntiate bet wee n  differe nt p o p ulati o ns of s u bjects wit hi n t he sa me st u d y (e. g. 
s u bject/care gi ver, pare nt/c hil d, patie nt/ p h ysicia n).  
 
Ai m 1:  T hi s i s a st u d y of p ati e nt s  ( m ot h er s a n d t h eir i nf a nt s).  W e ar e s p e cifi c all y i nt er e st e d i n 
p o st p art u m w o m e n at i n cr e a s e d ri s k of P P D.   
 
Ai m 2: T h e st u d y i n cl u d e s cli ni c al st aff a n d l e a d er s hi p  i d e ntifi e d t hr o u g h t h e O B G Y N P eri p art u m 
D e pr e s si o n C h a m pi o n s  C o m mitt e e, w hi c h c o n si st s of a d e pr e s si o n c h a m pi o n cli ni ci a n fr o m 
diff er e nt  K P N C f a ciliti e s. 
 
If t his is a m ultice nter st u d y, i n dicate t he t otal n u m ber of s u bjects t o be accr ue d acr oss all sites.  
 
N/ A  
 
b.  I ncl usi o n a n d E xcl usi o n Criteria 
•  
Descri be t he criteria t hat defi ne w h o will be i ncl u de d or e xcl u de d i n y o ur fi nal st u d y sa m ple.  
 
Ai m 1:  T h e fi n al st u d y s a m pl e will i n cl u d e 2 0 0 w o m e n r a n d o mi z e d i nt o 1 of 2 ar m s: 
I nt er v e nti o n ( M o m Zi n g, n = 1 0 0) or C o ntr ol ( U s u al C ar e, n = 1 0 0). 
 
W o m e n will b e c o n si d er e d eli gi bl e if  t h e y: 
 
•   
Ar e E n gli s h -s p e a ki n g a n d b et w e e n t h e a g e s of 1 8 a n d 4 5  
•  
H a d pr e n at al c ar e at K P N C a n d d eli v er e d t h eir c hil d at a K P N C h o s pit al  
•  
Ar e a t i n cr e a s e d ri s k of P P D b et w e e n 2 a n d 6 m o nt h s p o st p art u ma  
•   
Ow n a s m art p h o n e, c o m p ut er, or T V wit h i nt er n et a c c e s s  
•  
D o n ot h a v e a d e pr e s si o n di a g n o si s or r e c ei v e a n y tr e at m e nt f or d e pr e s si o n ( e. g. t a k e n 
a nti d e pr e s s a nt m e di c ati o n s or r e c ei v e d p s y c h ot h er a p y) 
•  
Ar e f r e e of a h e art c o n diti o n a n d a p h y si ci a n r e c o m m e n di n g m e di c all y s u p er vi s e d 
p h y si c al a cti vit y  
•  
D o n ot h a v e c h e st p ai n d uri n g p h y si c al a cti vit y, or d e v el o p e d  c h e st p ai n wit hi n t h e pri or 
m o nt h  
•  
D o n ot t a k e  m e di c ati o n f or h y p ert e n si o n or a h e art c o n diti o n  
•  
H a v e n o t e n d e n c y t o f all d u e t o s y n c o p e or di z zi n e s s  
•  
H a v e n o ort h o p e di c pr o bl e m s t h at mi g ht b e a g gr a v at e d b y p h y si c al a cti vit y  
•  
D o n ot h a v e e x er ci s e -i n d u c e d a st h m a 
•  
Ar e n ot pr e g n a nt or pl a n ni n g t o b e c o m e pr e g n a nt i n t h e e n s ui n g t hr e e m o nt h s  

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
1 3  
•  
H a v e a B o d y M a s s I n d e x ( B MI) b et w e e n 1 8. 5 a n d 4 0 ( k g/ m 2 ) 
•  
Ar e n ot e n g a gi n g i n r e g ul ar, m o d er at e -t o-vi g or o u s p h y si c al a cti vit y > 3 0 mi n ut e s p er 
w e e k  
 
a n d if t h eir i nf a nt s b : 
 
•   
Ar e b et w e e n 2  a n d 6  m o nt h s ol d  
•   
Wei g h b et w e e n 1 1 -2 2 p o u n d s  
•   
Ar e fr e e of c hr o ni c ill n e s s/ di s or d er t h at pr e v e nt s s o m e o n e fr o m h ol di n g or lifti n g t h e m    
 
a W o m e n  will b e c o n si d er e d at i n cr e a s e d ri s k f or P P D if t h e y d o n ot h a v e a c urr e nt 
d e pr e s si o n di a g n o si s d efi n e d a s a di a g n o si s b et w e e n d eli v er y a n d t h e ti m e of t h e P H Q -
9 s c or e b ut h a v e a P H Q -9 s c or e b et w e e n 1 0 -1 9.   W o m e n w h o h a v e a P H Q -2 s c or e  of 
≥3 , a d mi ni st er e d at w ell-b a b y vi sit s,  will al s o b e c o n si d er e d at i n cr e a s e d ri s k . 
b T h e m ot h er s i n t h e i nt er v e nti o n will b e i n str u ct e d h o w t o s af el y e x er ci s e b a s e d o n t h e 
i nf a nt s’ w ei g ht a n d d e v el o p m e nt al st a g e . 
 
Ai m 2: All cli ni ci a n s a n d cli ni c al l e a d er s w h o ar e  i d e ntifi e d t hr o u g h t h e O B G Y N 
P eri p art u m D e pr e s si o n C h a m pi o n s  C o m mitt e e, w hi c h c o n si st s of a d e pr e s si o n 
c h a m pi o n cli ni ci a n fr o m diff er e nt K P N C f a ciliti e s, will b e eli gi bl e t o p arti ci p at e i n t h e 
q u alit ati v e i nt er vi e w s . 
 
•  
Descri be h o w i n di vi d uals will be scree n e d f or eli gi bilit y.  
 
Pl e a s e s e e a b o v e f or eli gi bilit y r e q uir e m e nt s.  
 
Ai m 1: W e will i d e ntif y a n d r e cr uit w o m e n t hr o u g h t w o m et h o d s: 1) Cli ni ci a n r ef err al s  a n d 
2) E H R i d e ntifi c ati o n.  Cli ni ci a n r ef err al s: w e will w or k cl o s el y wit h t h e O B G Y N 
P eri p art u m D e pr e s si o n C h a m pi o n s at all K P N C cli ni c s  t o e n c o ur a g e cli ni ci a n s at t h eir 
cli ni c s t o r ef er t o t h e st u d y.  Cli ni c al st aff will b e a s k e d t o r ef er p ot e nti al p arti ci p a nt s t o 
t h e st u d y b y bri efl y d e s cri bi n g t h e st u d y a n d pr o vi di n g t h e st u d y br o c h ur e (h ar d c o p y if 
p o st p art u m vi sit i s i n -p er s o n a n d el e ctr o ni c all y if vi sit i s virt u al), w hi c h i n cl u d e s t h e st u d y 
c o nt a ct i nf or m ati o n , t h e n n otif y t h e st u d y t e a m t o f oll o w-u p wit h r ef err e d p ati e nt s.   
 
E H R i d e ntifi c ati o n: w e will r o uti n el y i d e ntif y eli gi bl e w o m e n fr o m t h e E H R at all cli ni c s 
t hr o u g h o ut K P N C a n d o bt ai n pr o vi d er a p pr o v al t o c o nt a ct hi s/ h er  p ati e nt.   
 
Ai m 2: T h er e will b e n o s cr e e ni n g f or eli gi bi lit y.  All cli ni ci a n s a n d cli ni c al l e a d er s w h o ar e  
i d e ntifi e d t hr o u g h t h e O B G Y N P eri p art u m D e pr e s si o n C h a m pi o n s  C o m mitt e e, w hi c h 
c o n si st s of a d e pr e s si o n c h a m pi o n cli ni ci a n fr o m diff er e nt K P N C f a ciliti e s , will b e eli gi bl e 
t o p arti ci p at e i n t h e q u alit ati v e i nt er vi e w s. 
 
•  
If i nf or mati o n or bi os peci me ns will be o btai ne d f or t he p ur p ose of scree ni n g, recr uiti n g, or 
deter mi ni n g eli gi bilit y, i nf or me d c o nse nt is n ot re q uire d if o ne of t he f oll o wi n g criteria is met. 
Select o ne of t he f oll o wi n g criteria a n d pr o vi de a brief e x plai n f or h o w t he criteria is met.   
 
  T he i n vesti gat or will o btai n i nf or mati o n t hr o u g h oral or writte n c o m m u nicati o n wit h t he 
pr os pecti ve s u bject or le gall y a ut h orize d re prese ntati v e, or  

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
1 4  
 
X  T he i n vesti gat or will o btai n i de ntifia ble pri vate i nf or mati o n or i de ntifia ble bi os peci me ns 
b y accessi n g rec or ds or st ore d i de ntifia ble bi os peci me ns  
 
F or  t h e p ur p o s e of s cr e e ni n g, r e cr uiti n g, a n d d et er mi ni n g eli gi bilit y, w e will n e e d t o 
a c c e s s P HI t o i d e ntif y p o st p art u m w o m e n , w h o ar e s cr e e n e d f or d e pr e s si o n at t h eir 
p o st p art u m vi sit , a n d cli ni ci a n s.  It i s n e c e s s ar y t o a c c e s s P HI t o a s s e m bl e t h e c o h ort, 
o bt ai n all t h e st u d y s p e cifi c v ari a bl e s  a n d li n k t h e d at a f or t hi s st u d y. Wit h o ut a c c e s s t o 
a n d u s e of t h e n e c e s s ar y P HI t h e r e s e ar c h c a n n ot b e c o n d u ct e d . 
 
I M P O R T A N T N O T ES : Alt h o u g h i nf or me d c o nse nt ma y n ot be re q uire d, HI P A A Pri vac y 
A ut h orizati o n ma y still be re q uire d. Als o, if t his st u d y is F D A -re g ulate d, t he n c o nse nt ma y be 
re q uire d. 
 
•  
Descri be t he pla n f or dis p ositi o n of i nf or mati o n/ bi os peci me ns c ollecte d d uri n g 
recr uit me nt/scree ni n g i n t he e ve nt of a scree n fail ure or w he n a p ote ntial s u bject is c o ntacte d b ut 
decli nes partici pati o n (e. g. destr o ye d i m me diatel y, destr o ye d at e n d of st u d y, retai ne d f or se parate 
a nal ysis or s o t hat s u bjects are n ot c o ntacte d re peate dl y a b o ut partici pati o n after t he y ha ve 
decli ne d, etc.) . 
 
D at a c oll e ct e d d uri n g r e cr uit m e nt/ s cr e e ni n g or w h e n a p ot e nti al s u bj e ct i s c o nt a ct e d f or 
p arti ci p ati o n  b ut d e cli n e s will b e d e str o y e d at t h e e n d of t h e st u d y.  S u bj e ct s will n ot b e 
c o nt a ct e d a b o ut p arti ci p ati o n aft er t h e y h a v e d e cli n e d . 
 
N o n -r e s p o n d e nt d at a will b e u s e d i n t h e st u d y.  A n y c oll e ct e d d at a will b e d e str o y e d at 
t h e e n d of t h e st u d y. 
 
F or t h o s e w h o d e cli n e t o h a v e t h eir d at a b e u s e d f or t hi s st u d y, a n y c oll e ct e d d at a will b e 
d e str o y e d at t h e e n d of t h e st u d y.  
 
c. S u bjects V ul nera ble  t o C oerci o n or U n d ue I nfl ue nce 
I n dicate w het her y o u will i ncl u de or e xcl u de eac h of t he f oll o wi n g s pecial p o p ulati o ns. J ustif y t he 
i ncl usi o n of a n y of t hese p o p ulati o ns. Descri be a d diti o nal safe g uar ds t o pr otect t he ri g hts a n d welfare of 
t hese s u bjects. N ote: T his refers t o s u bjects w h o are k n o w n me m bers of t hese p o p ulati o ns u p o n 
e nr oll me nt or at a n y ti me d uri n g t he st u d y.  
 
•  
C hil dre n 
 
W e will i n cl u d e c hil dr e n i n t h e pr o p o s e d st u d y.  W e will n e e d t o a c c e s s a n d li n k r e c or d s 
f or e a c h e nr oll e d m ot h er/ b a b y t o e xtr a ct d at a r e g ar di n g t h e pr e g n a n c y a n d ot h er h e alt h 
f a ct or s i n cl u di n g c hil d d e v el o p m e nt  a n d b e h a vi or al pr o bl e m s, m at er n al -i nf a nt i nt er a cti o n, 
a n d br e a stf e e di n g f or 3 r e a s o n s: 1) i n cl u si o n/ e x cl u si o n crit eri a (i. e. w e c a n n ot r e cr uit w o m e n 
wit h i nf a nt s t h at h a v e a c hr o ni c ill n e s s a n d t h u s n e e d t o a c c e s s t h eir m e di c al r e c or d s) , 2) t o 
a s s e s s t h e r el ati o n s hi p s a s o utli n e d i n t h e Ai m s , a n d 3) m o nit or  a d v er s e e v e nt s a n d s af et y 
o ut c o m e s  ( e. g. i d e ntif y a n y i nj uri e s t h at m a y h a v e b e e n tr e at e d b y a d o ct or or r e q uir e d 
h o s pit ali z ati o n a n d f oll o w -u p  a n d t h eir r el ati o n s hi p wit h t h e i nt er v e nti o n ). 
 O nl y p er s o n s dir e ctl y i n v ol v e d i n t h e st u d y will h a v e a c c e s s t o t h e d at a i d e ntif yi n g 
i n di vi d u al p arti ci p a nt s.  N a m e s of p arti ci p a nt s will b e o bt ai n e d f or r e c or d -k e e pi n g p ur p o s e s 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
1 5  
o nl y; n o n a m e s will b e r e c or d e d i n t h e d at a a n al y si s fil e s.  N o i n di vi d u al s will b e i d e ntifi e d i n 
t h e r e s ult s of t h e st u di e s.  A c c e s s t o c o m p ut er-st or e d i nf or m ati o n will r e q uir e si m ult a n e o u s 
k n o wl e d g e of t h e d at a f or m at, c o m p ut er l a n g u a g e, fil e n a m e, a n d p a s s w or d . 
 
•  
Ne o nates of u ncertai n via bilit y or n o n via ble ne o nates ( u p t o 2 8 da ys p ost birt h)  
 
N/ A  
 
•  
Pris o ners ( N O T E: T he K P I R B d oes n ot ha ve t he a p pr o priate me m bers hi p t o re vie w researc h 
i n v ol vi n g pris o ners. C o ns ultati o n wit h t he I R B Office  will be re q uire d.)  
 
I M P O R T A N T N O T E: C o nsi der w het her s u bjects will be i n a v ul nera ble cate g or y at t he ti me of 
i nf or mati o n/ bi os peci me n c ollecti o n or d uri n g a nal ysis.  F or i nsta nce, if y o u c ollect 
i nf or mati o n/ bi os peci me ns a b o ut c hil dre n w h o were a ges 1 2 – 1 5 fr o m years 2 0 0 0 – 2 0 0 2, y o u k n o w t hat 
n o w t h ose i n di vi d uals are n o l o n ger c hil dre n.  
I n di vi d uals wit h I m paire d Decisi o n-Ma ki n g Ca pacit y  
State w het her i n di vi d uals wit h i m paire d decisi o n-ma ki n g c a pacit y will be i ncl u de d . 
 
N/ A  
 
  
Ex plai n t he e xte nt of c o g niti ve i m pair me nt (c o m plete, fl uct uati n g, pr o gressi ve, or te m p orar y).   
 
N/ A  
 
             J ustif y t heir i ncl usi o n a n d e x plai n a n y pr otecti o ns t o miti gate ris k (s uc h as t he i n v ol ve me nt of a   
             care gi ver or le gall y a ut h orize d re prese ntati ve).   
 
N/ A  
 
             Descri be t he pr ocess t o deter mi ne w het her a n i n di vi d ual is ca pa ble of c o nse nt, a n d s u b mit a n y d oc u me nts   
t hat will be use d assess decisi o nal ca pacit y. 
 
 
N/ A   
 
List t he i n di vi d uals fr o m w h o m per missi o n will be o btai ne d i n or der of pri orit y. ( E. g., d ura ble p o wer of 
att or ne y f or healt h care, c o urt a p p oi nte d g uar dia n f or healt h care decisi o ns, s p o use, a n d a d ult c hil d.   
N/ A  
 
Descri be t he pr ocess f or asse nt of t he s u bjects b y a d dress i n g t he f oll o wi n g: 
 
•  
W het her asse nt will be re q uire d of all, s o me, or n o ne of t he s u bjects. If asse nt will be  
o btai ne d fr o m s o me s u bjects, i n dicate w hic h s u bjects will be re q uire d t o asse nt a n d w hic h 
will n ot.  
 
