Control Systems Engineering for Optimizing a Prenatal Weight Gain Intervention
Phase: NA
Conditions: Overweight and Obesity, Physical Activity, Weight Change, Body, Eating Behavior
Sponsor: Penn State University

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Protocol for
Human Subject Research
Protocol Title:
Healthy Mom Zone: Control Systems Engineering for Optimizing a Prenatal Weight Gain Intervention Study 2
Short title: Healthy Mom Zone Study 2
Principal Investigator:
Danielle Symons Downs, Ph.D.
Department of Kinesiology
814-863-0456
dsd11@psu.edu
Version Date:
October 28, 2015; December 18, 2015; February 26, 2016; March 29, 2016; April 27, 2016, June 9, 2016,
September 1, 2016; October 24, 2016; March 30, 2017; April 4, 2017, May 8, 2017; June 29, 2017; July 25,
2018
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
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
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Table of Contents
1.0
Objectives..........................................................................................................................................................2
2.0
Background........................................................................................................................................................3
3.0
Inclusion and Exclusion Criteria..........................................................................................................................5
4.0
Recruitment Methods........................................................................................................................................6
5.0
Consent Process and Documentation.................................................................................................................7
6.0
Study Design and Procedures.............................................................................................................................8
7.0
Data and Specimen Banking.............................................................................................................................13
8.0
Statistical Plan .................................................................................................................................................13
9.0
Confidentiality, Privacy and Data Management ...............................................................................................14
10.0
Data and Safety Monitoring Plan .....................................................................................................................15
11.0
Risks ................................................................................................................................................................19
12.0
Potential Benefits to Subjects and Others ........................................................................................................19
13.0
Sharing Results with Subjects...........................................................................................................................20
14.0
Economic Burden to Subjects...........................................................................................................................20
15.0
Number of Subjects .........................................................................................................................................20
16.0
Resources Available .........................................................................................................................................20
17.0
Other Approvals...............................................................................................................................................22
18.0
Subject Stipend and/or Travel Reimbursements ..............................................................................................22
19.0
Multi-Site Research..........................................................................................................................................23
20.0
Adverse Event Reporting..................................................................................................................................23
21.0
Study Monitoring, Auditing and Inspecting ......................................................................................................23
22.0
References.......................................................................................................................................................24
23.0     HIPAA Research Authorization and/or Waiver or Alteration of Authorization…………………………………………………25
24.0
Appendix .........................................................................................................................................................26
1.0
Objectives
1.1
Study Objectives
Purpose: The proposed overall research aims to establish feasibility of delivering an
individually-tailored, behavioral intervention to manage gestational weight gain [GWG] that
adapts to the unique needs and challenges of overweight/obese pregnant women [OW/OBPW]
and will utilize control systems engineering to optimize this intervention; in other words, make
this intervention manage GWG in OW/OBPW as effectively and efficiently as possible.
Aim 1: This application is to conduct the second study of the research plan (Study 2) to (a) test
an individually-tailored behavioral intervention (including components of physical activity,
healthy eating, goal-setting, self-monitoring, and GWG management) with decision rules for
when and how to adapt dosages for an individual and (b) the randomization, participant
retention, and data collection procedures with an intervention (treatment) and control groups in
a cohort of OW/OBPW from approximately ~6-35 weeks gestation; with follow-ups through
delivery to 6-weeks postpartum. We hypothesize that women in the intervention group will have
more positive eating and activity behaviors and psychosocial and behavioral outcomes as well
as manage their GWG better compared to controls.
Aim 2: R56: To prospectively characterize the effects of the intrauterine environment on fetal
growth and infant birth weight. Detailed, prospective data collection on Healthy Mom Zone
participants offers the novel opportunity to (a) assess how the intrauterine eating and physical
activity environment impacts fetal growth and (b) explore the effects of our GWG intervention on
fetal growth and infant weight. We hypothesize that by changing the maternal prenatal
eating/physical activity environment, a critical time in the lifecycle, we will observe differences
between intervention and control mother-infant dyads on in utero markers of fetal growth and
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infant birth weight. R56: In addition, we will explore how individual differences in maternal sleep
duration, hydration, and stress impact fetal growth and development and infant birth weight.   
Aim 3: To use data collected from Aim 1 and control systems engineering to build a model that
characterizes the effects of energy balance and planned/self-regulatory behaviors on GWG over
time and use this model to develop an optimized intervention. We will also use the data
collected in Aim 1 and 2 to build and validate dynamical systems models that characterize fetal
growth and infant birth weight as well as how fetal weight respond to changes in maternal sleep
duration and stress.
1.2
Primary Study Endpoints
Gestational Weight Gain [GWG] – amount of weight gained over the course of the total
pregnancy as well as in smaller time points such as weekly, monthly, and in the pregnancy
trimesters and weight behaviors
1.3
Secondary Study Endpoints
Healthy eating [HE] and physical activity [PA] behaviors
Self-regulation behaviors
Sleep behaviors
Adult temperament
Psychological well-being (body image satisfaction, depressive symptoms, anxiety, perceived
and actual stress)
Motivational determinants of HE and PA (attitude, social norm, perceived control, self-efficacy,
intention)
Social-demographic and health correlates (e.g., age, pregnancy history, etc.)
Fetal growth, weight, height, birth weight, postnatal weight
Mobile resting metabolic rate, basal metabolic rate, metabolism
R56:
C-reactive protein/micronutrients (e.g., folate)
Maternal and infant labor and delivery complications
Maternal/Fetal hydration
Maternal/Fetal medical record data
2.0
Background
2.1
Scientific Background and Gaps
Managing gestational weight gain (GWG) offers immediate and lifelong health benefits such as
reduced risk for pregnancy complications and metabolic syndrome in mothers, adverse birth
outcomes, and CVD/obesity in both mothers and offspring.1 Because overweight/obese
pregnant women (OW/OBPW) often exceed the GWG guidelines,1-4 managing weight gain in
this population is critical. Intervention components of education, behavior modification, and
healthy eating/physical activity behaviors have effectively controlled weight in non-pregnant5-7
and in normal weight pregnant women.8-10 However, they have been less useful at preventing
high GWG in OW/OBPW in part because they have challenges with managing weight and may
require a more hands-on and intensive approach [GAP #1]. An individually-tailored intervention
that provides OW/OBPW with support for managing GWG on a weekly basis and is adapted to
their unique needs over the course of pregnancy may be a highly promising way to prevent high
GWG. For example, a woman exceeding GWG goals may require a higher dosage than a
woman who is adequately managing her weight and there are likely individual differences in the
points during pregnancy this dosage will need to be tailored. Because the specific dosage
needed to prevent high GWG in OW/OBPW is not well understood, there is a critical need for
research in this area [GAP #2]. Our multidisciplinary team has the expertise to develop this
individually-tailored intervention.
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1.
Institute of Medicine (2009). Weight gain during pregnancy: Reexamining the guidelines. K. M.
Rasmussen and A. L. Yaktine, Eds, Committee to reexamine IOM pregnancy weight guidelines. Institute of Medicine, National
Research Council. Accessed on June 20th, 2012 at: http://www.nap.edu/.
2.
Walker, L.O. (1996). Predictors of weight gain at 6 and 18 months after childbirth: a pilot study. Journal of Obstetric,
Gynecologic, and Neonatal Nursing, 25, 39-48. PMID: 8627401.
3.
Gunderson, E. P., & Abrams, B. (1999). Epidemiology of gestational weight gain and body weight changes after pregnancy.
Epidemiological Review, 21, 261-275. PMID: 10682262.
4.
Butte, N. F., Ellis, K. J., Wong, W. W., Hopkinson, J. M., & O’Brian Smith, E. (2003). Composition of
gestational weight gain impacts maternal fat retention and infant birth weight. American Journal of Obstetrics and Gynecology,
189, 1,423-1,432. PMID: 14634581.
5.
The Diabetes Prevention Program Research Group. (2002). The Diabetes Prevention Program (DPP)
description of lifestyle intervention. Diabetes Care, 25, 2165-2171. PMCID: PMC1282458.
6.
The Diabetes Prevention Program Research Group (2009). 10-year follow-up of diabetes and weight loss in the Diabetes
Prevention Program Outcomes Study. Lancet, 374, 1677-1686. PMID: 19878986.
7.
Wadden, T. A., West, D. S., Neiberg, R. H., Wing, R. R., Ryan, D. H., Johnson, K. C., Foreyt, J. P., Hill,
J. O., Trence, D. L., & Vitolins, M. Z. (2009). One-year weight losses in the Look AHEAD study: Factors associated with
success. Obesity, 17, 713-722. PMID: 20876408.
8.
Polley, B. A., Wing, R. R., & Sims, C. J. (2002). Randomized controlled trial to prevent excessive
weight gain in pregnant women. International Journal of Obstetrics and Related Metabolic Disorders, 26, 1494-1502. PMID:
12439652.
9.
Olson, C. M., Strawderman, M. S., & Reed, R. G. (2004). Efficacy of an intervention to prevent excessive gestational weight
gain. American Journal of Obstetrics and Gynecology, 191, 530-536. PMID: 15343232.
10.
Phelan, S., Phipps, M. G., Abrams, B., Darroch, F., Schaffner, A., & Wing, R. A. (2011). Randomized
trial of a behavioral intervention to prevent excessive gestational weight gain: The Fit for Delivery Study. American Journal of
Clinical Nutrition, doi: 10.3945/ajcn.110.005306. PMID: 21310836.
11.         Newnham JP, Doherty DA, Kendall GE, Zubrick SR, Landau LL, Stanley FJ. Effects of repeated prenatal ultrasound
examinations on childhood outcome up to 8 years of age: follow-up of a randomised controlled trial. Lancet.
2004;364(9450):2038-44. doi: 10.1016/S0140-6736(04)17516-8. PubMed PMID: 15582061.
2.2
Previous Data
We have synergistically integrated methods and key principles from behavioral intervention,
psychology, engineering, statistics, mathematics, physiology, biology, kinesiology, and
nutritional sciences to construct a framework for an individually-tailored intervention that relies
on principles from behavioral theory (planned behavior and self-regulation), energy balance,
and control systems engineering (dynamical modeling, system identification, controller design)
to moderate GWG in OW/OBPW.11 Intervention program components of education, goal-setting,
self-monitoring, and engaging in healthy eating/physical activity (HE/PA) behaviors are informed
by past research5-10,12,13 and evidence from the labs of the PI, Dr. Downs on explaining HE/PA
behaviors with the Theory of Planned Behavior and interventions to promote prenatal health
(e.g., Active MOMS DK075867-02)14-22 and from the Co-I’s, Drs. Savage and Rolls on effective
weight management using a low energy density diet.23-30 A mathematical energy balance model
and computer-based applet developed by Drs. Rivera (Co-PI), Thomas (consultant), and Collins
(Co-I) will be used to forecast GWG as a teaching tool to guide feedback in real time for GWG
monitoring.31 E-health technology tools will be used for self-monitoring of GWG and healthy
eating/physical activity behaviors. Principles from adaptive intervention design (Collins)32 and
control systems engineering (Rivera)33 will inform program dosages to manage GWG over time
for each subject.
12.
Dong, Y., Rivera, D. E., Thomas, D. M., Navarro-Barrientos, J. E., Symons Downs, D., Savage, J. S., &
Collins, L. M. (2012). A dynamical systems model for improving gestational weight gain behavioral interventions. Proceedings
of the 2012 American Control Conference, Montreal, CN, 4059-4064.
13.
Look Ahead Research Group: Bray, G., Gregg, E., Haffner, S., Pi-Sunyer, XF., WagenKnecht, L. E.,
Walkup, M., & Wing, R. (2006). Baseline characteristics of the randomized cohort from the look AHEAD (Action for Health in
Diabetes) study. Diabetes & Vascular Disease Research, 3, 202-215.
14.
Phelan, S., Jankovitz, K., Hagobian, T., & Abrams, B. (2011). Reducing excessive gestational weight gain: Lessons from the
weight control literature and avenues for future research. Women’s Health, 7, 641-661.
15.
Symons Downs, D., & Hausenblas, H. A. (2003). Pregnant women’s exercise intention and behavior: A
prospective examination of the theory of planned behavior. Women’s Health Issues, 13, 222-228.
16.
Symons Downs, D., & Hausenblas, H. A. (2004). Exercising during pregnancy and postpartum: An elicitation study using the
framework of the theory of planned behavior. Journal of Midwifery and Women’s Health, 49, 138-144
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17.
Hausenblas, H. A., & Symons Downs, D. (2004). Prospective examination of the theory of planned
behavior applied to exercise behavior during women’s first trimester of pregnancy. Journal of Reproductive and Infant
Psychology, 22, 199-210.
18.
Symons Downs, D. (2006). Understanding exercise intention in an ethnically diverse sample of
postpartum women. Journal of Sport & Exercise Psychology, 28, 159-170.
19.
Symons Downs, D., & Hausenblas, H. A. (2007). Pregnant women’s third trimester exercise intention
and behavior: Application of the theory of planned behavior. Psychology and Health, 22, 545-559.
20
Symons Downs, D., & Ulbrecht, J. (2006). Exercise and gestational diabetes: An elicitation study based
on the theory of planned behavior. Diabetes Care, 29, 236-240.
21
Symons Downs, D., DiNallo, J. M., Rauff, E. L., Ulbrecht, J. S., Birch, L. L., & Paul, I. M. (2010). Pregnant women’s exercise
motivation and behavior: Preliminary findings from a randomized physical activity intervention. Journal of Sport & Exercise
Psychology, 32, S157-S158.
22.
Symons Downs, D. (2011). Determinants and outcomes of physical activity in pregnancy: Findings from Active MOMS, a
randomized physical activity intervention for pregnant women. Annals of Behavioral Medicine, 41, S135.
23.
Symons Downs, D., Feinberg M., Hillemeier, M. H., Weisman, C. S., Chase, G. A., Chuang, C. H., Parrott, R., & Francis, L. A.
(2009). Design of the Central Pennsylvania Women’s Health Study (CePAWHS) strong healthy women intervention: Improving
preconceptional health. Maternal and Child Health Journal, 13(1), 18-28.
24
Rolls, B.J., Bell, E.A., & Thorwart, M.L. (1999). Water incorporated into a food but not served with a food decreases energy
intake in lean women. American Journal of Clinical Nutrition, 70, 448-455. PMID: 10500012.
25.
Rolls, B.J., Morris, E.L., & Roe, L.S. (2002). Portion size of food affects energy intake in normal-weight
and overweight men and women. American Journal of Clinical Nutrition, 76, 1207-1213. PMID: 12450884).
26.
Ledikwe, J. H., Rolls, B. J., Smicklas-Wright, H., Mitchell, D. C., Ard, J., Champagne, C., Karanja, N., Lin, Pao-Hwa, Stevens,
V. J., & Appel, L. J. (2007). Reductions in dietary energy density are associated with weight loss in overweight and obese
participants in the PREMIER trial. American Journal of Clinical Nutrition, 85, 1212-1221. PMID: 17490955.
27.
Ledikwe, J.H., Blanck, H.M., Kettel-Khan L., Serdula, M.K., Seymour, J.D., Tohill, B.C., & Rolls, B.J. (2006). Dietary energy
density is associated with energy intake and weight status in US adults. American Journal of Clinical Nutrition, 83, 1362-1368.
PMID: 16762948.
28.
Ello-Martin, J. A., Roe, L. S., Ledikwe, J. H., Beach, A. M., & Rolls, B. J. (2007). Dietary energy density in the treatment of
obesity: A year long trial comparing 2 weight-loss diets. American Journal of Clinical Nutrition, 85 (6), 1465-1477. PMCID:
PMC2018610.
29.
Savage, J. S., Marini, M., & Birch, L. L. (2008). Dietary energy density predicts women’s weight change over 6y.  American
Journal of Clinical Nutrition, 88, 677-684.
30.
Savage, J. S., Hoffman, L., & Birch, L. L. (2009).  Dieting, restraint, and disinhibition predict women’s weight change over 6 y.  
The American Journal of Clinical Nutrition, 90, 33-40. doi:10.3945/ajcn.2008.26558.
31.
Savage, J. S., & Birch, L. L. (2010).  Patterns of weight control strategies predict differences in women’s 4-year weight gain.
Obesity (Silver Spring), 18, 513-520. doi:10.1038/oby.2009.265.
32.
Thomas, D., M., Navarro-Barrientos, J., Rivera, D. E., Heynsfield, S. B., Bredlau, C., Redman, L. M.,
Martin, C. K., Lederman, S. A., Collins, L. A., & Butte, N. F. (2012). Dynamic energy-balance model predicting gestational
weight gain. American Journal of Clinical Nutrition, 95, 115-122.
33.
Collins, L. M., Murphy, S. A., & Bierman, K. L. (2004). A conceptual framework for adaptive preventive
interventions. Prevention Science, 5, 185-196.
34.
Rivera, D. E., Pew, M. D., & Collins, L. M. (2007). Using engineering control principles to inform the
design of adaptive interventions: A conceptual introduction. Drug and Alcohol Dependence, 88, S31-S40.
2.3
Study Rationale
The research proposed here will establish the dosage of components needed to impact GWG
and develop an efficient (optimized) intervention to effectively manage GWG in OW/OBPW
before a randomized controlled trial (RCT) can be implemented.
Rationale for expanding recruitment to normal weight (body mass index 18.0 to 23.9)
women: this control-only alternative will be offered to women who are not eligible for the
intervention study because their body mass index is below the current cut-off of 24.0. The
purpose of extending the control group is to fulfill the target enrollment for the ancillary grant
(1R56HL126799-01).  
3.0
Inclusion and Exclusion Criteria
3.1
Inclusion Criteria

Pregnant women

Overweight or obese [body mass index range 24- >40 (if BMI is > 40, consultation with
woman’s health care provider (PCP/OBGYN) will be made to determine eligibility and
ensure she does not have any contraindications to exercise) PI Danielle Downs will have
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communication with Dr. Hovick from MNPG to give information on the woman.  We also
have a physician consent form (see Physician Patient Consent to Participate in documents)
that the physician will complete as to whether the woman is eligible or not eligible to
participate.  

