Gestational Weight Gain and Postpartum Weight Loss in Active Duty Women
Phase: NA
Conditions: Weight Gain, Weight Loss
Sponsor: University of Tennessee

 
 
 
 
 
 
 
 
 
 
COVER PAGE 
 
Gestational Weight Gain and Postpartum Weight Loss in Active Duty Women (Moms Fit 2 Fight) 
 
NCT03057808 
 
Study Protocol and Statistical Analysis Plan 
 
January 3, 2019 

 
Revised by PR 2019 
 
PROTOCOL FOR CLINICAL INVESTIGATION – NON-EXEMPT HUMAN 
(Wilford Hall Ambulatory Surgical Center – WHASC) 
 
PROTOCOL SUMMARY 
1.  Title: 
Behavioral Weight Management for Active Duty Military and DoD TRICARE Beneficiary Pregnant and 
Postpartum Women  
FWH20160036H 
 
2.0. Principal Investigator (PI): 
 
          WHASC PI: 
 
               SAMMC Co-PI: 
Name  
Dr. Gerald W. Talcott, PhD, Col, 
USAF (ret) 
Dr. Callie Cox-Bauer, DO 
Rank/Corps or Civilian Rating 
 
N/A 
Major  
Date of IRB Approved CITI Training 
25 Sept 2017 
02 Apr 2017 
Branch of Service 
N/A 
USAF 
AD Mil/DoD Civilian/Ctr/Non-DoD Civ Non-DoD Civ 
AD Mil 
Department  & Base 
University of Virginia 
59MDW/SGOWMP 
Chief, Outpatient Services 
OBGYN Department SAMMC 
Phone & Pager # 
 
210-292-3813/210-632-9178(c) 
210-916-1162 
E-Mail Address & 
 
AKO/DKO E-Mail Address 
gerald.w.talcott.ctr@mail.mil  
callie.m.coxbauer.mil@mail.mil 
DoD Assurance # and Expiration 
Date 
FWA00006183 
Expires: 13 Jun 2018 
DoD Assurance: A10041 
Expires: 1 Mar 2019 
 
3.0. Research Plan: 
 
3.1. Purpose:    
1) To randomize 450 participants to 1 of 3 arms: a) a gestational weight gain intervention (GWG-only); b) a 
postpartum weight loss intervention (PPWL-only), or c) a combined gestational weight gain and 
postpartum weight loss intervention (GWG+PPWL), and to determine the efficacy of the interventions 
on GWG as well as PPWL;   
2) To identify the impact of the interventions on pregnancy-related medical outcomes and health care 
utilization (from the electronic medical record) and fitness test data (pregravid to 12-month 
postpartum, from the military fitness database);  
3) To determine the impact of treatment engagement process data (e.g., session participation, self-
monitoring, meal replacement adherence) on intervention outcome. 
 
3.2. Hypotheses, Research Questions or Objectives:  
Hypothesis 1: Participants randomized to GWG-only and GWG+PPWL arms will gain less weight during 
pregnancy than in those randomized to the PPWL-only arm.  
Hypothesis 2: Participants randomized to the GWG+PPWL and PPWL-only arms will lose significantly more 
weight postpartum than those randomized to the GWG-only arm. 
 
4.  Brief Summary of the study:    
We will determine the extent to which a GWG intervention, a PPWL intervention, or a combination of the 
two interventions are efficacious in improving healthy GWG, PPWL, military readiness and maternal/child 
health and reducing health care utilization. From the treatment engagement data, we will identify 

 
Revised by PR 2019 
 
potentially important mediators of the treatment outcome. These outcomes are expected to have an 
important positive impact because the intervention(s) could be disseminated to the entire U. S. Military 
and integrated into standard health care for pregnant/postpartum military women. 
 
5. Subjects:   
Study participants will be female, active duty military personnel stationed at Joint Base San Antonio. 
 
6. Inclusion/exclusion criteria: 
Inclusion: 
• Participants will be female active duty military personnel and DoD beneficiaries (retirees and 
dependents), stationed at Joint Base San Antonio and at least 18 years old. 
• Participants must be less than 12 weeks gestation upon recruitment (based on the date of their last 
menstrual period and confirmed by first trimester ultrasound at the first prenatal visit). 
• Participants must be within the normal, overweight, or obese BMI ranges upon Baseline 
measurements. 
• Participants must have at least 1.5 years left on their current duty assignment. 
 
Exclusion: 
• Participants who have any medical conditions that limit a participant’s ability to engage in changes 
in dietary intake or increases in physical activity, based on the determination of physicians on the 
study team. 
• Participants who have a high-risk pregnancy (i.e., Type I or II diabetes at conception or current 
multiple gestation), based on the determination of physicians on the study team. 
• Participants who smoke at the time of conception (smoking cessation during pregnancy has 
significant benefits for fetal health, but the quitting process can be associated with weight gain and 
thus offers potential study confounds). 
 