N/ A  
 
•  
If asse nt will n ot be o btai ne d fr o m s o me or all s u bjects, a n e x pla nati o n of w h y n ot. 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
1 6  
 
N/ A  
 
•  
W he n asse nt is o btai ne d, descri be h o w it will be d oc u me nte d.  
 
N/ A  
 
HI V Stat us:  
If t he st u d y will be ascertai ni n g s u bject HI V stat us f or st u d y e xcl usi o n/i ncl usi o n, please i n dicate h o w: 
☐ Pr os pecti ve la b orat or y HI V testi n g of s u bjects f or t he st u d y  
☐ S ur ve yi n g s u bjects a b o ut t heir HI V stat us  
☐ K P N C HI V Re gistr y access or e xisti n g electr o nic healt h rec or d data *  
* If y o u c hec ke d t his o pti o n, y o u m ust first gai n a p pr o val fr o m t he HI V Steeri n g C o m mittee b y c o ntacti n g 
Mic hael J. Sil ver ber g, P h D, M P H.  T he HI V Steeri n g C o m mittee a p pr o val m ust be s u b mitte d t o I R B Net.  
 
Will T P M G p h ysicia ns be directl y c o ntacte d t o e nr oll as st u d y partici pa nts? ☒ Yes  ☐ N o  
 
If “ yes ” t he c o nt act m ust be a p pr o ve d b y Yi Fe n Ire ne C he n, M D, Ass oci ate E xec uti ve Direct or, 
T P M G,  pri or t o I R B re vie w. Dr. C he n’s a p pr o v al m ust be s u b mitte d t o I R B Net.  
 
Ot her P o p ulati o ns Tar gete d f or Recr uit me nt  
If y o u are tar geti n g a p o p ulati o n t hat ma y be v ul nera ble t o c oerci o n or u n d ue i nfl ue nce base d o n t he 
s pecific circ u msta nces of t he st u d y, descri be h o w y o u will e ns ure t hat partici pati o n is v ol u ntar y a n d 
mi ni mize a n y a d de d ris k. ( C o m m o n e xa m ples i ncl u de e m p l o yees, st u de nts, ec o n o micall y or e d ucati o nall y 
disa d va nta ge d pers o ns , etc.) 
 
N/ A  
 
d.  Setti n g  
Descri be t he sites or l ocati o ns w here y o ur researc h tea m will c o n d uct t he researc h.  
 
T hi s pr oj e ct will t a k e pl a c e at  t h e Di vi si o n of R e s e ar c h. 
 
If t his is a m ulti-site st u d y: 
•  
S pecif y w hat pr oce d ures are bei n g perf or me d at t his site or b y t his site’s pers o n nel (c o nsi der 
recr uit me nt, c o nse nt pr ocess, st u d y pr oce d ures, i nf or mati o n/ bi os peci me n a nal ysis, etc.).  
 
N/ A  
 
•  
State h o w eac h site will satisf y its I R B re vie w re q uire me nts.  I n dicate if y o u are as ki n g t his site’s 
I R B t o rel y o n a n ot her I R B or if a n ot her i nstit uti o n w o ul d li ke t o rel y o n t his site’s I R B a n d 
i ncl u de t his i nf or mati o n i n t he eI R B I nitial Pr oject s u b missi o n   
 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
1 7  
N/ A  
 
F or researc h c o n d ucte d o utsi de t his site descri be: ( C o m m u nit y, Reser vati o ns etc.)  
•  
Descri be s ite-s pecific re g ulati o ns or c ust o ms affecti n g t he researc h at t hat l ocati o n. 
 
N/ A  
 
•  
L ocal scie ntific a n d et hical re vie w str uct ure o utsi de t his site.  
 
N/ A  
 
6.  Recr uit me nt Met h o ds  
Descri be h o w st u d y partici pa nts will be recr uite d a n d e nr olle d.   
 
Ai m 1:  W e will i d e ntif y a n d r e cr uit w o m e n t hr o u g h t w o m et h o d s: 1) Cli ni ci a n r ef err al s  a n d 2) 
E H R i d e ntifi c ati o n.   
 
Cli ni ci a n r ef err al s: w e will w or k cl o s el y wit h t h e O B G Y N P eri p art u m D e pr e s si o n C h a m pi o n s at 
K P N C cli ni c s.   Cli ni c al st aff will b e a s k e d t o r ef er p ot e nti al p arti ci p a nt s t o t h e st u d y b y bri efl y 
d e s cri bi n g t h e st u d y a n d pr o vi di n g t h e st u d y br o c h ur e  (h ar d c o p y  if p o st p art u m vi sit i s i n-p er s o n 
a n d el e ctr o ni c all y if vi sit i s virt u al), w hi c h i n cl u d e s t h e st u d y c o nt a ct i nf or m ati o n , t h e n n otif y t h e 
st u d y t e a m t o f oll o w -u p wit h r ef err e d p ati e nt s.    
 
E H R i d e ntifi c ati o n: w e will r o uti n el y i d e ntif y eli gi bl e w o m e n fr o m t h e E H R at all cli ni c s 
t hr o u g h o ut K P N C a n d o bt ai n pr o vi d er a p pr o v al t o c o nt a ct t h eir p ati e nt.  If t h e pr o vi d er d o e s n ot 
r e s p o n d t o o ur r e q u e st, w e will w ait 1 4 d a y s  t o c o nt a ct t h e w o m a n .   
 
U si n g t h e st u d y e m ail ( P O W -St u d y @ k p. or g ), a K P O utl o o k a c c o u nt, w e will s e n d r ef err e d a n d 
i d e ntifi e d w o m e n a n e m ail r e q u e sti n g t h eir p arti ci p ati o n.  T h e e m ail will i n cl u d e t h e b a s eli n e 
s ur v e y li n k.  E a c h w o m a n will al s o n e e d t o pr o vi d e h er o w n u ni q u e cr e d e nti al s ( d at e of birt h ), 
t h u s a ut h e nti c ati n g h er o w n i d e ntit y.  Aft er l o g gi n g i n a n d a n s w eri n g a f e w eli gi bilit y q u e sti o n s, 
s h e m a y c h o o s e t o r ef u s e p arti ci p ati o n (“ N o” r e s p o n s e) or t o p arti ci p at e (“ Y e s” r e s p o n s e) i n t h e 
st u d y.  If s h e p arti ci p at e s, s h e will c o m pl et e t h e c o n s e nt b ef or e pr o c e e di n g t o t h e  b a s eli n e 
s ur v e y vi a R E D c a p.  W e will f oll o w -u p wit h w o m e n, b y p h o n e,  w h o d o n ot r e s p o n d or c o m pl et e 
t h e s ur v e y i n a ti m el y m a n n er.  Pl e a s e s e e t h e cli ni ci a n r ef err al s cri pt, st u d y br o c h ur e, s a m pl e 
p arti ci p a nt r e cr uit m e nt e m ail aft er  cli ni ci a n r ef err al , s a m pl e pr o vi d er e m ail, s a m pl e p arti ci p a nt 
r e cr uit m e nt e m ail, a n d t el e p h o n e s cri pt ( A p p e n di c e s A- F). 
 
Al s o, s e e t h e s a m pl e f oll o w -u p e m ail ( A p p e n di x G ) s e nt t o p arti ci p a nt s wit h t h e s ur v e y li n k  if 
t h e y ar e r e cr uit e d b y p h o n e vi a A p p e n di x F. 
 
Ai m 2: F or t h e cli ni ci a n  i nt er vi e w s, t h e Pri n ci p al I n v e sti g at or ( Dr. L y n d s a y A v al o s) wit h C o -
I n v e sti g at or ( Dr. Mi b h ali B h al al a ) will s e n d a n e m ail , t o O B G Y N s a n d O B G Y N  P eri p art u m 
D e pr e s si o n C h a m pi o n s  i nf or mi n g t h e m of t h e st u d y a n d a s ki n g f or t h eir p arti ci p ati o n.  If t h e y ar e 
i nt er e st e d i n p arti ci p ati n g, w e will c all a n d s et u p a ti m e f or a n i nt er vi e w, w hi c h will b e r e c or d e d 
a n d c o n d u ct e d i n -p er s o n, b y t el e p h o n e  or vi d e o ( vi a Mi cr o s oft T e a m s) , w hi c h e v er i s m or e 
c o n v e ni e nt f or t h e m.  I nt er vi e w r e c or di n g s will b e d e str o y e d at t h e e n d of t h e st u d y.  W e ar e 
r e q u e sti n g a w ai v er of t h e r e q uir e m e nt t o o bt ai n writt e n c o n s e nt f or t h e i nt er vi e w s, a n d i n st e a d 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
1 8  
pr o p o s e a st u d y i nf or m ati o n s h e et a n d v er b al c o n s e nt.  Pl e a s e s e e t h e r e cr uit m e nt e m ail t o 
cli ni ci a n s a n d t el e p h o n e s cri pt (A p p e n di c e s  Q a n d T).  
 
I n dicate w het her y o u will o pe nl y recr uit usi n g a d vertise me nts, we bsites , fl yer, or br oc h ures . ( U pl oa d t he 
fi nal versi o ns of all recr uit me nt materials t o y o ur s u b missi o n t o t he I R B.)  
 
Ai m 1: W e will u s e a st u d y br o c h ur e t h at  will b e pr o vi d e d t o K P N C cli ni c s s o t h e y m a y r ef er a n y 
p ot e nti al p arti ci p a nt s t o t h e st u d y.   Pl e a s e s e e A p p e n di x B.   All r e cr uit m e nt m at eri al s will al s o 
r ef er p arti ci p a nt s t o o ur st u d y w e b sit e  s h o ul d t h e y h a v e a n y q u e sti o n s a n d n e e d a d diti o n al 
i nf or m ati o n.  T h e w e b sit e will b e h o st e d i nt er n all y b y D O R I T a n d u s e d a s a n i nf or m ati v e t o ol 
r at h er t h a n a m e a n s t o o p e nl y r e cr uit. 
 
I n dicate if y o u  pla n t o  d o tar gete d recr uit me nt usi n g e xisti n g rec or ds or referral.  Please s u b mit fi nal      
versi o ns of all referral e mails/scri pts.   
Pl e a s e s e e a b o v e.  
 
Descri be, b y p ositi o n/title, w h o will be recr uiti n g a n d e nr olli n g partici pa nts ( pr o vi di n g t he s pecific na mes 
of researc h tea m me m bers is n ot necessar y).  
 
Ai m 1: A r e s e ar c h a s si st a nt will b e r e cr uiti n g a n d e nr olli n g p ati e nt p arti ci p a nt s.  S h e will s e n d 
t h e i niti al r e cr uit m e nt e m ail a n d f oll o w-u p wit h t h o s e w h o d o n ot r e s p o n d i n a ti m el y m a n n er.  
S h e will al s o f oll o w -u p wit h e nr oll e d p arti ci p a nt s r e mi n di n g t h e m t o w e ar t h eir a c c el er o m et er s 
a n d c o m pl et e f oll o w -u p s ur v e y s t hr o u g h o ut t h e st u d y p eri o d.  
 
Ai m 2: T h e Pri n ci p al I n v e sti g at or  (Dr. L y n d s a y A v al o s) wit h C o -I n v e sti g at or ( Dr. Mi b h ali B h al al a) 
will s e n d t h e pr o vi d er r e cr uit m e nt e m ail t o t h e cli ni ci a n s.  Dr. B h al al a  i s th e P eri p art u m 
D e pr e s si o n C h a m pi o n at t h e R e d w o o d Cit y O B cli ni c.  T h e r e s e ar c h a s si st a nt a n d C o -PI s will 
f oll o w-u p, i. e. s e n di n g e m ail r e mi n d er s, a n s w eri n g q u e sti o n s, et c. fr o m t h er e o n, u si n g t h e st u d y 
e m ail.  
 
Descri be a n y pla ns f or t he partici pa nts i n t he c urre ntl y pr o p ose d st u d y t o be re -c o ntacte d or recr uite d  f or 
f ut ure f oll o w-u p st u dies. ( N ote t hat partici pa nts s h o ul d be i nf or me d of t his p ote ntial f or re -recr uit me nt or 
f ut ure f oll o w-u p st u dies d uri n g t he c urre nt st u d y’s c o nse nt pr ocess.)  
 
T h er e ar e c urr e ntl y n o pl a n s f or a n y f ut ur e f oll o w -u p st u di e s h o w e v er, d uri n g t h e c o n s e nt 
pr o c e s s , p arti ci p a nt s will b e a s k e d t o s p e cif y w h et h er t h e y ar e i nt er e st e d i n b ei n g c o nt a ct e d t o 
l e ar n a b o ut f ut ur e st u di e s. 
 
Please n ote t he f oll o wi n g K P N C I R B g ui deli nes:  
•  
C o ntact of pr os pecti ve s u bjects will be li mite d t o t hree ( 3) atte m pts i n o ne wee k, f or n o l o n ger t ha n 
t hree ( 3) c o nti n u o us wee ks. 
•  
Messa ges left will be li mite d t o o ne ( 1) per wee k f or n o m ore t ha n t hree ( 3) wee ks.  
•  
N o m ore t ha n t w o ( 2) recr uit me nt maili n gs (e mail, fl yer, br oc h ure, etc.).  
•  
If per missi o n fr o m t he patie nt’s P C P is necessar y t o c o ntact t he patie nt: 
o  If P C P d oes n ot res p o n d t o re q uest, recr uit me nt atte m pts ( p h o ne, maili n gs, etc.) ma y n ot be gi n 
u ntil 2 wee ks after t he P C P’s per missi o n was re q ueste d.  
o  If P C P gra nts per missi o n, recr uit me nt atte m pts ma y be gi n wit h n o waiti n g peri o d. 
 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
1 9  
7.  I nf or me d C o nse nt Pr ocess 
a. Writte n C o nse nt  
Descri be h o w y o u will o btai n a n d d oc u me nt c o nse nt, i ncl u di n g:  
 
•  
W here, w he n a n d h o w t he c o nse nt pr ocess will ta ke place.  
 
Ai m 1: O n c e a n eli gi bl e w o m a n a gr e e s t o p arti ci p at e, s h e will a c c e s s t h e c o n s e nt  a n d 
HI P A A f or m  in R E D c a p b ef or e pr o c e e di n g t o t h e s ur v e y vi a t h e li n k pr o vi d e d t o h er.  S h e 
will n ot b e a bl e t o c o m pl et e t h e s ur v e y u ntil c o n s e nt i s o bt ai n e d fir st.  If p arti ci p a nt s h a v e 
t e c h ni c al i s s u e s n a vi g ati n g t h e c o n s e nt or q u e sti o n s a b o ut t h e c o n s e nt f or m it s elf, t h e y 
m a y c o nt a ct t h e st u d y t e a m b y p h o n e or e m ail.  U p o n pr o vi di n g c o n s e nt, w hi c h will b e 
d o c u m e nt e d b y si g ni n g wit h a st yl u s el e ctr o ni c all y, p arti ci p a nt s will b e i s s u e d a si g n e d 
c o p y of t h e c o n s e nt f or m.  Pl e a s e s e e i nf or m e d c o n s e nt ( A p p e n di x H).  
 
•  
H o w t he researc h tea m will e ns ure t hat s u bjects ha ve s ufficie nt ti me t o c o nsi der w het her t o 
partici pate i n t he researc h  
 
Ai m 1: F or  p arti ci p a nt s w h o ar e r ef err e d t o t h e st u d y b y t h eir cli ni ci a n s, t h e y will h a v e 
alr e a d y l e ar n e d a b o ut t h e st u d y a n d di s c u s s e d p arti ci p ati o n gi vi n g t h e m a m pl e ti m e t o 
c o n si d er w h et h er t h e y w o ul d li k e t o p arti ci p at e.  T h e r e s e ar c h a s si st a nt will al s o f oll o w -
u p b y p h o n e wit h w o m e n w h o n e e d ti m e t o c o n si d er p arti ci p ati o n, t h o s e w h o d o n ot 
r e s p o n d t o t h e e m ail, a n d t h o s e w h o i niti all y a gr e e b ut d o n ot c o m pl et e t h e s ur v e y i n a 
ti m el y m a n n er. 
 
•  
A pr ocess t o e ns ure o n g oi n g c o nse nt.  
 
C o n s e nt will b e o bt ai n e d b ef or e t h e b a s eli n e s ur v e y.  P arti ci p a nt s will b e i nf or m e d t h at 
t h eir p arti ci p ati o n i n t h e st u d y i s c o m pl et el y v ol u nt ar y a n d t h at t h e y ar e fr e e t o r ef u s e t o 
p arti ci p at e i n t h e st u d y.  T h e y m a y al s o wit h dr a w fr o m t h e st u d y o n c e e nr oll e d.   W e will 
n ot b e c o n s e nti n g a g ai n b ef or e t h e s u b s e q u e nt s ur v e y s.  
 