Normal weight women with a body mass index range of 18.0 to 23.9 can be enrolled in to
the study as control participants (same measures of data collection, no opportunity for
intervention).

Ages 18-40 years [based on our pilot data this group comprises >85% of the live births in
Central Pennsylvania]

1st, 2nd or 3rd pregnancy 6-16 weeks gestation

Able to read, understand, and speak English

Residing in and around State College, PA

1st and 2nd time pregnant mothers [none or one other live or still born, biological children >
25 weeks gestation prior to this pregnancy; it may be conceivable that a woman has a
blended family due to a mixed marriage and she will not be excluded if she is a parent to a
guardian, foster child, or step child]

Access to a computer or willingness to come onsite to complete study materials

Infants born to participants who are 6-10 weeks old
3.2
Exclusion Criteria

Having more than one live or stillborn child > 25 weeks gestation; late-term pregnancy loss

Diabetes at study entry [while future adaptations of this study will target women with
diabetes, for the pilot study, they will be excluded to control for this confound]

Contraindications to exercise in pregnancy [Hemodynamically significant heart disease,
Restrictive lung disease, Incompetent cervix/cerclage, Persistent second [or third] trimester
bleeding, Placenta previa after 26 weeks of gestation, Premature labor during the current
pregnancy, Ruptured membranes, Preeclampsia/pregnancy-induced hypertension] per the
ACOG guidelines [ACOG Committee on Obstetric Practice. [(2015, December). ACOG
Committee opinion. Number 650: Physical Activity and Exercise During Pregnancy and the
Postpartum Period. Obstetrics and Gynecology, 126,(6), 135-142].

Having a body mass index less than 18 or over 40 (exclusion only if physician doesn’t
provide consent for BMI is over 40)

Not planning to live in the area for the study duration

Severe allergies or dietary restrictions that would preclude eating healthy foods

Not able to read, understand, and/or speak English

Cognitively impaired

Currently smoking

Infants not born to participants

Infants younger than 6 weeks old
3.3
Early Withdrawal of Subjects
3.3.1
Criteria for removal from study
Safety reasons (develops a contraindication to exercise in pregnancy right after
recruitment that would exclude her participation from the study; develops a fetal
abnormality that requires her to withdrawal from the study per her provider’s
recommendation)
Failure of subject to adhere to protocol requirements (e.g., not completing assessments
and intervention sessions)
Subject withdrawals from study
No returned contact from the subject after recruitment
Pregnancy loss [e.g., miscarriage after recruitment]
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3.3.2
Follow-up for withdrawn subjects
Subjects will be withdrawn from the study based on the criteria listed above. We will
make multiple attempts to contact the subjects who fail to return contact after recruitment
[our general protocol is to call and email 3 times over a 2-week period, send 1 post card
reminder the following week, make 1 additional call and if no contact, the subject is
removed from the study] and her data will be coded as loss to follow-up. If a woman is
removed for safety reasons, failure to adhere to protocol requirements, or withdraws
from the study on her own, we will ask if we are able to continue to follow-up with her for
the post-intervention assessments she is willing to complete. If the answer is NO, we will
not contact the subject and keep the data that we have collected which will be coded as
no follow-up. If the answer is YES, we will maintain protocol contact as applicable (e.g.,
email/phone) and obtain the appropriate follow-up measures (e.g., completing surveys)
and these data will be coded as withdrawal-follow-up.
Subjects will be replaced in study 2 (randomized) according to the randomization
scheme. Co-I, Allen Kunselman, HMC, is in charge of the randomization scheme.
4.0
Recruitment Methods
4.1
Identification of subjects
A study recruitment letter will be given to pregnant women who attend Mount Nittany Physician
Group. Interested women will provide their contact information on the form and put it in a locked
drop box in the waiting room. These forms will be picked up on a weekly basis by a study staff
member. In addition, MNPG clinicians may tell their patients about our study and provide them
with study information (phone number of a study staff member to contact for more information;
website information). If women are interested, a screening process will take place right in the
office.  These screenings will be performed by the Research Coordinator or a member of the
study team.  The study team member will be trained in proper screening protocol.  Screening
will be done in a closed room in the doctor’s office for privacy.  Recruitment at Geisinger Grey’s
Woods OB/GYN office will also take place.  If screening doesn’t take place in the office, a phone
screening will take place. Flyers will be available for women to contact for more information.  We
will also advertise for the study through public websites, hanging flyers at local businesses, and
paper/radio advertisements.  Infants of women who participated in the Healthy Mom Zone will
be brought in to Noll Laboratory 6-8 weeks after birth.
4.2
Recruitment process
A study recruitment letter will be given to pregnant women who attend Mount Nittany Physician
Group. Interested women will provide their contact information on the form and put it in a locked
drop box in the waiting room. These forms will be picked up on a weekly basis by a study staff
member. In addition, MNPG clinicians may tell their patients about our study and provide them
with study information (phone number of a study staff member to contact for more information;
website information). If women are interested, a screening process will take place right in the
office. These screenings will be performed by the Research Coordinator or a member of the
study team.  The study team member will be trained in proper screening protocol.   Screening
will be done in a closed room in the doctor’s office for privacy. We will also hang flyers in the
waiting room and examination rooms with pull off tabs with study information. Recruitment at
Geisinger Grey’s Woods OB/GYN office will also take place. If screening doesn’t take place in
the office, a phone screening will take place. Flyers will be available for women to contact for
more information.  We will also advertise for the study by hanging tear-off flyers at local
businesses, and paper/radio/website advertisements.
4.3
Recruitment materials
We will use a study interest/contact form, flyers, tear-off flyers, and paper/radio/website
advertisements. I have included these documents as uploaded material.
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4.4
Eligibility/screening of subjects
Interested women who call the laboratory phone number from the recruitment documents will be
screened by phone by a study staff member. Women who provide their contact information on
the study interest form will be called by a study staff member for screening. If women are
interested at MNPG, they will be screened at the office.  If eligible, the scheduling of the initial
baseline visit will be done at that time.  These screenings will be performed by the Research
Coordinator or a member of the study team.  The study team member will be trained in proper
screening protocol.  Screening will be done in a closed room in the doctor’s office for privacy. In
addition, the initial scheduling of the baseline visit will be done during screening for women who
are eligible during the screening call. The screening scripts have been included as uploaded
material.
5.0
Consent Process and Documentation
5.1
Consent Process
5.1.1
Obtaining Informed Consent
5.1.1.1 Timing and Location of Consent
Subjects will provide verbal assent during the initial phone screening or on
site screening and written informed consent at the pre-intervention
assessment at the Penn State Clinical Research Center.
5.1.1.2 Coercion or Undue Influence during Consent
Subjects will be told about their rights during the consent process and that
study participation is voluntary. If subjects decline to participate in the study,
the research team will respect the subject’s wishes and no coercion will be
used to try to persuade them to participate in the research study.
5.1.2
Waiver or alteration of the informed consent requirement
N/A
5.2
Consent Documentation
5.2.1
Written Documentation of Consent
See written informed consent document.
5.2.2
Waiver of Documentation of Consent
N/A
5.3
Consent – Other Considerations
5.3.1
Non-English Speaking Subjects
N/A. Need to be able to read, understand, and speak English.
5.3.2
Cognitively Impaired Adults
Cognitive impairment is an exclusion criteria.
5.3.2.1 Capability of Providing Consent
N/A
5.3.2.2 Adults Unable To Consent
N/A
5.3.2.3 Assent
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N/A
5.3.3
Subjects who are not yet adults (infants, children, teenagers)
Inclusion criteria is 18-40 years. Infants of participants will be included.  Children and
teenagers are excluded.
5.3.3.1 Parental Permission
Parents of the infants (women who participated in the Healthy Mom Zone study) will
give permission to the study staff for their infant to partake in the PeaPod
measurement.
5.3.3.2 Assent
Assent will not be obtained from the infants because they will be too young (6-8
weeks old).
6.0
Study Design and Procedures
6.1
Study Design
Study 2 will test: (a) program delivery with decision rules for when/how to adapt dosages for an
individual and (b) randomization/retention/data collection procedures with an intervention and
control group in a cohort of OW/OBPW from ~6-35 weeks gestation with follow-up through
delivery to 6-8-weeks postpartum. Final revisions will be made as needed to the intervention/
assessment protocols. The second stage of Study 2 is to use data collected from Study 2 and
dynamical modeling from control systems engineering (system identification) to express
progression of GWG over time. We will then identify a customized intervention plan for each
woman based on her energy intake, PA, planned/self-regulatory behaviors and the extent to
which she is meeting GWG goals over pregnancy. This will lead to final intervention
modifications and result in an individually-tailored (adaptive) and optimized program. We will
test the efficacy of this intervention for managing GWG in OW/OBPW in a future RCT. R56: We
will also use the data collected in Study 2 to build and validate dynamical systems models that
characterize fetal growth and infant birth weight as well as how fetal weight respond to changes
in maternal sleep duration and stress.
The dynamical systems modeling aspect of the proposed research will be conducted in Study 2
on de-identified data that will be led by Co-Investigator, Dr. Daniel Rivera of Arizona State
University (see more information below).
6.2
Study Procedures
6.2.1 STUDY 2 PROCEDURES.
Visit A: Pre-Intervention Assessment. Subject recruitment, screening, and enrollment have
been described above. Thirty OW/OBPW who are interested and eligible will be asked to
complete a pre-intervention assessment at the Penn State Clinical Research Center to identify
the presence of any health issues that may preclude participation in the study. Study women will
be carefully screened for medical abnormalities. Women will be escorted to an evaluation room
by a project staff member who will then read them a study description, answer questions, and
obtained written informed consent. Participants will be given study forms (e.g., where to park,
what to do in the event of inclement weather and a session is cancelled, gift card compensation
form, etc.; these have been uploaded in the documents section of CATS).
The clinician will assess height, weight, and blood pressure and perform a physical exam to
identify health symptoms that may preclude participation (ACOG, 2015 guidelines). The clinician
will review the physician consent form and medical history. If no negative health symptoms are
present, women will be “cleared” for participation. If any abnormalities or issues are detected (or
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health issues that will preclude participation based on the ACOG 2015 guidelines) during the
CRC evaluation or baseline assessments we will, with permission of the subject, notify their
healthcare provider immediately (or given a referral if she does not have a healthcare provider).
We will not proceed with routine study testing if the managing provider deems it inadvisable to
continue. All records will be kept with strict confidentiality.  
During the CRC visit women will also have one blood draw done (less than 25 cc’s per draw; will
take less than 10 minutes) by a CRC nurse and have their body composition measured by
BodPod, waist circumference, and skinfold.  R01 and R56: Blood will be centrifuged and
aliquoted by a trained research technician using standard biohazard safety procedures.
Samples will then be frozen at -80o C.  Once all samples have been collected, they will be
transported on dry ice to selected laboratories for analyses.  The biomarkers selected for
analysis (listed below) have been linked to fetal growth, metabolic syndrome and cardiovascular
disease, which may be exacerbated in pregnancy due to high GWG or postpartum weight
retention. The blood biomarker measurements that we will be assessing are as follows: Iron,
CRP, Vitamin A, Vitamin D, Folate, Zinc, Selenium and Copper. Blood draws are being done for
data collection purposes and study team has applied for an Institutional Biosafety Committee
approval that was submitted on 12/14/15.
Women who are cleared for participation will be randomized into the intervention or control
group.  Once randomized, they will complete a series of paper based and online self-reported
measures of their healthy eating [HE; Three Factor Eating Questionnaire-18], physical activity
[PA; Leisure-Time Exercise Questionnaire], and weight [Pregnancy Weight Gain Attitude Scale],
, temperament [Rothbart Adult Temperament Questionnaire], psychological well-being [Center
for Epidemiological Studies Depression Inventory, Body Areas Satisfaction Scale and Figure
Rating Scale, State Trait Anxiety Inventory, Perceived Stress Scale], self-regulation of HE and
PA, self-control [Tangney Self-Control Scale], sleep [Pittsburgh Sleep Quality Index],
motivational determinants [self-efficacy, attitude, subjective norm, perceived control, intention,
beliefs], and sociodemographics. Descriptions of the measures can be found in Appendix A. For
complete list and schedule of these measures, please see Appendix B.  These surveys were all
completed as part of the Study 1 protocol with no issues by participants (CATS 00000122).
Subjects will also complete trainings of the Remote Food Photography Method (RFPM) and My
Fitness Pal for dietary intake, and the Breezing Device for metabolism. These measures and
descriptions are included as uploaded materials. Women will also be sent-home with a waist-
mounted activity monitor (i.e., Actigraph) and asked to wear it for the next 7 days, continuously
except for showering and at bed time for an accurate assessment of their activity time (activity
counts). They will also be asked to wear a wrist-worn activity monitor (e.g., Jawbone Up; looks
like a bracelet) and asked to wear this non-stop for the next 7 days and not to take it off (it can
be worn during showering and sleep) for a continuous assessment of activity and sleep
patterns. The PI, Dr. Downs, has used this activity monitoring protocol in previous research,
including IRB 24174 Active MOMS and our Study 1 protocol (CATS 00000122). There are no
risks associated with using activity monitors in pregnancy. Women will then be scheduled for
their first intervention session for the following week and they will return their waist-mounted
activity monitor to a study staff member. They will wear the wrist-worn monitor for the remainder
of the study. They will be given a standard food scale and weight scale (Wi-Fi Fit Bit Aria) to
take home for use in the intervention. If participant agrees to participate, they will be asked to
weigh themselves daily until delivery.  Urine samples will be collected weekly during the
prenatal period to assess basal cortisol level as it relates to stress.
R01 and R56: Participants will be asked to collect voided urine overnight, starting from the time
participant falls asleep and ending with the last collection being first morning void after waking
for the day.  We will provide 1 collection container for whole the whole study for storage of all
urine.  We will also provide a urine collection hat for easy collection.  Participants will track time
they went to bed, time of any/all collections overnight and time of first morning void.  
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Participants may keep the urine collection container beside the toilet/in the bathroom overnight,
and will be asked to refrigerate after first morning void until time of study visit, when they will
bring urine collection container with them.  We will provide a zip-top plastic bag for
transportation.  Study staff will process the urine samples in the CRC, following biohazard safety
protocols.  Urine samples for analysis will be transferred to cryovials by pipette and frozen in a -
20 degree freezer located in the CRC.  Cryovials will be labeled with participant ID # and date
only (i.e. no personally identifying information).  Once all samples have been collected, a
research study staff member will transport samples to the Biobehavioral Core Lab for
processing.  Urinary free cortisol (UFC), creatinine and osmolality levels will be measured and
UFC/creatinine ratio (Cort/Cr) calculated.  
R01 and R56: Participants will also complete abdominal Ultrasound scans at 13-15 weeks
gestation and every 5 weeks (+/- 5 days) thereafter in pregnancy, with a maximum of 6
ultrasound scans per participant.  A letter will be sent notifying the participant’s physician that
his/her patient will be receiving ultrasound scans as part of a research study.  Fetal growth
indicators will be collected by a trained sonographer with Registered Diagnostic Medical
Sonographer certification using 2D transabdominal sonography, using an ultrasound machine
(Philips iU22 MATRIX) and probe (C5-1 Broadband Curved Array or X6-1 PureWave
transducer). Women will enter the Clinical Research Center (CRC) to complete the ultrasound
biometry.  Each fetal ultrasound visit will last 20-30 minutes.  Routine measures include:
biparietal diameter (BPD), abdominal circumference (AC), femur length (FL), and head
circumference (HC), heart rate (HR), amount of amniotic fluid and estimated placental volume,
fetal fat mass measures (abdominal and mid-femur). Estimated fetal weight will be calculated
using polynomial equations containing BPD, AC, FL, and HC. We will measure uterine and
umbilical artery Doppler by ultrasound at each visit (per standard ultrasound procedures).
Healthy Mom Zone fetal ultrasound scans are for research purposes only; they will not be 1)
medical diagnostic scans (i.e., sonographer will not be examining fetus for structural
abnormalities that may exist externally or internally) or 2) anatomical scans (i.e., sonographer
will not disclose gender of fetus).  
Although this scan is non-diagnostic in nature, following each, indicators of fetal growth
collected by fetal ultrasound will be sent by Dr. Pauli (Co-I, OBGYN) at Hershey Medical Center
within 24-72 hours to ensure safety of mother-infant dyads. Dr. Pauli will complete a Review
Form for each scan to verify that the scan was reviewed and will highlight any potential medical
issues that may be impacting gestational weight gain or infant weight.  Dr. Pauli will send the
review forms to study research staff, who will then hand deliver to participant’s physician.  
Review forms with potential abnormalities noted will be delivered right away, while review forms
with normal growth will be delivered to the practice on a weekly basis.  
Visits B: Intervention Sessions and Weekly Assessments. During the intervention, all
participants will start out at the Baseline level.  The baseline level will last 2 weeks and there will
be an assessment to determine weight gain over those 2 weeks (See Appendix C for
description of adaptive steps).  If weight gain has succeeded the recommended amount,
participants will be adapted up to a new level of intervention.  After every 4 weeks, an
assessment will be performed and adaptations up will be made if necessary.  The adaptations
are as follows:
1.
Baseline: one 30-min face to face session with intervention leader for education and
guidance (self-monitoring, goal-setting) on GWG, HE, and PA and daily HE/PA self-
monitoring (i.e., keeping track daily of their activity and eating patterns in a diary and
completing the MyFitness Pal program either online or via a mobile phone app on 3 days
per week (Please see Appendix D for outline of education content). The face-to-face session
will take place in 128/208/223 Noll Laboratory. The written scripts for these intervention
sessions and handouts are attached in the document section of CATS and labeled by week.
The forms used to assess fidelity monitoring of these sessions are also attached in the
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documents section. Participants are encouraged to get 150 min of moderate to vigorous
intensity physical activity.
2.
Baseline + Active Learning 1: Condition 1 description + adding 4 pearls integrated into
cooking/grocery store demos: reinforcing messages and recipe booklet. A registered
dietician will deliver these demonstrations with Safe Serve Certification in the Clinical
Research Center kitchen in the Elmore Wing of Noll Laboratory. There will be 1 moderate to
vigorous intensity physical activity session located in 223 Noll Laboratory with 5-min of
introduction, 5-min of warm-up, 30-min of guided PA instruction lead by the intervention
leader, and 5-min of cool-down. Women will have their choice to engage in physical activity
via walking/light jogging on the treadmill, cycle ergometer, low impact guided aerobics, and
resistance training (bands/5 and 10 pound weights); all activities following the USDHHS
(2008) and ACOG (2015) national recommendations for regular moderate-intensity PA. The
written scripts for these demonstrations and the forms to assess fidelity monitoring are
attached in the documents section of CATS.  For self-regulation, there will be If-Then action
plans.  The written scripts/handouts for these demonstrations are attached in the document
section of CATS. The forms used to assess fidelity monitoring of these sessions are also
attached in the documents section.
3.
Baseline + Active Learning 2: Condition 1 description + the choice of a second 45-min
physical activity session on site or walking with an instructor and will receive a workout
booklet.  Healthy eating active learning will include education and the use of portion size and
containers.  Self-regulation activities include charting healthy eating and physical activity
behaviors and use weight data to regulate eating and exercise behaviors by using action
plans.  The written scripts/handouts for these demonstrations are attached in the document
section of CATS.  The forms used to assess fidelity monitoring of these sessions are also
attached in the documents section
4.
Baseline + Active Learning 3: Condition 1 description + grocery store receipt/pantry
analysis; grocery store tour/activities; favorite recipe makeover, a third 45-minute physical
activity session with the choice of coming on site or at home and we will provide feedback
regarding their self-regulation/monitoring behaviors.
5.
Baseline + Active Learning 4: Condition 1 description + adding 1 meal replacement (lunch or
dinner) for 7 days, a fourth physical activity session with the choice of on site or at home and
a weekly text/call/email feedback and encouragement for self-regulation/monitoring.  The
meal will be frozen meals, packaged for the week and they will meet the recommended
dietary guidelines for pregnant women for lunch or dinner.  The written scripts/handouts for
these demonstrations are attached in the document section of CATS.  The forms used to
assess fidelity monitoring of these sessions are also attached in the documents section
6.
Baseline + Active Learning 5: Condition 1 description + adding 1 meal replacement (lunch or
dinner) for 7 days, a fourth physical activity session with the choice of on site or at home and
text/call/email feedback and encouragement for self-regulation/monitoring 3x/week.  The
meal will be frozen meals, packaged for the week and they will meet the recommended
dietary guidelines for pregnant women for lunch or dinner.  The written scripts/handouts for
these demonstrations are attached in the document section of CATS.  The forms used to
assess fidelity monitoring of these sessions are also attached in the documents section
After the follow-up assessment at gestational week 35, the participants will be followed through
delivery and up to 6- weeks postpartum.
During the exercise
session, we will
employ the same
symptoms
monitoring system
that we used in
Active MOMS IRB
#24174 and CATS
Symptom Checklist
Pre
5-min
15-
min
25-
min
Post
Dizziness
Nausea
Headache
Abdominal Pain/Pressure
Cramping or contractions
Chest pain
Calf pain or swelling
Fluid leakage (urine, amniotic,
blood)
Unusual change in fetal movement
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00000122. A CRC nurse will be present for a portion of the exercise session to provide
oversight to the subject monitoring during normal business hours.  Trained fitness instructors
with CPR training will be present at all times during the after-hours exercise sessions.  If there
should be a need for immediate medical care, assistance from the CRC would be solicited
during normal business hours and after-hours, 911 would be called.  A study staff member will
also be present at all times during an exercise session.  If immediate medical attention is
needed, the study staff member will call 911, Penn State police and alert the PI.  Subjects will
be monitored by a trained study staff member at all times, and will be asked at pre-exercise, at
5-min, 15-min, 25-min, and post-exercise to report (a) standard rating of perceived exertion
(Borg Scale) and (b) symptoms checklist (ACOG, 2015):
35.         CK,
Correa JB, Han H, et al. Validity of the Remote Food Photography Method (RFPM) for
estimating energy and nutrient intake in near real-time. Obesity. Apr 2012;20(4):891-899.
36.
Martin
CK, Han H, Coulon SM, Allen HR, Champagne CM, Anton SD. A novel method to
remotely measure food intake of free-living individuals in real time: the remote food
photography method. The British journal of nutrition. Feb 2009;101(3):446-456.
37.
Beaton GH, Burema J, Ritenbaugh C. Errors in the interpretation of dietary
assessments. Am J Clin Nutr. Apr 1997;65(4 Suppl):1100S-1107S.
38.
Tran KM, Johnson RK, Soultanakis RP, Matthews DE. In-person vs telephone-administered multiple-pass 24-hour recalls in
women: validation with doubly labeled water. J Am Diet Assoc. Jul 2000;100(7):777-783.
39.
Schoeller DA, Bandini LG, Dietz WH. Inaccuracies in self-reported intake identified by comparison with the doubly labelled
water method. Can J Physiol Pharmacol. Jul 1990;68(7):941-949.
40.
Bandini LG, Schoeller DA, Cyr HN, Dietz WH. Validity of reported energy intake in obese and nonobese adolescents. Am J
Clin Nutr. Sep 1990;52(3):421-425.
41.
Goris AH, Westerterp-Plantenga MS, Westerterp KR. Undereating and underrecording of habitual food intake in obese men:
selective underreporting of fat intake. Am J Clin Nutr. Jan 2000;71(1):130-134.
42.
Goris AH, Westerterp KR. Underreporting of habitual food intake is explained by undereating in highly motivated lean women.
J Nutr. Apr 1999;129(4):878-882.
43.
Stone AA, Shiffman S. Ecological momentary assessment (EMA) in behavorial medicine. Annals of Behavioral Medicine. Sum
1994;16(3):199-202.
44.
USDA. USDA Food and Nutrient Database for Dietary Studies 2011-2012. http://www.ars.usda.gov/ba/bhnrc/fsrg2014.
45.
Williamson DA, Allen HR, Martin PD, Alfonso A, Gerald B, Hunt A. Digital photography: a new method for estimating food
intake in cafeteria settings. Eat Weight Disord. Mar 2004;9(1):24-28.
46.
Williamson DA, Allen HR, Martin PD, Alfonso AJ, Gerald B, Hunt A. Comparison of digital photography to weighed and visual
estimation of portion sizes. J Am Diet Assoc. Sep 2003;103(9):1139-1145.
Visit C Post-Intervention Assessment. Same procedures as followed in Visit A Pre-
Intervention Assessment with the exception of randomization and the CRC medical history
review. There will be a semi-structured intervention exit interview. These interviews will be
conducted with the women in the intervention to understand their thoughts, preferences, and
barriers to the intervention dosage they received over the intervention. The will be asked to talk
about their experiences with the program. A study facilitator will provide a brief overview of the
interview questions to explore their beliefs and preferences for the intervention they just
participated in. Questions to be asked to women are provided in the measures section of the
protocol. Interviews will be audio taped using an Olympus DM-420 digital voice recorder and are
expected to take 60 minutes. Content will be downloaded and transcribed using N Vivo
software. Standard formative research methods including principles of thematic analysis will be
used to code, categorize, and organize data. Content analysis will be used to identify common
categories of ideas and descriptive statistics used to rank-order salient themes.
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Accessing Prenatal and Labor/Delivery Data. After study completion, with subject’s HIPAA
authorization, we will access their medical record data for prenatal (e.g., gestational weight gain,
diagnosis of gestational diabetes, complications, etc.) and labor/delivery data. A subject can
chose to not allow us to have access – and she can decide to provide the health information she
wants to share. A study staff member will work with the subject’s OBGYN provider to coordinate
access to this data (e.g., electronic medical record access or hard copy of the prenatal and
labor/delivery data).
Visit D Postpartum Assessment and Weekly Measurements  At 6-8 weeks postpartum,
women will return to Noll Lab to complete maternal and infant measurements; they will be
expected to bring their infant with them to this session but if they do not want their infant
involved, they will still be asked to complete the measurements asked of them.  Women will be
asked to (1) weigh themselves using the Aria Wi-Fi scale for a 7-day period, (2) wear the
Jawbone wrist-worn activity monitor for a 7-day period, (3) complete one Breezing device
measurement, (4) provide one urine sample, (5) one BodPod assessment, and (6) take
photographs of their food for 2 weekdays and 1 weekend day.  While on site, the women’s
babies will (1) complete a PeaPod measurement. The baby’s test takes place in a similar small
space with a window where the baby can be seen the entire time.  The baby’s test is two
minutes long, and typically only one test is needed. We can stop the test at any point. The
baby will be placed in the warm measurement space free of any clothing or blankets.  The
PeaPod measurement is similar to the BodPod measurement.
Postpartum Survey Women will be emailed a link to a postpartum survey 2-6 weeks after
delivery. Women will complete this survey on REDCap. Women without access to the Internet
will be sent the survey via the mail. The survey has been uploaded as study materials.