7.  Number of Subjects:   
TOTAL NUMBER OF SUBJECTS (nation-wide/study-wide):  WHASC and SAMMC – 755 with 450 completing 
the study 
 
8.  Use of an Investigational New Drug: N/A 
 
9.  Use of an Investigational Device:  N/A 
 
10. Use of a Placebo: N/A 
 

 
 
Revised by PR 2019 
1 
PROTOCOL FOR CLINICAL INVESTIGATION – NON-EXEMPT HUMAN 
(Wilford Hall Ambulatory Surgical Center – WHASC) 
 
1.  Title: 
Behavioral Weight Management for Active Duty Military and DoD TRICARE Beneficiary Pregnant and 
Postpartum Women 
FWH20160036H 
 
2.0. Principal Investigator (PI): 
 
         WHASC PI: 
 
 
   SAMMC Co-PI: 
Name  
Dr. Gerald W. Talcott, PhD, 
Col, USAF (ret) 
Dr. Callie Cox-Bauer, MD 
Rank/Corps or Civilian Rating 
 
N/A 
Major  
Date of IRB Approved CITI Training 
25 Sept 2017 
02 Apr 2017 
Branch of Service 
N/A 
USAF 
AD Mil/DoD Civilian/Ctr/Non-DoD Civ 
Non-DoD Civ 
AD Mil 
Department  & Base  
University of Virginia 
59MDW/SGOWMP 
Chief, Outpatient Services 
OBGYN Department SAMMC 
Phone & Pager # 
 
210-292-3813/210-632-9178(c) 
210-916-1162 
E-Mail Address & 
 
AKO/DKO E-Mail Address 
gerald.w.talcott.ctr@mail.mil 
callie.m.coxbauer.mil@mail.mil 
DoD Assurance # and Expiration Date FWA00006183 
Expires: 13 Jun 2018 
DoD Assurance: A10041 
Expires: 1 Mar 2019 
 
 
 
 
 
 
 
 
 
2.1. Associate Investigators (AI):   
Provide the current list of all “engaged” AIs for the study based on 45 CFR 46.102, e.g., for purposes of 
research the AI: (1) obtains data through intervention or interaction with a research subject(s); and/or (2) 
obtains identifiable private information and/or protected health information about the research subject(s); 
and/or (3) obtains the informed consent of human subjects for research.  All “engaged” investigators 
must complete IRB approved CITI training. 
Name 
AD/DoD Civ/Ctr/ 
Non-DoD Civ 
Rank/Corps or 
Civilian Rating/Title 
Date of CITI 
Training 
Phone & Pager # 
Rebecca Krukowski, PhD 
Non-DoD Civ 
Civilian PI/UTHSC 
16 Apr 2018 
901-448-2426 
Robert Klesges, PhD 
Non-DoD Civ 
AI/UVa 
8 Oct 2017 
901-448-5900 
Melissa Little, PhD 
Non-DoD Civ 
AI/UVa 
6 Dec 2017 
901-448-6878 
Marion Hare, MD 
Non-DoD Civ 
AI/UTHSC 
23 Jan 2018 
901-448-3752 
Ann Hryshko-Mullen, PhD 
DoD Civ 
AI (WHASC) 
2 Mar 2017 
210-292-5968 
Daniel Cassidy, PhD 
AD 
Maj/AI (WHASC) 
13 Jul 2017 
210-292-5968 
Zoran Bursac, PhD 
Non-DoD Civ 
AI/Florida 
International Univ. 
29 Nov 2017 
901-448-2426 
Carol Copeland, PhD 
Non-DoD Civ 
AI/UVA 
3 Oct 2018 
210-292-3813 
 
2.2. Research Assistants (RA) & Coordinators (RC):   
Provide the current list of all “engaged” RAs & RCs for the study based on 45 CFR 46.102, e.g., for purposes 
of research the RA or RC: (1) obtains data through intervention or interaction with a research subject(s); 
and/or (2) obtains identifiable private information and/or protected health information about the research 
subject(s); and/or (3) obtains the informed consent of human subjects for research.  All “engaged” RAs 
and RCs must complete IRB approved CITI training. 

 
 
Revised by PR 2019 
2 
Name 
AD/DoD Civ/Ctr/ 
Non-DoD Civ 
Rank/Corps or Civilian 
Rating/Title 
Date of CITI 
Training  
Phone & Pager #  
Karen LeRoy 
Non-DoD Civ 
Research Director 
18 Apr 2016 
210-292-3504 
Leslie Gladney 
Non-DoD Civ 
Program Coordinator 
19 Jun 2017 
210-671-1997 
Allen Jones 
Non-DoD Civ 
Research Specialist 
12 Jan 2016 
210-671-1955 
Tina Boothe 
Non-DoD Civ 
Research Specialist 
05 Jan 2016 
210-671-8175 
Lisa McKenna 
Non-DoD Civ 
Administrative Coordinator 27 Nov 2017 
210-292-3813 
Mark Amen 
Non-DoD Civ 
IT Specialist 
09 Dec 2017 
210-292-4469 
Annette Martinez 
Non-DoD Civ 
Research Specialist 
18 May 2018 
210-671-0636 
Trina Bolden 
Non-DoD Civ 
Research Specialist 
18 April 2016 
210-671-8173 
Carmen Cardenas 
Non-DoD Civ 
Research Assistant 
22 Jun 2018 
210-671-1994 
Gloribel Bonilla 
Non-DoD Civ 
Research Specialist 
12 Feb 2018 
210-292-3813 
Jennifer Oates 
Non-DoD 
Research Specialist 
26 Jan 2017 
210-292-3813 
Shawnta Vermong 
Non-DoD Civ 
Research Specialist 
7 Aug 2018 
210-292-3813 
  