•  
Ste ps t hat will be ta ke n t o mi ni mize t he p ossi bilit y of c oerci o n or u n d ue i nfl ue nce.  
 
B y s e n di n g t h e p arti ci p a nt s a n e m ail wit h li n k t h at r e q uir e s t h eir u ni q u e cr e d e nti al s ( d at e 
of birt h ) t o l o gi n a n d b e c a u s e p arti ci p a nt s will n ot b e a bl e t o c o m pl et e t h e s ur v e y u ntil 
c o n s e nt i s o bt ai n e d fir st, t hi s e n s ur e s t h at t h e y h a v e h a d ti m e t o r e a d t h e c o n s e nt a n d 
u n d er st a n d t h eir r ol e s a n d ri g ht s a s p arti ci p a nt s. T h e y will p arti ci p at e u n d er t h eir o w n 
di s cr eti o n mi ni mi zi n g a n y p o s si bilit y of c o er ci o n or u n d u e i nfl u e n c e . 
 
•  
A n y ste ps t hat will be ta ke n t o e ns ure t he s u bjects’ u n dersta n di n g.  
 
St u d y c o nt a ct i nf or m ati o n ( st u d y li n e a n d e m ail) will b e pr o vi d e d d uri n g r e cr uit m e nt a n d 
i n t h e c o n s e nt if p arti ci p a nt s h a v e a n y q u e sti o n s b ef or e d e ci di n g t o p arti ci p at e.  T h e 
r e s e ar c h a s si st a nt will al s o f oll o w-u p wit h w o m e n  w h o n e e d ti m e t o c o n si d er 
p arti ci p ati o n, t h o s e w h o d o n ot r e s p o n d t o t h e e m ail, a n d t h o s e w h o i niti all y a gr e e b ut d o 
n ot c o m pl et e t h e s ur v e y i n a ti m el y m a n n er.  
 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
2 0  
N O T E:  F or eac h fe derall y -s u p p orte d cli nical trial, o ne I R B-a p pr o ve d i nf or me d c o nse nt f or m use d t o 
e nr oll s u bjects m ust be p oste d b y t he a war dee or s p o ns or c o n d ucti n g t he trial o n a p u blicl y a vaila ble 
Fe deral we bsite t hat will be esta blis he d as a re p osit or y f or s uc h i nf or me d c o nse nt f or ms.  
 
b.  Wai ver of I nf or me d C o nse nt   
Pr o vi de rati o nale a n d j ustificati o n f or t he Wai ver of I nf or me d C o nse nt f or t his st u d y, i ncl u di n g:   
 
•  
E x plai n h o w t he  pr o p ose d researc h prese nt s n o m ore t ha n mi ni mal ris k t o t he st u d y 
partici pa nts.  
 
W e ar e r e q u e sti n g a w ai v er of i nf or m e d c o n s e nt f or t h e p ur p o s e of eli gi bilit y 
s cr e e ni n g .  W e will c oll e ct i nf or m ati o n fr o m p ot e nti al p arti ci p a nt s t o d et er mi n e 
eli gi bilit y  pr e s e nti n g  n o m or e t h a n mi ni m al ri s k t o t h e s e p ot e nti al p arti ci p a nt s si n c e it 
i n v ol v e s a n s w eri n g a f e w q u e sti o n s a n d n o ot h er pr o c e d ur e s f or w hi c h writt e n 
c o n s e nt i s n or m all y r e q uir e d o ut si d e of t h e r e s e ar c h c o nt e xt.  T h e ri s k i s al s o 
vi g or o u sl y pr ot e ct e d t hr o u g h o ur d at a pr ot e cti o n m et h o d ol o g y . 
 
•  
E x plai n h o w t he wai ver of i nf or me d c o nse nt will n ot a d versel y affect t he ri g hts a n d welfare 
of t he partici pa nts.  
 
Eli gi bilit y s cr e e ni n g h a s n o dir e ct c orr el ati o n t o t h e c ar e of a n y p arti ci p a nt s. T h e 
c oll e ct e d i nf or m ati o n will b e stri ctl y pr ot e ct e d a n d will n ot b e di s cl o s e d t o a n y p art y 
n ot i n v ol v e d i n t h e st u d y. T h er e s h o ul d b e n o a d v er s e i m p a ct o n t h e ri g ht s a n d 
w elf ar e of t h e p arti ci p a nt s a s t h e o nl y ri s k i s a br e a c h of c o nfi d e nti alit y.  
 
•  
E x plai n w h y t his researc h ca n n ot practicall y be carrie d o ut wit h o ut a wai ver of i nf or me d 
c o nse nt. N ote: researc h re g ulati o ns re q uire t hat j ustificati o n f or a wai ver of c o nse nt e x plai n 
w h y it is i m practica ble t o perf or m t he researc h, a n d n ot j ust i m practica ble t o o btai n c o nse nt. 
Practica bilit y ca n n ot be deter mi ne d s olel y b y c o nsi derati o ns of c o n ve nie nce/c ost/s pee d.  
 
It w o ul d n ot b e f e a si bl e t o c o nt a ct e a c h p arti ci p a nt t o o bt ai n c o n s e nt t o s cr e e n f or 
eli gi bilit y a s w e will n e e d t o u s e t h e c oll e ct e d i nf or m ati o n t o c o m p ar e p arti ci p a nt s t o 
n o n -p arti ci p a nt s t o d e m o n str at e t h at o ur s a m pl e i s n ot bi a s e d , a n d t h e st u d y r e s ult s 
ar e g e n er ali z a bl e.  T h u s, it w o ul d b e i m pr a cti c a bl e t o c o n d u ct t h e r e s e ar c h  wit h o ut a 
w ai v er of i nf or m e d c o n s e nt  f or eli gi bilit y s cr e e ni n g. 
 
•  
If t he researc h i n v ol ves usi n g i de ntifia ble pri vate i nf or mati o n or i de ntifia ble bi os peci me ns, 
pr o vi de j ustificati o n f or w h y t he researc h ca n n ot practica bl y be carrie d o ut usi n g dei de ntifie d 
i nf or mati o n.  
 
It i s n ot pr a cti c a bl e t o o nl y u s e d ei d e ntifi e d i nf or m ati o n b e c a u s e w e n e e d t o r et ai n 
i d e ntifi er s i n or d er t o li n k i m p ort a nt s o ur c e s of d at a f or a n al y si s. W e al s o c o ul d n ot 
e x a mi n e p ati e nt o ut c o m e s o v er ti m e if w e d ei d e ntifi e d t h e d at a . 
 
•  
Assess w het h er it is a p pr o priate  t o pr o vi de t he s u bjects wit h a d diti o nal perti ne nt i nf or mati o n 
after partici pati o n. 
 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
2 1  
It w o ul d n ot b e a p pr o pri at e t o pr o vi d e t h e s u bj e ct s wit h a d diti o n al i nf or m ati o n aft er 
p arti ci p ati o n gi v e n s o m e m a y n ot b e eli gi bl e t o p arti ci p at e o n c e t h e y ar e s cr e e n e d.   
 
c. Wai ver of Si g ne d ( D oc u me nte d) I nf or me d C o nse nt  
Pr o vi de rati o nale a n d j ustificati o n f or t he Wai ver of Si g ne d  ( D oc u me nte d) I nf or me d C o nse nt b y 
i de ntif yi n g w hic h of t hese t hree c o n diti o ns a p plies a n d  j ustificati o n f or h o w t he criteria is met. 
 
1)  T he researc h i n v ol ves n o m ore t ha n mi ni mal ris k t o partici pa nts A N D i n v ol ves n o pr oce d ures f or 
w hic h writte n c o nse nt is n or mall y re q uire d o utsi de of t he researc h c o nte xt.    
 
Ai m 2: F or  t h e cli ni ci a n s, t h e r e cr uit m e nt e m ail will i n cl u d e t h e st u d y i nf or m ati o n s h e et.  
W e pr o p o s e w ai v er s of t h e r e q uir e m e nt t o o bt ai n writt e n c o n s e nt si n c e t h er e i s n o m or e 
t h a n mi ni m al ri s k t o t h e m a n d i n v ol v e s  n o pr o c e d ur e s b e y o n d a n i n -d e pt h  i nt er vi e w t o 
a d dr e s s i d e ntifi e d a v e n u e s f or a d o pti o n  of M o m Zi n g a n d b arri er s t o i m pl e m e nt ati o n a n d 
m ai nt e n a n c e  wit hi n cli ni c al pr a cti c e at K P N C .  Pl e a s e s e e t h e st u d y i nf or m ati o n s h e et 
( A p p e n di x R). 
 
2)  T he si g ne d c o nse nt f or m w o ul d be t he o nl y rec or d li n ki n g t he partici pa nts t o t he researc h, a n d t he 
pri nci pal ris k t o partici pa nts w o ul d be p ote ntial har m res ulti n g fr o m a breac h of c o nfi de ntialit y.  
 
Clic k or ta p here t o e nter te xt.  
 
3)  T he s u bjects or le gall y a ut h orize d re prese ntati ves are me m bers of a disti nct c ult ural gr o u p or 
c o m m u nit y i n w hic h si g ni n g f or ms is n ot t he n or m . 
a. Descri be t he disti nct c ult ural gr o u p or c o m m u nit y  
b.  Descri be w h y si g ni n g f or ms is n ot t he n or m  
c. E x plai n h o w t he researc h prese nts n o m ore t ha n mi ni mal ris k of har m t o t hese s u bjects  
d.  Pr o vi de a n a p pr o priate alter nati ve mec h a nis m f or d oc u me nti n g t hat i nf or me d c o nse nt is 
o btai ne d  
Clic k or ta p here t o e nter te xt.  
 
d.  Alterati o n of I nf or me d C o nse nt   
I de ntif y t he re q uire d ele me nts of i nf or me d c o nse nt t hat y o u wis h t o re m o ve or alter.  
 
N/ A  
 
Pr o vi de j ustificati o n f or t heir re m o val or alterati o n.  
 
Clic k or ta p here t o e nter te xt.  
 
e. N o n -E n glis h -S pea ki n g S u bjects   
If s u bjects w h o d o n ot s pea k E n glis h will be e nr olle d, descri be h o w t he c o nse nt disc ussi o n will ta ke place 
a n d i n dicate if tra nslate d c o nse nt f or ms or s h ort f or ms will be use d. C o nfir m t hat a n i nter preter will assist 
wit h t he i nitial c o nse nt pr ocess a n d s u bse q ue nt st u d y visits.  
 
N/ A  
 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
2 2  
I M P O R T A N T N O T E: Please be a ware t hat if it is e x pecte d t hat y o u will e nr oll n o n -E n glis h s pea kers i n 
t he st u d y, s h ort f or ms s h o ul d n ot be use d as t he o nl y C o nse nt o pti o n f or t hese i n di vi d uals, t he y s h o ul d 
o nl y be use d if a n o n -E n glis h s pea ki n g partici pa nt is u ne x pecte dl y e nc o u ntere d. H o we ver, t he p ossi bilit y 
of e nc o u nteri n g n o n -E n glis h s pea ki n g p ote ntial s u bjects i n t he Ba y Area is a p ossi bilit y a n d t his 
p ossi bilit y s h o ul d be c o nsi dere d, a n d b u d gete d f or, w he n pre pari n g t he i nitial st u d y s u b missi o n f or I R B 
re vie w.   
 
f. Asse nt of C hil dre n a n d Pare nt Per missi o n  
I M P O R T A N T N O T E: C hil d C o nse nt ma y be o btai ne d i n certai n sit uati o ns  (for e xa m ple, c o n d ucti n g 
fa mil y pla n ni n g or se x uall y tra ns mitte d disease ( S T D) researc h).  I n a d diti o n, f or ol der c hil dre n a ges 1 6 
a n d u p w h o partici pate i n a n a d ult st u d y, t he c o nse nt d oc u me nt ca n be use d i n place of t he asse nt 
d oc u me nt.   
 
Descri be h o w y o u will o btai n a n d d oc u me nt asse nt/ pare ntal per missi o n, i ncl u di n g:  
 
•  
Descri be y o ur pla n f or o btai ni n g pare nt per missi o n.  T he per missi o n of o ne pare nt is ge nerall y 
s ufficie nt f or mi ni mal ris k researc h, or f or greater t ha n mi ni mal ris k researc h if t here is t he 
p ote ntial f or direct be nefit t o t he c hil d.  For st u dies i n v ol vi n g greater t ha n mi ni mal ris k wit h n o 
pr os pect of direct be nefit t o t he c hil d, per missi o n of b ot h pare nts is re q uire d u nless o ne pare nt is 
decease d, u n k n o w n, i nc o m pete nt, or n ot reas o na bl y a vaila ble, or w he n o nl y o ne pare nt has le gal 
res p onsi bilit y f or t he care a n d c ust o d y of t he c hil d.  
 
Ai m 1: P ar e nt p er mi s si o n will b e o bt ai n e d f or a c c e s si n g c hil d r e c or d s a n d c hil d a s s e nt 
will n ot b e o bt ai n e d.   
 
•  
Descri be w het her per missi o n will be o btai ne d fr o m i n di vi d uals ot her t ha n pare nts, a n d if s o, w h o 
will be all o we d t o pr o vi de per missi o n.  
 
N / A 
 
•  
I n dicate w het her asse nt will be o btai ne d a n d d oc u me nte d fr o m all, s o me, or n o ne of t he c hil dre n.  
 
Ai m 1:  A s s e nt will n ot b e o bt ai n e d fr o m a n y of t h e c hil dr e n.  
 
•  
If asse nt will o nl y be o btai ne d fr o m s o me c hil dre n ( beca use of ver y y o u n g a ge, se vere c o g niti ve 
i m pair me nt, etc.), i n dicate w hic h c hil dre n will be re q uire d t o asse nt a n d w hic h will n ot.  
 
N / A 
 
•  
W he n asse nt of c hil dre n is o btai ne d, descri be w het her a n d h o w it will be d oc u me nte d.  
 
N / A 
 
•  
W he n s u bjects mi g ht reac h t he a ge of maj orit y d uri n g t he st u d y, descri be t he pla n t o o btai n 
c o nse nt fr o m t hese s u bjects at t hat ti me usi n g a n a d ult c o nse nt f or m.  
 
N / A 
 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
2 3  
g.  Sec o n dar y Researc h f or W hic h C o nse nt is N ot Re q uire d:  
N ote: Researc h i n v ol vi n g t he use of i de ntifia ble bi os peci me ns d oes n ot a p pl y t o t his secti o n.  
N ote: Alt h o u g h c o nse nt ma y n ot be re q uire d, j ustificati o n f or a wai ver of HI P A A Pri vac y   
A ut h orizati o n ma y still be re q uire d.  
 
Sec o n dar y Researc h of i de nti ﬁa ble pri vate i nf or mati o n or i de nti ﬁa ble bi os peci me ns ma y n ot 
re q uire i nf or me d c o nse nt if at least o ne of t he criteria liste d bel o w is met. Select at least o ne of 
t he f oll o wi n g criteria a n d pr o vi de a rati o nale f or h o w t he criteria is met: 
 
•  
Use of p u blicl y a vaila ble i de nti ﬁa ble pri vate i nf or mati o n or i de nti ﬁa ble 
bi os peci me ns.  
 
N/ A  
 
•  
T he i nf or mati o n a n d/ or bi os peci me ns are rec or de d b y t he i n vesti gat or i n s uc h a wa y 
t hat t he i de ntit y of t he s u bjects ca n n ot be rea dil y ascertai ne d, a n d t he i n vesti gat or 
will neit her c o ntact t he s u bjects n or re -i de ntif y s u bjects. 
 
N/ A  
 
•  
T he researc h i n v ol ves o nl y i nf or mati o n c ollecti o n (i.e. n o bi os peci me n c ollecti o n) 
a n d t he a nal ysis of t his i de nti ﬁa ble healt h i nf or mati o n is re g ulate d b y HI P A A.  
 
 
Ai m 1: W e will u s e n o n -r e s p o n d e nt d at a i n t w o w a y s.  Fir st, w e will c o m p ar e 
p arti ci p a nt s t o n o n -r e s p o n d er s o n d e m o gr a p hi c c h ar a ct eri sti c s a n d ot h er f a ct or s 
s u c h a s m e di c al c o n diti o n s ( e. g, c hr o ni c c o n diti o n s, m e nt al h e alt h c o n diti o n s, et c.) 
a n d pr e g n a n c y b e h a vi or s ( e. g. s u b st a n c e u s e) a v ail a bl e i n t h e E H R t o d e m o n str at e 
e xt er n al v ali dit y ( e. g. t h at o ur s a m pl e i s n ot bi a s e d a n d t h e st u d y r e s ult s ar e 
g e n er ali z a bl e ).   
 
