The SPROUT (Pilot) Project: Starting Pregnancy With Robustness for Optimal Upward Trajectories
Phase: NA
Conditions: Pregnancy Related, Infant Development, Adherence, Treatment, Activity, Motor
Sponsor: State University of New York - Upstate Medical University

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PROTOCOL TITLE: 
The SPROUT (pilot) project:  Starting pregnancy with robustness for optimal upward trajectories 
 
 
PROTOCOL VERSION/AMENDMENT # AND DATE 
Protocol Version 2 (7/20/2020) 
 
PRINCIPAL INVESTIGATOR: 
Erin Wentz, PT, PhD 
 
1.0 Objectives 
 
1.1 
Describe the purpose, specific aims, or objectives of this research. Specifically, 
explain why it is important to do the study. 
Historically, pregnant women were advised to refrain from exercise due to concerns of maternal 
and fetal risk such as preterm delivery, low infant birth rate and fetal stress.  Despite current 
research that has demonstrated substantial benefits for maternal, fetal, and infant health, only 9-
15% of pregnant women meet the current physical activity recommendations.1-3 In addition, 
pregnancy exercise research is confounded by a lack of randomized controlled trials (RCT) that 
include diversity in participant demographics, specifically inner city populations, and difficulty 
accurately quantifying weekly exercise volume. We propose a pilot RCT investigating two 
different approaches to exercise intervention across a spectrum of demographics that we believe 
will result in improved exercise adherence as well as in maternal and infant health outcomes. 
 
 
1.2  
State the hypothesis to be tested, if applicable. 
NOTE:  A hypothesis is a specific, testable prediction about what you expect to 
happen in your study that corresponds with your above listed objectives. 
 
Specific Aim #1:  To determine the feasibility of two types of exercise interventions (supervised 
& home exercise) in terms of design, implementation and adherence.  Our working hypothesis is 
that both supervised and home exercise interventions will be implementable as designed in 
pregnant women as evidenced by recruitment, eligibility, retention, follow-up and exercise 
adherence from 1st trimester through 6-months post-natal at a 60% rate, but that adherence to the 
two types of exercise interventions will differ by demographic.  A secondary exploratory 
hypothesis is that we will be able to successfully recruit and retain 50% of our pregnant women 
from the Syracuse Community Health Center (primarily women with lower resources). 
 

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Specific Aim #2: To determine the appropriateness of the outcome measures proposed for the 
exercise intervention in detecting changes in maternal aerobic fitness, quality of life (QOL), 
fatigue, sleep quality, depression, and weight change throughout pregnancy and 6-months post-
natal as measured by the Balke Ware submaximal test; SF-12 Generic Quality of Life (QOL); 
Multidimensional Fatigue Inventory (MFI); Pittsburgh Sleep Quality Index (PSQLI); Center for 
Epidemiologic Studies Depression Scale (CES-D); Edinburgh Postnatal Depression Scale 
(EPDS); and the Pregnancy Physical Activity Questionnaire (PPAQ). Our working hypothesis is 
that the above outcome measures will be able to detect changes in maternal outcome measures in 
both exercise groups. 
 
2.0 Scientific/Safety Endpoints 
 
2.1 
Describe the scientific endpoint(s), the main result or occurrence under study.   
NOTE:  Scientific endpoints are outcomes defined before the study begins to determine 
whether the objectives of the study have been met and to draw conclusions from the data.  
Include primary and secondary endpoints.  Some example endpoints are:  reduction of 
symptoms, improvement in quality of life, or survival.  Your response should not be a 
date.   
The scientific endpoint of this project is determining if the study is feasible in terms of the 
proposed approach and if the planned outcome measures are appropriate for detecting change in 
the maternal dependent variables in all three participant groups. 
 
 
3.0 Background 
 
3.1  
Provide the scientific or scholarly background, rationale, and significance of the 
research based on the existing literature and how it will contribute/fill in gaps to existing 
knowledge.  
Physical activity during pregnancy has substantial benefits for maternal and fetal health including: 
reduced risk of excessive weight gain, developing pre-eclampsia (PE), gestational diabetes mellitus 
(GDM) and gestational hypertension (GH), pre-term birth, macrosomia; depressive symptoms, and 
developing childhood obesity; and, can improve maternal sleep; and neonatal neuromotor skills at 1-
month of age.4-18 Despite the fact that African American women are two times more likely to have a pre-
term delivery, have a higher pre-pregnancy body mass index (BMI) than Caucasian women and have a 
higher obesity rate, non-Caucasian pregnant women are less likely to engage in exercise and participate in 
more sedentary activity compared to Caucasian pregnant women.19-22 Therefore, interventions that 
increase exercise adherence in a prescription that is achievable and sustainable for pregnant women across 
a wide demographic is of critical importance for optimal maternal and neonatal outcomes. 
 
Evidence suggests that cardiovascular exercise performed at moderate intensity starting in the first 
trimester and continuing until birth is not associated with an increased risk for preterm birth (<37 weeks) 

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or low birth weight, even in previously sedentary women; and, does not compromise maternal or fetal 
health as assessed by mean gestational age, type of delivery, incidence of preterm delivery, birthweight, 
neonatal head circumference, Apgar score or neonatal complications.23-24 A major benefit of exercise 
during pregnancy is assistance with weight control since excessive weight gain and inactivity are a risk 
factor for pregnancy complications including GDM, GH, and macrosomia.25-26 Modest increases in 
maternal BMI beyond standard ranges are associated with increased risk of stillbirth and neonatal, 
perinatal and infant death.27-28  Furthermore,  pre-natal exercise has been associated with a reduction in 
pre- and post-natal depression with some evidence for improvement in sleep quality, fatigue, and quality 
of life. 12,18, 29-31  
 
Besides being associated with higher Apgar scores, exercise during pregnancy has been linked to 
decreased risk for childhood obesity and has been demonstrated to increase serum growth factors in 
neonates which may have beneficial implications for brain health and cognitive performance in the 
developing fetus. 14,32-34 Infants of mothers who exercised during pregnancy demonstrated higher 
neuromotor abilities at 1-month of age than infants of mothers who did not exercise.14 Therefore, in order 
to minimize negative health prenatal outcomes and to maximize beneficial health outcomes in the pre and 
post-natal period, it is imperative that we discover how to promote participation and adherence to an 
appropriate pre-natal exercise intervention across a spectrum of demographics.   
 
 
 
3.2  
Include complete citations or references:  
 
Literature cited 
 
1. 
Evenson KR, Wen F. Prevalence and correlates of objectively measured physical activity and  
 
sedentary behavior among US pregnant women. Prev Med. 2011;53(1-2):39-43. 
 
2. 
Jukic AMZ, Evenson KR, Herring AH, Wilcox AJ, Hartmann KE, Daniels JL. Correlates of 
 
physical activity at two time points during pregnancy. J Phys Act Health. 2012;9:325-35. 
 
3. 
Santo EC, Forbes PW, Oken E, Belfort MB. Determinants of physical activity frequency and 
 
provider advice during pregnancy. BMC Pregnancy Childbirth. 2017;17(1):286. 
 
4. 
Nascimento SL, Surita FG, Cecatti JG. Physical exercise during pregnancy: A systematic review. 
 
Curr Opin Obstet Gynecol. 2012;24:387-394. 
 
5. 
Kramer MS, McDonald SW. Aerobic exercise for women during pregnancy. Cochrane 
 
Database Syst Rev. 2006;3:CD000180. 
 
6. 
Ramirez-Velez R, Aguilar de Plata AC, Escudero MM, Echeverry I, Ortega JG, Salazar B, et 
 
al. Influence of regular aerobic exercise on endothelium-dependent vasodilation and  
 
cardiorespiratory fitness in pregnant women. J Obstet Gynecol Res. 2011;37:1601-08. 
 
7. 
Hegaard HK, Pedersen BK, Nielsen BB, Damm P. Leisure time physical activity during 
 
pregnancy and impact on gestational diabetes mellitus, pre-eclampsia, preterm delivery, and 
 
birth weight: A review. Acta Obstet Gyne Scan. 2007;86:1290-96. 