2.3. The research relevance of this protocol focuses on: 
[] Diagnosis [x] Treatment   [] Medical Utilization/Managed Care   [x] Prevention   [] Medical Readiness  
[] Other  
 
2.4. Location(s):   
a. Collaborating Facilities: WHASC and SAMMC 
 
b. Air Force Sites seeking Regional IRB:  N/A 
 
c. List study sponsors: NIH 
 
3.0 Research Plan: 
 
3.1. Purpose:   
1) To randomize 450 participants to 1 of 3 arms: a) a gestational weight gain intervention (GWG-only); b) a 
postpartum weight loss intervention (PPWL-only), or c) a combined gestational weight gain and 
postpartum weight loss intervention (GWG+PPWL), and to determine the efficacy of the interventions 
on GWG as well as PPWL;   
2) To identify the impact of the interventions on pregnancy-related medical outcomes and health care 
utilization (from the electronic medical record) and fitness test data (pregravid to 12-month 
postpartum, from the military fitness database);  
3) To determine the impact of treatment engagement process data (e.g., session participation, self-
monitoring, meal replacement adherence) on intervention outcome. 
 
3.2. Hypotheses, Research Questions or Objectives: 
Hypothesis 1: Participants randomized to GWG-only and GWG+PPWL arms will gain less weight during 
pregnancy than in those randomized to the PPWL-only arm.  
Hypothesis 2: Participants randomized to the GWG+PPWL and PPWL-only arms will lose significantly more 
weight postpartum than those randomized to the GWG-only arm 
   
3.3. Significance; 3.4. Military Relevance; & 3.5. Background and Review of Literature:  
Considerable attention has been given to the alarming prevalence of overweight and obesity in the U.S. 
population [1]. This epidemic extends to women of childbearing age [1], including women who are active 
duty personnel in the U.S. military and DoD TRICARE beneficiaries (retirees and dependents). As of 2011, 
34% of active duty military women were overweight and 6% were obese [2].  Indeed, excess weight is 

 
 
Revised by PR 2019 
3 
associated with $1.1 billion dollars each year in medical costs in the military health care system [3]. 
Furthermore, specifically for active duty personnel, excess weight and inadequate fitness are frequent 
causes for discharge. The military must then recruit and train replacements for about $50,000 per person, 
thus spending more than $60 million a year due to failed first-term enlistees [3]. While the long-term 
impact of pregnancy on military fitness test performance is unknown, several studies have found that 
women have significantly lower fitness test scores at 6-months postpartum [4, 5]. Finally, pregravid 
overweight/obesity has been found to be a key risk factor for perinatal complications in both civilian [6] 
and military populations [7].  
 
In addition to pregravid weight status, excessive gestational weight gain is another key risk factor for 
pregnancy and delivery complications (e.g., gestational diabetes, preeclampsia, caesarean delivery) [8-11] 
and negative health outcomes for infants [6, 10, 12] as well as overweight status later in life [11-14]. 
Excessive gestational weight gain is also associated with postpartum weight retention [15-19], a key 
concern for the U.S. military. Thus, gestational weight gain is a critical consideration, because it is a 
modifiable risk factor that can be addressed upon pregnancy confirmation. 
 
Women are not meeting the Institute of Medicine guidelines for gestational weight gain. Recent research 
indicates that many pregnant women do not gain within the 2009 Institute of Medicine guidelines; 
specifically, 53-71% of normal weight women, 77-84% of overweight, and 74-83% of obese women exceeded 
the Institute of Medicine guidelines [20, 21]. Although there is limited research on excessive gestational 
weight gain among TRICARE beneficiaries, there is some indication that many active duty women, like the 
civilian population, are exceeding gestational weight gain guidelines [22].  
 
Excessive gestational weight gain is a key predictor of postpartum weight retention [23, 24]. Postpartum 
weight retention is critical, not only negatively impacting returning to pregravid fitness levels, but the 
increased body mass index also places the mother and fetus at higher risk for negative health outcomes in 
subsequent pregnancies [6, 7, 25]. Furthermore, postpartum weight retention is associated with long-term 
maternal overweight/obesity [26-28] and increased waist circumference [29]. 
 