Ai m 2: N o n -r e s p o n d e nt d at a will b e u s e d t o a s s e s s i m pl e m e nt ati o n of t h e 
i nt er v e nti o n i nt o t h e h e alt h c ar e s y st e m a n d will r e q uir e d e m o gr a p hi c a n d h e alt h d at a 
a s d e s cri b e d a b o v e f or all eli gi bl e w o m e n.   A s s u c h, t h e r e s e ar c h i n v ol v e s o nl y 
i nf or m ati o n c oll e ct e d a n d t h e a n al y si s of t hi s i d e ntifi a bl e h e alt h i nf or m ati o n i s 
r e g ul at e d b y HI P A A. 
 
8.  HI P A A Pri v ac y R ule A ut h oriz ati o n   
a. Writte n HI P A A Pri vac y R ule A ut h orizati o n:  
Descri be t he pla n t o o btai n a si g ne d Pri vac y R ule A ut h orizati o n fr o m eac h s u bject.  
 
W e will o bt ai n a si g n e d Pri v a c y R ul e A ut h ori z ati o n fr o m e a c h e nr oll e d s u bj e ct u p o n 
pr o vi di n g c o n s e nt.   Pl e a s e s e e A p p e n di x I. 
 
b.  Wai ver of HI P A A Pri vac y R ule A ut h orizati o n   
If y o u will n ot o btai n a si g ne d HI P A A Pri vac y R ule A ut h orizati o n or if y o u wa nt t o eli mi nate a n y 
re q uire d la n g ua ge fr o m t he a ut h orizati o n, pr o vi de t he f oll o wi n g rati o nale a n d j ustificati o n.  
 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
2 4  
•  
E x plai n w h y t he researc h c o ul d n ot practica bl y be c o n d ucte d wit h o ut t he wai ver.  N ote: researc h 
re g ulati o ns re q uire t hat j ustificati o n f or a wai ver of HI P A A A ut h orizati o n e x plai n w h y it is 
i m practica ble t o perf or m t he rese arc h, a n d n ot j ust i m practica ble t o o btai n HI P A A A ut h orizati o n. 
Practica bilit y ca n n ot be deter mi ne d s olel y b y c o nsi derati o ns of c o n ve nie nce/c ost/s pee d.  
 
Ai m 1:  W e ar e r e q u e sti n g a w ai v er of t h e r e q uir e m e nt f or a si g n e d a ut h ori z ati o n f or t h e 
p ur p o s e of i d e ntif yi n g p ot e nti al p arti ci p a nt s f or r e cr uit m e nt.   W e n e e d t o a c c e s s P HI t o 
i d e ntif y p o st p art u m p ati e nt s a s w ell a s cli ni ci a n s t o c o n d u ct i nt er vi e w s.  T h e cli ni ci a n 
r e cr uit m e nt e m ail s will i n cl u d e a st u d y i nf or m ati o n s h e et a s w ell .  B e c a u s e t h e r e s e ar c h 
i n v ol v e s n o m or e t h a n mi ni m al ri s k t o cli ni ci a n s a n d i n v ol v e s n o pr o c e d ur e s f or w hi c h 
writt e n c o n s e nt i s n or m all y r e q uir e d o ut si d e of t h e r e s e ar c h c o nt e xt, it w o ul d b e 
i m pr a cti c a bl e t o o bt ai n t h e si g n e d a ut h ori z ati o n. 
 
W e ar e al s o r e q u e sti n g a w ai v er of t h e r e q uir e m e nt f or a si g n e d a ut h ori z ati o n f or n o n -
r e s p o n d e nt d at a.  W e n e e d t o a c c e s s n o n-r e s p o n d e nt d at a t o c o m p ar e p arti ci p a nt s t o 
n o n -r e s p o n d er s o n d e m o gr a p hi c c h ar a ct eri sti c s a n d ot h er f a ct or s s u c h a s m e di c al 
c o n diti o n s a n d pr e g n a n c y b e h a vi or s a v ail a bl e i n t h e E H R t o d e m o n str at e t h at o ur 
s a m pl e i s n ot bi a s e d a n d t h e st u d y r e s ult s ar e g e n er ali z a bl e.   
 
Ai m 2: A d diti o n all y, t o a s s e s s i m pl e m e nt ati o n of t h e i nt er v e nti o n i nt o t h e h e alt h c ar e 
s y st e m r e q uir e s d e m o gr a p hi c a n d h e alt h d at a a s d e s cri b e d a b o v e f or all eli gi bl e w o m e n.  
A s s u c h, wit h o ut a w ai v er of a ut h ori z ati o n, it w o ul d n ot b e f e a si bl e t o i d e ntif y a n d 
a s s e m bl e t h e s e c o h ort s or c o n d u ct s e c o n d ar y a n al y si s . 
 
•  
E x plai n w h y access t o a n d use of t he P HI is necessar y f or t he researc h.  
 
W e n e e d t o a c c e s s P HI t o i d e ntif y p o st p art u m p ati e nt s a n d cli ni ci a n s  a n d c o n d u ct 
s e c o n d ar y a n al y si s.  It i s n e c e s s ar y t o a c c e s s P HI t o a s s e m bl e t h e c o h ort, o bt ai n all t h e 
st u d y s p e cifi c v ari a bl e s a n d li n k t h e d at a f or t hi s st u d y.  Wit h o ut a c c e s s t o a n d u s e of t h e 
n e c e s s ar y P HI t h e r e s e ar c h c a n n ot b e c o n d u ct e d . 
 
•  
E x plai n w h y t he use or discl os ure of P HI f or t he researc h p oses n o m ore t ha n mi ni mal ris k t o t he 
s u bjects' pri vac y.  
 
W e will n e e d t o a c c e s s P HI o nl y f or t h e p ur p o s e of i d e ntif yi n g p ot e nti al p arti ci p a nt s f or 
r e cr uit m e nt a n d c o n d u cti n g s e c o n d ar y a n al y si s.  T h e r e s e ar c h i n v ol v e s n o m or e t h a n 
mi ni m al ri s k t o p arti ci p a nt s A N D i n v ol v e s n o pr o c e d ur e s f or w hi c h writt e n c o n s e nt i s 
n or m all y r e q uir e d o ut si d e of t h e r e s e ar c h c o nt e xt.  
 
•  Pr o vi de a n a de q uate pla n t o pr otect t he P HI fr o m i m pr o per use or discl os ure.  
 
A n y d at a wit h i d e ntifi a bl e i nf or m ati o n will b e p a s s w or d pr ot e ct e d b y t h e pr o gr a m m er.  A n 
a d diti o n al d at a s et will b e cr e at e d a n d u s e d b y t h e pr o gr a m m er w hi c h will n ot i n cl u d e a n y 
P HI.  W e will pr o vi d e a s s ur a n c e of t h e c o nfi d e nti alit y a n d pr o p er pr o c e d ur e s f or 
pr ot e cti n g P HI a s s et f ort h b y t h e K P N C I R B.  
 
•  Pr o vi de a pla n t o destr o y i de ntifiers at t he earliest o p p ort u nit y c o nsiste nt wit h t he p ur p ose of t he  
researc h. 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
2 5  
 
P er s o n al i d e ntifi er s will b e d e str o y e d at t h e e n d of st u d y a c c or di n g t o I R B r e q uir e m e nt s.  
 
c. HI P A A Discl os ure Acc o u nti n g  
T he Healt h I ns ura nce P orta bilit y a n d Acc o u nta bilit y Act ( HI P A A ) Pri vac y R ule gi ves patie nts t he 
ri g ht t o recei ve a listi n g, k n o w n as a n acc o u nti n g of discl os ure, of t heir i nf or mati o n t hat is discl ose d 
t o ot hers f or reas o ns ot her t ha n treat me nt, pa y me nt, or healt h care o perati o ns. K P m ust acc o u nt f or all 
k n o w n  discl os ures of pr otecte d healt h i nf or mati o n f or researc h p ur p oses wit h o ut t he i n di vi d ual’s 
a ut h orizati o n (a wai ver or alterati o n of HI P A A A ut h orizati o n)  b ot h wit hi n a K P re gi o n (bet wee n a 
Per ma ne nte Me dical Gr o u p, Kaiser F o u n dati o n H os pitals, a n d a Kaiser F o u n dati o n Healt h Pla n)  a n d 
o utsi de of K P.  
 
•  
W hat t y pe of P HI is bei n g discl ose d?  
☒ Cli nical/ Dia g n ostic  
☒ De m o gra p hics  
☒ Healt hcare  
 
•  
H o w ma n y partici pa nts are e x pecte d t o be e nr olle d i n t his st u d y at y o ur re gi o n?  
☐ 4 9 or less i n di vi d uals   
 
               T he i n vesti gat or s h o ul d mai ntai n a n i n di vi d ual acc o u nti n g rec or d of all Discl os ures ma de b y t he 
researc h tea m t hat   are s u bject t o t he HI P A A trac ki n g re q uire me nts. T he i n vesti gat or m ust als o 
tra ns mit t his trac ki n g i nf or mati o n wit hi n 2 0 da ys of Discl os ure t o t he Re gi o nal C o m plia nce 
Officer. Usi n g: Healt h C o n nect Q uic k Discl os ure or  C o m plete t he Discl os ure of P HI a b o ut a 
si n gle i n di vi d ual f or a researc h p ur p ose F or m.  
 
☒  5 0 or m ore i n di vi d uals  
 
If 5 0 or m ore i n di vi d uals, please pr o vi de t he i nf or mati o n f or eac h e ntit y t hat s p o ns ore d t he 
researc h w here P HI is bei n g discl ose d. Ple ase n ote: If y o u are discl osi n g P HI t o m ore t h a n o ne 
e ntity, t he f oll o wi n g is nee de d f or e ac h e ntity.  
•  
N a me  
B et w e e n e m pl o y e e s of T h e P er m a n e nt e M e di c al Gr o u p a n d  K P N C A L K ai s er 
F o u n d ati o n H e alt h Pl a n/ H o s pit al e m pl o y e e s (f or t hi s pr oj e ct r e s e ar c h t e a m m e m b er s 
ar e eit h er T P M G or K P N C A L K F H/ H P e m pl o y e e s )  
•  
A d dress  
K P N C A L R e gi o n  
•  
P h o ne N u m ber  
Di vi si o n of R e s e ar c h 5 1 0 -8 9 1 -3 4 0 0                                                     
 
        
K P R e d w o o d Cit y 6 5 0 -2 9 9 -2 0 0 0  
 
If discl osi n g P HI t o m ore t ha n o ne e ntit y, please c o nti n ue e nteri n g t he re q uire d i nf or mati o n bel o w: 
N/ A  
9.  St u d y Pr oce d ures  

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
2 6  
a. Descri pti o n  
Descri be a n d e x plai n t he st u d y desi g n, i ncl u di n g:  
 
•  
A detaile d c hr o n ol o gical descri pti o n of all researc h pr oce d ures.   
 
T hi s i s  a h y bri d eff e cti v e n e s s -i m pl e m e nt ati o n st u d y i n cl u di n g 1) a r a n d o mi z e d 
c o ntr oll e d tri al t o t e st  t h e eff e cti v e n e s s of M o m Zi n g t o i n cr e a s e p h y si c al a cti vit y a n d 
r e d u c e p o st p art u m d e pr e s si v e s y m pt o m s i n w o m e n at i n cr e a s e d ri s k of P P D a n d 2) 
e v al u ati o n of i m pl e m e nt ati o n of M o m Zi n g wit hi n t h e K P N C h e alt h c ar e d eli v er y 
s y st e m.  W e will i d e ntif y p ot e nti al p arti ci p a nt s a n d a s s e s s t h e m t hr o u g h cli ni ci a n 
r ef err al s a n d u si n g K P N C’ s el e ctr o ni c h e alt h r e c or d s d at a f or eli gi bilit y.  All eli gi bl e 
a n d r e cr uit e d w o m e n will c o m pl et e a  b a s eli n e s ur v e y i n cl u di n g s elf -r e p ort of P A a n d 
w e ar a r e s e ar c h -gr a d e a c c el er o m et er f or 7 c o nti n u o u s d a y s t o a s s e s s b a s eli n e P A.   
W e will m ail t h e a c c el er o m et er a n d w e ari n g i n str u cti o n s, a n d  al s o pr o vi d e a s elf -
a d dr e s s e d pr e p ai d p o st a g e e n v el o p e f or p arti ci p a nt s t o r et ur n t h e it e m s aft er e a c h 
m e a s ur e m e nt p eri o d.   All p arti ci p a nt s will b e i nf or m e d t h at t h e y d o n ot h a v e t o 
a n s w er a n y q u e sti o n i n t h e s ur v e y s t h e y d o n ot wi s h t o a n s w er .  W e will t h e n 
r a n d o mi z e 2 0 0 w o m e n i nt o 1 of 2 ar m s: 1) I nt er v e nti o n ( M o m Zi n g, n = 1 0 0) or 
2)  C o ntr ol ( U s u al c ar e, n = 1 0 0) u si n g a r e stri ct e d r a n d o mi z ati o n s c h e m e t o e n s ur e a n 
a c c e pt a bl e l e v el of b et w e e n -ar m b al a n c e i n t h e di stri b uti o n of i m p ort a nt c o v ari at e s 
( e. g. K P cli ni c, r a c e/ et h ni cit y, a g e, p arit y, m arit al st at u s, a n d e d u c ati o n ).  T h e n at ur e 
of t h e gr o u p a s si g n m e nt a n d i nt er v e nti o n d o e s n ot all o w f or bli n di n g of t h e tr e at m e nt 
c o n diti o n s  fr o m t h e p arti ci p a nt or t h e r e s e ar c h a s si st a nt w h o s e t a s k i s t o r e gi st er a n d 
e x pl ai n t h e u s e of t h e M o m Zi n g i nt er v e nti o n.  T h e pr o gr a m m er/ a n al y st, 
bi o st ati sti ci a n, a n d i n v e sti g at or s will b e bli n d e d t o t h e st u d y ar m s.  O n c e r a n d o mi z e d, 
p arti ci p a nt s will b e gi n t h eir a s si g n e d gr o u p ’ s i nt er v e nti o n or c o ntr ol tr e at m e nt f or 3 
m o nt h s .  W e will o bt ai n b ot h s elf-r e p ort a n d a c c el er o m et er-m e a s ur e d P A a n d 
d e pr e s si v e s y m pt o m s at 3 m o nt h s  ( T 1) a n d 6 m o nt h s ( T 2) p o st -b a s eli n e  f or e a c h 
w o m a n i n t h eir r e s p e cti v e ar m s.  T h er e will b e o n e fi n al s ur v e y w h e n t h e p arti ci p a nt’ s 
c hil d i s 1 2 m o nt h s ol d t o a s s e s s c hil d d e v el o p m e nt.   N o n -r e s p o n d e nt d at a will b e 
u s e d f or t h o s e w h o d o n ot r e s p o n d t o t h e r e cr uit m e nt e m ail s a n d c all s.  T h e y will b e 
gi v e n 3 0 d a y s t o o pt o ut of t h e st u d y a n d i nf or m e d t h at t h eir d at a m a y b e u s e d if t h e y 
d o n ot r e s p o n d . 
 
M o m Zi n g I nt er v e nti o n – W o m e n i n t hi s ar m will p arti ci p at e i n t h e  o nli n e  fit n e s s 
pr o gr a m , i n cl u di n g s etti n g p h y si c al a cti vit y g o al s, tr a c ki n g t h eir w or k o ut s u si n g t h e 
b uilt -i n w or k o ut tr a c k er o n t h e M o m Zi n g w e b sit e, a n d  pl a yi n g t h e e x er ci s e vi d e o s.   
 
C o ntr ol ( U s u al c ar e) – P arti ci p a nt s i n t hi s ar m will r e c ei v e u s u al p o st p art u m c ar e f or 
w o m e n at i n cr e a s e d ri s k of d e pr e s si o n, w hi c h i s c urr e ntl y a bri ef di s c u s si o n a b o ut 
t h eir d e pr e s si o n s y m pt o m s.  
 
T o e v al u at e pr o c e d ur e s f or i m pl e m e nt ati o n of M o m Zi n g at K P N C, w e wil l c o n d u ct 
r e c or d e d q u alit ati v e i nt er vi e w s wit h cli ni ci a n s a n d cli ni c al l e a d er s t o h el p i d e ntif y a 
s a m pl e of a p pr o xi m at el y 2 0 cli ni ci a n s .  I nt er vi e w r e c or di n g s will b e d e str o y e d at t h e 
e n d of t h e st u d y.   
 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
2 7  
•  
Pr oce d ures t o m o nit or s u bjects f or safet y, i ncl u di n g w h o will re vie w t he data a n d at w hat 
fre q ue nc y f or safet y iss ues. 
 