                                                                 Page 4 of 32 
 
 
8. 
Muktabhant B, Lawrie TA, Lumbiganon P, Laopaiboon M. Diet or exercise or both for  
 
preventing excessive weight gain in pregnancy. Cochrane Database Syst Rev. 2015;6:CD007145. 
 
9. 
Robledo-Colonia AF, Sandoval-Restrepo N, Mosquera-Valderrama YF, Escobar-Hurtado C, 
Ramirez-Velez R. Aerobic training during pregnancy reduces depressive symptoms in 
Nulliparous women: A randomized trial. J Physiother. 2012;58:9-15. 
 
10. 
Baker JH, Rothenberger SD, Kline CE, Okun ML. Exercise during early pregnancy is  
 
associated with greater sleep continuity. Behav Sleep Med. 2018;16(5):482-93. 
 
11. 
Krzepota J, Sadowska D, Biernat E. Relationships between physical activity and quality of 
 
life in pregnant women in the second and third trimester. Int J Environ Res Public Health. 
 
2018;15(12):2745-57. 
 
12. 
Kolomanska-Bogucka D, Mazur-Bialy M. Physical activity and occurrence of postnatal 
 
depression: A systematic review. Medicina. 2019;55:560-76. 
 
13. 
Wiebe HW, Boule NG, Chari R, Davenport MH. The effect of supervised prenatal exercise on 
 
fetal growth: A meta-analysis. Obstet Gynecol. 2015;125:1185-94. 
 
14. 
McMillan AG, May LE, Gaines GG, Isler C, Kuehn D. Effects of aerobic exercise during  
 
pregnancy on 1-month infant neuromotor skills. Med Sci Sport Exerc. 2019;51(8):1671-76. 
 
15. 
Davenport MH, McCurdy AP, Mottola MF et al. Impact of prenatal exercise on both prenatal and  
 
postnatal anxiety and depressive symptoms: A systematic review and meta-analysis. Br J Sports 
 
Med. 2018;52:1376-85. 
 
16. 
Davenport MH, Ruchat SM, Poitras VJ et al. Prenatal exercise for the prevention of gestational 
 
diabetes mellitus and hypertensive disorders of pregnancy: A systematic review and meta- 
 
analysis. Br J Sports Med. 2018;52:1367-75. 
 
17. 
Davenport MH, Meah VL, Ruchat SM et al. The impact of prenatal maternal exercise on 
 
neonatal and childhood outcomes: A systematic review and meta-analysis. Br J Sports Med. 
 
2018;52:1386-96. 
 
18. 
Campolong K, Jenkins S, Clark MM. The association of exercise during pregnancy with 
             trimester-specific and postpartum quality of life and depressive symptoms in a cohort of 
 
healthy pregnant women. Arch Womens Ment Health. 2018;21:215-224. 
 
19. 
Bediako PT, BeLue R, Hillemeier MM. A comparison of birth outcomes among black, hispanic,  
 
and black Hispanic women. J Racial Ethnic Health Disparities. 2015;2:573-82. 
 
20. 
Mutambudzi M, Meyer JD, Reisine S, Warren N. A review of recent literature on materialist 
 
and psychosocial models for racial and ethnic disparities in birth outcomes in the US, 2000- 
 
2014. Ethnicity Health. 2017;22(3):311-332. 
 
21. 
Christian LM. At the forefront of psychoneuroimmunology in pregnancy: Implications for 
 
racial disparities in birth outcomes PART 1: behavioral risk factors. Neurosci Biobehav Rev. 
 
2019;Apr 18: S0149-7634(19)30331-8. 
 

                                                                 Page 5 of 32 
 
22. 
Gaston A, Cramp A. Exercise during pregnancy: A review of patterns and determinants. J 
 
Sci Med Sport. 2011;14:299-305. 
 
23. 
DiMascio D, Magro-Malosso ER, Saccone G et al. Exercise during pregnancy in normal- 
 
weight women and risk of preterm birth. Am J Obstet Gynecol. 2016;215(5):561-571. 
 
24. 
Barakat R, Pelaez M, Cordero Y et al. Exercise during pregnancy protects against hypertension  
 
and macrosomia. Am J Obstet Gynecol. 2016;214(5):649.e1-649.e8. 
 
25. 
DaSilva S, Ricardo L, Evenson K et al. Leisure-time physical activity in pregnancy and maternal- 
 
child health: A systematic review and meta-analysis of randomized controlled trials and cohort 
 
studies. Sports Med. 2017;47:295-317. 
 
26. 
Tobias DK, Zhang C, van Dam RM, Bowers K, Hu FB, Physical activity before and during  
 
pregnancy and risk of gestational diabetes: A meta-analysis. Diabetes Care. 2011;34:223-29. 
 
27. 
Aune D, Saugstad OD, Henriksen T, Tonstad S. Maternal body mass index and the risk of 
 
fetal death, stillbirth, and infant death: A systematic review and metal-analysis. JAMA. 2014: 
 
311:1536-46. 
 
28. 
Streuling I, Beyerlein A, Rosenfeld E, Hofmann H, Schulz T, von Kries R. Physical activity 
 
and gestational weight gain: A meta-analysis of intervention trials. BJOG. 2011;118:278-84. 
 
 
29. 
Vargas-Terrones M, Barakat R, Satacruz B, Fernandez-Buhigas, Mottola MF. Physical 
 
exercise programme during pregnancy decreases perinatal depression risk: A randomized 
 
controlled trial. Br J Sports Med. 2019;53:348-53. 
 
30. 
Goodwin A, Astbury J, McMeeken J.Body image and psychological well-being in pregnancy. A 
comparison of exercisers and non-exercisers. Aust NZ J Obstet Gynecol. 2000; 
             40:442–447. 
 
31. 
Chan CWH, Yeung EA, Law BMH. Effectiveness of physical activity interventions on 
 
pregnancy-related outcomes among pregnant women: A systematic review. Int J Environ Res 
 
Public Health. 2019;16:1840-82. 
 
32. 
Haakstad LA, Bo K. Exercise in pregnant women and birth weight: A randomized controlled 
 
trial. BMC Pregn Child. 2011;11(1):66. 
 
33. 
Vega SR, Kleinert J, Sulprizio M, Hollmann W, Bloch W, Struder HK. Responses of serum 
 
neurotrophic factors to exercise in pregnant and postpartum women. Psychoneuroendocrin. 
 
2011;36(2):220-27. 
 
34. 
Labonte-Lemoyne E, Curnier D, Ellemberg D. Exercise during pregnancy enhances maturation 
 
in the newborn: A randomized controlled trial. J Clin Experim Neuropsychol. 2017;39(4):347-54. 
 
35. 
Hopkins, S.A, Cutfield, WS. Exercise in pregnancy: weighing up the long-term impact on the 
             next generation. Exer Sport Sciences Rev. 2011;39(3):120-27. 
 
36. 
Lewis BA, Schuver K, Dunsinger S. Rationale, design, and baseline data for the Healthy Mom 
 
II Trial: A randomized trial examining the efficacy of exercise and wellness interventions for  

                                                                 Page 6 of 32 
 
 
The prevention of postpartum depression. Contemp Clin Trials. 2018;70:15-23. 
 
37. 
Shakeel N, Richardsen KR, Martinsen EW, Eberhard-Gran M, Slinning K, Jenum AK.  
 
Physical activity in pregnancy and postpartum depressive symptoms in a multiethnic cohort. 
 
J Affect Disord. 2018;236:93-100. 
 
38. 
O’Hara MW, McCabe JE. Postpartum depression: Current status and future directions. Annu 
 
Rev Clin Psychol. 2013;9:379-407. 
 
39. 
Robertson E, Grace S, Wallington T et al. Antenatal risk factors for postpartum depression: A 
synthesis of recent literature. Gen Hosp Psychiatry. 2004;26:289-95. 
 
40. 
Sexton MB, Flynn HA, Lancaster C et al. Predictors of recovery from prenatal depressive 
 
symptoms from pregnancy through postpartum. J Womens Health. 2012;21:43-9. 
 