Clearly, gestational weight gain and postpartum weight retention are important factors in maternal and 
child health as well as military readiness; however, little is known about gestational weight gain and 
postpartum weight retention among TRICARE beneficiaries.  
 
3.5.1. Bibliography:  
1. Flegal, K.M., et al., Prevalence and trends in obesity among US adults, 1999-2008. Journal of the 
American Medical Assocation, 2010. 303(3): p. 235-241. 
2. Department of Defense, 2011 Health Related Behaviors Survey of Active Duty Military Personnel, 2013. 
3. Dall, T.M., et al., Cost associated with being overweight and with obesity, high alcohol consumption, 
and tobacco use within the military health system's TRICARE prime-enrolled population. American 
Journal of Health Promotion, 2007. 22(2): p. 120-139. 
4. Armitage, N.H. and D.A. Smart, Changes in Air Force Fitness Measurements Pre-and Post-Childbirth. 
Military medicine, 2012. 177(12): p. 1519-1523. 
5. Usher Weina, S. and S.U. Weina, Effects of pregnancy on the Army physical fitness test. Military 
medicine, 2006. 171(6): p. 534-537. 
6. Baeten, J.M., E.A. Bukusi, and M. Lambe, Pregnancy complications and outcomes among overweight 
and obese nulliparous women. American Journal of Public Health, 2001. 91(3): p. 436-440. 
7. Hill, C.C. and D.J. Gloeb, Military Maternal Weight Trends and Perinatal Outcomes. Military medicine, 
2013. 178(8): p. 880-886. 

 
 
Revised by PR 2019 
4 
8. DeVader, S.R., et al., Evaluation of gestational weight gain guidelines for women with normal 
prepregnancy body mass index. Obstetrics & Gynecology, 2007. 110(4): p. 745-751. 
9. Kiel, D.W., et al., Gestational weight gain and pregnancy outcomes in obese women: how much is 
enough? Obstetrics and Gynecology, 2007. 110(4): p. 752-758. 
10. Parker, J.D. and B. Abrams, Prenatal weight gain advice: an examination of the recent prenatal 
weight gain recommendations of the Institute of Medicine. Obstetrics & Gynecology, 1992. 79: p. 664-
669. 
11. Thorsdottir, I., et al., Weight gain in women of normal weight before pregnancy: Complications in 
pregnancy or delivery and birth outcome. Obstetrics & Gynecology, 2002. 99(5, Part 1): p. 799-806. 
12. Oken, E., et al., Gestational weight gain and child adiposity at age 3 years. American Journal of 
Obstetrics and Gynecology, 2007. 196(4): p. 322.e1-322.e8. 
13. Olson, C., M. Strawderman, and B. Dennison, Maternal weight gain during pregnancy and child 
weight at age 3 years. Maternal and Child Health Journal, 2009. 13(6): p. 839-846. 
14. Schack-Nielsen, L., et al., Gestational weight gain in relation to offspring body mass index and obesity 
from infancy through adulthood. International Journal of Obesity, 2010. 34: p. 67-74. 
15. Amorim, A.R., et al., Does excess pregnancy weight gain constitute a major risk for increasing long-
term BMI? Obesity, 2007. 15(5): p. 1278-1286. 
16. Keppel, K.G. and S.M. Taffel, Pregnancy-related weight gain and retention: implications of the 1990 
Institute of Medicine guidelines. American Journal of Public Health, 1993. 83(8): p. 1100-1103. 
17. Claesson, I.M., et al., Weight gain restriction for obese pregnant women: a case–control intervention 
study. BJOG: An International Journal of Obstetrics & Gynaecology, 2008. 115(1): p. 44-50. 
18. Olson, C., et al., Gestational weight gain and postpartum behaviors associated with weight change 
from early pregnancy to 1y postpartum. International journal of obesity, 2003. 27(1): p. 117-127. 
19. Phelan, S., et al., Does behavioral intervention in pregnancy reduce postpartum weight retention? 
Twelve-month outcomes of the Fit for Delivery randomized trial. The American journal of clinical 
nutrition, 2014: p. ajcn. 070151. 
20. Chauhan, S.P., et al., Compliance With Regulations on Weight Gain 6 Months After Delivery in Active 
Duty Military Women. Military medicine, 2013. 178(4): p. 406-411. 
21. Krukowski, R.A., et al., Exploring Potential Health Disparities in Excessive Gestational Weight Gain.  
Journal of Women's Health, 2013. 22(6), 494-500. 
22. Kwolek, L.A., C.S. Berry-Cabán, and S.F. Thomas, Pregnant soldiers' participation in physical training: 
A descriptive study. Military medicine, 2011. 176(8): p. 926-931. 
23. Linne, Y. and M. Neovius, Identification of women at risk of adverse weight development following 
pregnancy. International journal of obesity, 2006. 30(8): p. 1234-1239. 
24. Walker, L.O., Predictors of weight gain at 6 and 18 months after childbirth: A pilot study. Journal of 
Obstetric, Gynecologic, & Neonatal Nursing, 1996. 25(1): p. 39-48. 
25. Villamor, E. and S. Cnattingius, Interpregnancy weight change and risk of adverse pregnancy 
outcomes: a population-based study. The Lancet, 2006. 368(9542): p. 1164-1170. 
26. Linné, Y., et al., Long‐Term Weight Development in Women: A 15‐Year Follow‐up of the Effects of 
Pregnancy. Obesity research, 2004. 12(7): p. 1166-1178. 
27. Cohen, A., et al., Excessive gestational weight gain over multiple pregnancies and the prevalence of 
obesity at age 40. International Journal of Obesity, 2013. 
28. Nehring, I., et al., Gestational weight gain and long-term postpartum weight retention: a meta-
analysis. The American journal of clinical nutrition, 2011. 94(5): p. 1225-1231. 
29. Gunderson, E., et al., Excess gains in weight and waist circumference associated with childbearing: 
The Coronary Artery Risk Development in Young Adults Study (CARDIA). International journal of 
obesity, 2004. 28(4): p. 525-535. 
 