T h e st u d y t e a m, s p e cifi c all y t h e pr oj e ct m a n a g er, pr o gr a m m er, a n d r e s e ar c h 
a s si st a nt will m o nit or s u bj e ct s f or s af et y a n d a s si st p arti ci p a nt s w h e n n a vi g ati n g t h e 
s ur v e y s  a n d M o m Zi n g w e b sit e, if n e e d e d.  T h e y will al s o r e vi e w a d v er s e e v e nt d at a 
e v er y 6 m o nt h s d uri n g t h e d at a c oll e cti o n p eri o d  t o a s s e s s a n y p ot e nti al  s af et y 
i s s u e s.  T h e r e s e ar c h a s si st a nt will al s o e n s ur e p arti ci p a nt s, e s p e ci all y at b a s eli n e, 
ar e pr o p erl y w e ari n g t h e a c c el er o m et er a n d a n s w er a n y q u e sti o n s.  S h o ul d a n y 
i s s u e s ari s e, t h e y will a d dr e s s t h e m, a c c or di n gl y, i n cl u di n g c o n s ulti n g wit h t h e PI a n d 
C o -I s. T h e PI s will r e vi e w all s af et y d at a c oll e ct e d at  t h e 3-m o nt h  ( T 1) a n d 6 -m o nt h 
( T 2) f oll o w-u p s ur v e y s e v er y 6 m o nt h s d uri n g d at a c oll e cti o n . 
 
•  
Pr oce d ures perf or me d t o lesse n t he pr o ba bilit y or ma g nit u de of ris ks.  
 
T o l e s s e n t h e pr o b a bilit y or m a g nit u d e of ri s k s, o nl y t h e st u d y e m ail a d dr e s s will b e 
u s e d t o s e n d a n d r e c ei v e p arti ci p a nt e m ail.  Al s o, t h e s ur v e y li n k t h at will b e s e nt i s 
u ni q u e f or e a c h p arti ci p a nt a n d t h u s will mi ni mi z e a n y ri s k s a s w ell.  L a stl y, 
p ar ti ci p a nt s will n e e d t o pr o vi d e t h eir o w n cr e d e nti al s ( d at e of birt h) t o a ut h e nti c at e 
t h eir i d e ntiti e s b ef or e st arti n g t h e s ur v e y.  
 
•  
T he s o urce rec or ds t hat will be use d t o c ollect i nf or mati o n a b o ut s u bjects. ( Attac h all s ur ve ys, 
scri pts, a n d data c ollecti o n f or ms.) 
 
Pl e a s e s e e t h e f o ur s ur v e y s ( b a s eli n e, 3 m o nt h s p o st -b a s eli n e, 6 m o nt h s p o st -
b a s eli n e , a n d A S Q-3 i nf a nt 1 2 -m o nt h s ur v e y) t h at will b e c o n d u ct e d vi a R E D c a p f or 
p ati e nt p arti ci p a nt s  ( A p p e n di c e s M- P) a n d t h e i nt er vi e w g ui d e f or t h e cli ni ci a n 
i nt er vi e w s ( A p p e n di x S). 
 
•  W hat i nf or mati o n a n d/ or bi os peci me ns will be c ollecte d i ncl u di n g  d uri n g l o n g-ter m 
f oll o w- u p.  
Ple ase n ote, if bi os peci me ns bei n g c ollecte d  are bei n g use d t o devel o p a n i nvesti g ati o n al 
i n vitr o di a g n ostic device, a n I D E f or t he device m ay be nee de d. Ple ase revie w t he I V D 
Device F A Qs i n I R B Net f or g ui d a nce . 
 
D at a S o ur c e s: D at a u s e d i n t hi s st u d y will b e fr o m a c o m bi n ati o n of E H R d at a b a s e s, 
s ur v e y s, a c c el er o m et er s, a n d t h e M o m Zi n g w e b sit e.  W e will c o n d u ct s ur v e y s vi a 
R E D c a p a n d a c c el er o m et er -m e a s ur e d P A d at a c oll e cti o n at 3 ti m e p oi nt s: a) b a s eli n e 
(T 0, b ef or e i nt er v e nti o n), b)  3 m o nt h s p o st -b a s eli n e  ( T 1), a n d c) 6 m o nt h s p o st -b a s eli n e  
( T 2).  T h er e will b e o n e fi n al s ur v e y t o a s s e s s 1 2 -m o nt h c hil d d e v el o p m e nt a s w ell.  
L a stl y, w e will c o n d u ct q u alit ati v e i nt er vi e w s wit h k e y st a k e h ol d er s t o e v al u at e 
pr o c e d ur e s f or i m pl e m e nt ati o n.  
 
M e a s ur e s:  
D e m o gr a p hi c c h ar a ct eri sti c s a n d h e alt h i nf or m ati o n. I nf or m ati o n o n m o m a n d b a b y wit h 
r e g ar d s t o r a c e/ et h ni cit y, a g e, e d u c ati o n, i n c o m e, m arit al st at u s, p arit y, s u b st a n c e u s e, 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
2 8  
g e n er al h e alt h,  h e alt h b e h a vi or s, h e alt h c ar e utili z ati o n  will b e a s c ert ai n e d fr o m a 
c o m bi n ati o n of K P N C E H R d at a b a s e s a n d t h e o nli n e s ur v e y s.  
 
O ut c o m e s  
P h y si c al A cti vit y . P A will b e m e a s ur e d u si n g a c c el er o m etr y (A cti gr a p h w G T 3 X - B T 
p h y si c al a cti vit y m o nit or) a n d s elf -r e p ort ( s p ort s/ e x er ci s e d o m ai n of t h e Pr e g n a n c y 
P h y si c al A cti vit y Q u e sti o n n air e) at T 0, T 1, a n d T 2.  
 
D e pr e s si o n a n d D e pr e s si v e s y m pt o m s. D e pr e s si v e s y m pt o m s will b e m e a s ur e d at 
r e cr uit m e nt, T 1, a n d T 2 u si n g t h e P ati e nt H e alt h Q u e sti o n n air e ( P H Q - 8) a n d a s s e s s e d 
a s a c o nti n u o u s o ut c o m e .  T h e 8 -it e m, P H Q- 8 d e pr e s si o n s cr e e n er i s a v ali d at e d 
i n str u m e nt a d a pt e d fr o m t h e P H Q-9. T h e P H Q -8 e x cl u d e s t h e q u e sti o n r e g ar di n g 
s ui ci d al t h o u g ht s. P H Q -8 s c or e s r a n g e fr o m 0 -2 4. A s c or e of 1 -4 s u g g e st s mi ni m al 
d e pr e s si o n, 5 -9 mil d d e pr e s si o n, 1 0 -1 4 m o d er at e d e pr e s si o n, 1 5 -1 9 m o d er at el y s e v er e 
d e pr e s si o n a n d 2 0 -2 4 s e v er e d e pr e s si o n. D e pr e s si o n di a g n o s e s will b e a s c ert ai n e d 
fr o m t h e E H R. 
 
A n xi et y  a n d A n xi et y  s y m pt o m s . A n xi et y s y m pt o m s  will b e e v al u at e d u si n g t h e 
G e n er ali z e d A n xi et y Di s or d er 7 -It e m S c al e ( G A D-7), a s elf -r at e d a s s e s s m e nt d e v el o p e d 
t o s cr e e n f or g e n er al a n xi et y di s or d er. A n xi et y di a g n o s e s will b e a s c ert ai n e d f or m t h e 
E H R.  
 
A d h er e n c e . T h e M o m Zi n g  w e b sit e a ut o m ati c all y r e c or d s a d h er e n c e d at a (ti m e, t y p e, 
d at e, d ur ati o n of e x er ci s e vi d e o) f or e a c h p arti ci p a nt.  Q u art erl y u s a g e r e p ort s f or 
p arti ci p a nt s i n t h e i nt er v e nti o n will b e g e n er at e d a n d s e nt t o u s b y Kl ei n B u e n d el.  
 
A d diti o n al o ut c o m e s m e a s ur e s i n cl u d e d i n t h e s ur v e y:  sl e e p, p ati e nt s ati sf a cti o n, s elf -
effi c a c y, s o ci al s u p p ort f or a n d b arri er s t o P A, t h e i m p a ct of C O VI D -1 9 o n pr e g n a n c y, 
s u b st a n c e u s e m e a s ur e s, a n d i nf a nt d e v el o p m e nt. 
 
I m pl e m e nt ati o n e v al u ati o n m e a s ur e s. Pr o c e s s m e a s ur e s a n d k e y st a k e h ol d er i nt er vi e w s 
will b e u s e d t o a s s e s s t h e R e a c h, Eff e cti v e n e s s, A d o pti o n, I m pl e m e nt ati o n, a n d 
M ai nt e n a n c e c o m p o n e nt s of t h e R E -AI M fr a m e w or k. 6 8   R e a c h of t h e i nt er v e nti o n will b e 
e v al u at e d u si n g t h e p arti ci p ati o n r at e a m o n g c o nt a ct e d eli gi bl e p arti ci p a nt s a n d 
c o m p ari s o n of c h ar a ct eri sti c s a v ail a bl e i n t h e E H R b et w e e n p arti ci p a nt s a n d eli gi bl e 
n o n -p arti ci p a nt s.  Eff e cti v e n e s s  will b e m e a s ur e d t hr o u g h t h e r e s ult s of t h e r a n d o mi z e d 
c o ntr oll e d tri al, b y e x a mi ni n g t h e d at a f or a d o s e -r e s p o n s e a s s o ci ati o n b et w e e n 
i nt er v e nti o n e n g a g e m e nt/ a d h er e n c e ( n u m b er of e x er ci s e vi d e o s vi e w e d), P A, a n d 
d e pr e s si v e s y m pt o m s, a n d t hr o u g h p arti ci p a nt s ati sf a cti o n wit h t h e i nt er v e nti o n.  
S ati sf a cti o n will b e a s s e s s e d a s p art of t h e T 1 o nli n e s ur v e y s.  A d o pti o n will b e 
a s s e s s e d b y c al c ul ati n g p er s o n n el c o st s a s s o ci at e d wit h t h e i nt er v e nti o n ( e. g. cli ni c 
r ef err al st aff).  A d diti o n all y, k e y st a k e h ol d er i nt er vi e w s wit h cli ni ci a n s a n d cli ni c al  l e a d er s 
will a d dr e s s i d e ntifi e d a v e n u e s f or a d o pti o n  of M o m Zi n g a n d b arri er s t o i m pl e m e nt ati o n 
a n d m ai nt e n a n c e  wit hi n cli ni c al pr a cti c e at K P N C.  T h e st a n d ar d crit eri a f or g e n er ati n g a 
R E -AI M p u bli c h e alt h i m p a ct s c or e will b e f oll o w e d. 6 8  
 
•  
T he d urati o n of a n i n di vi d ual s u bject’s partici pati o n i n t he st u d y.  
 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
2 9  
F or t h e p ati e nt p arti ci p a nt s, p arti ci p ati o n will b e gi n b et w e e n 2 a n d 6 m o nt h s 
p o st p art u m ( b a s eli n e), d e p e n di n g w h e n t h e y ar e r e cr uit e d, a n d will c o n cl u d e aft er 
t h e w o m e n c o m pl et e t h e fi n al s ur v e y w h e n t h eir c hil d i s 1 2 m o nt h s ol d. 
 
F or t h e cli ni ci a n s, p arti ci p ati o n i s c o m pl et e aft er t h e o n e -ti m e i nt er vi e w t o i d e ntif y 
b arri er s a n d a d dr e s si n g i m pl e m e nt ati o n a n d e v al u at e p ot e nti al a d o pti o n of M o m Zi n g.  
 
•  
T he d urati o n a ntici pate d t o e nr oll all st u d y s u bjects.  
 
T h e a nti ci p at e d d ur ati o n t o e nr oll all st u d y s u bj e ct s will b e fr o m 0 8/ 0 1/ 2 0 2 0 -
0 3/ 3 1/ 2 0 2 2.  
 
Ye ar 1  
Ye ar 2  
Ye ar 3  
I R B a p pr o val 
 
M  
 
 
 
 
 
 
 
 
 
 
M o m Zi n g de vel o p me nt /fi nal pr o d uct 
 
D  
 
 
 
 
 
 
 
 
D  
 
Cli nic i m ple me ntati o n w or kfl o w /pr ot oc ol  
 
D  
 
 
 
 
 
 
 
 
D  
 
Partici pa nt recr uit me nt  
 
 
 
 
 
 
 
 
M  
 
 
 
Data c ollecti o n  
 
 
 
 
 
 
 
 
 
 
M  
 
Sta ke h ol der i nter vie ws  
 
M  
 
 
 
 
 
 
 
 
M  
 
Data a nal ysis  
 
 
 
 
 
 
 
 
 
 
 
M  
M o m Zi n g effecti ve ness ma n uscri pt  
 
 
 
 
 
 
 
 
 
 
 
D  
I m ple me ntati o n fi n di n gs re p ort 
 
 
 
 
 
 
 
 
 
 
 
D  
 
M = milest o ne, D = deli vera ble  
 
 
•  
T he esti mate d date f or t he i n vesti gat ors t o c o m plete t his st u d y (c o m plete pri mar y a nal yses)  
N O T E:  It s h o ul d be clear e xactl y w hic h pr oce d ures will be c o n d ucte d f or t he researc h as 
o p p ose d t o pr oce d ures t he s u bjects w o ul d u n der g o (i n t he e xact ma n ner descri be d i n t he 
pr ot oc ol) e ve n if t he y were n ot partici pati n g i n t he st u d y.  
 
T h e e sti m at e d d at e will b e 1 2/ 3 1/ 2 0 2 2.   
 
•  
Descri be pr oce d ures t hat will be f oll o we d w he n s u bjects wit h dra w fr o m t he researc h, 
i ncl u di n g wit h dra wal fr o m i nter ve nti o n b ut c o nti n ue d i nf or mati o n a n d/ or bi os peci me n 
c ollecti o n. 
 
D uri n g r e cr uit m e nt , p arti ci p a nt s will b e i nf or m e d t h at t h eir p arti ci p ati o n i n t h e st u d y i s 
c o m pl et el y v ol u nt ar y a n d t h at t h e y ar e fr e e t o r ef u s e t o p arti ci p at e i n t h e st u d y.  T h eir 
d e ci si o n w h et h er or n ot t o p arti ci p at e i n t h e st u d y will n ot aff e ct t h eir m e di c al c ar e.  If 
th e y d e ci d e t o p arti ci p at e, t h e y ar e fr e e t o c h a n g e t h eir mi n d a n d di s c o nti n u e 
p arti ci p ati o n at a n y ti m e wit h o ut a n y eff e ct o n t h eir m e di c al c ar e or eli gi bilit y f or 
f ut ur e c ar e or m e m b er s hi p i n K F H P.  At a n y ti m e d uri n g t h e st u d y, if p arti ci p a nt s n o 
l o n g er w a nt t o p arti ci p at e or h a v e t h eir i nf or m ati o n u s e d a s p art of t h e st u d y, t h e y 
m u st writ e a l ett er st ati n g t h at t h e y wit h dr a w t h eir p arti ci p ati o n a n d a ut h ori z ati o n a n d 
s e n d it t o t h e PI, Dr. L y n d s a y A v al o s, at w hi c h ti m e w e w o ul d r e m o v e h er fr o m t h e 
st u d y.   W e will u s e  a n y P HI  o bt ai n e d  f or t hi s st u d y  b ef or e  t h e y wit h dr a w  t h eir 
a ut h ori z ati o n b ut  will  n ot  u s e  a n y  P HI  o bt ai n e d  aft er  t h eir wit h dr a w al.  
 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
3 0  
•  
Descri be a n y a ntici pate d circ u msta nces u n der w hic h s u bjects c o ul d be wit h dra w n fr o m t he 
researc h wit h o ut t heir c o nse nt.  
 
W o m e n w h o b e c o m e pr e g n a nt d uri n g t h e st u d y will b e wit h dr a w n  fr o m t h e st u d y. 
 
•  
Descri be a n y pr oce d ures f or or derl y ter mi nati o n.  
 
N/ A  
 
•  
If t he st u d y i n v ol ves ge netic testi n g or c ollecti o n of ge netic i nf or mati o n, descri be t his. 
 
N/ A  
 
•  
Clarif y w het her researc h i n v ol vi n g bi os peci me ns will (if k n o w n) or mi g ht i ncl u de w h ole 
ge n o me se q ue nci n g (i.e., se q ue nci n g of a h u ma n ger mli ne or s o matic s peci me n wit h t he 
i nte nt t o ge nerate t he ge n o me or e x o me se q ue nce of t hat s peci me n). 
 
N/ A  
 
b.  Data A nal ysis  
Descri be t he data a nal ysis pla n, i ncl u di n g:  
 
•  
Statistical pr oce d ures.  
 