41. 
Coll CV, Domingues MR, Goncalves H, Bertoldi AD. Perceived barriers to leisure-time 
 
physical activity during pregnancy: A literature review of quantitative and qualitative 
 
evidence. J Med Sci Sport. 2017;20:17-25. 
 
42. 
Evenson KR, Moos MK, Carrier K, Siega-Riz AM. Perceived barriers to physical 
 
activity among pregnant women. Matern Child Health J. 2009;13:364-75. 
 
43. 
Census bureau statistics for Syracuse. Available at:  
 
https://www.census.gov/quickfacts/fact/table/syracusecitynewyork/IPE120218   
 
[accessed 02.04.2020] 
 
44. 
American College of Sports Medicine. ACSM’s guidelines for exercise testing and prescription. 
10th ed. Philadelphia, PA: Wolters Kluwer/Lippincott Williams & Wilkins; 2018. 
 
45. 
ACOG Committee Opinion No. 650. Physical activity and exercise during pregnancy and the 
postpartum period. Obstet Gynecol. 2015;126:e135-42. 
 
46. 
Pollock, ML, Foster C, Schmidt C, Hellman C, Linnerud AC, Ward A.  Comparative analysis of  
             physiologic responses to three different maximal graded exercise test protocols in healthy women. 
             Am Heart J. 1982;103(3): 363–73.  
 
47. 
Emmanuel E, St John W, Sun J. Relationship between social support and quality of life in 
 
childbearing women during the perinatal period. J Obstet Gynecol Neonatal Nurs. 2012;41:E62- 
 
70. 
 
48. 
Fisher J, Wynter K, Hammarberg K et al. Age, mode of conception, health service use and 
 
pregnancy health: A prospective study of Australian women. BMC Pregn Child. 2013; 
 
13:88. 
 
49. 
dePascalis L, Agostini F, Monti F, Paterlini M, Fagandini P, la Sala GB. A comparison of 
 
quality of life following spontaneous conception and assisted reproduction. Int J Gynaecol 
 
Obstet. 2012;118:216-9. 
 
50. 
Smets E, Garssen B, Bonke B, DeHaes J. The multidimensional fatigue inventory (MFI) 
 
psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995;39(3): 
 
315-25. 

                                                                 Page 7 of 32 
 
 
51. 
Buysse D, Reynolds III T, Monk S, Berman S, Kupfer D. The Pittsburgh sleep quality index: 
 
A new instrument for psychiatric practice and research. J Psychiat Res. 1989;28:193-213. 
 
52. 
Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression: Development of the 
 
10-item Edinburgh postnatal depression scale. Br J Psychiatry. 1987;150:782-86. 
 
53. 
Beeghly M, Olson KL, Weinberg MK, Pierre SC, Downey N, Tronick EZ. Prevalence, 
 
stability, and socio-demographic correlates of depressive symptoms in black mothers during 
 
the first 18 months postpartum. Matern Child Health J.2003;7:157-68. 
 
54. 
Boyd RC, Le HN, Somberg. Review of screening instruments for postpartum depression. 
 
Arch Womens Ment Health. 2005;8:141-53. 
 
55. 
Campbell SB, Cohn JF. Prevalence and correlates of postpartum depression in first-time 
 
mothers. J Abnorm Psychol.1991;100:594-99. 
 
56. 
Davies GA, Wolfe LA, Mottola MF, MacKinnon C. Joint SOGC/CSEP clinical practice 
guideline: exercise in pregnancy and the postpartum period. Can J Appl Physiol. 2003;28(3): 
330-41. 
 
57. 
Chasan-Taber L, Schmidt MD, Roberts DE, Hosmer D, Markenson G, Freedson PS.  
 
Development and validation of a Pregnancy Physical Activity Questionnaire. Med Sci 
 
Sports Exerc. 2004;36(10):1750-60. 
 
58. 
Bayley N. Aylward GP. Bayley scales of infant and toddler development. 4th ed. Pearson  
 
Professional Assessment; Indianapolis,IN. 2019. 
 
59. 
Bamfo JE, Kametas N, Nicolaides KH, Chambers JB. Maternal left ventricular diastolic 
 
and systolic long-axis function during normal pregnancy. Eur J Echocardiog. 2007;8(5): 
 
360-68. 
 
60. 
Naqvi TZ, Elkayam U. Serial echocardiographic assessment of the human heart in normal 
 
pregnancy. Circ Cardiovasc Imaging. 2012;5(3):283-85. 
 
61. 
vanDelft K, Schwertner-Tiepelmann N, Thakar R. Sultan AH. Recruitment of pregnant 
 
women in research. J Obstet Gynaecol. 2013;33(5):442-46. 
 
62. 
Carpenter RE, Emery SJ, Rassi D, Uzun O, Lewis MJ. Recruitment of pregnant women to an 
exercise-intervention study. J Obstet Gynaecol. 2016;36(2):200-7. 
 
 
 
 
4.0 Study Design 
 
4.1  
Describe and explain the study design (e.g. case-control, cross-sectional, 
experimental, interventional, longitudinal, and observational). Indicate if there is 
randomization, blinding, control group, etc. If randomizing, explain how this will be 

                                                                 Page 8 of 32 
 
achieved. For studies that have a complex study design (i.e., multiple arms and 
treatments), include a schematic diagram. 
This is a pilot investigation (feasibility) of a future larger study of interventional design with 
randomization.  Participants in the pilot phase of the project will be randomized using a free 
online research randomizer (randomizer.org).   
 
 
5.0 Data Management and Analysis 
 
5.1 
Describe the data analysis plan, including any statistical procedures.  This 
section applies to both quantitative and qualitative analysis.  
Statistical analysis used to determine feasibility of the exercise intervention will include general 
descriptive statistics to assess recruitment, eligibility, retention, follow-up and exercise adherence.  In 
addition, we will conduct a survey and interview of subjects related to acceptability to participate in EX 
and HOMEEX and discuss barriers to regular exercise which will be analyzed using descriptive statistics 
and a phenomenological approach.   To determine the feasibility of maternal and infant outcomes, 
Kruskal-Wallis and Friedman’s ANOVA will be used to investigate between group and within group 
differences.  Relationships between variables will be analyzed using Spearman correlation coefficient.  
Because this is a feasibility study, the results will be used as preliminary data to apply for future funding 
and also will provide variable quantitative and qualitative data for validating interventions that can 
increase adherence to exercise guidelines during pregnancy in women with different ethnic and 
socioeconomic backgrounds.  
 
 
 
5.2 
If applicable, provide a power analysis for the number of subjects to be included. 
If qualitative research, so state, and provide general justification for the total number of 
subjects proposed.  
NOTE:  This may not apply to certain types of studies, including chart/records 
reviews, survey studies, or observational studies.  This question is asked to elicit whether 
the investigator has an adequate sample size to achieve the study objectives and justify a 
conclusion.  
This is a pilot project aimed to investigate feasibility of approach and appropriateness of 
maternal outcome measures.  If the working hypotheses are supported, the next phase will be a 
large, randomized intervention study.  Pilot data from this project can be utilized in the power 
analysis for the larger study. 
 
 
 
6.0 Local Number of Subjects 
 

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6.1 
Indicate the total number of subjects who will be enrolled or records that will be 
reviewed through Upstate. 
No more than 18 total participants (six per group) 
6.2 
If applicable, indicate your screen failure rate, i.e., how many subjects you expect 
to screen to reach your target sample.   
54 (anticipate that for every three women screened, one will participate in the study) 
 
6.3 
Justify the feasibility of recruiting the proposed number of eligible subjects within 
the anticipated recruitment period. For example, how many potential subjects do you 
have access to? What percentage of those potential subjects do you need to recruit? 
The feasibility of recruitment is part of what is being investigated in this pilot project and 
findings from this project will inform the recruitment plan of the future large intervention study.  
The plan for the pilot is to recruit no more than 18 (six per group) low risk pregnant women with 
a singleton pregnancy from Syracuse Community Health Center (50%), University OB/GYN 
Associates, and Upstate Community OB/GYN.   All women will be enrolled during the 1st 
trimester (6 to 13-weeks’ gestation) and without absolute contraindications to moderate intensity 
exercise during pregnancy as defined by American College of Sports Medicine (ACSM) and 
American College of Obstetricians and Gynecologists (ACOG). 44-45 All participants will be 
cleared for exercise by their OB/GYN. 
 