R56: The additional normal weight (body mass index 18.0-23.9) subjects will be
assigned to the control group (i.e. will not be randomized); these subjects will complete
all measures to expand data collection of indicators of fetal growth as well as self-report
data.  
6.3
Duration of Participation
Visit A Pre-Intervention Assessment: 120 minutes (can be split into two 60-minute sessions
or if participants choose, can be one 120 minute session).
Visit B Intervention Sessions: For those in the intervention group, they will be participating in
one 30-min/week education session.  Given the adaptive “step-up dosage” nature of this
intervention, participation will increase as the dosage increases, ranging from 1 day per week of
30-min to up to 4-days/week for 150 minutes plus 10-30 min/week of guided instructor
feedback.   
Visit C Post-Intervention Assessment: 60 minutes for the interview and 20 minutes for the
postpartum survey.
7.0
Data and Specimen Banking
7.1
Data and/or specimens being stored
Blood specimens will be stored a -80oC freezer.  Urine samples will be stored in a -20 oC
freezer.
7.2
Location of storage
Specimens will be stored in a -80oC  -20 oC and freezer space located in the Clinical Research
Center.
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7.3
Duration of storage
All biological samples except whole blood will be transported to designated
locations/laboratories for analyses on the same day as collection,
7.4
Access to data and/or specimens
Freezers are kept in a locked room.  Only research staff will access the biological samples.
7.5
Procedures to release data or specimens
Frozen samples will be shipped on dry ice to selected laboratories for analysis the same day as
collection, either delivered by research technician to local laboratories or by using a company
compliant with biohazard safety protocols for shipping.  Laboratories will be sent biological
samples with a participant ID# (we will not be sending personally identifying information).  All
laboratory results will be identified by participant ID# only.
7.6
Process for returning results
Since the blood work and urine samples are non-diagnostic, we will not be sharing the results
with the participants unless otherwise asked for.
8.0
Statistical Plan
8.1
Sample size determination
For Study 2, Julios50 effectively argues a sample size of 12 per group is adequate to assess
feasibility, address regulatory considerations, and obtain sufficient precision of the mean and
variance to perform a formal sample size and power calculation for the future RCT. The primary
endpoint of the future RCT will be powered on GWG. Factoring in an anticipated 20% subject
drop-out based on our pilot work,50-52 we will recruit a total of 30 subjects (i.e., 15 per group).
47.
Symons Downs, D., DiNallo, J. M., Rauff, E. L., Ulbrecht, J. S., Birch, L. L., & Paul, I. M. (2010). Pregnant women’s exercise
motivation and behavior: Preliminary findings from a randomized physical activity intervention. Journal of Sport & Exercise
Psychology, 32, S157-S158.
48.
Symons Downs, D. (2011). Determinants and outcomes of physical activity in pregnancy: Findings from Active MOMS, a
randomized physical activity intervention for pregnant women. Annals of Behavioral Medicine, 41, S135.
49.
Symons Downs, D., Feinberg M., Hillemeier, M. H., Weisman, C. S., Chase, G. A., Chuang, C. H., Parrott, R., & Francis, L. A.
(2009). Design of the Central Pennsylvania Women’s Health Study (CePAWHS) strong healthy women intervention: Improving
preconceptional health. Maternal and Child Health Journal, 13(1), 18-28.
50.
Julios, S. A. (2005). Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics, 4, 287-291.
8.2
Statistical methods
Biostatistician, Co-I Kunselman, will be responsible for coordinating data management and
statistical design/analyses aspects required for feasibility studies including data cleaning,
analytical set construction, documentation, analyses, and preparation of data summaries for
reporting purposes. He will provide leadership in designing/formatting data collection forms to
reduce data collection/recording errors and develop a well-defined/comprehensive data quality
assurance program to ensure complete, accurate, and valid data, while limiting variability in data
collection/recording. Study data will be managed using REDCap (Research Electronic Data
Capture), is a secure web application designed to support data capture for research studies,
providing user-friendly web-based case reports, real-time data entry validation (data types/range
checks) audit trails, and a de-identified data export mechanism to statistical packages (SPSS,
SAS, Stata, R/S-Plus). Analysis Plan. Study 2 is to establish feasibility; descriptive statistics,
including means/standard deviations (continuous variables) and frequencies (categorical
variables) will be used to characterize the data. Study 2 will provide estimates for the primary
endpoint (GWG) to power a future RCT. Linear mixed-effects models will be used to assess
differences between intervention and control groups with respect to changes in continuous
outcomes over time (from pre- to post-intervention; daily/weekly) on GWG and related health
outcomes. Generalized estimating equations with a logit link will be used to assess differences
between intervention and control groups for dichotomous outcomes over time. Because this is a
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pilot study, the primary focus of these analyses is for parameter estimation; any hypothesis test
will be interpreted with extreme caution to guide the future RCT as this pilot study is deliberately
not powered to make definitive claims. All modeling development and simulation will be done in
Matlab with SIMULINK and the use of functional data analysis modeling for time-varying
modeling will rely on SAS. Participant Dropout & Other Missing Data. While every attempt
will be made to collect complete data and prevent participant dropout, missing data are
inevitable. We have inflated the sample size for Study 2 as described above. We will compare
characteristics of those with missing data to those with complete data. These feasibility studies
will provide valuable information to minimize missing data in the future RCT (e.g., they will help
determine reasons for drop-out, assess which methods for data collection need to be
modified/changed, examine data collection and retention of the control group, etc).
9.0
Confidentiality, Privacy and Data Management
9.1
Confidentiality
Data will be secured using password protected computer files, locked file cabinets for hard copy
data, locked offices and laboratory space within locked facilities (Rec Hall for the Exercise
Psychology Laboratory and Noll Laboratory where the intervention will be delivered). Subject
data will also be coded with participant IDs for coding purposes. Data will be entered and stored
in the secure REDcap system.  Ultrasound scan data and biological specimens will be identified
by participant ID # only and will not include any personal identifiers.  The same participant ID #’s
will be used for these data as for the parent Healthy Mom Zone study.  A master list linking
participant identifying information and participant ID #’s will be stored in a locked, secure
location.  Only authorized personnel listed on the protocol will have access to data and
specimens.  
9.1.1
Identifiers associated with data and/or specimens
Identifiers will include name, home address, telephone number, email address, medical
record data.
9.1.1.1 Use of Codes, Master List
A list containing a code associating the identified data with the participant ID
will be stored in the secure Redcap system. Access to the identified data will
be limited to project staff who will need to understand this information for
contact and tracking purposes (reminder calls, repeated data collection, etc.)
which will include:
The PI, Dr. Danielle Downs
Project Coordinator, Abigail Pauley who will be directly working with the
scheduling of participants, reminders and Redcap
Project Staff Member Lindsey Hess who will also be working with the
scheduling of participants, reminders, and Redcap
This list will be destroyed for 5 years after the study has been completed per
American Psychological Association guidelines.
9.1.2
Storage of Data and/or Specimens
Electronic data will be stored in the secure Redcap system. Hard copy of data will be
stored in locked file cabinets in locked laboratory space. Data will be saved for 5 years
after the study has been completed per American Psychological Association guidelines.
This study will be issued a Certificate of Confidentiality. Researchers will not disclose or
provide any identifiable information without the subject’s prior consent or where
permitted according to NIH’s Policy on Issuing Certificates of Confidentiality.
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9.1.3
Access to Data and/or Specimens
Access to the data will have different levels in the Redcap system. As noted above, the
PI Dr. Downs, Lindsey Hess, and Abigail Pauley will have access to fully identified data.
The other collaborators and research assistants will have access to deidentified data.
Non-PSU study team members will be made aware they are also subject to the
disclosure restrictions according to NIH’s Policy on Issuing Certificates of Confidentiality.
9.1.4
Transferring Data and/or Specimens
De-identified electronic data will be shared with the PSU collaborators and Dr. Daniel
Rivera at Arizona State University via the secure Redcap system. The researchers do
not plan to release identifiable information collected in the study. However, if researchers
consider releasing identifiable information in the future – the individual or institution
receiving the identifiable information will be made aware they are also subject to the
requirements of subsection 301(d) of the Public Health Service Act.
9.2
Privacy
We will take all possible steps to ensure confidentiality. Subjects will be continually ensured
through the consent process, data collection procedures, and intervention sessions that they are
not obligated to participate in this study and that their answers will be held with strict
confidentiality. We will be using the secure system of Redcap for data entry, collection, storage,
and management. The security of the research project data will be maintained through network
hardware and user authentication (usernames and passwords). Access to Redcap will be
restricted. Back-ups of the project data files will occur every night, with user data backed-up
incrementally Monday through Thursday and complete back-ups every Friday. Archival back-
ups, stored indefinitely, are cut on the last weekend of every month. Section 9.1.3. illustrates
who will have access to which levels of data in Redcap.
As far as privacy for the subjects, they will complete a consent form for participation which
explains the study. HIPAA authorization will be obtained from subjects in order for us to have
access to their medical record data to obtain their prenatal record (e.g., gestational weight gain,
complications, etc) and labor/delivery data. A subject can chose to not allow us to have access
– and she can decide to provide the health information she wants to share.
Steps to protect subject privacy and privacy interest include using Subject ID codes, limiting the
access to identified data, conducting the intervention in a closed-door facility with limited traffic
and access, not disclosing who is participating in the study in any public fashion (never
identifying individual subjects in research presentations, discussions, etc.), using the secure
Redcap system for subjects to enter their data and not answering study questions out loud in
public places or laboratory spaces with others present, and conducting the physical
assessments in the CRC.  
10.0 Data and Safety Monitoring Plan
This research does not involve more than minimal risk to the subjects. However, because this is a
federally-funded study, a DSMP was required by the granting agency and therefore, we have a DSMP.
This research involves minimal risk to the subjects as defined in SOP HRP-001 “Minimal Risk is the
probability and magnitude of harm or discomfort anticipated in the research that are not greater in and
of themselves than those ordinarily encountered in daily life or during the performance of routine
physical or psychological examinations or tests.”  
10.1
Periodic evaluation of data
Daily weight data will be collected for intervention monitoring. Weekly HE and PA behaviors,
self-regulation, psychological well-being, motivational determinants of HE and PA, and weight
behaviors will also be collected and used to inform the intervention counseling in the following
week. Also, as described above, will also collect PA session data on symptoms monitoring at
pre-exercise, 5-min, 15-min, 25-min, and post-exercise.
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See attached protocol for unexpected or adverse events monitoring.
10.2
Data that are reviewed
Definition of adverse event. An adverse event shall be defined as any detrimental change in the
participant's condition, whether it is related to study interventions, study outcomes, or to another
unrelated illness.
Adverse events unrelated to the study interventions. Adverse events due to illnesses unrelated
to study interventions may be grounds for withdrawal if the illness is considered significant by
the study investigators or if the participant is no longer able to effectively participate in the study.
A significant illness would be one that would compromise the women’s ability to function
normally and thrive such as the diagnosis of a disease requiring ongoing and intensive
treatment and/or one requiring repeated hospitalizations or physician visits. Subjects
experiencing routine, minor, self-limited acute illnesses that typically occur during pregnancy
and do not affect long-term growth will not be recorded, and the women will continue to
participate in the study. Examples of minor illnesses include bronchiolitis, upper respiratory
infections, and urinary tract infections. Examples of minor unanticipated events from the PA
session may be minor aches, a cold, feeling uncomfortable, mild nausea. Medications for acute,
self-limited illnesses such as those stated above will not be recorded, but chronic medication
use (> 1 month) will be recorded. Further surgical conditions that could impact HE, PA and
GWG will be recorded and if the participant’s physician determines that these conditions can
affect prenatal weight gain, the participant will be withdrawn from the study.
Documentation of an AE unrelated to the study interventions that are not considered minor
illnesses and those that can significantly affect the baby will be recorded on the AE form and
reported to the IRB. See the protocol for unexpected or adverse events for actions and reporting
of the unexpected events and AEs.
Adverse events potentially related to the study interventions. While the majority of OW/OBPW
have excessive GWG (over the threshold ranges for prepregnancy weight category as
illustrated in the table below:
Institute of Medicine Weight Gain Recommendations for Pregnancy
Prepregnancy Weight
Category
Body Mass Index*
Recommended
Range of
Total Weight (lb)
Recommended Rates
of Weight Gain† in the
Second and Third
Trimesters (lb)
(Mean Range [lb/wk])
Underweight
Less than 18.5
28–40
1 (1–1.3)
Normal Weight
18.5–24.9
25–35
1 (0.8–1)
Overweight
25–29.9
15–25
0.6 (0.5–0.7)
Obese (includes all classes)
30 and greater
11–20
0.5 (0.4–0.6)
*Body mass index is calculated as weight in kilograms divided by height in meters squared or as weight in pounds multiplied by 703 divided by height in inches.
†Calculations assume a 1.1–4.4 lb weight gain in the first trimester.
Modified from Institute of Medicine (US). Weight gain during pregnancy: reexamining the guidelines. Washington, DC. National Academies Press; 2009. ©2009
National Academy of Sciences.
It is theoretically possible that behavioral interventions designed to manage GWG in OW/OBPW
could result in energy imbalance and insufficient weight gain. The pilot studies that serve as the
foundation for the current study did not find an association between study interventions and
these adverse events. However, we will be monitoring weight on a daily basis and examining
GWG on a weekly basis and will consult with co-investigator, Dr. Rick Legro, OBGYN to identify
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if a woman has insufficient weight gain for gestational week. Indicators of insufficient weight
gain are, for example, weight loss of >3% in a week, or 0% weight gain in a 4-week cycle.
OW/OBPW should gain, on average, .5 lb per week, so we will use this as a threshold to
understand the context of the weekly GWG relative to her overall GWG and clinical insight. We
will consult with the participants OBGYN provider and Dr. Legro to determine if the participant
should be removed from the study for insufficient GWG.
The study’s informed consent document will include information indicating that the study team
will communicate with the participant’s OBGYN or Primary Care Provider. The study team will
ensure that open lines of communication exist with the healthcare provider in addition to the
weight monitoring and review. To establish the lines of communication between the study team
and the PCPs, upon participant randomization, the participant is required to have a physician
consent form completed to “clear her” for study participation. Healthcare providers will also be
directly notified about their patient’s participation in the study. A brief description of the study will
be shared with them as well as a contact number to call the study team should the provider
become concerned about insufficient GWG by their patient. Recognizing that weight monitoring
is typically performed at all regularly scheduled primary care appointments, we will ask
providers for their collaboration in monitoring prenatal weight gain in that we would like to be
alerted to any concerns that their patient is demonstrating insufficient weight gain.
During each face to face visit, staff will calculate weight, BMI, and weight change.  If the adverse
risk for inadequate weight is identified, we will modify treatment (i.e., recommending increased
energy intake). The PIs will review weight and applet data at least twice monthly and then
contact the healthcare providers and co-investigator, Dr. Legro when appropriate after each
individual is closely evaluated as described below. For any individual who meets initial
screening criteria for weight gain concerns, numerous factors will be considered in determining
whether the women’s weight gain is problematic and/or related to study interventions. Examples
of such factors include nausea, vomiting, and interval illness. If either the healthcare provider or
the study investigators believe that it is possible that these growth patterns are a negative result
from study participation, the women will be withdrawn from the study.
Co-Investigator, Kunselman, our biostatistician, will include protocol compliance with inclusion
and exclusion criteria, participant compliance with the interventions, and adverse events in
consultation with the PI Dr. Downs, Co-I, Legro, and study staff (Lindsey Hess, Abigail Pauley).
10.3
Method of collection of safety information
The DSMP for this study focuses on close monitoring of GWG in conjunction with a safety
officer and data and safety monitoring board (DSMB), along with prompt reporting of excessive
adverse events and any serious adverse events to the NIH/NHLBI and to the Institutional
Review Board (IRB). Because behavioral interventions aimed at preventing excessive GWG
could theoretically result in insufficient weight gain by study participants, individual participant
weight will be closely monitored by the investigators in conjunction with the participants’ primary
care providers as described below in detail (see above in section 10.2 for more information).  
The DSMB will also closely monitor fetal growth, blood and urine findings.  Safety reports will be
sent to the study statistician, the PIs, and the safety officer quarterly. At least once per year, the
DSMB will convene to review study progress and issues related to the safety of the study
interventions. Meetings may be more frequent than once per year if the need for such meetings
becomes apparent to the safety officer, PIs, IRB, or NIH/NHLBI. The project manager will be
responsible for assembling the data and producing these reports in conjunction with the study
statistical team, as well as assuring that all parties obtain copies of these reports.
10.4
Frequency of data collection
As described in study design and procedures section, daily weight data will be collected for
intervention monitoring. This data will be reviewed by the program leader in weekly face-to-face
sessions. Participants who lose weight will be flagged and their data will be sent to the physician
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on staff for review. The frequency of data review for this study differs according to the type of
data and can be summarized in the following table:
Data type
Frequency of review
Subject accrual (protocol adherence regarding demographics,
inclusion/exclusion)
Bi-Yearly
Adverse event rates including X Y Z (examples) analyses
Bi-Yearly
Individual out of range weight gain