 

 
 
Revised by PR 2019 
5 
3.6. Research Design and Methods:  
We will implement a stepped-care GWG intervention and a PPWL intervention for women with TRICARE 
benefits, while accommodating the unique military lifestyle and environment. We will randomize 450 
participants to 1 of 3 arms: a) a gestational weight gain intervention (GWG-only); b) a postpartum weight 
loss intervention (PPWL-only), or c) a combined gestational weight gain and postpartum weight loss 
intervention (GWG+PPWL) in order to determine the efficacy of the interventions on GWG as well as 
PPWL. This design will allow the PPWL-only arm to be the comparison group for GWG (at the final 
pregnancy follow-up visit); the GWG-only arm to be the comparison group for PPWL (at 6-months and 12-
months follow-up) and the GWG+PPWL arm to determine the additive or synergistic effects. Study 
measures will be obtained at screening, baseline, gestational week 32 and 36, and 6-weeks, 6-months, and 
12-months postpartum and will include weight, height, maternal and infant medical outcomes, health care 
utilization, fitness test scores, waist circumference, self-reported exercise behaviors and nausea 
symptoms, accelerometry, feeding practices, demographics and program satisfaction. Process measures 
(e.g., session participation, self-monitoring) will be collected throughout the trial. 
 
No inducements, monetary or otherwise, will be offered to terminate a pregnancy.  Individuals engaged in 
the research will have no part in any decisions as to the timing, method, or procedures used to terminate a 
pregnancy and individuals engaged in the research will have no part in determining the viability of a 
neonate (45 CFR 46.204). 
  
3.6.1. Interventions, Observations, or Data Sought: 
Procedure: Interested individuals will be directed from our recruitment materials (e.g., posters, flyers, 
business cards, listservs, and electronic media) to visit the study recruitment office (located in the 
obstetric clinics) to learn more and determine whether they meet the eligibility criteria. If, after learning 
more about the study, individuals continue to be interested, written informed consent will be obtained 
and measures will be administrated. The potential participant will also be asked to complete a one-week 
dietary and exercise self-monitoring run-in, turn in a copy of their fitness scores to study staff (if active 
duty), and receive medical clearance from their obstetrician to participate. (Note: In the unfortunate event 
that a potential participant miscarries before being randomized, she will have the opportunity to re-screen 
if she chooses.)  Should she continue to be interested, she will return for a Baseline Visit and will be 
randomized to 1 of 3 conditions: a) GWG-only; b) PPWL-only; or c) GWG+PPWL and oriented to the 
assigned treatment condition.  
 
Randomization: Participants (n=450) will be randomly allocated to 1 of the 3 conditions, using a computer 
algorithm under the direction of the study biostatistician, Dr. Bursac, with a sequence blocked by  
screening BMI category (i.e., normal weight, overweight, obese) in order to ensure equal distribution by 
condition with respect to BMI category. Each condition will have the same number of subjects.  
 
Intervention Overview: The novel stepped-care behavioral GWG and/or PPWL intervention--designed to 
assist participants meet the Institute of Medicine (IOM)-recommended GWG guidelines and produce 
PPWL-- will be based on the Look AHEAD Intensive Lifestyle Intervention. The Look AHEAD Intensive 
Lifestyle Intervention methods are consistent with those utilized in previous studies of effective 
approaches to producing appropriate GWG and PPWL. However, the Look AHEAD approach offers greater 
structure and support than some of the methods used in previous work. We will also tailor our 
intervention to the military lifestyle (e.g., managing stressors such as increases in dietary intake, reduced 
physical activity related to spouse deployment, environmental facilitators such as access to the free fitness 
centers). We have previously tailored our interventions to the military lifestyle and environment, and our 
programs have been extremely well received by military personnel.  
 