 
7.0 Inclusion and Exclusion Criteria 
 
7.1 
Describe, in bullet points, the criteria that define who will be included in this 
study: 
• Adult pregnant women (i.e. 18 years of age and older) 
• Low risk, singleton pregnancy 
• In first trimester of pregnancy (6 to 13 weeks gestation) 
• Without absolute contraindications to moderate intensity exercise during pregnancy as 
defined by the American College of Obstetricians and Gynecologists 
• Exercise clearance from OB/GYN  
 
 
7.2 
Describe, in bullet points, the criteria that define who will be excluded from this 
study: 
• Pregnancies greater than low risk for any reason 
• Pregnant with more than one fetus 
• Absolute exercise contraindications and/or lack of exercise clearance from OB/GYN 

                                                                 Page 10 of 32 
 
 
 
7.3 
Indicate whether you are specifically recruiting or targeting any of the following 
special populations in your study using the checkboxes below. 
 
 
☐ 
Adults unable to consent (complete and upload Supplemental Form A) 
☐ 
Minors (under 18 years old) 
☒ 
Pregnant women 
☐ 
Prisoners 
 
6.4 
Indicate if you will include minorities (American Indians, Alaskan Native, Asian, 
Native Hawaiian, Pacific Islander, Black [not of Hispanic origin] and Hispanic) as 
Federal mandates require that you include minorities unless you can justify their 
exclusion 
 
☒ 
Yes 
 
☐ 
No, Justify: 
 
8.0 Vulnerable Populations 
 
8.1 
For research that involves pregnant women, review, complete and upload 
Supplemental Form B:  Research Involving Pregnant Women, Fetuses, or Neonates. 
☒ 
Confirmed 
☐ 
N/A:  This research does not involve pregnant women. 
 
8.2  
For research that involves neonates of uncertain viability or non-viable neonates, 
review, complete and upload Supplemental Form B:  Research involving Pregnant 
Women, Fetuses, or Neonates. 
☐ 
Confirmed 
☒ 
N/A:  This research does not involve non-viable neonates or neonates of uncertain 
viability. 
 
8.3 
For research that involves prisoners, review, complete and upload Supplemental 
Form C: Research involving Prisoners  
☐ 
Confirmed 
☒ 
N/A:  This research does not involve prisoners. 
 
8.4 
For research that involves minors (under 18 years), review, complete and upload  
Supplemental Form D: Research involving Minors 

                                                                 Page 11 of 32 
 
☒ 
Confirmed 
☐ 
N/A:  This research does not involve minors (under 18 years),  
 
8.5 
Consider if other specifically targeted populations such as students, employees of 
or educationally or economically disadvantaged persons are vulnerable.  Provide 
information regarding their safeguards and protections, including safeguards to 
eliminate coercion or undue influence. 
 
 
☒ 
N/A 
 
9.0 Eligibility Screening  
 
9.1 
Describe screening procedures for determining subjects’ eligibility.  Screening 
refers to determining if prospective participants meet inclusion and exclusion criteria.  
Include (upload) all relevant screening documents with your submission (e.g. screening 
protocol, script, questionnaires). 
Protocol:  Interested pregnant women (responding to internet requests for participants or posted 
flyers) will be contacted by phone or email to answer questions about the study and to verify 
eligibility for the study (i.e. inclusion, exclusion criteria).  Participants that are interested in 
registering for the study will be required to get exercise clearance from their OB/GYN before 
being randomized into one of the three groups and then beginning that group’s exercise protocol. 
 
Clearance for participation must be provided by the participant’s OB/GYN (not primary care 
physician or non-physician providers) 
☐ 
N/A:  There is no screening as part of this protocol. 
 
10.0 Recruitment Methods 
☐ 
N/A:  Subjects will not be recruited.   
 
10.1 
Describe source of subjects: When, where, and how potential subjects will be 
recruited.  
NOTE:  Recruitment refers to how you are identifying potential participants and 
introducing them to the study; for example, physician referral, database search, 
reviewing medical records, research participant groups/help/advocacy groups, 
advertising companies, call centers, in person announcements / presentations, etc. 
 

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Participants will be recruited via physician referral, posted flyers and internet postings (e.g. local 
mom’s groups, Upstate announcements, Department of Physical Therapy Education Facebook 
page, etc) 
 
10.2 
Describe how you will protect the privacy interests of prospective subjects during 
the recruitment process.   
NOTE:  Privacy refers to an individual’s right to control access to him or herself. 
This is NOT asking about confidentiality of data.   
All screening and information exchanges with prospective participants will happen in private (in 
a one on one setting). 
 
 
10.3 
Identify all materials that will be used to recruit subjects and upload copies of 
these documents (such as telephone scripts, flyers, questionnaires, posters, letters, e-
mails, pamphlets, advertisements).  
Flyers, e-mails 
 
 
11.0 Research Methods & Procedures  
Provide a detailed description of the methods and procedures that will be used to carry out the 
study.  Include a summary of study visits and procedures (i.e., schedule of events table) in the 
space below or as an attachment. 
 
Please make sure to include: 
• Dosing of drugs and other details of study drug administration and study treatments 
• A list and description of any experimental procedures  
• A list and description all tests & procedures that would no be done if the subjects were 
not in the study 
• An explanation how study participation differs from the standard of care 
• Procedures being performed to monitor subjects for safety or to minimize risks 
 
Eighteen low risk pregnant women with a singleton pregnancy will be recruited for this pilot 
project from Syracuse Community Health Center (50%), University OB/GYN Associates, and 
Upstate Community OB/GYN.   All women will be enrolled during the 1st trimester (6 to 13-
weeks’ gestation) and without absolute contraindications to moderate intensity exercise during 
pregnancy as defined by American College of Sports Medicine (ACSM) and American College 
of Obstetricians and Gynecologists (ACOG). 44-45 All participants will be cleared for exercise by 
their OB/GYN. The ACSM and ACOG guidelines include 150 min/wk of cardiovascular activity 
at a moderate intensity; 2-3 days/week of resistance training; and 2-3 days/wk of flexibility 
training.44-45 Clearance will come exclusively from the OB/GYN. 

                                                                 Page 13 of 32 
 
 
Women will be randomly assigned to either UA, EX or HOMEEX.  Women randomized to EX 
will attend three exercise classes/week at the Institute for Human Performance (IHP) and given 
flexibility to attend classes between the hours of 7:30a-6p, Mon-Fri.  Each session will consist 
of: 5-min flexibility warm-up and cool-down; 40 min of moderate intensity calculated as 40-59% 
Heart Rate Reserve (HRR) along with Rating of Perceived Exertion (RPE) between 13-14; and 
20 minutes of resistance with an additional 30 minutes of unsupervised home aerobic activity per 
week.  The women will be given their choice of aerobic equipment or walking either track/ 
treadmill to achieve a total of 40 minutes of moderate intensity exercise.  
  
Women assigned to HOMEEX will receive instructions for their home walking program 
including tips for walking indoors and outdoors, exercise handouts for warm-up/cool-down 
activities, demonstrations for resistance training activities and an exercise log.  HOMEEX 
women will be contacted twice per week to discuss their progress, barriers/challenges faced, ask 
questions, and strategies to achieve the exercise guidelines.  If women in either EX or HOMEEX 
are unable to achieve 30-40 minutes of continuous aerobic exercise at the start of the study, they 
will be given an individualized, progressive exercise program that breaks activity into smaller 10 
minute sessions and/or increases rest between sessions to achieve the 150 minutes/week of 
moderate intensity activity.   
 
Both exercise groups will receive exercise counseling during their first meeting in addition to 
materials on the benefits of exercise, a log to record additional activity completed each week, 
goal setting, making time for exercise/making exercise a habit and exercise behavioral strategies.  
The UA group will receive an exercise log to record any weekly activity in addition to a weekly 
phone call/text/email to remind the individual to download information from the Polar Ignite 
watch (Bethpage, NY) and a reminder to complete the weekly exercise log.  
 