Continuous
Discontinued subjects and Stopping rules report
Bi-Yearly
10.5
Individual’s reviewing the data
Our safety officer is Dr. Stephanie Estes and we have an established DSMB including:
Stephanie J. Estes, MD. The safety officer for this trial will be Stephanie J. Estes, MD. Dr. Estes
is a reproductive endocrinologist and Director of Robotic Surgery at Penn State Hershey
Obstetrics and Gynecology. Dr. Estes has an MD degree from Penn State Hershey College of
Medicine. She completes her OB/Gyn residency at Abington Memorial Hospital, and a
fellowship in Reproductive Endocrinology at Bringham & Women’s Hospital. An OB/Gyn, she is
very familiar with normal and abnormal patterns of infant growth and maternal weight gain
during pregnancy.  As Safety Officer, Dr. Estes will review the reports sent by the project
manager (at the frequency outlined above) and will use the checklist attached to this document
to determine whether there is any corrective action, trigger of an DSMB review, or stopping rule
violation that should be communicated to the study investigators, the IRB, and the NIDDK. She
will also serve as the Chair of all DSMB meetings.
Kathleen Rasmussen, Sc.D. Professor of Nutrition in the Division of Nutritional Sciences and
International Professor of Nutritional Science at Cornell University. Dr. Rasmussen received her
AB degree from Brown University in molecular biology and both her ScM and ScD degrees from
Harvard University in nutrition. She has experience running intervention studies and
observational studies, and studies the relationship between maternal nutritional status during
the reproductive period and short- and long-term maternal and child health outcomes.  Her
research has been supported by NIH, USDA and numerous other organizations. Dr.
Rasmussen has been a member of several expert committees at the Institute of Medicine,
served as the chair of the Committee on Reexamination of IOM Pregnancy Weight Guidelines,
and just completed chairing a committee to disseminate these new guidelines. Dr. Rasmussen
is the Program Director of Training in Maternal and Child Nutrition, NIH/NICHD. She is an
internationally known for her research on maternal and child nutrition and her expertise makes
her ideal as a content expert for the topic of the study and recruitment and retention of
overweight and obese pregnant women.
Kelly Evenson, PhD. Dr. Evenson is a Research Professor in the Department of Epidemiology
at The University of North Carolina as Chapel Hill’s Gillings School of Global Public Health. Dr.
Evenson holds a master’s degree in exercise physiology from the University of Wisconsin–La
Crosse and a doctorate in epidemiology from UNC. Dr. Evenson has collaborated on or led a
number of studies on physical activity intervention, measurement, and analysis, with a special
focus on policies and environments that support physical activity. Her research interests include
studying changes in physical activity behavior from pregnancy through postpartum and the
influence of the physical environment and policies on physical activity. These interests make her
ideal as a content expert for the topic of this study.
Colin MacNeill, M.D. Dr. MacNeill is a practicing OB/Gyn at Penn State Hershey Obsetrics and
Gynecology and Assistant Professor of Obstetrics and Gynecology at Penn State Hershey
College of Medicine.
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Lynn Parker Klees, MA, RD, CDE, LDN Lynn Parker Klees is an instructor in the Department
Nutritional Sciences at Penn State University.  She has expertise in dietetics and clinical
management of pregnant women with gestational diabetes.
The Safety Officer will review data and safety reports quarterly and lead the DSMB meeting at
least once per year with more frequent meetings as necessary. Meetings will be organized by
the Safety Officer with help from administrative staff associated with the IRB. As stated above,
our board has been established and under CATS00000122, we have had two meetings and are
scheduled for another meeting in Spring 2016.
10.6
Frequency of review of cumulative data
The frequency of cumulate data review for this study is outlined above and will occur yearly or
more frequently as determined by the data safety monitoring committee.
10.7
Statistical tests
Descriptive frequencies, means, and trajectories for weight and GWG.
10.8
Suspension of research
As outlined above, we will continuously monitor adverse event rates in all participants. The
safety officer, together with the study investigators, will alert the IRB and the NIH if a greater
than or equal to 20% adverse event rate potentially due to study interventions should occur in
the treatment group or if significant differences between treatment groups occur.
Discontinuing subjects from the study. Any subject with a physician-diagnosed serious adverse
event related to the study interventions will be discontinued from the study. Should insufficient
weight gain be detected and the cause of this weight gain is potentially related to the study
interventions as determined by the PIs after consultation with the participant’s primary care
provider, the participant will be discontinued from the study. Other non-minor concurrent
illnesses or major changes in the family social environment would also lead to discontinuation
as determined by the investigators alone or in consultation with the PCP.
If a woman experiences a contraindication to exercise in pregnancy that precludes her
continued participation, she will be discontinued from the study. These are: Hemodynamically
significant heart disease, Restrictive lung disease, Incompetent cervix/cerclage, Persistent
second [or third] trimester bleeding, Placenta previa after 26 weeks of gestation, Premature
labor during the current pregnancy, Ruptured membranes, Preeclampsia/pregnancy-induced
hypertension] per the ACOG guidelines [(2015, December). ACOG Committee opinion. Number
650: Physical Activity and Exercise During Pregnancy and the Postpartum Period. Obstetrics
and Gynecology, 126,(6), 135-142].
If she experiences a warning sign to continuing exercise (moderate to severe dizziness, nausea,
headache, abdominal pain/pressure, cramping or contractions, chest pain, calf pain or swelling,
fluid leakage, unusual change in fetal movement; see our protocol for unexpected or AE), she
will discontinue or stop exercising, immediately.
Criteria for stopping the trial. It is exceedingly unlikely that any new, outside information will
become available during this trial that would necessitate stopping the trial. There are two
situations, however, that could potentially necessitate stopping the trial: 1) poor recruitment
and/or retention and 2) disparate serious adverse events related to GWG.  
11.0 Risks
This research does not involve more than minimal risk to the participants as defined in SOP HRP-001
“Minimal Risk is the probability and magnitude of harm or discomfort anticipated in the research that are
not greater in and of themselves than those ordinarily encountered in daily life or during the
performance of routine physical or psychological examinations or tests.” Engaging in regular moderate-
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intensity PA and eating a healthy diet are not high risk activities. The education, active learning, goal-
setting, and self-monitoring procedures employed in this study do not place the participants at risk for
harm. There are some minimal risks associated with engaging in physical activity (e.g., sore muscles,
dizziness, etc) that are no greater than those ordinarily encountered in daily life or during the
performance of routine activity. Women with obstetric and medical complications and or who meet the
ACOG (2015) criteria for a contraindication to exercise will be excluded from study participation. There
are no known risks of a mother eating a healthy diet and engaging in PA to the fetus. Most
epidemiological data and the USDHHS (2008) guidelines illustrate benefits to the mother and the fetus
such as improved stamina during delivery, lower rates of emergency C-sections, and reduced
complications during delivery among healthy mothers. CRC nurses will check in during the exercise
sessions during normal business hours.  Trained fitness instructors with CPR training will be present at
all times during the after-hours exercise sessions.  If there should be a need for immediate medical
care, assistance from the CRC would be solicited during normal business hours and after-hours, 911
would be called.  A study staff member will also be present at all times during an exercise session.  If
immediate medical attention is needed, the study staff member will call 911, Penn State police and alert
the PI.  
There are no known economic, legal, or social risks associated with participation in this study. Some of
the self-reported surveys may ask questions about your thoughts or feelings and make you feel
uncomfortable, but they are not expected to cause feelings different from what is experienced in
everyday life (e.g., completing a survey in a magazine or at the doctor’s office). There are no risks
associated with wearing activity monitors or using the breathing device for measuring metabolism.  
There are no risks associated with participating in the interview.  Some discomfort may be experiences
while in the BodPod if there is fear of small-enclosed spaces.  The capsule has a window to see out of
and to let light in.  There is a blue button to press that will stop the measurement and let the participant
out immediately.  There are no risks to the women or child having a PeaPod measurement done.  Mild
nausea or dislike of food items may occur during the healthy eating demonstration due to normal
pregnancy symptoms.  There is a risk of loss of confidentiality if information or the participant’s identity
is obtained by someone other than the investigators, but precautions will be taken to prevent this from
happening. See examples in the privacy section.  
Some women experience minimal discomfort from the ultrasound scan. The sonographer may need to
press firmly on the abdomen to get a clear image of the fetus. Having multiple ultrasound examinations
during pregnancy does not result in negative short- or long-term effects on the physical or developmental
growth of the baby. Official Statement on Safety in Training and Research Work (Approved, March 1997):
“Diagnostic ultrasound has been in use since the late 1950’s. There are no confirmed adverse biological
effects on patients resulting from this usage. Although no hazard has been identified that would preclude
the prudent and conservative use of diagnostic ultrasound in education and research, experience from
normal diagnostic practice may or may not be relevant to the extended exposure times and altered
exposure conditions. It is therefore considered appropriate to make the following recommendation: In
those special situations in which examinations are to be carried out for purposes other than direct medical
benefit to the individual being examined, the subject should be informed of the anticipated conditions, and
how these compare with conditions for normal practice.”
Blood draws may cause mild pain, swelling or bleeding. Participants may feel a small pinch or slight
discomfort when the needle is inserted. If the initial blood draw is unsuccessful it may need to be
repeated, with permission. There may be some bruising (blood under the surface of the skin), which
can be minimized by pressing on the site after the needle is removed. There is also a slight chance of
infection, dizziness or fainting. These risks will be minimized and most likely eliminated by having
trained staff draw the blood in a clinical setting using sterile supplies. If dizziness or fainting occurs, the
symptoms will be alleviated by having the woman lie flat with her feet raised. If these should occur, we
may ask that the woman remain at the clinic until we have checked her blood pressure and we are sure
that she feels well.  Syringes used for venous blood draws will be used only once and then immediately
discarded in a biohazardous waste container approved for sharps. Any staff member collecting or
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processing blood will wear protective gloves at all times and will be training in safe techniques to
minimize risk to the staff member.
Adverse events will be tracked and reported (see below in the DSMP section for more information) by
the trained study staff with oversight from the CRC nurse. Safety-related events will be monitored and
reported as required by the DSMP and the IRB. Intervention staff reporting and managing adverse
events will inform the PI and in consultation with the study’s Safety Officer, will determine if it is an
unanticipated AE or unanticipated non-AE. Women with any health complications discovered at any
time during the assessments will be referred for follow-up with their healthcare provider or given a list of
local providers if they do not have a regular physician.  Women who are not achieving appropriate
GWG will be given the option to have a follow-up individual phone counseling session that week with
the intervention facilitator to further discuss problem solving strategies. If any medical issues are
uncovered that may be impacting their GWG, they will be referred to follow-up with their physician and
Co-I, Dr. Legro will provide clinical consultation to determine if any changes to the intervention protocol
should be made. See below for the monitoring plan for GWG in the DSMP section. Women in the
intervention group who develop gestational diabetes during the study will receive the standard of
prenatal care by their obstetrician or healthcare provider in which an established standard of care plan
is provided for the treatment and management of gestational diabetes.  The protocol for unexpected or
adverse event during an exercise session is below:
I. REASONS FOR ACTION
Symptoms Checklist: Warning Signs to Stop Exercise (ACOG, 2015):
Moderate to severe:
AND/OR:
RPE 15 or higher
during
exercise:
II. ACTION
1.
STOP activity
2.
Place participant in position of comfort.
3.
Call CRC if Monday-Friday (8 am – 5 pm) at 814-865-7103. Send research assistant or staff person for help
to CRC if needed (CRC is directly around the corner to the Left). Phone 911 if necessary.
4.
If the CRC is closed or no nurse is present, phone 911 if necessary.
5.
Notify participant’s emergency contact person(s) as needed and/or per participant’s request
6.
Call PI Dr. Downs 814-571-4908.
7.
Complete ORP significant event form (nurse or staff member).
8.
Report on study AE log (nurse or staff member).
9.
PI Dr. Downs need to submit a report to IRB within 5 weekdays; IRB determines if problems represent
unanticipated problems that would potentially cause harm.
10. See below for reporting AE and unanticipated problems.
Symptom Checklist
Pre
5-min
15-min
25-min
Post
Dizziness
Nausea
Headache
Regular painful contractions
Dyspnea before exertion
Chest pain
Calf pain or swelling
Fluid leakage (urine, amniotic,
blood)
Muscle weakness affecting balance
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12.0 Potential Benefits to Subjects and Others
12.1
Potential Benefits to Subjects
The minimal risks to the participants are greatly outweighed by the benefits of the intervention
they receive and the anticipated benefits to themselves and to others if the intervention is shown
to be effective. The potential benefit to the participants is greater understanding of healthy
behaviors that, if started in pregnancy could positively affect both maternal and fetal short- and
long-term health. They will also receive significantly more information on appropriate weight
gain in pregnancy, nutrition and healthy eating, self-regulatory behaviors, and psychological
health than is usually possible in routine obstetric care.  Subjects in the intervention group may
achieve better adherence to the Institute of Medicine GWG guidelines (table cited above),  
which may reduce their risk of hypertension, diabetes, obstetrical complications, and postpartum
weight retention.
12.2
Potential Benefits to Others
The benefit of this research to others is the possible development of a novel approach to
pregnancy care, which can positively impact maternal/child health in the future, particularly for
OW/OB women.  
13.0 Sharing Results with Subjects
Subjects will complete HIPAA forms if they want us to share information with their physician; we will
share information on their physical activity, healthy eating, weight, goal-setting, and self-monitoring
behaviors on a weekly basis as part of the intervention counseling and feedback component. This
information will be presented to the participant during the sessions.
14.0 Economic Burden to Subjects
14.1
Costs
None known.
14.2
Compensation for research-related injury
It is the policy of the institution to provide neither financial compensation nor free medical
treatment for research-related injury. In the event of injury resulting from this research, medical
treatment is available but will be provided at the usual charge. Costs for the treatment of
research-related injuries will be charged to subjects or their insurance carriers.
15.0 Number of Subjects
Study 2: target = 30 + anticipated 50 screened failures + 20% dropout (6) + 20 additional control
subjects = 106
16.0 Resources Available
16.1
Facilities and locations
Dr. Downs, the PI, is the Director of the Exercise Psychology Laboratory (EPL) at Penn State
and has been here since 2002. She has extensive experience with conducting research through
her laboratory, Noll laboratory, the CRC, and associated centers and affiliations at Penn State.
She has two laboratory spaces, the Exercise Psychology Lab is in Recreation Building and the
Healthy Mom Zone Laboratory for the sole purpose of this project is located in Noll Laboratory,
directly next to the CRC. The lab spaces are equipped with computer/data analysis and
workspace resources and the exercise area is equipped with a Quinton Q65 treadmill, Quinton
Q710 ECG monitoring system, a Medical Graphics metabolic monitoring system, and activity
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monitoring devices. In addition, Dr. Downs owns or has copyright access to nearly 100
psychological tests and measurements, with those listed in this study. Dr. Downs advises both
doctoral and undergraduate students. The EPL is capable of 100% availability for this project.
Dr. Downs also has personal office space in Recreation Building that is separate from her
laboratory and is equipped with a PC, laser printer, and all of the computer/data analysis
software in the laboratory. Dr. Downs is requesting funds for a laptop computer to assist with the
pre- and post-intervention assessment data collection as well as for use at the face-to-face
intervention sessions for the intervention instructor to upload intervention participant data from
the online system such as fitbit.com for daily weight self-monitoring.
The Noll laboratory space specific to this project includes two rooms for exercise participation,
healthy eating counseling and demonstrations, office/project management space, fitness
equipment (treadmill, recumbent bicycle, resistance bands, hand weights, core balls, mats,
space for low-impact aerobics), desk space for one-on-one education consultation, and
refrigerator and storage for food snacks and water.
Noll Laboratory
Noll Laboratory is housed in its own dedicated building with over 30,000 square feet of research
space containing a vast array of specialized instrumentation, equipment and chambers for the
measurement of physiological processes under various environmental conditions. Noll
Laboratory is supported by 5 technical (computer and electrical/equipment maintenance and
repair) and 1 administrative staff person to support research. Faculty affiliated with the
Department of Kinesiology in the Penn State College of Health and Human Development have
access to Noll Laboratory facilities for research purposes.
Clinical Research Center
The Clinical Research Center (CRC) facilities at the Penn State University Park campus (three
floors and 14,000 square feet) add to the capability for accomplishing the proposed work. The
GCRC staff is supportive of this proposal and are prepared to assist in research activities as
described in the proposal. More specifically, The CRC facilities will be used to perform the
baseline and follow-up assessments and to conduct the physical activity interventions. The CRC
was originally supported by a grant (M01-17032) from the National Center for Research
Resources of the National Institutes of Health to provide personnel and facilities for investigator
initiated peer-reviewed research with human subjects. Since July 1995, approximately 50
protocols and 40 investigators have used the CRC site in Noll Physiology Laboratory at the
University Park site. The GCRC hosts investigators funded by NIH and other federal, state and
local agencies as well as by the private sector. If needed, the CRC provides inpatient and
outpatient rooms, expert support personnel including nurses, computer system manager and
biostatistician; and supplies and equipment necessary to perform quality clinical research
studies. A skilled research staff of physicians, registered nurses, three medical assistants, and a
physician’s assistant experienced in research procedures is available. For the proposed