St ati sti c al A n al y si s:  
Pr i m ar y a n al y s e s will i n cl u d e e sti m ati o n of m e a n mi n ut e s of m o d er at e/ vi g or o u s p h y si c al 
a cti vit y a n d m e a n P H Q -8 d e pr e s si o n s cr e e ni n g s c or e  at e a c h p oi nt i n ti m e str atifi e d b y 
tr e at m e nt ar m. P att er n s i n t h e gr o u p diff er e n c e s a cr o s s ti m e will b e n ot e d, a n d t h e r e s ult s of 
t h e s e ti m e-str atifi e d a n al y s e s will b e s y nt h e si z e d vi a li n e ar r e gr e s si o n m o d el s wit h 
p ar a m et er e sti m ati o n vi a g e n er ali z e d e sti m ati n g e q u ati o n s ( G E E)  f or e a c h o ut c o m e 
s e p ar at el y . G E E a c c o m m o d at e s t h e wit hi n-p ati e nt c orr el ati o n i n r e p e at e d m e a s ur e s t o 
o bt ai n v ali d e sti m at e s of i nt er v e nti o n eff e ct s a n d a s s o ci at e d st a n d ar d err or s. I n a d diti o n t o 
st u d y ar m a n d ti m e ( c at e g ori c al v ari a bl e), m o d el c o v ari at e s will i n cl u d e t h o s e u s e d i n t h e 
r a n d o mi z ati o n pr o c e d ur e ( K P cli ni c, r a c e/ et h ni cit y, a g e, p arit y, m arit al st at u s, e d u c ati o n). I n 
a d diti o n, t hi s a pri ori s p e cifi e d s et of m o d el c o v ari at e s will i n cl u d e b a s eli n e d e pr e s si o n s c or e 
a n d h o u s e h ol d i n c o m e a s m ai n eff e ct s i n r e gr e s si o n m o d el s gi v e n t h eir str o n g a s s o ci ati o n 
wit h t h e o ut c o m e; i n cl u si o n of s u c h c o v ari at e s c a n i m pr o v e st ati sti c al p o w er a n d p r e ci si o n.8 7,  
H et er o g e n eit y i n eff e ct b y ti m e si n c e b a s eli n e will b e a s s e s s e d b y i n cl u di n g a tr e at m e nt b y 
ti m e i nt er a cti o n t er m.  
 
T h e a p pr o a c h t o a n al y si s of a d diti o n al c o nti n u o u s o ut c o m e s ( sl e e p, str e s s, a n xi et y 
s y m pt o m s, m at er n al i nf a nt b o n di n g, i nf a nt d e v el o p m e nt) will utili z e m ulti v ari a bl e li n e ar 
r e gr e s si o n a n al y si s, wit h t h e a p pr o a c h t o e sti m ati o n ( G E E), i n cl u si o n of m o d el c o v ari at e s, 
a n d e x a mi ni n g of h et er o g e n eit y i n tr e at m e nt eff e ct o v er ti m e a s d e s cri b e d a b o v e.  
 
T h e a p pr o a c h t o a n al y si s of a d diti o n al c at e g ori c al o ut c o m e s ( m e eti n g P A g ui d eli n e s, 
d e pr e s si o n di a g n o si s, a n xi et y di a g n o si s) will utili z e m ulti v ari a bl e l o g-bi n o mi al  r e gr e s si o n 
a n al y si s, wit h t h e a p pr o a c h t o e sti m ati o n ( G E E), i n cl u si o n of m o d el c o v ari at e s, a n d 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
3 1  
e x a mi ni n g of h et er o g e n eit y i n tr e at m e nt eff e ct o v er ti m e a s d e s cri b e d a b o v e. W e pr o p o s e 
t h e l o g bi n o mi al r e gr e s si o n m o d el f or p oi nt a n d i nt er v al e sti m ati o n of r el ati v e ri s k s (r ati o of 
pr o p orti o n s) r at h er t h a n t h e l o gi sti c r e gr e s si o n m o d el f or e sti m ati o n of  o d d s r ati o s, f or e a s e 
i n i nt er pr et ati o n a n d a v oi d a n c e of o d d s r ati o mi si nt er pr et ati o n gi v e n t h e r el ati v el y hi g h 
e x p e ct e d fr e q u e n c y of t h e s e o ut c o m e s.    
 
S e n siti vit y a n al y s e s will e x a mi n e i n cl u si o n of a d diti o n al c o v ari at e s i n o ur e sti m ati o n of 
tr e at m e nt eff e ct, wit h a f o c u s o n v ari a bl e s wit h c h a n c e i m b al a n c e i n di stri b uti o n s b y 
tr e at m e nt gr o u p ( d et er mi n e d i n pr eli mi n ar y a n al y s e s). A n al y s e s r e s ulti n g i n a n ap pr e ci a bl e 
c h a n g e i n t h e e sti m at e of tr e at m e nt diff er e n c e s or i n cr e a s e i n t h e pr e ci si o n of t h e tr e at m e nt 
eff e ct will b e n ot e d.   
 
•  
W he n a p plica ble, t he p o wer a nal ysis.  
 
W e will r e cr uit 2 0 0 w o m e n ( 1 0 0 p er gr o u p).  For d e pr e s si v e s y m pt o m s, t h e mi ni m u m -
d et e ct a bl e diff er e n c e b et w e e n gr o u p s i s i n t h e “ s m all” t o “ m e di u m” eff e ct r a n g e of . 4 3 
st a n d ar d d e vi ati o n u nit s (t w o -si d e d t e st, α =. 0 5). 9 1   F or  a n al y s e s of m e eti n g P A g ui d eli n e s , 
w e will h a v e s uffi ci e nt p o w er (. 8 0) t o d et e ct a 2 0 p oi nt diff er e n c e a s b a s e d o n t h e lit er at ur e 
b et w e e n t h e M o m Zi n g i nt er v e nti o n ( 4 3 % 3 3 ) a n d c o ntr ol gr o u p ( 2 3 %8 9 ), all o wi n g f or u p t o a 
1 6 % l o s s -t o-f oll o w-u p ( w hi c h i s si mil ar t o t h at of pr e vi o u s lif e st yl e i nt er v e nti o n st u di e s at 
K P N C 7 2, 9 0 ).  
 
•  
A n y pr oce d ures t hat will be use d f or q ualit y c o ntr ol of c ollecte d data.  
 
T h e pr o gr a m m er a n d st u d y i n v e sti g at or s will f oll o w st a n d ar d d at a m a n a g e m e nt pr o c e d ur e s 
t o e n s ur e t h e q u alit y of t h e d at a. T h e pr o gr a m m er will dr a w fr o m s h ar e d r e s o ur c e s of t h e 
pr o gr a m m er gr o u p, w hi c h i n cl u d e d et ail e d d o c u m e nt ati o n a b o ut d at a s o ur c e s a n d 
c h ar a ct eri sti c s, s h ar e d pr o gr a m mi n g c o d e t o pr e p ar e d at a s et s a c c or di n g t o st a n d ar di z e d 
p ar a m et er s, a n d c o n s ult ati o n wit h ot h er pr o gr a m m er s t o a s c ert ai n b e st pr a cti c e s b a s e d o n 
pr o c e d ur e s d e v el o p e d i n e arli er pr oj e ct s. T h er e will b e s y st e m ati c  d at a  c h e c k s b y a s s e s si n g 
t h e pr e s e n c e of o utli er s a n d mi s si n g v al u e s a n d c al c ul ati n g t h e di stri b uti o n s of v ari a bl e s 
o v er ti m e p eri o d s, m e di c al  f a ciliti e s, d e m o gr a p hi c s u b gr o u p s, a n d ot h er c at e g ori e s. T h e 
st u d y t e a m will al s o c o m p ar e t h e s e r e s ult s t o e x p e ct ati o n s b a s e d o n ot h er c o m p ari s o n d at a 
or st u di e s, a n d f urt h er i n v e sti g at e p o s si bl e r e a s o n s f or a n y d at a a n o m ali e s. T h e y will 
d e v el o p pr o c e d ur e s t o a d dr e s s d at a irr e g ul ariti e s, s u c h a s b y cl e a ni n g t h e d at a, a u g m e nti n g 
t h e d at a wit h ot h er r el e v a nt v ari a bl e s, or u si n g a n al yti c t e c h ni q u e s t o r e d u c e a s m u c h a s 
p o s si bl e t h e i m p a ct of bi a s i n t h e  d at a.  
 
c. S hari n g of Res ults wit h S u bjects  
Descri be w het her res ults (st u d y res ults or i n di vi d ual s u bject res ults, s uc h as res ults of sta n dar d or researc h 
la b tests a n d ge netic tests) will be s hare d wit h s u bjects or t heir pr o vi ders a n d u n der w hic h circ u msta nces . 
 
I n di vi d u al r e s ult s will n ot b e s h ar e d wit h s u bj e ct s or t h eir pr o vi d er s b ut f or t h o s e w h o w a nt t h e m, 
t h e st u d y r e s ult s, o n c e p u bli s h e d, will b e m a d e a v ail a bl e. 
 
If t he st u d y carries a ris k of i nci de ntal fi n di n gs, descri be y o ur pla n f or e val uati n g t hese a n d deter mi ni n g 
w het her a n d h o w s u bjects or t heir pr o vi ders will be gi ve n t his i nf or mati o n.  
N/ A   
  
 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
3 2  
 
If la b orat or y res ults will be s hare d wit h s u bjects or t heir healt hcare pr o vi ders, verif y t hat t he la b orat or y 
c o n d ucti n g t he test is Cli nical La b orat or y I m pr o ve me nt A me n d me nts ( C LI A) certifie d.  
N/ A  
 
1 0.  Pri v ac y, C o nfi de nti alit y  a n d D at a Sec urit y  
Descri be t he ste ps t hat will be ta ke n t o pr otect s u bjects’ pri vac y d uri n g recr uit me nt, c o nse nt a n d st u d y 
pr oce d ures.  
 
All d at a c oll e ct e d a s p art of t hi s st u d y will b e h el d i n stri ct c o nfi d e n c e. O nl y st u d y st aff will h a v e 
a c c e s s t o t h e d at a c oll e ct e d a s p art of t h e st u d y, a n d n o i d e ntif yi n g i nf or m ati o n will b e u s e d i n 
a n y r e p ort e d fi n di n g s, t h u s e n s ur i n g t h at p arti ci p a nt s f e el c o mf ort a bl e a n d t h at t h er e i s 
r e a s o n a bl e pri v a c y. 
 
D at a c oll e ct e d d uri n g r e cr uit m e nt/ s cr e e ni n g or w h e n a p ot e nti al s u bj e ct i s c o nt a ct e d f or t h e 
s ur v e y b ut d e cli n e s p arti ci p ati o n will b e d e str o y e d at  t h e e n d of t h e st u d y. S u bj e ct s will n ot b e 
c o nt a ct e d a b o ut p arti ci p ati o n aft er t h e y h a v e  d e cli n e d.  
 
Descri be t he pla n f or st ora ge of data  a n d/ or bi o s peci me ns i ncl u di n g: 
 
•  
W h o will ha ve access a n d h o w . 
 
T h e PI, C o -I’ s, a n d st u d y t e a m will all h a v e a c c e s s t o i d e ntifi a bl e i nf or m ati o n fr o m t h e 
m e di c al r e c or d a n d ot h er cli ni c al d at a b a s e s d e s cri b e d a b o v e . 
 
•  
W here t he data/ materials will be st ore d a n d f or h o w l o n g.  I n dicate if data will be e ncr y pte d a n d 
pass w or d pr otecte d a n d if tra ns p orta ble/re m o va ble me dia will be use d.  
 
P HI will b e st or e d i n p a s s w or d pr ot e ct e d or e n cr y pt e d el e ctr o ni c fil e s a n d st or e d o n 
pr ot e ct e d K P N C  s er v er s wit hi n t h e K P n et w or k s e c ur e d b y fir e w all s. P a s s w or d s will n ot 
b e di s cl o s e d t o a n y p art y n ot i n v ol v e d i n t h e st u d y.  P ati e nt i d e ntifi er s will n ot a p p e ar i n 
a n y p art of t h e p u bli c ati o n s. W h e n it i s n e c e s s ar y t o s h ar e P HI i nf or m ati o n a m o n g st u d y 
p arti e s wit hi n K P N C , w e will tr a n s mit t h e fil e s ( p a s s w or d-pr ot e ct e d/ e n cr y pt e d) t hr o u g h 
e n cr y pt e d e m ail or s e c ur e fil e tr a n sf er.  T h e i nf or m ati o n will b e st or e d f or t h e l e n gt h of 
t h e pr oj e ct a n d d e str o y e d aft er t h e fi n al m a n u s cri pt s ar e p u bli s h e d.  
 
•  
If a p plica ble, h o w will data be tra ns mitte d? 
 
T h e d at a will b e tr a n s mitt e d u si n g t h e K P N C A L s e c ur e fil e tr a n sf er s y st e m . 
 
•  
W hat i de ntifiers will be i ncl u de d.  
 
N a m e s a n d ot h er i d e ntif yi n g i nf or m ati o n o n st u d y s u bj e ct s  s u c h a s d at e s, p o st al 
a d dr e s s e s, p h o n e n u m b er s, e m ail a d dr e s s e s, a n d m e di c al r e c or d n u m b er s will b e 
i n cl u d e d. 
 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
3 3  
•  
A n y ot her ste ps t hat will be ta ke n t o e ns ure sec urit y (e. g., trai ni n g of staff, a ut h orizati o n of 
access, pass w or d pr otecti o n, e ncr y pti o n, p h ysical sec urit y, a n d se parati o n of i de ntifiers fr o m data 
a n d s peci me ns, certificates of c o nfi de ntialit y).  
 
T o e n s ur e s e c urit y w e will pr o p erl y tr ai n st aff a n d r e stri ct a c c e s s t o d at a o nl y t o t h e st u d y 
t e a m.  A s s u c h, w e b eli e v e o ur pl a n t o pr ot e ct t h e d at a i s a p pr o pri at el y miti g at e d . 
 
•  
Descri be t he pla n t o destr o y/arc hi ve or retai n data at t he e n d of t he st u d y.  If st ori n g i nf or mati o n 
a n d/ or i de ntifia ble bi os peci me ns f or f ut ure researc h, c o m plete t he ne xt secti o n.  
 
P er s o n al i d e ntifi er s a s s o ci at e d wit h p arti ci p a nt s will b e d e str o y e d a s s o o n a s p o s si bl e 
aft er t h e st u d y h a s fi ni s h e d a n d all m a n u s cri pt s  h a v e b e e n p u bli s h e d. Si n c e m a n u s cri pt 
s u b mi s si o n a n d r e vi si o n pr o c e s s oft e n r e q uir e s r e -a c c e s s of p ati e nt i nf or m ati o n, p ati e nt 
i d e ntifi er s will b e k e pt u ntil all p u bli c ati o n s g e n er at e d fr o m t h e st u d y h a v e b e e n fi ni s h e d, 
at w hi c h ti m e all p ati e nt i d e ntifi er s will b e d e str o y e d  at t h e cl o s e of t h e st u d y . 
 
1 1.  I nf or m ati o n a n d/ or Bi os peci me n B a n ki n g f or F ut ure Rese arc h 
If y o u are creati n g a re p osit or y, please s u b mit a se parate pr ot oc ol. 
 
I n dicate if bi o s peci me ns ma y be use d f or f ut ure researc h a n d w het her t hat ma y i ncl u de ge netic 
researc h.  
 
N/ A  
 
State if i nf or mati o n or bi o s peci me ns will be se nt t o a se parate re p osit or y. If data or s peci me ns will be 
ba n ke d i n a re p osit or y f or f ut ure use as part of t his pr ot oc ol s u b missi o n a d dress t he f oll o wi n g q uesti o ns:  
 
•  
W hat will be ba n ke d a n d w hat i de ntifiers will be ass ociate d wit h t he i nf or mati o n or 
bi o s peci me ns? 
 
N/ A  
 
•  
W here a n d h o w will t he i nf or mati o n or s peci me ns be st ore d?  
 
N/ A  
 
•  
F or w hat p ur p ose will t he i nf or mati o n or s peci me ns be use d?  I ncl u de a ge neral descri pti o n of t he 
t y pes of researc h t hat ma y be c o n d ucte d wit h t he i de ntifia ble pri vate i nf or mati o n/ bi os peci me ns 
(e. g. researc h o n ca ncer). 
 
N/ A  
 
•  
H o w will t he i nf or mati o n or s peci me ns be accesse d, a n d w h o will ha ve access?  
 
N/ A  
 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
3 4  
•  
Descri be t he pr oce d ures t o release i nf or mati o n or s peci me ns, i ncl u di n g t he pr ocess t o re q uest a 
release, a p pr o vals re q uire d f or release, w h o ca n o btai n i nf or mati o n or s peci me ns, a n d t he 
i nf or mati o n t o be pr o vi de d wit h s peci me ns. 
 