Each woman enrolled in the study will be given a Polar Ignite watch to wear for the study 
duration.  This monitor will be programmed for moderate intensity HRR and will alarm if HR 
falls above/below during exercise for both exercise groups.  In addition, the monitor will record 
all other activity within the HRR range and will be used to verify information obtained from 
activity and QOL questionnaires to reduce self-reported bias in all groups.  For the control group, 
the watch will record activity by HR intensity level that can be quantified on a weekly basis.  
 
Regardless of randomization, all women will report to the IHP between weeks 11-13 (late 1st 
trimester) for baseline testing and to review past medical history, medications and exercise 
history.  Height will be measured to the nearest 0.25 inch using a stadiometer and converted to 
meters.  BMI will be calculated using the self-reported pre-pregnancy weight.  Gestational 
weight gain will be calculated from subtracting the pre-pregnancy weight from weight at the last 
obstetrics visit prior to delivery. All women will also perform a submaximal Balke-Ware 

                                                                 Page 14 of 32 
 
submaximal treadmill test to determine HRR for the two exercise groups and estimate VO2max 
using the Pollock equation which will be repeated at 3- and 6-months after birth to compare 
aerobic fitness levels.46  
 
All women will complete the following questionnaires at baseline (late 1st trimester), 25-26 
weeks (late 2nd trimester), and 37-38 weeks (late 3rd trimester), and monthly through 6-months 
post-natal: MFI, SF-12 QOL; PSQLI; CES-D; EPDS; and the PPAQ.  All questionnaires have 
been demonstrated to have good validity, reliability, and internal consistency and the CES-D and 
EPDS are similar to each other in regards to internal consistency and test-retest reliability.47-57 
 
Infants from mothers in all three groups will have their gross and fine motor, and cognitive 
development measured monthly (months 1-6) at home using the Bayley Scales of Motor 
Development, 4th edition.58 The Bayley 4 is a standardized, norm-referenced tool with subtest 
level scaled scores, domain level composite scores, percentile ranks, and developmental age 
equivalents.58 Infant height and weight will be measured monthly through 6-months of age.  
 
Women assigned to EX will have all of their supervised pregnancy exercise sessions, 
questionnaires, and weight measured at the IHP.  After delivery, women assigned to EX will 
resume their supervised IHP exercise program between 4-8 weeks (depending on delivery mode) 
when they are cleared for activity by their physician, complete exercise testing at 3- and 6-
months and will have monthly home visits for infant testing through 6 months. HOMEEX and 
UC women will visit the IHP at baseline, 3 & 6-months post-delivery for exercise testing, 
questionnaires, and weight measurement.  HOMEX and UC groups will receive home visits for: 
2nd & 3rd trimester questionnaires and weight measurement and every month post-delivery for 
questionnaires, weight measurement and infant testing. 
 
Statistical analysis used to determine feasibility of the exercise intervention will include general 
descriptive statistics to assess recruitment, eligibility, retention, follow-up and exercise 
adherence.  In addition, we will conduct a survey and interview of subjects related to 
acceptability to participate in EX and HOMEEX and discuss barriers to regular exercise which 
will be analyzed using descriptive statistics and a phenomenological approach.   To determine 
the feasibility of maternal and infant outcomes, Kruskal-Wallis and Friedman’s ANOVA will be 
used to investigate between group and within group differences.  Relationships between 
variables will be analyzed using Spearman correlation coefficient.  Because this is a feasibility 
study, the results will be used as preliminary data to apply for future funding and also will 
provide variable quantitative and qualitative data for validating interventions that can increase 
adherence to exercise guidelines during pregnancy in women with different ethnic and 
socioeconomic backgrounds. 
 

                                                                 Page 15 of 32 
 
In order to monitor the safety of the participants, all exercise performed by the EX, HOMEXX, 
and UC groups will follow ACSM and ACOG guidelines for moderate-intensity cardiovascular 
and resistance exercise.  In addition, all women will wear a Polar Ignite watch that will alarm if 
their HR exceeds moderate level intensity.  All women in the EX will be supervised during their 
exercise sessions.  Women in the HOMEEX group will be meet individually with either Dr. 
Wentz or Dr. Sames to discuss safe exercise principles.  They will be given written information 
on exercising in a moderate intensity range for both cardiovascular and resistance exercise.  In 
addition, they will be contacted twice per week to discuss their program and any questions about 
exercise.  Lastly, their HR data will be downloaded and analyzed to confirm that they are 
exercising in a moderate intensity rate.  Women in the UC group will be told to continue 
participating in whatever activity they are currently engaged.  They will be given an activity log 
to record their activity and we will download their HR data. 
 
 
 
11.1 
Describe what data, including long-term follow-up, will be collected.   
NOTE:  For studies with multiple data collection points or long-term follow up, 
consider including a schedule or table in your response. 
 
Instruments being utilized in this study: 
• The Bayley Scales of Infant Development, 4th edition 
• Physical Activity diary 
• Pregnancy Physical Activity Questionnaire 
• Short-Form 12 (SF-12) Health survey 
• Pittsburgh Sleep Quality Index 
• Multidimensional Fatigue Inventory 
• Edinburgh Post-Natal Depression Scale 
• Center for Epidemiologic Studies Depression Scale 
 
 

                                                                 Page 16 of 32 
 
 
 
List, and upload, any instruments or measurement tools used to collect data (e.g. survey, 
scripts, questionnaire, interview guide, validated instrument, data collection form).   
 
 
 
11.2 
Describe any source records that will be used to collect data about subjects (e.g. 
school records, electronic medical records). 
n/a 
 
 
11.3 
Describe whether individual subject results (such as results of investigational 
diagnostic tests, genetic tests, or incidental findings) will be shared with subjects or 
others (e.g., the subject’s primary care physicians) and if so, describe how it will be 
shared. 
Participants will have access to the results of their testing immediately if requested but a 
summary of information will be provided to each participant at the end of their participation in 
the study. 
 
Participants will independently choose if they wish to share any of their results with their 
primary care physician/OB/GYN  
 
 
11.4 
Indicate whether or not generalized study results will be shared with subjects or 
others, and if so, describe how these will be shared. 
Overall (generalized) study results will be shared with participants at the completion of the study 
via an electronic and/or hard copy summary of results/findings. 
 
 
 
Activity
2020 September to December
2021 January to April
2021 May to August
2021 September to December
2022 January to April
2022 May to June
Recruitment (6 UC, 6 EX, 6 HOMEEX)
X
Maternal Interventions 
X
X
X
X
X
Maternal Baseline Measurements
X
X
Maternal Prenatal Measurements 
X
X
X
Maternal Post Natal Measurements 
X
X
X
Infant Measurements 
X
X
X
X
Data Analysis
X
X
Dissemination of results
X
First publication submission
X
Target grant submission
X

                                                                 Page 17 of 32 
 
12.0 Study Timelines 
 
12.1 
Describe the anticipated duration of the study needed to enroll all study subjects. 
The plan is to enroll all study participants in three months. 
 
 
12.2 
Describe the duration of an individual subject’s participation in the study. Include 
length of study visits, and overall study follow-up time. 
Each participant’s time in the study will be 15 months +/- 4-8 weeks (depending on what point in 
the first trimester a participant begins) 
 
 
12.3 
Describe the estimated duration for the investigators to complete this study (i.e. 
all data is collected and all analyses have been completed). 
  
The time from first recruitment to wrap up of this phase of the project is estimated to be 22 
months. 
 
13.0 Research Setting 
 
13.1 
Describe all facilities/sites/locations where you will be screening and conducting 
research procedures.  Include a description of the security and privacy of the facilities 
(e.g. locked facility, limited access, privacy barriers).  Facility, department, and type of 
room are relevant.  Do not abbreviate facility names.   
Example: “A classroom setting in the New Academic Building equipped with a 
computer with relevant survey administration software”, “The angiogram suite at 
University Hospital downtown campus”, The Clinical Research Unit in the 
Institute for Human Performance.” 
 