research, the GCRC will provide the nurse time, on-call physician time, and necessary supplies
and equipment to do the baseline and follow-up assessments. The CRC includes a
comprehensive list of nutritional services including registered dieticians, a certified dietary
manager, and student kitchen employees. Nutrition staff skills and support services are provided
for study protocols to include nutrition counseling, dietary analysis, metabolic kitchen, and a
“house diet” for meal and snack replacements.
For the dynamical modeling aspects of this project:
ARIZONA STATE UNIVERSITY: Pursuing a goal to become a model for the New American
University, Arizona State University (ASU) provides an infrastructure that promotes its primary
mission, which includes transforming society, promoting entrepreneurship, conducting
application-focused research, and fusing intellectual disciplines. Focus on such innovative,
transformative research has led to ASU’s research awards surpassing $347 M in 2010 alone.  
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Researchers at ASU have access to library facilities with nearly $11 M in electronic and print
resources, including 4.5 million volumes, 2.6 million unique titles, and over 91,000 serial titles.
ASU’s My Apps web application offers Dr. Rivera remote access to over 100 software
packages. Dr. Rivera and his research group conduct research primarily in ASU’s Control
Systems Engineering Laboratory (CSEL). CSEL is located in the Engineering Research Center
(ERC) on ASU’s Tempe campus. ERC is approximately 670 sq. ft. and is occupied by one part
time and four full-time predoctoral students. This space features a meeting area equipped for
video and phone conferences, high speed wired and wireless internet access, laser printing, five
Dell PCs with Windows operating system, one Dell PC with UNIX operating system, and two
Macintosh computers with the OSX operating system.  Investigators in CSEL also have access
to Saguaro 2, a supercomputer maintained by ASU’s High Performance Computing Initiative.
Software packages that are readily available to investigators include Microsoft Office,
Mathematica technical computing and computational software, SPSS data mining and statistical
analysis software, and MATLAB with Simulink for simulation and control design. The laboratory
also has access to TOMLAB and CPLEX optimization software that will be used in the
development and testing of the hybrid Model Predictive Control algorithm that serves as the
decision policy for the optimized behavioral intervention.
16.2
Feasibility of recruiting the required number of subjects
For Study 2, we will recruit 30 OW/OBPW who meet the eligibility requirements. We do not
anticipate any issues with retaining this sample for the study. We will use our past experience
with recruiting/retaining pregnant women to recruit OW/OBPW for the proposed research. The
PI, Dr. Downs, has years of experience recruiting pregnant women and recruited 127 pregnant
women into the Active MOMS RCT, DK07586702 (52% pre-pregnancy OW/OB; <5% drop-out)
from State College, PA. MNPG OBGYNs patient population is large and contributes to the
>1,200 births per year at MNMC. We were also successful with recruiting our target of 24
participants for study 1 in CATS 00000122.
R56: For the study 2 extension of control subjects, we will recruit up to 20 additional normal
weight women who meet the eligibility requirements.  
16.3
PI Time devoted to conducting the research
The PI, Dr. Downs has 25% academic year time and 50% summer year time dedicated to this
project.
16.4
Availability of medical or psychological resources
We do not anticipate the need for medical or psychological resources due to study participation;
however, the participants will have access to CRC clinical staff, a study staff nurse, and we will
work in conjunction with their healthcare provider of any AEs are identified. We will also make
referrals to medical or psychological resources if needed.  During the intervention, participants
will complete surveys at baseline and follow-up sessions.  There are measures in the surveys
that may display symptomology of depression or other psychological disorders.  If there so
happens to be a participant that displays a high “score” that could be evident of symptomology
of a disorder, the CRC and study staff will have references for psychological referrals.  For
example, in the baseline and follow-up on site survey, there is a measure called the Center for
Epidemiologic Studies Depression Scale (CES-D) that measures current levels of depressive
symptomology (with emphasis on the affective component, depressed mood) in the general
population.  If the final score shows a high level of symptomology (>16), the CRC nurse or study
staff will give the participant a handout with local phone numbers for assistance and referrals as
necessary.  If the CRC nurse detects any psychological issues, she will refer the participant to
her OBGYN or primary care provider or provide a list of local clinics if the participant does not
have her own healthcare provider. We will also recommend that the participant follow-up with
her OBGYN or primary care provider to talk about her symptoms. For the exercise sessions,
CRC nurses will check in during the sessions during normal business hours.  Trained fitness
instructors with CPR training will be present at all times during the after-hours exercise
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sessions.  If there should be a need for immediate medical care, assistance from the CRC
would be solicited during normal business hours and after-hours, 911 would be called.  A study
staff member will also be present at all times during an exercise session.  If immediate medical
attention is needed, the study staff member will call 911, Penn State police and alert the PI.  
16.5
Process for informing Study Team
All study staff are required to have CITI, HIPAA, Laboratory Safety and study protocol training.
Study staff will be informed on a weekly basis of study activities at face-to-face meetings, phone
calls, and emails; collaborators will be informed of activities on a bi-monthly basis or more
frequently as needed.
17.0 Other Approvals
NHLBI funding 1R01HL119245-01
R56 funding 1R56HL126799-01
CTSI Pilot Funding Award  
CATS 00000122
Institutional Biosafety Committee (IBC #46853)
18.0 Subject Stipend and/or Travel Reimbursements
Reimbursement:
All participants will receive:
$100 for the pre-intervention assessments
$200 for the post-intervention assessments
Wi-Fi weight scale to keep upon completion of the study ($125 value)
If the study is completed in its entirety an additional $200
Free parking on PSU campus
Picture of baby after each scan
Those also randomized to the intervention will receive:
$15 per month in merchandise gift-cards for self-monitoring x 6 months = $90 total
A food scale ($25 value)
Total of compensation in gifts and money: $740
Additional compensation at the Postpartum period:
$25 for completing the Remote Food Photography during the 3rd trimester
$50 for your baby’s measurements
$50 for your postpartum onsite measurements
$75 for the weekly measurements
Totaling $200.
R56: The additional normal weight control subjects will receive up to $300 in compensation for data
collection only:
$25 for each study visit (baseline, follow-up, and postpartum) for a total of up to $75
$5 per week for daily weighing, urine collection, and surveys for a total of up to $200
A bonus $25 for completing all visits and measures
Free parking on Penn State campus during your in-person visits
Free childcare during in-person visits to the Penn State campus (must schedule in advance)
Procedures will be followed for reporting payments to the University for tax purposes.
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19.0 Multi-Site Research
19.1
Communication Plans
While our collaborator, Dr. Rivera, at ASU will be receiving the de-identified data for dynamical
modeling purposes, we will NOT be collecting data at ASU – so this is not a multi-site trial. But
relevant is that we will communicate on a weekly basis with Dr. Rivera through a scheduled
conference call. Dr. Rivera will have access to Redcap for data purposes through a Friends of
Penn State account and will have access to de-identified data.
19.2
Data Submission and Security Plan
Dr. Rivera will be conducting secondary data analysis; he will not have access to the full data
set. He will have access to the multiple point (daily, weekly) data, but not identified data.
19.3
Subject Enrollment
NA
19.4
Reporting of Adverse Events and New Information
NA
19.5
Audit and Monitoring Plans
NA
20.0 Adverse Event Reporting
20.1
Reporting Adverse Reactions and Unanticipated Problems to the Responsible IRB
In accordance with applicable policies of The Pennsylvania State University Institutional Review
Board (IRB), the investigator will report, to the IRB, any observed or reported harm (adverse
event) experienced by a subject or other individual, which in the opinion of the investigator is
determined to be (1) unexpected; and (2) probably related to the research procedures. Harms
(adverse events) will be submitted to the IRB in accordance with the IRB policies and
procedures. See above information in the DSMP and our protocol for reporting AEs in the
uploaded document.
20.2
Auditing and Inspecting
The investigator will permit study-related monitoring, audits, and inspections by the Penn State
quality assurance program office(s), IRB, the sponsor, and government regulatory bodies, of all
study related documents (e.g. source documents, regulatory documents, data collection
instruments, study data etc.).  The investigator will ensure the capability for inspections of
applicable study-related facilities (e.g. pharmacy, diagnostic laboratory, etc.).
21.0 Study Monitoring, Auditing and Inspecting
21.1
Auditing and Inspecting
The investigator will permit study-related monitoring, audits, and inspections by the Penn State
quality assurance program office(s), IRB, the sponsor, and government regulatory bodies, of all
study related documents (e.g., source documents, regulatory documents, data collection
instruments, study data etc.).  The investigator will ensure the capability for inspections of
applicable study-related facilities (e.g., pharmacy, diagnostic laboratory, etc.).
22.0 References
Incorporated throughout the protocol.
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23.0 HIPAA Research Authorization and/or Waiver or Alteration of
Authorization
23.1
Authorization and/or Waiver or Alteration of Authorization for the Uses and Disclosures
of PHI
Check all that apply:
Authorization will be obtained and documented as part of the consent process.
Partial waiver is requested for recruitment purposes only (Check this box if patients’
medical records will be accessed to determine eligibility before consent/authorization
has been obtained)
Full waiver is requested for entire research study (e.g., medical record review studies)
Alteration is requested to waive requirement for written documentation of authorization
24.0 Appendix
Appendix A. List of Measures and Descriptions
A. Weight, GWG, and Height
i.
Weight and GWG will be assessed: (1) pre- and post-intervention at the CRC using standard
procedures (measured in duplicate to nearest kg using a high precision stand-on adult scale) and
(2) daily at home using the FitBit Aria Wi-Fi Smart Scale (www.fitbit.com; weights will be wirelessly
uploaded to online program). GWG will be standardized: target weight gain will be determined for
each woman based on BMI status (OW = 15-25 lb, OB = 11-20 lb).1 For the criterion measure to
determine when to adapt the intervention, weight gain will be calculated to determine if a woman is
gaining < her goal (-), at the exact amount of her goal (0), or > her goal (+). Pre-pregnancy weight
and GWG from the first prenatal visit to the last pre-delivery weight will also be obtained from
clinical records.72
ii.
Height will be assessed at pre-and post-intervention with a stadiometer using standard CRC
procedures.
B. Healthy Eating Behavior Measures
i.
Three Factor Eating Questionnaire: The Three Factor Eating Questionnaire is a 51-item questionnaire
developed by Stunkard and Messick (1985) to measure three dimensions of human eating behavior: 1)
dietary restraint, or cognitive control of eating behavior, 2) dietary disinhibition, or disinhibition of
cognitive control of eating, and 3) susceptibility to hunger. We are only using 18 items of the revised
TFEQ from Cappelleri (2009). These items are known as TFEQ-R18 as reported in (de Lauzon et al.,
2004).
C. Physical Activity Behavior Measures
i.
Leisure Time Exercise Questionnaire: The Leisure-Time Exercise Questionnaire (LTEQ) is a 3 item
questionnaire developed by Godin and Shephard (1985) to measure the amount and intensity of
exercise a person engages in during a one week period. The LTEQ’s original validated version is
based on 15 minute bouts of leisure exercise. The LTEQ assesses the amount of strenuous (e.g.,
running, fast swimming), moderate (e.g., brisk walking, tennis), and mild exercise (e.g., easy
walking, golf) that is done for at least 15-min during leisure-time in the past week. A total metabolic
equivalent (MET) score is generated by multiplying the intensity level by the estimated rate of
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energy expenditure [total LTEQ = (9 x strenuous) + (5 x moderate) + (3 x mild)]. Previous research
using this measure has modified the quantification of exercise to include average minutes rather
than metabolic equivalents across a week to better examine whether or not participants were
meeting exercise guidelines (Courneya et al., 2004; Courneya, et al., 2007). Thus, outcomes can
be quantified in MET equivalents or by multiplying reported values of strenuous, moderate, and mild
physical activity (PA) by 15 to get total min/week for each type and then adding those values
together to total min of weekly exercise.
ii.
Physical Activity (PA) Log: Women will be completing a daily PA log asking them series of
questions: ‘what time they put their activity monitor on and what time they took it off’, ‘if they were
physically active that day’- if yes ‘what activities they did’, if it was a normal day in terms of their
physical activity and if no, an ‘explanation of why’.
iii.
Actigraph wGt3X-BTl: Women will be wearing the Actigraph monitor for 7 days during their free
living immediately following their baseline appointment and again for 7 days immediately following
their final appointment. Women will also be wearing the Actigraph for 3 weeks during the
intervention phase of the study – the Actigraph is being counterbalanced with the UP Jawbone
where half of the women will wear the Actigraph for the first two weeks of the intervention phase
and the other half for the last two weeks of the intervention phase.
iv.
UP Jawbone: Women will be wearing the UP Jawbone for the entire six week intervention. UP will
track how you sleep, move and eat so the women will be able to make smarter choices. Women will
be wearing the UP Jawbone in counterbalance with the Actigraph wGt3X-BTI.
D. Personality Measures
i.
Adult Temperament Questionnaire: The Adult Temperament Questionnaire (ATQ) is a 177 item (77
item short form) questionnaire adapted from the Physiological Reactions Questionnaire developed
by Derryberry and Rothbart (1988) that assesses the constructs associated with adult
temperament. Based upon the results from recent studies (Rothbart, Ahadi, & Evans, 2000; Evans
& Rothbart, in preparation) we have formulated a self-report model of temperament that includes
general constructs of effortful control, negative affect, extraversion/surgency, and orienting
sensitivity. The general constructs are referred to as factor scales (i.e., they have resulted in
superfactors) and the sub-constructs are referred to as scales. Both the normal and short form
include the same constructs. We are using the Effortful Control and Negative Affect Subscales of
the Rothert Adult Temperament.
The three factors included in the Effortful Control Subscale are as follows:
-
Attentional Control: Capacity to focus attention as well as to shift attention when desired,
-
Inhibitory Control: Capacity to focus attention as well as to shift attention when desired.
-
Activation Control: Capacity to perform an action when there is a strong tendency to avoid it.
The four factors included in the Negative Affect Subscale are as follows:
-
Fear: Negative affect related to anticipation of distress.
-
Sadness: Negative affect and lowered mood and energy related to exposure to suffering,
disappointment, and object loss.
-
Discomfort: Negative affect related to sensory qualities of stimulation, including intensity,
rate or complexity of visual, auditory, smell/taste, and tactile stimulation.
-
Frustration: Negative affect related to interruption of ongoing tasks or goal blocking.
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E. Psychological Well Being Measures
i.
Body Area Satisfaction Scale: The Body Area Satisfaction Scale (BASS) measure is a 9-item
subscale originating from the Multidimensional Body-Self Relations Questionnaire (MBSRQ), which
is a 69-item self-report inventory for the assessment of self-attitudinal aspects of the construct of
body-image. Developed by Cash (1990), the BASS assesses one’s personal satisfaction with body
parts such as arms, legs, and face in which participants rate their degree of body satisfaction with
each specified body party from 1 (very dissatisfied) to 5 (very satisfied).
ii.
Center for Epidemiological Studies Depression Scale: The Center for Epidemiological Studies
Depression (CES-D) scale is a 20 item self-report scale developed by Radloff (1977) that is
designed to measure current levels of depressive symptomology (with emphasis on the affective
component, depressed mood) in the general population. The CES-D is a short scale including items
selected from a pool of items from previously validated depression scales and the major
components of depressive symptomology were identified from the clinical literature and factor
analytic studies. These components included: depressed mood, feelings of guilt and worthlessness,
feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep
disturbance. To emphasize current state, the directions read “How often this past week did you…”
The 20 item scale asked participants to indicate the occurrence of the 20 items on a 5 point Likert
scale. Responses included in the scale range from “rarely/not at all” to “most days” and incorporate
an additional “does not apply to me” option for each item. A cut off score of 16 is used to determine
case status (depressed versus not depressed).
iii.
Pregnancy Figure Rating Scale: The Body Figures Rating Scale is a 3-item scale that was
developed by Stunkard, Sorenson and Schulsinger (1983), to assess body dissatisfaction. The
scale consists of a set of nine male and female figures that range from underweight to overweight.
Subjects are asked to rate the nine figures based on their current body size and their ideal body
size which has been adapted to pregnancy figures. Subjects are asked to rate the figures based on
the following instructional protocol: (a) current size (i.e. which figure looks the most like you) and (b)
ideal size (i.e. which figure would you like to look like). The difference between the ratings is a
discrepancy index and is considered to represent the individual’s level of dissatisfaction.  
iv.
State-Trait Anxiety Inventory: The State-Trait Anxiety Inventory (STAI) is a 20-item questionnaire
developed by Spielberger (1983), to measure state and trait anxiety. The State version of the STAI
is being used for the current study. This scale consists of twenty items that evaluate how
respondents feel “right now, at this moment.” In responding to the STAI State-Anxiety scale,
participants choose the response statement that best describes the intensity of their feelings: (1) not
at all; (2) somewhat; (3) moderately so; (4) very much so. The state version of the STAI can also be
used to evaluate how someone felt at a particular time in the recent past and how they anticipant
they will feel either in a specific situation that is likely to be encountered in the future or in a variety
of hypothetical situations.
v.
Perceived Stress Scale: The Perceived Stress Scale (PSS) is a 10-item scale developed by Cohen
(1988) that measures the degree to which situations in one’s life are appraised as stressful. The
PSS was designed for use with community samples with at least a junior high-school education.
The 14 items are easy to understand and the response alternatives (never, almost never, neutral,
sometimes, fairly often, very often) are simple to grasp. The questions are quite general in nature
and hence relatively free of content specific to any sub-population group.
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F. Self-Regulation Measures
i.
Self-Regulation of Healthy Eating: These items were taken from Ryan Rhodes items for self-
regulation of PA and adapted for HE behaviors. Therefore, these items are novel for assessing self-
regulation of healthy eating. Ryan has indicated that these items work really well as an index for PA
self-regulation because these behaviors are naturally inter-connected but to look at specific self-
regulatory behaviors:

Item #1: self-monitoring

Item #2: goal-setting

Item # 3: action planning

Item #4: coping planning

Item #5: scheduling

Item #6, 7, 8, and 9

Items 10 &11: affective
There are also 2 sets of 8 questions—first 8 examine prospective behaviors while the second
set assesses retrospective behaviors.
ii.
Self-Regulation of Physical Activity: These items are taken from Ryan Rhodes. Ryan has indicated
that these items work really well as an index because these behaviors are naturally inter-connected
but to look at specific self-regulatory behaviors:

Item #1: self-monitoring

Item #2: goal-setting

Item # 3: action planning

Item #4: coping planning

Item #5: scheduling

Item #6, 7, 8, 9: cuing - #6 was developed by Ryan, 7, 8, and 9 we developed

Items 10 & 11: affective
There are also 2 sets of 8 questions—first 8 examine prospective behaviors while the second
set assesses retrospective behaviors.
iii.
Tangney Self-Control Scale: The Tangney Self Control Scale is a 13-item scale, developed by
Tangney et al. (2004), designed to measure the degree of self-control participants have in their
lives. Tangney and colleagues began by generating a larger pool of 93 items that encompassed all
the spheres of self-control failure covered in an extensive review they conducted on published
studies on self-control processes and failures (i.e., control over thoughts, emotional control, impulse
control, performance regulation, and habit breaking). Items were rated on a 5-point scale, anchored
from 1 “not at all like me” to 5 “very much like me.” Using both rational and empirical methods, the
scale was reduced to its final form comprising 36 items, based on an analysis of Study 1 data.
Items with low item-total correlations, duplicate or nearly duplicate items, and items likely to vary
substantially by gender differences were deleted. Based on a review of item-total correlations from
both Study 1 and Study 2, Tangney and colleagues also constructed a 13-item Brief Self-Control
Scale. For the current study, we are using the shorter, 13 item version of the SCS.
G. Sleep Behavior Measures
i.
Pittsburgh Sleep Quality Index: The Pittsburgh Sleep Quality Index (PSQI) is an 18-item measure
developed by Smyth (2003) to measure the quality and patterns of sleep in older adults. It
differentiates “poor” from “good” sleep by measuring seven areas: subjective sleep quality, sleep
latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication
and daytime dysfunction over the last month. The participant self-rates each of these seven areas
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of sleep. Scoring of answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on
the Likert Scale. Although there are several questions that request the evaluation of the
participant’s bedmate or roommate, these are not scored (these questions are not reflected in the
form being used for the current study).
H. Social Cognitive Measures
i.    Weight Efficacy Life-Style Questionnaire: The Weight Efficacy Life-Style Questionnaire (WEL) is a
20-item measure that was developed by Clark and colleagues (1991) to assess a participant’s
confidence to successfully resist the desire to eat. The measure was initially 40 items adapted from
Condiotte and Lichtenstein’s (1981) Smoking Confidence Questionnaire. A validation study of the
questionnaire revealed a 5 component solution, resulting in a final questionnaire of 20 items. The five
components or subscales include: Negative Emotions, Availability, Social Pressure, Physical
Discomfort, and Positive Activities. Participants are asked to rate their confidence about being able to
successfully resist the desire to eat using a 10-point scale ranging from 0 (not confident) to 9 (very
confident).
ii.   Sui Healthy Eating and Physical Activity Self Efficacy:  The Sui Healthy Eating and Physical
Activity Self Efficacy measure is an 8-item measure developed by Sui, Turnbull, & Dodd (2013) to
evaluate overweight and obese women’s perceptions of making behavior change during pregnancy.
They explored women’s beliefs through self-administered questionnaires and semi-structured face-to-
face interviews. The questions were designed according to the Health Belief Model. The results from
their questionnaire findings yielded interesting themes in regards to women’s self-efficacy to make
behavior change during pregnancy. Therefore, we took 8 items under self-efficacy themes from table
3 in the manuscript and adapted them into a questionnaire.
I.
Sociodemographic Measures: Participants will be completing measures assessing general
demographic information, their health history and family health history as well as their pregnancy
history and complications in any previous pregnancies they may have had that did go to full term.
J.
Theory of Planned Behavior Measures
i.
Healthy Eating
a.
Beliefs: These items were developed from the work of Blanchard et al. (2009a; 2009b),
Murnaghan et al. (2010) and the research team to assess Theory of Planned Behavior
(TPB) behavioral, control, and normative beliefs about healthy eating. There are eight items
to assess behavioral beliefs. The question stem asks “Eating healthy foods (fruits,
vegetables, whole grains) each day in the next week will…” with responses ranging from 1
(extremely unlikely) to 7 (extremely likely) for each of the seven items (e.g., help to control
my weight, improve my health). For the normative beliefs, there are seven items. The
question stem asks “During the next week, the following people definitely think I should eat
healthy foods (fruits, vegetables, whole grains) each day…” with responses ranging from 1
(not strongly) to 7 (very strongly). Example items include significant others such as
husband/partner/fiancé, friends, co-workers. For the control beliefs, there are ten items. The
question stem asks “How difficult will it be for you to eat healthy foods (fruits, vegetables,
whole grains) each day in the next week given the following…” with responses ranging from
1 (not difficult) to 7 (extremely difficult). The items women respond to represent a variety of
barriers they are likely to face towards eating healthy such as “I don’t have access to healthy
foods like fruits and vegetables,” “I don’t know how make/prepare healthy foods/meals,” or
“My life is extremely busy and I have limited time to prepare healthy foods.”
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b.
Main Constructs: The Theory of Planned Behavior (TPB) Healthy Eating Main Constructs
measure is a 38-item measure developed from the work of Blanchard et al. (2009a; 2009b),
Murnaghan et al. (2010), as well as from the recommendations of Azjen (1991) and the
research team to assess the main constructs of the TPB (i.e., attitude, subjective norm,
perceived behavioral control, intention) as they relate to healthy eating behavior.
Attitude: 14 items are used to assess attitude using seven semantic differential pairs. Seven
items ask women to describe how they feel about eating healthy foods each day in the next
week and the other seven items were developed by the research team to understand how
women feel about limiting sugary beverages, eating chips, candy, baked goods, and fried
foods each day in the next week. Participants rate each pair on a 7 point Likert scale. The
semantic differential pairs include: 1) useless-useful, 2) harmful-beneficial, 3) bad–good, 4)
foolish–wise, 5) unpleasant–pleasant, 6) unenjoyable–enjoyable, and 7) boring–interesting.
The additional items that ask about limiting sugary beverages and unhealthy foods were
developed by the research team. We used the same 7 semantic differential pairs that are
being used to assess PA behavior related TPB constructs for consistency in measuring
attitude across the two behaviors.
Subjective Norm: Subjective norm is assessed with six items with responses ranging from 1
(strongly disagree/disagree) to 7 (strongly agree/ agree). Three items measure how women
perceive that significant others in their life feel about them eating healthy each day in the
next week and the other three items are regarding how they perceive significant others feel
about them limiting sugary beverages, eating chips, candy, baked goods, and fried foods
each day in the next week.  The items about limiting sugary beverages and unhealthy foods
were developed by the research team. The subjective norm items are the same items being
asked for PA behavior related TPB constructs for consistency in measuring subjective norm
across the two behaviors.
Perceived Behavioral Control: Six items are used to assess perceived behavioral control.
Three questions ask women to respond on a 7 point Likert scale from 1 (extremely
difficult/very little control/strongly disagree) to 7 (extremely easy/complete control/strongly
agree) in regards to the ease in which they can eat healthy each day in the next week.
Three questions ask women to respond using the same 7 point Likert scale ranging from 1
(extremely difficult/very little control/strongly disagree) to 7 (extremely easy/complete
control/strongly agree) in regards to the ease in which they can limit drinking sugary
beverages, eating chips, candy, baked goods, and fried foods each day in the next week.
These items are the same 3 items we ask in regards to perceived behavioral control for PA
to achieve consistency in measuring perceived behavioral control across the two behaviors.
Intention: 12 items are used to assess intention for healthy eating. We used the three items
that have been used in the PESS study and added adapted those to healthy eating. We also
added three 3 items that asked about women’s intentions to limit drinking sugary beverages,
eating chips, candy, baked goods, and fried foods. The remaining six items were developed
from work by Ryan Rhodes. Three of the added items pertain to women’s intentions,
motivation, and plans to eat healthy each day in the next week and the other pertain to
women’s intentions to limit drinking sugary beverages and unhealthy foods. Responses
range from 1 (strongly disagree/definitely not/not at all) to 7 (strongly agree/definitely/very
much).
ii.
Physical Activity
a.
Beliefs: These items were developed from the work of Blanchard et al. (2009a;
2009b), Murnaghan et al. (2010, and the research team to assess Theory of Planned
Behavior (TPB) behavioral, control, and normative beliefs about physical activity
behavior. There are 8 items that assess behavioral beliefs, 9 items assess control
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beliefs, and 7 items assess normative beliefs. All 3 constructs are assessed using a
7 point Likert Scale. For the behavioral beliefs the question stem asks “Being
physically active in the next week will...” with responses ranging from 1 (extremely
unlikely) to 7 (extremely likely). For the control beliefs, the question stem asks “How
difficult will it be for you to be physically active in the next week given the following...”
with responses ranging from 1 (not difficult) to 7 (extremely difficult). For the
normative beliefs, the question stem asks “How strongly will these people approve of
you being physically active in the next week…?” with responses ranging from 1 (not
strongly) to 7 (very strongly).
b.
Main Constructs: The Theory of Planned Behavior (TPB) Physical Activity Main
Constructs measure is a 19-item measure developed from the recommendations of
Azjen (1991) and by the research team to assess the main constructs of the TPB
(i.e., attitude, subjective norm, perceived behavioral control, intention) as they relate
to physical activity behavior.
Attitude: 7 items are used to assess attitude using 7 semantic differential pairs that
describe how women feel about being active each day in the next week. Participants
rate each pair on a 7 point Likert scale. The semantic differential pairs include: 1)
useless-useful, 2) harmful-beneficial, 3) bad–good, 4) foolish–wise, 5) unpleasant–
pleasant, 6) unenjoyable–enjoyable, and 7) boring–interesting.
Subjective Norm: Subjective norm is assessed with 3 items with responses ranging
from 1 (strongly disagree/disagree) to 7 (strongly agree/ agree) in regards to how
women perceive that significant others in their life feel about them being physically
each day in the next week. Perceived Behavioral Control: 3 items are used to assess
perceived behavioral control. Questions ask women to respond on a 7 point Likert
scale from 1 (extremely difficult/very little control/strongly disagree) to 7 (extremely
easy/complete control/strongly agree) in regards to the ease in which they can
exercise each day in the next week.
Intention: 6 items are used to assess intention for physical activity. We used the 3
items that have been used in the PESS study and added 3 items that Ryan Rhodes
commonly uses in his research. Questions pertain to women’s intentions, motivation,
and plans to be physically active each day in the next week. Responses range from
1 (strongly disagree/definitely not/not at all) to 7 (strongly agree/definitely/very
much).
K. Weight Beliefs Measures
i.
Pregnancy Weight Gain Attitude Scale: The PWGAS is an 18-item questionnaire developed by
Palmer, Jennings, & Massey (1985), to evaluate and assess plausible attitudes of pregnant women
towards their weight gain during pregnancy. A Likert scale is used ranging from 1 (strongly agree)
to 5 (strongly disagree). The scores on individual statements are summed to yield a composite
score. Higher total scores indicate a more positive attitude towards gaining weight in pregnancy
while lower scores indicate a more negative attitudes towards pregnancy weight gain.
L. Bloodwork: Blood work will be obtained according to standard CRC procedures and our established
assays once at baseline and once in the third trimester of pregnancy. Less than 25 cc’s of blood will be
drawn by trained nursing staff.  Participants do not need to be fasting.  We will ask participants
two questions at the time of each blood draw: 1) what time did you eat last?  And 2) what did you
eat?  These biomarkers are linked to metabolic syndrome (and may be exacerbated in pregnancy due to
high GWG) and thus, they will be important outcomes of the future RCT. The biomarkers selected for
STUDY00003752
Approval: 8/9/2022