 
 
Revised by PR 2019 
6 
GWG Intervention: The GWG intervention will begin upon randomization to the GWG-only or the 
GWG+PPWL arm, and continue until the birth of the participant’s child. This intervention will provide 
individual, telephone-based sessions (20-30 minutes each), as detailed in Table 1, by trained 
interventionists. The number of possible telephone sessions will depend on the gestational age at 
randomization and the level of support needed by the participant to meet the IOM guidelines. The 
intervention will focus on self-monitoring, clear goals (i.e., GWG, caloric intake exercise), and problem 
solving.  
 
Table 1. Stepped-Care Gestational Weight Gain Intervention  
 
Being above the GWG recommendations will trigger an increase in the intervention intensity (i.e., moving 
to the next step—so gaining more weight at any monthly telephone session for those in Step 1 will trigger 
an increase in the intervention intensity (i.e., moving to Step 2), and any participant in Step 2 who is above 
the line for 2 consecutive biweekly sessions will trigger an increase in the intervention intensity (i.e., 
moving to Step 3). This stepped-care approach will have optimal translation to the practice setting, 
because it allows targeted allocation of resources.  Further, this approach allows greatest tailoring of the 
intervention intensity to the individual (those who have trouble staying within the guidelines early in 
pregnancy will get more assistance at that time, with a decrease in intervention intensity when their GWG 
is within the recommended range; those who stay within guidelines early on but require assistance 
maintaining adherence with guidelines later in their pregnancy receive assistance when they start to 
experience challenges). A similar stepped-care approach, designed by Dr. Krukowski, has been well 
received by pregnant women in the “Glowing” study.   
 
 
Step 1 
Step 2 
Step 3 
Trigger to Increase 
Intervention Intensity 
-  >0.5 lb above GWG 
guidelines at any monthly 
session 
- >0.5 lb above GWG 
guidelines for 2 consecutive 
biweekly sessions  
-N/A 
Contact Frequency 
-Monthly 20-30 minute 
telephone session 
 
-Biweekly 20-30 minute 
telephone session 
 
-Weekly 20-30 minute 
telephone session 
- Weekly emailed materials 
Dietary 
Recommendations 
1st trimester: Maintain 
2nd trimester: ↑ by 340 
calories per day 
3rd trimester: ↑ by 452 
calories per day  
Same as Step 1 with portion 
size measuring and daily 
dietary intake monitoring  
↓ by 100-200 calories per 
day until appropriate GWG 
achieved  
Exercise 
-150 minutes per week of 
moderate activity  
-Fitness tracker 
-150 minutes per week of 
moderate activity 
-Fitness tracker 
-150 minutes per week of 
moderate activity  
-Fitness tracker 
Behavioral Strategies 
-Weekly self monitoring of 
weight  
-Weekly emailed graph 
 
-Daily self monitoring of 
weight, daily food intake & 
exercise 
-Weekly emailed graph 
-Goal setting & problem 
solving  
-Daily self monitoring of 
weight, daily food intake & 
exercise 
-Weekly emailed graph  
-Goal setting & problem 
solving 
-Meal replacements & 
structured meal plans 
- Adapted Look AHEAD ILI 
lesson materials  
-Toolbox resources 
Trigger to Reduce 
Intervention Intensity  
N/A 
Return to GWG within the 
IOM guidelines  
Return to GWG within the 
IOM guidelines 

 
 
Revised by PR 2019 
7 
Weight goals: The GWG goals for each participant will reflect the 2009 IOM guidelines[30]: a) for normal 
weight women (BMI 18.5-24.9 kg/m2): 11-16 kgs (25-35 lbs); b) for overweight women (BMI 25.0-29.9 kg/m2): 
7-11.5 kgs (15-25 lbs); and c) for obese women (BMI 30-39.9 kg/m2): 5-9 kgs (11-20 lbs) based on their weight 
collected at their screening appointments. Ongoing weight self-monitoring will be a central feature of the 
intervention at all steps. Most experts considered frequent weighing a key component to any weight 
management program (83-86) and it appears to be important in pregnancy-related weight interventions as 
well. For this reason, participants will be prompted to weigh themselves at least weekly on an electronic 
scale, which they will be given at baseline. The electronic scale will be issued to the subject as part of 
treatment on a hand receipt.  Due to depreciation of the scale over 21 months of use during the study, the 
scales would be valued at near zero, and therefore subjects will not be required to return them.   The 
electronic scales are part of the treatment and not considered a form of compensation for participating in 
the study.  Each time a participant weighs, the electronic scale will upload the weight automatically to a 
secure website. Each week, participants will receive an email from their interventionist with a weight 
graph tailored to their screening weight BMI and their current weight trajectory as well as personalized 
feedback from their interventionist about their trajectory. Participants who gain less weight than the 
guidelines will be instructed to increase their caloric intake and to monitor their weight daily.  Study staff 
will notify Obstetrics staff about participants who gain less weight than the guidelines at two consecutive 
intervention sessions, but will be retained in the study. 
 