The second floor of the Institute for Human Performance (private room as needed for evaluation 
and/or exercise prescription and the physical therapy gym); individual participant’s homes 
 
13.2 
For research procedures being conducted, for this study, external to Upstate (e.g., 
in schools, out-of-state, internationally, etc.) describe:  
• Site-specific regulations or customs affecting the research 
• The composition and involvement of any community advisory board 
• Local scientific and ethical review structure outside the organization. 
• Local issues affecting the research and rights of research subjects.  

                                                                 Page 18 of 32 
 
NOTE:  This question is not referring to multi-center research.  If this research is 
being conducted internationally, Supplemental Form E must be completed and 
uploaded.  
 
 
☒ 
N/A:  This study is not conducted outside of Upstate. 
 
14.0 Resources and Qualifications 
 
14.1 
The Principal Investigator (PI) must confirm, in consultation with Chair and 
Dean as applicable, that adequate resources are present to conduct and complete the 
study compliantly and safely. Specifically: 
• The proposed subject population(s) are available in sufficient numbers to meet 
the study requirements  
• Sufficient funds are available to conduct and complete the study compliantly and 
safely  
• The PI and study team have sufficient time to conduct and complete the study 
compliantly and safely  
• The PI has determined that the named study team is qualified to conduct the 
research compliantly and to monitor the safety and welfare of the enrolled 
research subjects effectively 
• The PI ensures that the study team is fully aware of his/her involvement in this 
study and the details of the study protocol 
• The PI ensures that the study teams will only be involved in research procedures 
for which they have been trained, and are currently certified and/or licensed, if 
required. 
 
☒ 
Confirmed 
 
14.2 
Describe the availability of medical or psychological resources that subjects 
might need as a result of anticipated consequences of the research, if applicable. (e.g, 
“on-call availability of a counselor or psychologist for a study that screens subjects for 
depression”). 
 Each participant’s OB/GYN and their emergency care contact will be immediately contacted in 
the event of any adverse events. 
 
 
14.3 
Describe your process to ensure that all study team members are updated on the 
progress of the research and the regulatory requirements (including enrolled subjects, 
unanticipated problems etc.)  

                                                                 Page 19 of 32 
 
Dr. Wentz and Dr. Sames will be supervising the EX subjects training, fitness testing, collection 
of questionnaires in addition to the weekly contact of the HOMEEX subjects.  In addition, Dr. 
Wentz and Dr. Sames will be conducting all follow-up testing and home visits.  Upstate DPT 
students and Vitality Fitness staff members will be used to help with the supervision of the EX 
subjects and testing of the EX, HOMEEX, and UC groups. Since Dr. Wentz and Dr. Sames are 
directly supervising and testing subjects in this study, they will be aware of the research progress 
and any unanticipated problems which can be conveyed to the DPT students and Vitality Fitness 
staff.  Any individuals assisting in the conduct of the study will be added to the registration form. 
 
15.0 Provisions to Protect the Privacy Interests of Subjects 
 
15.1 
Describe how you will protect subjects’ privacy interests during the course of the 
research and any steps you will take to make the subject feel at ease. 
NOTE:  Privacy refers to an individual’s desire/right to control access to or to 
place limits on whom they interact with or whom they provide personal information.  
Privacy applies to the person.  Confidentiality refers to how data collected about 
individuals for the research will be protected by the researcher from release.  
Confidentiality applies to the data.   
Examples of appropriate responses include:  “participant only meets with a study 
coordinator in a private office setting where no one can overhear”, or “the participant is 
reminded that they are free to refuse to answer any questions that they do not feel 
comfortable answering.”   
Participants will only be evaluated in a private office setting where no one can overhear and they 
will also be able to request that exercise sessions occur in a similar private setting if that is their 
preference.  Participants will be reminded that they are free to refuse to answer any questions 
that they do not feel comfortable answering. 
 
 
16.0 Confidentiality 
   A. Confidentiality/Security of Study Data 
 
Describe the local procedures for maintenance of security and confidentiality of study 
data and any records that will be reviewed for data collection.   
 
16.1 
Where and how will all data and records be stored?  Include information about:  
password protection, encryption, physical controls, authorization of access, certificates 
of confidentiality, and separation of identifiers and data, as applicable.  Include physical 
(e.g. paper) and electronic files. 
All paper data collection files will be stored in a locked credenza located in Room 2016 of the 
IHP (Dr. Sames office).  This office is locked with key access held by Dr. Sames and Amy Allen 

                                                                 Page 20 of 32 
 
(Vitality Fitness staff member).  All demographic, testing, questionnaire, and exercise data will 
be electronically stored on the Shared T drive (CR1\app2\Shared\Vitality) in a separate folder 
which is password protected.  Data will be entered into the Shared by Dr. Wentz, Dr. Sames and 
Vitality Fitness staff member Amy Allen. 
 
 
16.2 
How long will the data be stored? 
There is no scheduled date at which this information will be destroyed or no longer used.  
Because this information is a feasibility study, we will continue to use this study to apply for 
future grants and could be used for and it is not possible to determine when this will be complete. 
 
16.3 
Who will have access to the data? 
Dr. Wentz, Dr. Sames  
 
 
16.4 
Who is responsible for receipt or transmission of the data? 
Dr. Sames 
 
 
16.5 
How will the data be transported/transmitted? 
na 
 
B. Confidentiality of Study Specimens 
 
Describe the local procedures for maintenance of confidentiality of study specimens.   
 
☒ 
N/A:  No specimens will be collected or analyzed in this research.   
(Skip to Section 17.0) 
 
16.6 
Where and how will all specimens be stored?  Include information about:  
physical controls, authorization of access, and labeling of specimens, as applicable.   
 
 
 
16.7 
How long will the specimens be stored? 
 
 
16.8 
Who will have access to the specimens? 
 
 

                                                                 Page 21 of 32 
 
 
16.9 
Who is responsible for receipt or transmission of the specimens? 
 
 
 
16.10 How will the specimens be transported? 
 
 
 
17.0 Provisions to Monitor the Data to Ensure the Safety of Subjects  
☒ 
N/A:  This study is not enrolling subjects OR is limited to records review procedures 
only OR is a minimal risk study 
 
17.1 
Describe the plan to evaluate the data periodically regarding both harms and 
benefits to determine whether subjects remain safe. The plan might include establishing a 
data safety monitoring committee and a plan for reporting data monitoring committee 
findings to the IRB and the sponsor. 
 
 
 
17.2 
Describe what data are reviewed, including safety data, untoward events, and 
efficacy data. 
 
 
 
17.3 
Describe any primary or secondary safety endpoints. 
 
 
 
17.4 
Describe how the safety information will be collected (e.g., with case report 
forms, at study visits, by telephone calls with participants). 
 
 
 
17.5 
Describe the frequency of safety data collection, including when safety data 
collection starts. 
 
 
17.6 
Describe who will review the safety data. 
 

                                                                 Page 22 of 32 
 
 
 
17.7 
Describe the frequency of review of cumulative safety data. 
 
 
 
17.8 
Describe the statistical tests for analyzing the safety data to determine whether 
harm is occurring. 
 
 
 
17.9 
Describe any conditions that trigger an immediate suspension of the research. 
 
 
 
18.0 Withdrawal of Subjects 
☐ 
N/A:  This study is not enrolling subjects.  This section does not apply. 
 
18.1 
Describe anticipated circumstances under which subjects may be withdrawn from 
the research without their consent. 
Failure to take part in scheduled visits without notification AND failure to respond to attempts at 
contact. 
 
 
18.2 
Describe any procedures for orderly termination.   
NOTE:  Examples may include return of study drug, exit interview with clinician.  
Include whether additional follow up is recommended for safety reasons for physical or 
emotional health.  
n/a 
 
 
18.3 
Describe procedures that will be followed when subjects withdraw from the 
research, including retention of already collected data, and partial withdrawal from 
procedures with continued data collection, as applicable. 
If a subject withdrawals from the study, their data will be included in the study up to the point of 
withdrawal.   
 