Page 36 of 48 (V. 5/8/2017)
analysis (listed below) have been linked to fetal growth, metabolic syndrome and cardiovascular disease,
which may be exacerbated in pregnancy due to high GWG or postpartum weight retention. The blood
biomarker measurements that we will be assessing are as follows: Iron, CRP, Vitamin A, Vitamin D, Folate,
Zinc, Selenium and Copper.  Blood will be centrifuged and aliquotted by a trained research technician
using standard biohazard safety procedures.  Samples will then be frozen at -80o C.  Once all samples
have been collected, they will be transported on dry ice to selected laboratories for analyses.  
M. Urine: Urine samples will be collected weekly during the prenatal period to assess basal cortisol level as it
relates to stress. Participants will be asked to collect voided urine overnight, starting from the time
participant falls asleep and ending with the last collection being first morning void after waking for the day.  
We will provide 1 collection container for whole the whole study for storage of all urine.  We will also
provide a urine collection hat for easy collection.  Participants will track time they went to bed, time of
any/all collections overnight and time of first morning void.  Participants may keep the urine collection
container beside the toilet/in the bathroom overnight, and will be asked to refrigerate after first morning void
until time of study visit, when they will bring urine collection container with them.  We will provide a zip-top
plastic bag for transportation.  Study staff will process the urine samples in the CRC, following biohazard
safety protocols.  Urine samples for analysis will be transferred to cryovials by pipette and frozen in a -20
degree freezer located in the CRC.  Cryovials will be labeled with participant ID # and date only (i.e. no
personally identifying information). Once all samples have been collected, a research study staff member
will transport samples to the Biobehavioral Core Lab for processing.  Urinary free cortisol (UFC) and
creatinine levels will be measured and UFC/creatinine ratio (Cort/Cr) calculated.  
N. Adiposity (Body Composition)
Standard CRC procedures will be used to assess:
i.
Maternal waist circumference using an inelastic tape in area between ribs and iliac crest and
recorded to nearest 0.1 cm
ii.
Skin fold Thickness measured at five sites per the Anthropometric Standardization Reference
Manual75
iii.
Air-displacement Plesmography [BOD POD; Life Measurement, Inc, Concord, CA) measuring
weight (mass) and volume to calculate body density (mass/volume) and percent body fat. (PeaPod
for infants)]
O. Dietary Intake
i.
Remote Food Photography Method: The Remote Food Photography Method© (RFPM) and the
SmartIntake™smartphone app were developed by Corby Martin, Ph.D., H. Raymond Allen, Ph.D.
and colleagues at the Pennington Biomedical Research Center as a way to accurately measure the
energy intake of adults in free-living conditions.  RFPM as been validated and is currently used in
multiple studies across the country.  Using a smartphone, participants capture images (photos) of
all food and beverages consumed both prior to consuming the meal or snack and of the leftover
food or beverage that was not consumed.  These images and accompanying food identifier data
(e.g., barcodes, PLU numbers, food descriptions) are emailed to Pennington Biomedical Research
Center (PBRC) and are stored in the Automated Data Management Utility (ADMU).  These images
are used to estimate energy intake by trained PBRC staff.
ii.
MyFitness Pal: Web-based and smartphone app dietary intake tracker.  Participants will have
accounts created for them and will record their diets 3days/week.
P. Metabolism
i.
The Breezing Device: An indirect calorimetry analyzer that measures the rate of oxygen
consumption and carbon dioxide production and determines how much energy the body is burning
STUDY00003752
Approval: 8/9/2022

Page 37 of 48 (V. 5/8/2017)
due to the metabolism of nutrients (named Resting Energy Expenditure, REE), and the type of
nutrients the body uses to produce energy (Energy source = respiratory quotient, RQ).  Developed
at Arizona State University.  The Breezing is a cellphone-size, battery operated, portable
technology that syncs with smartphones.  This tracker takes a traditional laboratory-based
measurement and makes it faster, more affordable and mobile.  Breezing has a 99.8% correlation
with the gold standard method, Douglas Bag (Forzani, Tao, et.al., Clinical Nutrition, 2013).
STUDY00003752
Approval: 8/9/2022

Page 38 of 48 (V. 5/8/2017)
Appendix B. Schedule of Assessment for Self-Reported Measures
HMZ SELF-REPORTED MEASURES: CONSTRUCT GROUPING
Survey
#
Measure
#
items
Data
Collection
Pre
(Onsite)
Pre
(7-day)
Weekly
Biweekly
Monthly
Post
(Onsite)
Post
(7-day)
Demographics and Health Data
1
Demographics (SF-
12 included)
7 min 31 sec
13
REDCAP
(DDE)
Pa
--
--
--
--
--
--
2
Health Hx
Included with the
demographics
85
REDCAP
(DDE)
Pa
--
--
--
--
--
--
3
CRC Medical Hx
8 min 23 sec
108
REDCAP
(DDE)
Pa
--
--
--
--
--
--
Theory of Planned Behavior
1
TPB PA ATT, SN,
PBC, INT
3 min 17 sec
19
REDCAP
SURVEYS
--
O
--
--
O
O
--
2
TPB PA Beliefs
3 min 25 sec
25
REDCAP
SURVEYS
--
O
--
O
(CB)
O
(NB/BB)
O
--
3
TPB HE ATT, SN,
PBC, INT
3 min 18 sec
37
REDCAP
SURVEYS
--
O
--
--
O
O
--
4
TPB HE Beliefs
3 min 43 sec
26
REDCAP
SURVEYS
--
O
--
O
(CB)
O
(NB/BB)
O
--
Self-Regulation
1
PA Self-Regulation
3 min 10 sec
22
REDCAP
SURVEYS
--
O
--
O
--
O
--
2
HE Self-Regulation
3 min 2 sec
22
REDCAP
SURVEYS
--
O
--
O
--
O
--
3
Tangney Brief Self-
Control Scale
2 min 1 sec
13
REDCAP
SURVEYS
--
O
--
--
O
O
--
Self-Efficacy
1
Sui SE (HE/PA)
2 min 9 sec
8
REDCAP
SURVEYS
--
O
--
--
O
O
--
2
Clark Weight SE
2 min 35 sec
17
REDCAP
SURVEYS
--
O
--
--
O
O
--
Notes. P = paper; O = online; DDE = double data entry. aBefore Clinical Research Center Physical Exam.

Page 39 of 48 (V. 5/8/2017)
Survey
#
Measure
#
items
Data
Collection
Pre
(Onsite)
Pre
(7-day)
Weekly
Biweekly
Monthly
Post
(Onsite)
Post
(7-day)
Behavior
1
3-Factor Eating
Quest  (TFEQ18)
2 min 24 sec
18
REDCAP
SURVEYS
--
O
--
--
O
O
--
2
Leisure-Time EX  
Quest (LTEQ)
1 min 50 sec
3
REDCAP
SURVEYS
--
O
--
--
O
O
--
3
Pittsburgh Sleep
Quality Index (PSQI)
2 min 30 sec
18
REDCAP
SURVEYS
--
O
--
--
O
O
--
4
ACT Tracking
1 min 3 sec
3
REDCAP
(DDE)
--
P
--
--
P (daily with ACT)
--
P
Weight
1
Palmer Attitudes
Towards Weight in
Pregnancy (PWGAS)
2 min 43 sec
18
REDCAP
SURVEYS
--
O
--
--
O
O
--
Psychosocial
1
Center for Epidem.
Studies Depression
Scale (CES-D)
3 min 7 sec
20
REDCAP
SURVEYS
Pa
--
--
--
O (with system in place to
check)
P
--
2
State Trait Anxiety
Inventory (STAI)
2 min 36 sec
20
REDCAP
SURVEYS
Pa
--
--
O
6 Item
O
20 Item
P
--
3
Body Areas
Satisfaction Scale
(BASS)
1 min 55 sec
9
REDCAP
SURVEYS
Pa
--
--
--
O
P
--
4
Perceived Stress
Scale (PSS)
3 min 6 sec
10
REDCAP
SURVEYS
P
X (P?)
--
P
5
Rothbart Adult
Temperament
3 min 4 sec
45
REDCAP
SURVEYS
Pa
--
--
--
--
--
--
6
Pregnancy Figure
Rating Scale (PFRS)
1 min 27 sec
6
REDCAP
SURVEYS
O
O
O
--

Page 40 of 48 (V. 5/8/2017)
Survey
#
Measure
#
items
Data
Collection
Pre
(Onsite)
Pre
(7-day)
Weekly
Biweekly
Monthly
Post
(Onsite)
Post
(7-day)
Dietary Intake
1
RFPM
--
PHONE,
APP
X
--
--
3 (2 weekday, 1 weekend
at week Baseline, 16, 22,
28, 35 (post) weeks are
gestational week)
X
--
2
MyFitnessPal
--
PHONE
APP,
WEBSITE
--
--
O
(3-5 days/
week)
--
--
--
--
Resting Metabolic Rate
1
Breezing Device
--
BREEZING
DEVICE,
PHONE
APP
X
--
--
--
3 (2 weekday, 1 weekend
at week Baseline, 16, 22,
28, 35(post) weeks are
gestational week)
X
--
Notes. P = paper; O = online; DDE = double data entry. aBefore Clinical Research Center Physical Exam.
SCHEDULE OF ASSESSMENT FOR OBJECTIVE PA ASSESSMENTS
HMZ SCHEDULE OF ASSESSMENT FOR OTHER PHYSICAL ASSESSMENTS
Measure
# of
items
Data
Collection
Pre
(Onsite)
Pre
(7-day)
Weekly
Biweekly
Monthly
Post
(Onsite)
Post
(7-day)
Actigraph Accelerometer
--
Enter in
excel file
sheet
NOT IN
REDCAP
--
X
--
--
X (1 week,  at week
Baseline, 16, 22, 28,
35(post)))
--
X
Up Jawbone Wrist Monitor
--
Phone App,
Enter in
excel file
sheet
NOT IN
REDCAP
--
X (daily)
X (daily)
--
--
--
X (daily)
Aria Fitbit W-Fi
--
At home
Website,
Enter in
excel file
sheet
--
X (daily)
X (daily)
--
--
--
X (daily)
Standardized Scale
--
CRC/Noll
Enter in
excel file
sheet
X
--
X
(session)
--
--
X
--
Medical Record Data
--
REDCAP
(DDE)
--
--
--
--
Monthly prenatal visits
--
--

Page 41 of 48 (V. 5/8/2017)
Measure
# of
items
Location
Pre
(Onsite)
Pre (7-
day)
Weekly
Biweekly
Monthly
Post
(Onsite)
Post
(7-day)
BodPod
--
128 Noll
X
--
--
--
--
X
--
Blood
--
CRC
X
--
--
--
--
X
--
Cortisol (Urine)
--
CRC
X
--
X
--
--
X
--

Page 42 of 48 (V. 5/8/2017)
Appendix C. Baseline Assessment and Adaptive Step-Layout
Recruit
(~6-8 wk)
Baseline
Measures Week
(on-site & home)
Acclimation
(2 weeks)
- on-site session
- education
- goals
- self-regulation
- ILD measures
GWG
Assmt
Above GWG
Step-up Dosage
Within GWG
Maintain Dosage
continue to evaluate every 3-4 wks
Gestational
Week
Study
Week
Lesson
#
Adaptation
8
1
BASELINE ASSESSMENT (Onsite visit + home surveys and GWG/HE/PA monitoring)
9
2
1
10
3
2
11
4
3
12
5
4
BASELINE INTERVENTION
Education Modules [GWG, PA/HE, Self-Monitoring, Goal-Setting; Using guideline recommendations (GWG, HE, PA)]; Focus on health of baby/weekly “fun facts”
Encouraged to get 150 min MVPA per week [to meet this goal, aiming to walk 10,000 steps/day and increase intensity (e.g., jogging/workout) as appropriate]
GWG/PA/Self-Monitoring/Goal-Setting education delivered by PA instructor; HE counseling delivered by RD
GWG Assessment and Decision Rules for Adapting Intervention
13 (2nd Tri)
6
5
14
7
6
15
8
7
16
9
8
Baseline
Intervention +
STEP-UP 1: Active Learning I
HE Active Learning: 4 Pearls Integrated into Cooking/Grocery Store Demo’s: Reinforcing Messages + Recipe Booklet
PA Active Learning: 1st MVPA Session in Lab (combo treadmill, cycle, low impact aerobics, resistance exercises) in addition to 10,000 steps
Self-Regulation Active Learninga: If-Then Action Plans (attach mental contrasting and implementation intentions to goal-setting)
GWG Assessment and Decision Rules for Adapting Intervention
17
10
9
18
11
10
19
12
11
20
13
12
Baseline
Intervention +
Step-Up 1
+
STEP-UP 2: Active Learning II
HE Active Learning: Portion Sizes and Containers
PA Active Learning: 2nd MVPA: Choice of Lab workout or walking with instructor + Workout Booklet (and 10,000 steps)
Self-Regulation Active Learningb: Participants engage in charting their own HE/PA behaviors; use weight data to regulate
eating and exercise behaviors; tie this process into action plans
GWG Assessment and Decision Rules for Adapting Intervention
21
14
13
22
15
14
23
16
15
24
17
16
Baseline
Intervention +
Step-Up 1
+
Step-Up 2
+
STEP-UP 3: Active Learning III
HE Active Learning: Grocery store receipt/pantry analysis; grocery store tour/activities; favorite recipe
make-over
PA Active Learning: 3rd MVPA session: Choice of Lab (individual or group?) or at-home workout
Self-Regulation Active Learning: We monitor HE/PA daily and provide feedback “check” (EMA-I)
GWG Assessment and Decision Rules for Adapting Intervention
25
18
17
26
19
18
27
20
19
Baseline
Intervention +
Step-Up 1
+
Step-Up 2
+
Step-Up 3
+
STEP-UP 4: Active Learning IV
HE Active Learning: 1 MR/day for 7 days (give bulk frozen 7 meals for either
lunch/dinner)