N/ A  
 
•  
H o w l o n g will i de ntifia ble pri vate i nf or mati o n/ bi os peci me ns be st ore d?  
 
N/ A  
 
1 2.  C ollecti o n of d at a fr o m s u bjects electr o nic all y  
If y o u will  c ollect a n y data fr o m partici pa nts electr o nicall y (i ncl u di n g e mail, we bsite, etc.), e x plai n:  
 
•  
D oes t he st u d y i n v ol ve a M o bile De vice or A p plicati o n.  If yes, please i n dicate t he 
s o urce/ ma n ufact urer/ de vel o per of t he pr o d uct: 
 
T h e c o n s e nt a n d p ati e nt s ur v e y s will b e d e v el o p e d i n R E D c a p.  T h e i nt er v e nti o n ar m 
al s o i n cl u d e s  t h e M o m Zi n g w e b sit e, w hi c h c a n b e a c c e s s e d u si n g a n y i nt er n et -e n a bl e d 
d e vi c e  a n d a ut o m ati c all y r e c or d s a d h er e n c e d at a (ti m e, t y p e, d at e, d ur ati o n of e x er ci s e 
vi d e o) f or e a c h p arti ci p a nt.  Q u art erl y u s a g e r e p ort s f or p arti ci p a nt s i n t h e i nt er v e nti o n 
will b e g e n er at e d a n d s e nt t o u s b y Kl ei n B u e n d el  ( K B), w h o will o nl y r e c ei v e st u d y I D s, 
a s si g n e d t o e a c h p arti ci p a nt u p o n e nr oll m e nt i n t h e i nt er v e nti o n.   K B i s a b eh a vi or al 
h e alt h c o m m u ni c ati o n s fir m s p e ci ali zi n g i n t h e d e v el o p m e nt of pr o gr a m s t o e d u c at e 
c o m m u niti e s a b o ut h e alt h i s s u e s.  K B a n d it s r ol e i n t h e st u d y h a s alr e a d y b e e n 
r e vi e w e d a n d a p pr o v e d b y T R O ( s e e A p p e n di x V). 
 
I nt er vi e w s wit h t h e cli ni ci a n s will b e c o n d u ct e d i n -p er s o n, b y t el e p h o n e or vi d e o ( vi a 
Mi cr o s oft T e a m s), w hi c h e v er i s m or e c o n v e ni e nt f or t h e m.  
 
•  
H o w a n d w hat data will be c ollecte d.   I n dicate if P HI is c ollecte d electr o nicall y (i ncl u di n g via a n 
a p p) a n d if t here is a n y i nterface wit h t he s u bject ’s pers o nal acc o u nts (f or e xa m ple: if s u bjects 
nee d t o create a n acc o u nt t o use t he de vice, or if t he de vice i nterfaces wit h a n e xter nal s o urce of 
data, or me dical rec or d).  
 
P ati e nt s ur v e y s: I nf or m ati o n o n p h y si c al a cti vit y, d e m o gr a p hi c c h ar a ct eri sti c s a n d ot h er 
f a ct or s i n cl u di n g q u e sti o n n air e s t o a s s e s s s o ci al s u p p ort, d e pr e s si v e s y m pt o m s, str e s s, 
sl e e p q u alit y  a n d ot h er s, will b e a s c ert ai n e d i n t h e s ur v e y s.   P HI ( p h o n e, m aili n g 
a d dr e s s, a n d e m ail) will b e c oll e ct e d el e ctr o ni c all y.  P arti ci p a nt s will n ot n e e d t o cr e at e 
a n y a c c o u nt s t o a c c e s s R E D c a p. O n c e t h e y cli c k t h e pr o vi d e d li n k, t h e y will g o dir e ctl y 
t o t h e pl atf or m. 
 
M o m Zi n g: T h e M o m Zi n g w e b sit e will r e c or d a d h er e n c e d at a a n d Kl ei n B u e n d el will s e n d 
u s a g e r e p ort s u si n g st u d y I D s , a s si g n e d a n d pr o vi d e d b y u s,  o nl y.  P HI will n ot b e 
c oll e ct e d el e ctr o ni c all y.  P arti ci p a nt s i n t h e i nt er v e nti o n will n ot n e e d t o cr e at e a n y 
a c c o u nt s t o  a c c e s s t h e w e b sit e .  A c c o u nt s will alr e a d y b e s et -u p b y t h e st u d y t e a m.  
O n c e a p arti ci p a nt e nr oll s a n d i s r a n d o mi z ed t o t h e i nt er v e nti o n ar m, s h e will b e gi v e n 
t h e a c c o u nt i nf or m ati o n ( u s er a n d p a s s w or d) t o l o g-i n a n d b e gi n t h e pr o gr a m. 
 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
3 5  
•  
H o w t he i nf or mati o n will be sec ure d /tra ns mitte d/st ore d (e ncr y pti o n, pass w or d pr otecti o n, etc.; 
ma y re q uire c o ns ultati o n wit h I T de part me nt).  I ncl u de a data fl o w dia gra m if data will fl o w 
t hr o u g h m ulti ple parties (s uc h as a h osti n g pr o vi der or c o or di nati n g ce nter). 
 
D at a will b e st or e d o n pr ot e ct e d K P N C s er v er s wit hi n t h e K P n et w or k s e c ur e d b y 
fir e w all s a n d m o nit or e d b y t h e I T d e p art m e nt.  W h e n it i s n e c e s s ar y t o s h ar e d at a 
a m o n g st u d y p arti e s wit hi n K P N C, w e will tr a n s mit t h e fil e s ( p a s s w or d -
pr ot e ct e d/ e n cr y pt e d) t hr o u g h e n cr y pt e d e m ail or s e c ur e fil e tr a n sf er.  T h e i nf or m ati o n 
will b e st or e d f or t h e l e n gt h of t h e pr oj e ct a n d d e str o y e d aft er t h e st u d y i s c o m pl et e.  
 
D at a ( n o P HI) will b e st or e d o n t h e M o m zi n g w e b sit e, m ai nt ai n e d b y Kl ei n B u e n d el, 
u si n g a S e c ur e S o c k et s L a y er ( S S L) pr ot o c ol.  W h e n t h e y s e n d t h e a d h er e n c e d at a 
( p a s s w or d pr ot e ct e d . c s v fil e s), t h e y will u s e e n cr y pt e d e m ail or s e c ur e fil e tr a n sf er.  T h e 
i nf or m ati o n will b e st or e d o n pr ot e ct e d K P N C s er v er s f or t h e l e n gt h of t h e pr oj e ct a n d 
d e str o y e d aft er t h e st u d y i s c o m pl et e.  
 
•  
A n y ris ks t o t he partici pa nts’ pri vac y p ose d b y usi n g t hese met h o ds ( descri be i n c o nse nt, as 
a p plica ble). 
 
N o, t h er e will b e n o ri s k s t o p arti ci p a nt s’ pri v a c y; w e b eli e v e o ur pl a n t o pr ot e ct t h eir 
pri v a c y i s a p pr o pri at el y miti g at e d . 
 
•  
Descri be if e mail c o ntai ni n g P HI will be use d t o c o m m u nicate wit h partici pa nts? ( Per K P p olic y, 
sec uri n g messa gi n g m ust be use d f or all c o m m u nicati o ns c o ntai ni n g P HI.) 
 
N o e m ail m e s s a gi n g c o nt ai ni n g P HI will b e u s e d t o c o m m u ni c at e wit h p arti ci p a nt s.  
 
•  
H o w y o u will verif y t he partici pa nt’s i de ntit y.  
 
P arti ci p a nt s: W e will u s e t h e e m ail o n fil e i n K P. or g f or e a c h p arti ci p a nt.  U si n g R E D c a p, 
w e will cr e at e a st u d y I D a n d u ni q u e s ur v e y li n k f or e a c h w o m a n a n d att a c h i n e a c h r e cr uit m e nt 
e m ail .  S h e will al s o n e e d t o pr o vi d e h er o w n u ni q u e cr e d e nti al s ( d at e of birt h ), t h u s 
a ut h e nti c ati n g h er i d e ntit y.   F or p arti ci p a nt s w h o ar e r e cr uit e d i niti all y b y p h o n e, s h e will n ot 
n e e d t o pr o vi d e h er d at e of birt h  a s h er i d e ntit y will b e c o nfir m e d b y t h e r e s e ar c h a s si st a nt.  
 
Cli ni ci a n s: w e will o nl y u s e t h eir K P -i s s u e d w or k e m ail t o s e n d t h e r e cr uit m e nt e m ail s. 
 
1 3.  D iscl os ure of P HI t o a c oll a b or at or 
If a n y data will be se nt o utsi de of t his site, list eac h reci pie nt ( ma y list b y r ole or cate g or y if t he 
i nf or mati o n is t he sa me f or se veral differe nt e ntities).  F or eac h reci pie nt, descri be: 
 
•  
T he na me a n d l ocati o n of t he i n di vi d ual/e ntit y recei vi n g t he i nf or mati o n.  
 
N/ A   
 
•  
W hat i nf or mati o n a n d/ or bi os peci me ns will be se nt.  
N/ A  
 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
3 6  
•  
W het her t he i nf or mati o n will be f ull y i de ntifia ble ( P HI, if healt h i nf or mati o n), a Li mite d Data 
Set, de -i de ntifie d, or a g gre gate. 
 
N/ A  
 
•  
H o w t he data/ materials will be tra nsferre d sec urel y (f or i nsta nce, Sec ure File Tra nsfer).  I n dicate 
if har d c o p y P HI will be st ore d/se nt t o a c olla b orat or. 
 
N/ A  
 
•  
W he n a p plica ble, clarif y w het her t here are writte n ass ura nces fr o m c olla b orat ors t hat P HI will n ot 
be re use d or r e-discl ose d t o a n y ot her e ntit y . Descri be ass ura nces t hat P HI will be st ore d sec urel y.  
 
N/ A  
 
 
1 4.  Pr o visi o ns t o M o nit or D at a t o E ns ure t he S afet y of S u bjects  
T his is re q uire d w he n researc h i n v ol ves m ore t ha n Mi ni mal Ris k t o s u bjects.  
 
T he pla n mi g ht i ncl u de esta blis hi n g a data m o nit ori n g c o m mittee a n d a pla n f or re p orti n g data m o nit ori n g 
c o m mittee fi n di n gs t o t he I R B a n d t he s p o ns or. Descri be:  
 
•  
W h o will m o nit or t he st u d y data f or safet y?  
 
T h e PI s will r e vi e w all s af et y d at a c oll e ct e d at t h e 3 -m o nt h ( T 1) a n d 6 -m o nt h ( T 2) f oll o w -
u p s ur v e y s . 
 
•  
T he pla n t o  peri o dicall y e val uate t he data c ollecte d re gar di n g b ot h har ms a n d be nefits t o 
deter mi ne w h et her s u bjects re mai n safe.  
 
T h e PI s will r e vi e w r e p ort e d a d v er s e e v e nt s c oll e ct e d at t h e 3 -m o nt h ( T 1) a n d 6 -m o nt h 
( T 2) f oll o w-u p s ur v e y s  e v er y 6 m o nt h s d uri n g d at a c oll e cti o n.  
 
•  
W hat data are re vie we d, i ncl u di n g safet y data, u nt o war d e ve nts, a n d efficac y data.  
 
W e will c oll e ct d at a o n s e v er e or lif e -t hr e at e ni n g i nj ur y or ill n e s s t h at r e q uir e d 
h o s pit ali z ati o n  o v er ni g ht  i n p o st p art u m p arti ci p a nt s or t h eir i nf a nt s, w h et h er a d v er s e 
e v e nt s w er e r el at e d t o e x er ci s e, a n d w h et h er a d v er s e e v e nt s r e s ult e d i n p er si st e nt or 
si g nifi c a nt di s a bilit y or i n c a p a cit ati o n . 
 
•  
H o w t he safet y i nf or mati o n will be c ollecte d (e. g., wit h case re p ort f or ms, at st u d y visits, b y 
tele p h o ne calls wit h partici pa nts). 
 
A d v er s e e v e nt  i nf or m ati o n will b e r e p ort e d b y p arti ci p a nt s a s p art of f oll o w-u p s ur v e y s.  
 
•  
T he fre q ue nc y of data c ollecti o n, i ncl u di n g w he n safet y data c ollecti o n starts.  
 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
3 7  
A d v er s e e v e nt  i nf or m ati o n will b e c oll e ct e d a s p art of t h e 3-m o nt h a n d 6 -m o nt h f oll o w -
u p s s ur v e y s .  
 
•  
T he fre q ue nc y or peri o dicit y of re vie w of c u m ulati ve data.  
 
A d v er s e e v e nt d at a will b e r e vi e w e d b y t h e PI s e v er y  6 m o nt h s d uri n g d at a c oll e cti o n . 
 
•  
Criteria f or ta ki n g acti o n o n m o nit ori n g fi n di n gs (f or i nsta nce, st o p pi n g r ules, i m me diate 
s us pe nsi o n, re p orti n g, pr ot oc ol c ha n ges, c ha n ges t o m o nit ori n g fre q ue nc y or pla n). 
 
S eri o u s a d v er s e e v e nt s a r e n ot a nti ci p at e d i n t hi s st u d y. If s eri o u s a d v er s e e v e nt s 
( a d v er s e e v e nt s t h at r e q uir e h o s pit ali z ati o n or r e s ult s i n a p er si st e nt or si g nifi c a nt 
di s a bilit y or i n c a p a cit ati o n i n t h e p o st p art u m p arti ci p a nt or h er  i nf a nt) ar e r e p ort e d 
r el at e d t o e x er ci s e, t h e PI s will r e p ort t h e s e e v e nt s t o t h e I R B a n d r e m o v e p arti ci p a nt s 
w h o e x p eri e n c e s eri o u s a d v er s e e v e nt s fr o m t h e st u d y. T h e PI s will i n c or p or at e pr ot o c ol 
c h a n g e s, i n cl u di n g i n cr e a si n g a d v er s e e v e nt m o nit ori n g  t o i n cl u d e i d e ntifi c ati o n of 
h o s pit ali z ati o n e v e nt s i n p arti ci p a nt s u si n g t h e el e ctr o ni c h e alt h r e c or d s o n a  m or e 
fr e q u e nt b a si s (i. e. m o nt hl y ). 
 
•  
F or st u dies m o nit ore d b y a D S M B/ C, descri be t he c o m mittee me m bers hi p a n d str uct ure, meeti n g 
f or mat, a n d q u or u m re q uire me nts.  U pl oa d t he b oar d/c o m mittee c h arter, if o ne e xists. 
 
N/ A  
 
1 5.  Ris ks a n d Be nefits  
a. Ris ks t o S u bjects  
List t he reas o na bl y f oreseea ble ris ks, disc o mf orts, hazar ds, or i nc o n ve nie nces t o t he s u bjects relate d t he 
s u bjects’ partici pati o n i n t he researc h. C o nsi der p h ysical, ps yc h ol o gical, s ocial, le gal, a n d ec o n o mic ris ks.  
 
P ati e nt p arti ci p a nt s : Th er e m a y b e s o m e i n c o n v e ni e n c e s  i n p arti ci p ati n g, i n cl u di n g r e g ul arl y 
a c c e s si n g a c o m p ut er, m o bil e d e vi c e, or T V wit h i nt er n et a c c e s s f or e m ail , s ur v e y c o m pl eti o n, 
a n d l o g gi n g i n t o M o m zi n g  h o w e v er, p arti ci p a nt s will b e i nf or m e d of all t h e st e p s i n v ol v e d i n 
p arti ci p ati o n b ef or e b ei n g e nr oll e d i n t h e i nt er v e nti o n.   Al s o, s o m e of t h e eli gi bilit y a n d s ur v e y 
q u e sti o n s (i. e. P H Q -8) m a y tri g g er e m oti o n al di s c o mf ort or f e eli n g s.   If it i s n ot e d t h at a 
p arti ci p a nt h a s a s c or e of 2 0 or hi g h er o n t hi s s e cti o n, w e will f oll o w o ur pr ot o c ol f or c o nt a cti n g 
t h o s e p arti ci p a nt s ( pl e a s e s e e A p p e n di x U).   L a stl y, p arti ci p a nt s i n t h e i nt er v e nti o n gr o u p c o ul d 
e x p eri e n c e f ati g u e, m u s cl e s or e n e s s, a n d i nj ur y, s u c h a s a s pr ai n e d a n kl e or str ai n e d m u s cl e, 
w hil e e x er ci si n g.  T h e y c a n r e d u c e t h e s e ri s k s b y pr o p er w ar m -u p a n d c o ol -d o w n p eri o d s, 
a d e q u at e h y dr ati o n, a n d c ar ef ull y m o nit ori n g a n d pl a n ni n g t h eir e x er ci s e.  
 