 
18.4 
Describe what will happen to data already collected.  

                                                                 Page 23 of 32 
 
Data that has already been collected will be stored physically and electronically as stated 
previously.   
 
 
19.0 Risks to Subjects 
 
19.1 In your opinion, what is the overall risk (physical and nonphysical) to research 
subjects in this study (minimal, greater than minimal or unknown)  
minimal 
 
 
19.2 Describe if any subjects are withdrawn from therapeutic procedures or drugs (e.g., 
washout periods) prior to, or during, their participation in the study.   
N/A 
 
 
19.3 List the reasonably foreseeable risks, discomforts, hazards, or inconveniences to the 
subjects related to their participation in the research. Consider physical, psychological, 
social, legal, and economic risks.  Include a description of the probability, magnitude, 
duration, and reversibility of the risks.  
NOTE:  Breach of confidentiality is always a risk for identifiable subject data. 
If a woman has been sedentary she may experience muscle soreness from participation in the 
exercise program that will dissipate after 4-7 days of regular exercise.  In addition, a previously 
sedentary woman may experience initial fatigue (lasting 1 to 2 days) which will also dissipate 
within 4-6 weeks of consistent exercise.  Participation in this research has minimal risks to the 
mother and fetus and all participants will be instructed as to what constitutes adverse responses 
and when to not engage in exercise.  For mothers in the structured exercise group (EX), 
transportation to the IHP may be inconvenient and/or difficult. Following delivery, it may be 
more difficult for mothers to engage in the exercise program (HOMEX and EX) if they don’t 
have childcare. 
 
 
19.4 Describe procedures performed to minimize the probability or magnitude of risks, 
including procedures being performed to monitor subjects for safety. 
All exercise performed by the EX, HOMEXX, and UC groups will follow ACSM and ACOG 
guidelines for moderate-intensity.  In addition, all women will wear a Polar Ignite watch that will 
alarm if their HR exceeds moderate level intensity.  All women in the EX will be supervised 
during their exercise sessions.  Women in the HOMEEX group will be meet individually with 
either Dr. Wentz or Dr. Sames to discuss safe exercise principles.  They will be given written 
information on exercising in a moderate intensity range for both cardiovascular and resistance 

                                                                 Page 24 of 32 
 
exercise.  In addition, they will be contacted twice per week to discuss their program and any 
questions about exercise.  Lastly, their HR data will be downloaded and analyzed to confirm that 
they are exercising in a moderate intensity rate.  Women in the UC group will be told to continue 
participating in whatever activity they are currently engaged.  They will be given an activity log 
to record their activity and we will download their HR data. 
 
All women will be told that during exercise they may experience adverse changes including: 
abnormal blood pressure; fainting; and disorders of heart rhythm that can be minimized by 
stopping their exercise and immediately informing their physician of any unusual symptoms.  In 
addition, they will be told to maintain their exercise intensity at a moderate level (conversational 
level) throughout each and all exercise sessions.  
 
At the beginning and throughout the study, participants will be reminded that their participation 
is voluntary and they can stop participating in the study at any time.   
 
With the exception of the depression questionnaires, the information being asked of participants 
is not sensitive information—e.g. how is your sleep, activity, fatigue and QOL?  Participant 
information is confidential, not shared, securely kept, and coded by number.  
 
While we will not be analyzing the data (e.g. results of depression or other questionnaires) 
during the study to avoid compromising interactions (e.g. bias) with participants, study personnel 
will be speaking to participants in the HOMEEX and EX groups multiple times per week.  
Participants will be asked about their next OB/GYN appointment and if anything about their 
health status has changed (this helps to also insure that each participant is maintaining an active 
relationship with her OB provider).  The physician approval form that provides a participant with 
clearance to participate in the study will include a statement that asks the physician to inform 
study personnel immediately if the participant develops any contraindication, relative or 
absolute, to participation in an exercise program (e.g. fetal growth restriction or gestational 
hypertensive disorder).  Gestational diabetes mellitus (GDM) will be handled per individual 
participant’s OB/GYN recommendations.  If a participant develops an absolute contraindication 
to participation in the study, they will be removed from the study.  If a participant experiences an 
adverse event, a new clearance must be provided by OB/GYN for the participant to return to the 
study.  In the case of an emergency, participants will be advised to seek care at Upstate 
Community Hospital.  If a participant needs NICU care, they will be advised to seek care at 
Crouse or St. Joseph’s hospital. 
 
Only full term infants (birth at 37+ weeks gestation) will go on to participate in the neonatal 
portion of the study.  Infants participating in this portion of the study will undergo monthly 
height, weight, motor and cognitive assessments that pose minimal to no risk to the infant.  In the 

                                                                 Page 25 of 32 
 
event, that an assessment uncovers unexpected information (e.g. loss of weight, significantly 
delayed motor development), participants will be advised to contact their pediatrician.  
 
Participants will regularly be asked how they are feeling.  If a participant expresses that she is 
feeling blue or is having depressive thoughts, study personnel will recommend that she contact 
her health provider. We will follow up each week to check the status of these symptoms and to 
make sure they have spoken with their health provider.  Participants in the control group are also 
being contacted weekly, so relationships are being established, and the same process for 
experiencing undesirable thoughts or feelings would apply.   
 
19.5 If applicable, indicate which procedures may have risks to the subjects that are 
currently unforeseeable. 
n/a 
 
 
19.6 Indicate which research procedures, if any, may have risks to an embryo or fetus 
should the subject be or become pregnant. 
 
 
☒ 
N/A 
 
19.7 If you responded to 19.6 that there are such risks, how will you minimize the risk of 
a pregnancy occurring during the course of the study?  (Select all that apply) 
 
☐ 
Counseling on birth control and /or abstinence 
☐ 
Pregnancy test during the study 
☐ 
Pregnancy test prior to initiation of the study 
☐ 
Other   _____ 
☐ 
N/A    
 
19.8 If applicable, describe possible risks to others who are not subjects. 
 
n/a 
 
20.0 Potential Benefits to Subjects 
 
20.1 
Describe the potential benefits that individual subjects may experience by taking 
part in the research.  Include the probability, magnitude, and duration of the potential 
benefits.   

                                                                 Page 26 of 32 
 
For pregnant women, regular exercise has been associated with a reduced risk of maternal and 
fetal health including: reduced risk of excessive weight gain, developing pre-eclampsia (PE), 
gestational diabetes mellitus (GDM) and gestational hypertension (GH), pre-term birth, 
macrosomia; depressive symptoms, and developing childhood obesity; and, can improve 
maternal sleep; and neonatal neuromotor skills at 1-month of age.  Adopting a sedentary 
lifestyle, has greater negative consequences on both maternal and neonatal health.  Benefits of 
exercise last a lifetime and have both primary and secondary risk reduction of CVD, the number 
one killer of adults. 
 
 
 
20.2 
Indicate if there is no direct benefit.   
NOTE:  Compensation cannot be stated as a benefit. 
 
 
Indicate if there is a potential benefit to others, future science or society.    
Future science and practice for optimal maternal, fetal and neonatal outcomes during and after 
pregnancy. 
 
 
21.0 Compensation for Research-Related Injury 
X☐ 
  
 
21.1 
If the research procedures carry a risk of research related injury, describe the 
available compensation to subjects in the event that such injury should occur.   
In the event of a research related injury, treatment is available at University Hospital but is not 
free of charge. The costs will be billed to the participant and/or the participant’s insurance 
company.  SUNY Upstate Medical University has no funds set aside to compensate for injuries.   
 
 
 
22.0 Economic Burden to Subjects 
 
22.1 
Describe any costs that subjects may be responsible for because of participation 
in the research.   
NOTE:  Some examples include transportation or parking. 
 
Parking stickers will be purchased so participants do not need to be reimbursed—participants 
will be given stickers when they come to IHP.    
☐ 
 

                                                                 Page 27 of 32 
 
 
N/A:  This study is not enrolling subjects, or is limited to records review procedures only.  This 
section does not apply. 
 