Page 43 of 48 (V. 5/8/2017)
Gestational
Week
Study
Week
Lesson
#
Adaptation
28 (3rd TRI)
21
20
PA Active Learning: 4th MVPA session: Choice of lab (indiv or group?) or at-home
workout
Self-Regulation Active Learning: (1 x/week) Text/Call/Email Feedback & Encouragement
GWG Assessment and Decision Rules for Adapting Intervention
29
22
21
30
23
22
31
24
23
32
25
24
33
26
25
34
27
26
Baseline
Intervention +
Step-Up 1
+
Step-Up 2
+
Step-Up 3
+
Step-Up
4 +
STEP-UP 5: Active Learning V
HE Active Learning: Same as step-up 4
PA Active Learning: Same as step-up 4
Self-Regulation Active Learning: (3 x/week) Text/Call/Email FB &
Encourage
35
28
FOLLOW-UP ASSESSMENT (Onsite visit + home surveys and GWG/HE/PA monitoring)
36-40
29-33
--
MAINTAIN LAST DOSAGE UNTIL DELIVERY
Appendix D. Intervention Content Outline
Green cells = Baseline Intervention, delivered
Given At Session
Emailed
Gest
Week
Study
Week
Lesson
#
PA Education
HE Education
Self-Monitoring
Goal-
Setting/Action
Plans
Featured Evidence/
Baby’s Health
Baby Fun Facts
8
1             Baseline Assessment Session
9
2
1
- Importance of EX in
Pregnancy
- EX Definitions and
Principles
- EX/ PA Guidelines
- Safety Checklist / EX
to avoid
-  Dietary guidelines
-  Hunger and fullness
cues
-  1st TRI:  “Eating for
two” (in relation to GWG
guidelines)
- SM overview &
strategies
HE: MyFitnessPal
overview
PA: Sleep/PA Log and
Jawbone/
Actigraph overview
GWG:  GWG Plot,
reminder about daily
weighing
- Overview of goal
setting principles
- Establish HE and
PA goals
- Establish action
plans
- Featured Evidence: “Mom’s
Healthy Lifestyle Choices
Impact on Baby
- Overview of how mom’s
food and PA choices impact
baby
- Why important to change
habits now (future health
risks for baby)
I. Your baby is as big as a green olive!
II. Your baby’s heart is almost completely
developed
III. … eyelids are forming
IV. … fingers and toes are now only slightly
webbed, and the tail (yes, your baby had
one) is gone.
10
3
2
- Benefits of EX for
Pregnancy
- The Importance of
Sleep in Pregnancy
- Sleep & the Brain
- Things to Know About
Sleep in the 1st
Trimester
- Being Active: A
choice and way of life
- 1st TRI Myths,
Concerns, Fears
- Smaller portions
(serving vs. portion)
-  Focus on tools for
portion size: food scale,
nutrition labels, visuals
(portion size kit; use
small vs. large portion
images and calorie
counts)
Same
- Review goals from
previous session and
set goals for next
session
- Review HE/PA
action plans
PA Goals: Meet PA
guidelines,  Min
MVPA, Time of
day/Mode
Healthy Eating:
Target calories, food
groups
- Featured evidence: “Early
GWG effects on Baby Health
I. Your baby is as big as a prune!
II. Your baby… is starting to do occasional
breathing movements!
III. has working arm joints, and the cartilage
and bones are forming.
IV. … fingernails and hair are starting to
appear, too.
V. … eyelids begin to fuse for protection.
11
4
3
- Tips for EX in the 1st
Trimester
-  Introduce calorie
density (what is it, how to
Same
Same
- Featured evidence: “Mom’s
Exercise Reduces Baby’s
I. Your baby is as big as a lime!
II. Your baby’s … genitals begin to take on

Page 44 of 48 (V. 5/8/2017)
Given At Session
Emailed
Gest
Week
Study
Week
Lesson
#
PA Education
HE Education
Self-Monitoring
Goal-
Setting/Action
Plans
Featured Evidence/
Baby’s Health
Baby Fun Facts
- Why EX is Good For
Sleep
- Sleep & Hormones
- Hydration during EX
- Eating as fuel for EX
- Step Count with
Jawbone
calculate)
-  How to decrease calorie
density
-  Switching out high for
low kcal foods -  
Increasing fruits and
vegetables
-  Water
-  Whole grains
-  Fiber
Risk for Childhood Obesity”
either male or female forms!
III. Nearly all the organs and body
structures are formed and beginning to
function.
IV. Your baby can sigh, stretch, move its
head, and suck its thumb!
12
5
4
- EX and Stress
Reduction I
- Basics for Good Sleep
- What to DO If You
Can’t Fall Asleep
- Sound Sleep
- 2nd TRI Myths,
Concerns, Fears
- (Stress Monster
Worksheet)
- Fats and sugars
-  Empty calories
-   SSB (juice, Gatorade,
soda, caffeine)
Same
Same
- Featured evidence: Sleep
I. Your baby is as big as a plum!
II. Your baby’s… arms, legs, and fingers are
growing out and tapering to look more like a
newborn’s!
III. … is about to enter the growth and
maturation stage, in which the organs and
tissues will grow and develop rapidly.
IV. … is now developing reflexes.
13 (2nd
Tri)
6
5
- Understanding EX
Barriers & Roadblocks
- Problem-Solving
Techniques
- What To Do if You
Are Sick or Injured
- What to Know About
Sleep in the 2nd
Trimester
- Exercises Role in
Helping Me Prepare for
Labor & Delivery
- (Barriers to Being
Active Quiz)
- 2nd TRI:  “eating for
two” (in relation to GWG
guidelines)
- Snacking (what, when,
how much)
- Eating late
evening/Emotional eating
- Cravings
Same
Same
- Featured evidence: “Mom’s
Exercise and Baby Brain
Development”
I. Your baby is as big as a peach!
II. Your baby… is forming vocal cords and
teeth
III. … and already has fingerprints.
IV. … begins to produce and excrete urine.
V. … is flexing the new and developing
muscles and joints in your womb.
14
7
6
- Talking Back to
Negative Thoughts
- What Does it Mean to
be Sedentary & Why is
it Bad?
- Recommendations for
Sitting & Standing
- Jawbone “Idle Alert”
- Life-Long Activity
- Eating away from home
-  Special occasions
- Planning ahead  (eating
away from home,
holidays, vacations,
special occasions)
Same
Same
I. Your baby is as big as a lemon!
II. Your baby… is growing lanugo, a thin,
peach-fuzz-like hair, all over for warmth!
III.  If you could see your baby’s face, you
might be able to see a wince and grimace,
because the facial muscles are developing
and flexing.
15
8
7
- Increasing Social
Support
- Benefits of Group
Exercise
Same
Same
- Featured evidence: “Social
Support”
I. Your baby is as big as a naval orange!
II. You probably can’t feel it yet, but your
baby squirming a ton!
III. … and might even be hiccupping in
there.
IV. Starting now, female fetuses show
mouth movements more often than males.
16
9
8
- Grocery store: planning
meals in advance, grocery
- How to create effective goals and action plan
(Up until this point we have provided standard
I. Your baby is as big as an Avocado!
II. Your baby… is listening to your voice,

Page 45 of 48 (V. 5/8/2017)
Given At Session
Emailed
Gest
Week
Study
Week
Lesson
#
PA Education
HE Education
Self-Monitoring
Goal-
Setting/Action
Plans
Featured Evidence/
Baby’s Health
Baby Fun Facts
list, tricks and tips for
grocery shopping  
set goals, now we will have a lesson on creating
their own)  
thanks to tiny bone formations.
III. … is growing hair, lashes, and
eyebrows.
IV. … is forming taste buds.
V. At any time, you will begin to feel fetal
movement as the baby’s bones harden, and
starts a growth spurt.
17
10
9
- Staying Motivated I
- Rewards for EX
- Tips to Reduce
Swelling
- Tips for EX in 2nd TRI
Same
Same
I. Your baby is as big as an onion!
II. Your baby… is growing some meat on
the new  bones- putting on some fat.
III. … and is growing a stronger, thicker
umbilical cord.
18
11
10
- Eating environment
- Social support/home
environment
Same
Same
I. Your baby is as big as a sweet potato!
II. Your baby… is yawning, hiccupping,
sucking and swallowing.
III. … is twisting, rolling, punching, kicking
IV. … retinas have become light sensitive,
and your baby may be able to detect a glow
if you shine bright lights at your belly (even
though their eyelids are sealed).
19
12
11
- Understanding 3rd
Trimester EX Barriers
& Roadblocks
- Overcoming Barriers
- Tips to Reduce Sitting
(Home, Work, Travel)
- Easy Ways to Exercise
At (Home, Work,
Travel)
Same
Same
I. Your baby is as big as a mango!
II. Your baby… is developing a protective
coating over the skin, called the vernix
caseosa. It’s greasy and white and you may
see some of it at the time of birth.
III. … is working on the five senses. Nerve
cells for a sense of taste, hearing, sight and
smell are developing in the brain.
IV. If your baby is a girl, early ovaries
contain follicles with forming eggs.
20
13
12
- Mindfulness/eating with
awareness (not eating in
front of TV, tasting the
flavors, savoring,
enjoying what you are
eating, etc.)
Same
Same
I. Your baby is as big as a banana!
II. Your baby… has got working taste buds
III. Now… is gulping down several ounces
of amniotic fluid each day- that’s
significantly more than before.
IV. … sweat glands formed.
21
14
13
- Exercise Goals,
Review & Progress
- Reminders for Step
Count, Idle Alert, Sleep
- Important Keys to
Remember About Goal
Setting (Goal Review &
Progress Worksheet)
Same
Same
- Featured Evidence: “Mom’s
Exercise and Baby Heart
Health”
I. Your baby is as big as a pomegranate!
II. As your baby’s… digestive system preps
for the outside world, your baby’s
manufacturing meconium- a tarry black
substance you’ll find in the first dirty diaper.
III. … eyebrows/eyelids are fully developed.
IV. … eyelids are sealed, but eyes are
active.
22
15
14
- HE Review/Progress,
Overcoming Barriers
Same
Same
I. Your baby is as big as a papaya!
II. Your baby… is sleeping in cycles- about
12-14 hours per day.
III. Blood is travelling through the umbilical
cord at four miles per hour, fueling growth
with oxygen and nutrients.
23
16
15
- EX in 3rd TRI:
Common Myths,
Same
Same
I. Your baby is as big as a grapefruit!
II. Your baby… is forming little nipples.

Page 46 of 48 (V. 5/8/2017)
Given At Session
Emailed
Gest
Week
Study
Week
Lesson
#
PA Education
HE Education
Self-Monitoring
Goal-
Setting/Action
Plans
Featured Evidence/
Baby’s Health
Baby Fun Facts
Concerns, Fears
- Sleep in the 3rd
Trimester
- Tips for 3rd TRI EX
and improving sleep
III. … face is fully formed now- just needs a
little extra fat to fill it out.
IV. … is listening to your voice and your
heartbeat- and even loud sounds like cars
honking and dogs barking.
24
17
16
- 3rd TRI:  “eating for
two” (in relation to GWG
guidelines)
- Review lessons to date
Same
Same
I. Your baby is as big as a cantaloupe!
II. Your baby’s… see-through skin is
gradually becoming more opaque. It’s got a
new pink glow, thanks to the small
capillaries that have recently formed.
25
18
17
- What is Stress,
Manage in 3rd Tri, How
Does it Impact Me &
My Baby
- Create WIN Statement
- Fatigue/EX in 3rd TRI
- Warning Signs of
Overdoing It
- 3rd TRI EX Guidelines
Same
Same
- Featured evidence: “Mom’s
Exercise Improves Mood and
Beats Baby Blues”
I. Your baby is as big as a cauliflower!
II. Your baby… is enjoying a sense of
equilibrium, now knows up from down.
III. … is growing more fat and more hair
too!
IV. … can now touch/hold feet/make a fist.
V. Partner may hear baby’s heartbeat by
pressing his ear against your belly.
26
19
18
- HE and stress
management
Same
Same
I. Your baby is as big as a head of lettuce!
II. Your baby’s… eyelashes are now fully
growth.
III. … is getting an immune system ready
for life on the outside by soaking up your
antibodies.
IV. This week marks a major milestone in
your baby’s hearing system (cochlea and
peripheral sensory end organs), which began
fine development during week eighteen, is
now completely formed, and over the next
few weeks, your baby will become
increasingly sensitive to sound.
27
20
19
- Benefits of EX For
Labor & Delivery
- EX Until Your Due
Date (Staying Motivated
to Delivery)
- Tell Tale Signs of
Labor
- EX to Help with Labor
(Courtenay’s Email)
Same
Same
- Featured evidence: “Mom's
late pregnancy exercise and
ease of labor and delivery”
I. Your baby is as big as a rutabaga!
II. Your baby… is practicing inhaling and
exhaling with the rapidly developing lungs.
III.  It’s official: Baby’s showing brain
activity! - brain will keep on getting more
complex.
28
(3rd
Tri)
21
20
- Stocking a healthier
kitchen – what’s in the
pantry?  
- Quick and easy meals
Same
Same
I. Your baby is as big as an eggplant!
II. Your baby… is starting to develop more
fat, so the wrinkly skin will start to get
smoother.
III. … lungs are mature enough for survival
in the outside world.
IV. … can now taste and smell and produce
tears.
29
22
21
- Tips in the Weeks
Leading Up to Labor
- Tips for Preparing for
Same
Same
I. Your baby is as big as an acorn squash!
II. Your baby… is growing white fat
deposits under the skin, and has energy is

Page 47 of 48 (V. 5/8/2017)
Given At Session
Emailed
Gest
Week
Study
Week
Lesson
#
PA Education
HE Education
Self-Monitoring
Goal-
Setting/Action
Plans
Featured Evidence/
Baby’s Health
Baby Fun Facts
Labor & Delivery
- Tips for Pain
Management
- Planning Ahead…
Check Off Your “To
Do” List
surging because of it.
III. … adrenal glands are producing a
chemical which will be made into estriol (a
form of estrogen) by the placenta. This
estriol is thought to stimulate the production
of prolactin by your body, and the prolactin
makes you produce milk. So even if your
baby comes early, you’ll still be able to
breastfeed.
30
23
22
- Creative Cooking:
Using a crockpot and
leftovers
Same
Same
I. Your baby is as big as a cucumber!
II. Your baby’s…  skin is getting smoother.
III. … is now strong enough to grasp a
finger.
IV. … most important organ, the brain,
continues to develop at a rapid pace.
31
24
23
- EX Postpartum:
Common Fears, Myths,
Concerns
- Beginning Postpartum
EX
- Benefits of Postpartum
EX
- Starting to EX
Postpartum
Same
Same
- Featured Evidence:
Exercise and Postpartum
I. Your baby is as big as a pineapple!
II. Your baby… is going through major
brain and nerve development.
III. …irises now react to light.
IV. All five senses are in working order.
V. … begins to run out of room as with an
increasing weight. You should feel about ten
kicks in an hour.
32
25
24
17
- Benefits of
breastfeeding
Same
Same
I. Your baby is as big as a squash.
II. Your baby… is getting ready for descent-
and is likely to be in the head-down position
now.
III. …REM (dream- cycle) sleep is
beginning.
33
26
25
- Staying Motivated to
EX During Postpartum
- EX & Postpartum
Weight Loss
- EX & Stress
Reduction: After the
Baby is Born
- Postpartum
Depression: How EX
Can Help
Same
Same
I. Your baby is as big as a Durian
II. Your baby… keeps open eyes while
awake.
III. … bones are hardening.
IV. …  is also in the process of receiving
your antibodies.
34
27
26
- Lessons learned for
lifelong Activity
- Increasing Social
Support After Baby
- The Perfect Postnatal
Workout
- Fun Activities for You
& Baby
- Tips for staying active,
- Lessons learned on HE
as a Lifestyle (lessons
learned not just for
pregnancy)
- Weight retention
- Increase Social Support
for HE After Baby
Lessons Learned
Lessons Learned
I. Your baby is as big as a coconut!
II. Your baby’s… hearing is fully
developed, and is responding best to high
pitched noises.
III. …nervous system and immune system
are still maturing.
IV. If it’s a boy, his testes have probably
fully descended.

Page 48 of 48 (V. 5/8/2017)
Given At Session
Emailed
Gest
Week
Study
Week
Lesson
#
PA Education
HE Education
Self-Monitoring
Goal-
Setting/Action
Plans
Featured Evidence/
Baby’s Health
Baby Fun Facts
quality sleep, decreasing
sitting time, routine, and
(as applicable) preparing
for the next pregnancy
35
28             Follow-up Assessment Session