Dietary goals:  Consistent with the IOM recommendations[30], participants will be advised to continue 
consuming the same number of calories in the first trimester as they did pre-pregnancy, and increase 
baseline intake (if they are otherwise meeting their GWG goals) by approximately 340 calories in the 
second trimester, and by 452 calories in the third trimester. Participants will be given examples of 350 and 
450 calories of food, in order to guide adherence with these goals. Other dietary recommendations will be 
consistent with a “healthy” diet for pregnant women (e.g., limiting fish consumption), with an emphasis 
on consuming a diet high in fruits, vegetables, and whole grains. We will pair self-monitoring, with 
instructions in food label reading and measuring foods to improve self-monitoring accuracy. However, 
among women who are gaining in excess of the guidelines who have self-reported calorie intakes within 
the specified goal ranges, recommendations for decreases in the calorie goals will be made; this is 
predicated on the assumption that the actual energy intake is higher than the self-reported intake and that 
lowering the goal for self-reported intake will achieve an intake level that supports appropriate GWG.  
 
Exercise goals: Participants will be encouraged to engage in 150 minutes per week of moderate exercise. 
Fitness trackers will be issued with a hand receipt to participants as part of treatment to facilitate reaching 
their exercise goal. The fitness trackers are part of the treatment and not considered a form of 
compensation for participating in the study.   After 21 months of use, the value of the fitness tracker will be 
near zero due to depreciation and advances in technology; therefore, participants will not be asked to 
return the fitness trackers.  If the participant’s obstetrician recommends limiting physical activity or 
complete bed rest, the exercise goal will be modified or halted. 
 
PPWL Intervention: The PPWL intervention will begin at 6-weeks postpartum (when most women will be 
approved for weight loss and exercise by their obstetrician) for those participants randomized to the 
PPWL-only or the GWG+PPWL arms, and will continue until 12-months postpartum. The PPWL intervention 
will provide at least monthly individual, telephone-based sessions (20-30 minutes each), as detailed in 
Table 2, by trained interventionists. (The number of possible telephone sessions will depend on the level of 
support needed by each participant to meet her weight loss goals). Similar to the GWG intervention, the 
PPWL intervention will focus on self-monitoring; weight, dietary intake and exercise goals; and problem 
solving.  
 

 
 
Revised by PR 2019 
8 
 
Table 2. Stepped-Care Postpartum Weight Loss Intervention  
 
Step 1 
Step 2 
Step 3 
Trigger to Increase 
Intervention Intensity 
<0.5-1 lb of weight loss 
per week at any monthly 
session 
<0.5-1 lb of weight loss per 
week for 2 consecutive 
biweekly sessions  
N/A 
Contact Frequency 
-Monthly 20-30 minute 
telephone sessions 
 
-Biweekly 20-30 minute 
telephone sessions 
 
-Weekly 20-30 minute 
telephone sessions 
-Weekly emailed materials 
Dietary 
Recommendations 
500 calorie deficit, 
tailored to 
breastfeeding status  
Same as Step 1 with portion 
size measuring and daily 
dietary intake monitoring  
↓ by 100-200 calorie per day 
until recommended weight 
loss achieved  
Exercise 
-↑ exercise to pregravid 
levels 
-Fitness tracker 
-↑ exercise to pregravid 
levels 
-Fitness tracker 
-↑ exercise to pregravid 
levels 
-Fitness tracker 
Behavioral Strategies 
-Weekly self monitoring 
of weight 
-Weekly emailed graph 
 
-Daily self monitoring of 
weight, daily food intake & 
exercise 
-Weekly emailed graph 
-Goal setting and problem 
solving  
-Daily self monitoring of 
weight, daily food intake & 
exercise 
-Weekly emailed graph  
-Goal setting & problem 
solving 
-Meal replacements & 
structured meal plans 
- Adapted Look AHEAD ILI 
materials  
-Toolbox resources 
Trigger to Reduce 
Intervention Intensity  
N/A 
Return to weight loss within 
recommended range 
Return to weight loss within 
recommended range 
 
Failure to lose weight based on the expected trajectory (i.e., 1 lb per week until returning to their pregravid 
weight (for women who are in any pregravid weight category) or until they have achieved a 5% weight loss 
(for overweight and obese women, if they desire)) will trigger an increase in the intervention intensity (i.e., 
moving to the next step). That is, failure to lose weight based on the expected trajectory at any monthly 
session for those in Step 1 will trigger an increase in the intervention intensity (i.e., moving to Step 2) and 
any participant in Step 2 who is losing less than the expected trajectory for two consecutive biweekly 
sessions will trigger an increase in the intervention intensity (i.e., move to Step 3). 
 