Cli ni ci a n s: T h e ri s k s ar e mi ni m al f or cli ni ci a n s p arti ci p ati n g i n k e y st a k e h ol d er i nt er vi e w s a s t h e y 
will b e a s k e d t o a d dr e s s i d e ntifi e d a v e n u e s f or a d o pti o n of M o m Zi n g  a s a r e s o ur c e f or t h eir 
p ati e nt s at i n cr e a s e d ri s k of p o st p art u m d e pr e s si o n  a n d b arri er s t o i m pl a nt ati o n a n d 
m ai nt e n a n c e wit hi n cli ni c al pr a cti c e at K P N C, w hi c h s h o ul d n ot h a v e a n y ri s k s.   
 
D escri be t he pr o ba bilit y, ma g nit u de, d urati o n, a n d re versi bilit y of t he ris ks.  

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
3 8  
P arti ci p a nt s will b e  i nf or m e d of all  t h e st e p s i n v ol v e d i n p arti ci p ati o n b ef or e b ei n g e nr oll e d i n t h e 
st u d y i n cl u di n g  a n y  ri s k s.  C o n si d eri n g t h e i nt er v e nti o n i s n ot p h y si c all y i n v a si v e, t h e p h y si c al 
a n d p s y c h ol o gi c al ri s k s m e nti o n e d a b o v e  ar e l o w i n pr o b a bilit y a n d m a g nit u d e .  
 
If a p plica ble, i n dicate w hic h pr oce d ures ma y ha ve ris ks t o t he s u bjects t hat are c urre ntl y u nf oreseea ble. 
 
N/ A  
 
If a p plica ble, i n dicate w hic h pr oce d ures ma y ha ve ris ks t o a n e m br y o or fet us s h o ul d t he s u bject be or 
bec o me pre g na nt.  
 
N/ A  
 
If a p plica ble, descri be ris ks t o ot hers w h o are n ot s u bjects a n d ris ks t o Kaiser Per ma ne nte 
  
N/ A  
 
b.  P ote ntial Be nefits t o S u bjects  
Descri be t he p ote ntial be nefits t hat i n di vi d ual s u bjects ma y e x perie nce fr o m ta ki n g part i n t he researc h. 
I ncl u de as ma y be usef ul f or t he I R B’s c o nsi derati o n, t he pr o ba bilit y, ma g nit u de, a n d d urati o n of t he 
p ote ntial be nefits. I n dicate if t here is n o dire ct be nefit. D o n ot i ncl u de be nefits t o s ociet y or ot hers.  
 
P arti ci p a nt s i n t h e i nt er v e nti o n ar m m a y b e n efit fr o m t h e i nt er v e nti o n if o ur h y p ot h e si s i s c orr e ct 
a n d t h e y e x p eri e n c e a d e cr e a s e i n p o st p art u m d e pr e s si v e s y m pt o m s a n d a n i n cr e a s e i n 
p h y si c al a cti vit y , w hi c h m a y al s o p o siti v el y i m p a ct ot h er a s p e ct s of t h eir lif e i n cl u di n g p h y si c al 
( e. g. d e cr e a s e i n p o st p art u m w ei g ht r et e nti o n) a n d m e nt al h e alt h ( d e cr e a s e i n str e s s a n d 
a n xi et y).       
 
c. Ris ks t o K P   
Is t here a n yt hi n g a b o ut t he nat ure of t his st u d y w hic h, if re veale d t o t he p u blic, c o ul d p ut K P at ris k or 
c o m petiti ve disa d va nta ge? ☐ Yes  ☒ N o  
 
If “ yes” descri be i n detail.              
 
1 6.  Ec o n o mic B ur de n t o S u bjects  
Descri be a n y c osts t hat s u bjects ma y be res p o nsi ble f or beca use of partici pati o n i n t he researc h st u d y (f or 
e xa m ple, c o -pa ys; pa yi n g f or treat me nt, t hera pies, or ot her i nter ve nti o ns, or t he deli ver y of t hese) a n d 
h o w y o u will i nf or m partici pa nts of t hese c osts pri or t o t heir e nr oll me nt i n t his st u d y.  
 
N/ A  
 
1 7.  C o m pe ns ati o n t o P artici p a nts  
Descri be a n y c o m pe nsati o n pr o vi de d t o partici pa nts, f or e xa m ple, f or ti me i nc o n ve nie nce, disc o mf ort, 
tra vel, or i n t he e ve nt of researc h relate d i nj ur y. If a p plica ble, descri be h o w y o u will i nf or m partici pa nts 
of t his pri or t o t heir e nr oll me nt i n t he st u d y, i ncl u di n g if pa y me nt will be pr orate d if t he s u bject 
wit h dra ws earl y fr o m t he st u d y.  
 
N O T E: pa y me nt ma y n ot be wit h hel d as a n i nce nti ve f or partici pa nts t o c o m plete a n y p orti o n of t he 
st u d y. 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
3 9  
 
P arti ci p a nt s will r e c ei v e a t ot al of $ 7 0 i n t h e st u d y f or t h eir p arti ci p ati o n .  T h e y will b e i s s u e d:  
 
•  
O n e $ 2 0 T ar g et e -gift c ar d aft er c o m pl eti o n of t h e fir st ( b a s eli n e) s ur v e y a n d r et ur n of 
t h e w or n p h y si c al a cti vit y m o nit or; 
•  
O n e $ 2 0 T ar g et e -gift c ar d aft er c o m pl eti o n of t h e s e c o n d ( 3 m o nt h s p o st-b a s eli n e) 
s ur v e y a n d r et ur n of t h e w or n p h y si c al a cti vit y m o nit or;  
•  
O n e $ 3 0 T ar g et e -gift c ar d aft er c o m pl eti o n of t h e t hir d ( 6 m o nt h s p o st -b a s eli n e) s ur v e y, 
r et ur n of t h e w or n p h y si c al a cti vit y m o nit or, a n d c o m pl eti o n of t h e fi n al s ur v e y ( w h e n t h e 
p arti ci p a nt’ s b a b y i s 1 2 m o nt h s ol d).  
 
1 8.  Res o urces A v ail a ble  
Descri be a n y s pecial res o urces or e x pertise re q uire d t o c o n d uct t he st u d y.  
 
N/ A  
 
1 9.  Pri nci p al I n vesti g at or  
a.  Has t he Pri nci pal I n vesti gat or ( PI) pre vi o usl y bee n a p pr o ve d as PI f or a st u d y wit hi n K P N C?   ☒ 
Yes  ☐ N o  
b.  Has t he PI bee n a u dite d /assesse d wit hi n t he past t hree years? ☐ Yes  ☒ N o  
If Yes, c hec k all t hat a p pl y a n d pr o vi de t he o utc o me/fi n di n gs : 
☐ F D A    ☐ R Q C C    ☐ C T P    ☐ C C R U 
O utc o me/ Fi n di n gs: Clic k or ta p here t o e nter te xt.  
c.  Is t he PI c urre ntl y u n der a C orrecti ve A n d Pre ve ntati ve Acti o n ( C A P A) pla n? 
☐ Yes  ☒ N o  
If Yes, pr o vi de a brief descri pti o n: Clic k or ta p here t o e nter te xt. 
 
2 0.  Re q uire d A p pr o v als  
a.  Descri be a n y a p pr o vals t hat will be o btai ne d pri or t o c o m me nci n g t he researc h. (e. g., sc h o ol, 
e xter nal site. f u n di n g a ge nc y, or ot her K P de part me nts). Be s ure t o list eac h K P site (f or e xa m ple, 
K P Sa n Fra ncisc o H os pital, Di visi o n of Researc h, K P Oa kla n d Re g – 1 8 0 0 Harris o n, etc.)  
 
Di vi si o n of R e s e ar c h  
R e d w o o d Cit y M e di c al C e nt er  
 
b.  F acilit y -B ase d Rese arc h: K P N C I R B re q uires t hat t he Pri nci pal I n vesti gat or ( PI) o btai n 
a p pr o val si g nat ures at e ac h  K P N C f acilit y  w here researc h acti vit y will occ ur. T hese ma y i ncl u de 
l ocal researc h c hair, P h ysicia n-i n-C hief, de part me ntal c hair, Area M a na ger, i nf or mati o n 
tec h n ol o g y re vie w (as a p pr o priate), a n d Di visi o n of Researc h scie ntific re vie w (st u de nt researc h).  
 
List eac h K P facilit y t hat researc h acti vit y will occ ur a n d s pecif y w h ose si g nat ure has bee n/ will 
be o btai ne d.  
 
Na me of Facilit y: Di vi si o n of R e s e ar c h  
 
L ocal Researc h C hair ( L R C): Mi c h a el Sil v er b er g  a n d M ar y R e e d  
 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
4 0  
C hief of Ser vice: Tr a c y Li e u  
 
P h ysicia n -i n-c hief ( PI C):  Clic k or ta p here t o e nter te xt.  
 
Area Ma na gers (if a p plica ble): Clic k or ta p here t o e nter te xt.  
 
Na me of Facilit y: R e d w o o d Cit y M e di c al C e nt er  
 
L ocal Researc h C hair ( L R C): R o n al d M ell e s  
 
C hief of Ser vice: K ari C arl s o n  
 
P h ysicia n -i n-c hief ( PI C):  Gr a c e  Firt c h  
 
Area Ma na gers (if a p plica ble): S h ei l a Gil s o n 
 
c. N o n -F acilit y -B ase d Rese arc h  (e x: N ort her n Calif or nia Re gi o nal a n d Pr o gra m Office): F or n o n-
facilit y-base d researc h, t he PI’s s u per vis or  an d de part me nt hea d are re q uire d i n lie u of a p pr o vals 
fr o m t he C hief of Ser vice, P h ysicia n-i n-c hief, a n d Area Ma na ger. T he Ce ntral Researc h 
C o m mittee C hair pers o n ser ves as t he L R C. As s uc h, list eac h K P n o n -facilit y t hat researc h 
acti vit y will occ ur a n d c o nfir m w h ose si g nat ure has bee n/ will be o btai ne d.  
 
PI’s S u per vis or: Clic k or t a p h er e t o e nt er t ext.  
 
De part me nt Hea d: Clic k or t a p h er e t o e nt er t ext.  
 
Ce ntral Researc h C o m mittee C hair pers o n:  Clic k or t a p h er e t o e nt er t ext.  
 
d.  Sites wit h n o L oc al Rese a rc h C h air:  F or sites wit h n o L ocal Researc h C hair, t he Ce ntral 
Researc h C o m mittee C hair pers o n ser ves as t he L ocal Researc h C hair:  
 
Site:  Clic k or ta p here t o e nter te xt.  
 
Ce ntral Researc h C o m mittee C hair pers o n: Clic k or ta p here t o e nter te xt.  
 
2 1.  Dr u gs or De vices  
N O T E: see t he I C H -G C P g ui da nce f or a s u m mar y of i n vesti gat or a n d s p o ns or res p o nsi bilities i n cli nical 
trials. 
 
List a ll dr u gs a n d de vices use d i n t he researc h a n d t he p ur p ose of t heir use, a n d t heir re g ulat or y a p pr o val 
stat us. 
 
N/ A  
 
 
a. Dr u g St u dies  
If t he researc h i n v ol ves dr u gs a n d is i n vesti gat or-i nitiate d, i n dicate w het her t here is a n y p ossi bilit y t hat 
t he res ults will be re p orte d t o F D A (e. g. as part of a ne w dr u g a p plicati o n [ N D A]). 

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
4 1  
 
N/ A  
 
If t he dr u g is i n vesti gati o nal ( has a n I N D), c o nfir m t hat y o u will c o m pl y wit h all a p plica ble F D A 
re q uire me nts f or i n vesti gat ors.   
 
N/ A  
 
C o nfir m t hat y o u will f oll o w a p plica ble K P p har mac y p olicies a n d pr oce d ures.  
 
N/ A  
 
Descri be y o ur pla n f or dr u g st ora ge, ha n dli n g, a n d acc o u nta bilit y, i ncl u di n g distri b uti o n, ret ur n, a n d 
destr ucti o n of t he dr u g(s).  
 
N/ A  
 
b.  De vice St u dies:  
If t his is a de vice st u d y a n d y o u t hi n k t he de vice is N o n-Si g nifica nt Ris k, i ncl u de j ustificati o n here or 
u pl oa d it as a se parate d oc u me nt al o n g wit h a n y a vaila ble de vice i nf or mati o n (i nstr ucti o ns f or use, etc.).  
 
N/ A  
 
If t he researc h i n v ol ves de vices a n d is i n vesti gat or-i nitiate d, i n dicate w het her t here is a n y p ossi bilit y t hat 
t he res ults will be re p orte d t o F D A (e. g. as part of a pre mar ket a p pr o val a p plicati o n [ P M A]). 
 
N/ A  
 
If t he de vice has a n I D E or a clai m of a b bre viate d I D E ( N o n-Si g nifica nt Ris k de vice), c o nfir m t hat y o u 
will c o m pl y wit h all a p plica ble F D A re q uire me nts f or i n vesti gat ors.   
 
N/ A  
 
Descri be t he de vice, t he ma n ufact uri n g pr ocess, a n d t he de vice la beli n g, i ncl u di n g safet y i nstr ucti o ns or 
war ni n gs.  If a vaila ble, t his ma y be a d dresse d i n se paratel y u pl oa de d de vice i nf or mati o n (s uc h as 
i nstr ucti o ns f or use).  
 
N/ A  
 
Descri be de vice st ora ge, ha n dli n g, a n d acc o u nta bilit y, i ncl u di n g h o w access t o t he de vice will be li mite d 
t o a p pr o priate pers o n nel a n d h o w y o u will e ns ure t he de vice will be use d o nl y f or a p pr o priate st u d y 
s u bjects.  
 
N/ A  
 
2 2.  M ulti -Site Rese arc h   
a. If t his is a m ulti-site st u d y a n d y o u are t he lea d i n vesti gat or or t his site will be t he c o or di nati n g 
ce nter f or a n y acti vit y, descri be t he pr ocesses t o e ns ure c o m m u nicati o n a m o n g sites, s uc h as:  

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
4 2  
 
•  
All sites ha ve t he m ost c urre nt versi o n of t he pr ot oc ol, c o nse nt d oc u me nt, a n d 
HI P A A a ut h orizati o n.   
N/ A  
•  
All re q uire d a p pr o vals ha ve bee n o btai ne d at eac h site (i ncl u di n g a p pr o val b y t he 
site’s I R B of rec or d).  
N/ A  
•  
All m o dificati o ns ha ve bee n c o m m u nicate d t o sites, a n d a p pr o ve d (i ncl u di n g 
a p pr o val b y t he site’s I R B of rec or d) bef ore t he m o dificati o n is i m ple me nte d.  
N/ A  
•  
All e n ga ge d partici pati n g sites will safe g uar d data as re q uire d b y l ocal i nf or mati o n 
sec urit y p olicies.  
N/ A  
•  
All l ocal site i n vesti gat ors c o n d uct t he st u d y a p pr o priatel y.   
N/ A  
b.  Descri be t he met h o d f or c o m m u nicati n g t o e n ga ge d partici pati n g sites t he f oll o wi n g:  
 
•  
Pr o ble ms.  
 
N/ A  
 
•  
I nteri m res ults.  
 
N/ A  
 
•  
T he cl os ure of a st u d y.   
 
N/ A  
 
c. Descri be a n y s pecial res o urces or e x pertise re q uire d t o c o n d uct t he st u d y.  
 
N/ A  
 
2 3.  C o m m u nit y -B ase d P artici p at or y Rese arc h  
Descri be i n v ol ve me nt of t he c o m m u nit y i n t he desi g n a n d c o n d uct of t he researc h.  

 
Pr ot oc ol Te m pl ate  
( Use wit h C ore D at a F or m) 
F or m  
N C R S P H R P F O R M K P -2 0 2, Versi o n 2. 1   
     K P N C A L I m ple me ntati o n Date: 0 8/ 3 0/ 2 0 1 9  
 
 
4 3  
 
N/ A  
 
Descri be y o ur pla n f or e ns uri n g t hat c o m m u nit y researc h part ners are a p pr o priatel y trai ne d i n h u ma n 
s u bjects’ pr otecti o n.  
 
N/ A  
 
N O T E: “ C o m m u nit y -base d Partici pat or y Researc h” is a c olla b orati ve a p pr oac h t o researc h t hat e q uita bl y 
i n v ol ves all part ners i n t he researc h pr ocess a n d rec o g nizes t he u ni q ue stre n gt hs t hat eac h bri n gs. 
C o m m u nit y -base d Partici pat or y Researc h be gi ns wit h a r esearc h t o pic of i m p orta nce t o t he c o m m u nit y, 
has t he ai m of c o m bi ni n g k n o wle d ge wit h acti o n a n d ac hie vi n g s ocial c ha n ge t o i m pr o ve healt h o utc o mes 
a n d eli mi nate healt h dis parities.