23.0 Compensation for Participation 
☐ 
N/A:  There is no compensation for participation.  This section does not apply.  
 
23.1 
Describe the amount/nature and timing/scheduling of any compensation to 
subjects, including monetary, course credit, or gift card compensation. Describe any 
prorated payments based on participation. 
Participants will be given parking stickers when they come to IHP when they have to park there 
for scheduled visits.  If subjects do not have personal transportation, public transportation or 
private transportation costs from Uber or Lyft will be reimbursed. Additionally, subjects will 
receive $10 in appreciation for their time for each face to face visit.  Payments will be made on 
the 15th of month for expenses incurred in the month prior. 
 
 
24.0 Informed Consent 
 
24.1   Will you be obtaining consent from subjects?   
☒ 
Yes 
(If yes, Provide responses to each question in this Section, and upload 
your consent documents) 
☐ 
No 
(If no, Skip to next section) 
 
24.2 
Describe how the capacity to consent will be assessed for all subjects. (See SOPs, 
section 14.7.2  for guidance)  
The subject’s ability to consent will be assessed by discussing the proposed study as presented in 
24.3 and then asking them questions about the study including questions about randomization; 
requirements to participate in the study; ability to withdrawal from the study; and risks and 
benefits of participating in the study. 
 
 
24.3 
Describe the consent process that will be conducted to ensure that subject is fully 
informed regarding study details and subject rights. Include where the consent process 
will take place, with consideration of the need to protect the subject’s right to privacy.  
Subjects will meet individually in a private office (2016 IHP) where a discussion of the study 
requirements will be explained including the randomization process and requirements for each 
group; subject rights including withdrawal from the study; who will be looking at their protected 
health data; access to their health data and results; and risks and benefits of participating in the 

                                                                 Page 28 of 32 
 
study.  After this brief discussion and a positive assessment of their ability to consent, subjects 
will be given the consent form and encouraged to read it in its entirety.  
 
 
 
24.4 
Describe the process to ensure that subjects are provided with sufficient time to 
consider taking part in the research study.  Include whether there is any time period 
expected between informing the prospective subject and obtaining the consent.   
NOTE:  It is respectful to the prospective subject to ensure that sufficient time is 
given to have their questions answered and to consider their participation 
 
Prospective participants will be supplied with a copy of the consent (electronic or hard copy) to 
review for several days before the first visit occurs.  At the time of the first visit, the consent will 
be reviewed and questions will be answered before the participant is asked to sign the consent. 
 
24.5 
Describe the process to ensure ongoing consent, defined as a subject’s 
willingness to continue participation for the duration of the research study.   
Subjects will be informed during the consenting process that their participation is completely 
voluntary and that they may withdraw from the study at any time, for any reason, no questions 
asked.  Any subjects express hesitancy or appear hesitant about continuing in the study after the 
initial consenting process with be counseled again about their ability to withdraw without 
repercussions of any type. 
 
Non-English Speaking Subjects  
☒ 
N/A:  This study will not enroll Non-English speaking subjects.   
 
24.6 
Indicate which language(s) other than English are likely to be spoken/understood 
by the prospective study population or their legally authorized representatives. 
 
 
 
24.7 
If subjects who do not speak English will be enrolled, describe the process to 
consent the subjects, as well as the process to be used to ensure their understanding of 
research procedures throughout the conduct of the study. Review SOP’s section 13.9.1 
for important policies in this regard.  
Response:  
 
 
 
Adults Unable to Consent  

                                                                 Page 29 of 32 
 
☒ 
N/A:  This study will not enroll adults unable to consent (go to next section).  
 
24.8 
Justify why it is necessary to include adult subjects who are unable to consent. 
 
 
 
24.9 
Describe how you will identify Legally Authorized Representatives (LAR) for the 
subjects that will be consistent with the NYS law (Review SOP’s section 13.3) 
Note:  For research conducted outside of New York State, provide information 
that describes which individuals are authorized under applicable law to consent on 
behalf of a prospective subject to their participation in the research.   
 
 
 
24.10 Describe the process for obtaining assent from the adult subjects 
Indicate whether assent will be obtained from all, some, or none of the subjects.  If some, 
indicate which adults will be required to assent and which will not. 
 
 
 
If assent will not be obtained from some or all subjects, provide an explanation of why 
not. 
 
 
 
24.11 Describe whether assent of the adult subjects will be documented and the process 
to document assent.   
 
 
 
24.12 Describe how you will obtain consent from a subject to use their data if they later 
become capable of consent.  How will capacity to consent be assessed and by whom?  
 
 
 
25.0 Waiver or Alteration of Consent Process 
Complete this section if: 
• Informed consent will not be obtained at all 
• Informed consent will be obtained, but not documented, or 

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• consent will be obtained, but not all required information will be disclosed (e.g., in 
deception research) 
☒ N/A:  A waiver or alteration of consent is not being requested. 
 
25.1 
Review, complete, and upload Supplemental Form F: General Waiver or 
Alteration of Consent 
☐  
 Confirmed 
 
26.2 
If the research involves a waiver of the consent process for planned emergency 
research, please contact the IRB Office for guidance regarding assistance in complying 
with federal regulations governing this activity (see SOPs section 13.12).   
 
26.0 Multi-Site Research (Multisite/Multicenter Only) 
☒ N/A:  This study is not an investigator-initiated, multi-site study.  This section does 
not apply. 
 
26.1 
If this is a multi-site study where Upstate is the lead site and/or the IRB of record, 
describe the processes to ensure communication among sites. Include:  
• All sites have the most current version of the IRB documents, including the 
protocol, consent document, and HIPAA authorization. 
• All required approvals have been obtained at each site (including approval by the 
site’s IRB of record). 
• All modifications have been communicated to sites, and approved (including 
approval by the site’s IRB of record) before the modification is implemented. 
• All engaged participating sites will safeguard data as required by local 
information security policies. 
• All local site investigators conduct the study appropriately. 
• All non-compliance with the study protocol or applicable requirements will be 
reported in accordance with local policy. 
 
 
 
26.2 
Describe the method for communicating to engaged participating sites: 
• Problems 
• Interim results 
• Study closure 
 
 
 

                                                                 Page 31 of 32 
 
26.3 
Indicate and statistically justify the total number of subjects that will be enrolled 
or records that will be reviewed across all sites. 
 
 
 
27.0 Banking Data or Specimens for Future Unspecified Use 
☒ 
N/A:  This study is not storing data or specimens for research outside the scope of 
the present protocol.  This section does not apply. 
 
27.1 
If data will be banked (stored) for research outside of the scope of the present 
protocol, describe where the data will be stored, how long they will be stored, how will 
they be accessed, and who will have access to the data  
NOTE:  The response here must be consistent with the information provided to 
subjects in the Consent Documents  
 
 
 
27.2 
If specimens will be banked (stored) for research outside of the scope of the 
present protocol, describe where the specimens will be stored, how long they will be 
stored, identifiers that will be associated with each specimen, how will they be accessed, 
and who will have access to the specimens  
NOTE:  The response here must be consistent with the information provided to 
subjects in the Consent Documents  
 
 
27.3 
Describe the procedures to release banked data and/or specimens for future uses, 
including: the process to request a release, approvals required for release, who can 
obtain data or specimens, and the data to be provided with specimens. 
 
 
 
28.0 Drugs and Devices 
☒ 
N/A:  This study does not involve drugs or devices.  This section does not apply. 
 
28.1 
Does this study involve use of radiopharmaceuticals? ☐ Yes  ☐ No 
  
28.2 
For investigational devices (including marketed devices being used off label & 
humanitarian use devices), Provide the following information: 

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• Where will the device(s) be stored? Note that the storage area must be within an 
area under the PI’s control     
• Describe the security of the storage unit/facility   
• Provide full detail regarding how the dispensing of the device(s) will be 
controlled (accountability of removal/return of used devices, and disposition of 
remaining devices at the conclusion of the investigation) and documented 
(accounting records/logs)    
 
 
 
28.3 
For research including drugs (investigational and FDA approved). Complete and 
upload the Pharmacy Worksheet and supporting materials (IB’s) and obtain Pharmacy 
approval and sign off. 
 
☐ Confirmed 
☐ N/A: This study does not involve drugs