Weight goals: Weight loss from birth to 6-weeks postpartum is fairly standard—approximately 6 kilograms 
(or 13 pounds)—regardless of pregravid weight category and GWG [29]. For women with a normal 
pregravid BMI, the PPWL goal (initiated at 6-weeks postpartum) will be to return to the pregravid weight. 
For women who were overweight or obese pre-pregnancy, the PPWL goal (initiated at 6-weeks 
postpartum) will be to at least return to their pregravid weight and, if desired, lose up to an additional 5% 
of their pregravid weight. All participants will be advised to lose weight at a rate of approximately 1 pound 
per week, which has been shown to not have adverse effects on infant growth or breast milk production. 
All women will be given a tailored graph indicating the recommended PPWL trajectory. They will be 
prompted to weigh themselves at least weekly on the electronic scale provided at baseline (which will 
upload the weight automatically to a secure website).  The electronic scale will be issued to the subject as 
part of treatment on a hand receipt.  Due to depreciation of the scale over 21 months of use during the 
study, the scales would be valued at near zero, and therefore subjects will not be required to return them.  
The electronic scales are part of the treatment and not considered a form of compensation for 
participating in the study.    These weights will be plotted on a graph and emailed to them weekly along 

 
 
Revised by PR 2019 
9 
with personalized feedback from their interventionist about their weight trajectory. The graph will clearly 
identify weight losses that are both greater than recommended and below recommendations. Participants 
who are losing weight faster than expected will be instructed to increase their caloric intake and to 
monitor their weight daily.  Participants who lose more weight than expected at 2 consecutive monthly 
intervention sessions will be referred to their obstetrician for guidance, but will be retained in the study. 
 
Dietary goals: Calorie goals will be based on their baseline caloric intake and their current breastfeeding 
status. Women who are breastfeeding will be given a calorie goal that allows for the additional energy 
expenditure of breastfeeding (i.e., an extra 450-500 calories). While the primary emphasis will be to stay 
within the prescribed goal, participants will be also encouraged to eat a balanced diet in line with the 
current U.S. Dietary Guidelines. Among women who are not losing weight at the expected rate who have 
self-reported calorie intakes within the specified goal ranges, decreases in their calorie goal will be made; 
this is predicated on the assumption that the actual energy intake is higher than the self-reported intake 
and that lowering the goal for self-reported intake will achieve an intake level that supports appropriate 
weight loss. 
 
Exercise goals:  When approved by their obstetrician, participants will be encouraged to gradually resume 
their pregravid levels of exercise. Participants will be advised to set an initial exercise goal of 100 minutes 
per week and gradually increase the amount of moderate exercise that they perform. Fitness trackers will 
be issued with a hand receipt to participants as part of treatment to facilitate the exercise goal.  After 21 
months, the value of the fitness tracker will be near zero due to depreciation and advances in technology; 
therefore, participants will not be asked to return the fitness trackers. The electronic scales are part of the 
treatment and not considered a form of compensation for participating in the study.  If the participant’s 
obstetrician recommends limiting physical activity, the exercise goal will be modified or halted. 
Participants will also receive guidance about their ability to resume strength training (e.g., push-ups, sit-
ups) at their first (i.e., 6-weeks) postpartum visit with their obstetrician, consistent with standard clinic 
practice. 
 
Common Intervention Components for the GWG and the PPWL Interventions: In both interventions, 
participants will be taught behavioral techniques, as needed, to assist them in meeting their weight, 
calorie, and exercise goals. 
• Self-monitoring: Self-monitoring will consist of recording weight, caloric intake, and/or exercise, using a 
website or app. depending upon the intervention step (see Tables 1 & 2), participants will be given 
appropriate self-monitoring targets. Weight monitoring (at least weekly) will be conducted at all levels 
of intervention.  
• Feedback: Participants will be taught to use weight, calorie and/or exercise monitoring as an ongoing 
source of feedback. A major role of the interventionist will be to monitor and evaluate the progress of 
participants and provide positive reinforcement for behavior changes. The interventionist will 
encourage small steps toward behavior change and will elicit personalized behavioral goals.  
• Goal setting: The interventionist will engage the participant in goal setting to achieve the behavioral 
goals (i.e., caloric intake, exercise) likely to realize the GWG recommendations and PPWL goals. They 
will also identify their personal reasons for striving for healthy GWG and/or PPWL as a strategy to 
develop and maintain motivation.   
• Problem solving: Participants will be taught to use problem solving strategies to deal with situations 
that pose difficulties for changing their eating and exercise habits (e.g., vacations, spouse deployment, 
work stress).   
 

 
 
Revised by PR 2019 
10 
Meal replacements: Meal replacements appropriate for pregnant and postpartum women will be offered 
to those women at the highest “step” or intensity of the interventions, as a method to achieve their 
weight and calorie goals as well as a strategy to control portions. With an eye toward sustainability, we will 
use commercially-available meal replacements (e.g., Slim Fast, Better Oats oatmeal, Healthy Choice frozen 
meals), like we have in our ongoing Fit Blue trial (FWH20130095H) at Lackland AFB.  Meal replacements will 
be purchased through food vouchers and through actual food provided (e.g., oatmeal packets) and given, 
at no-cost, to participants who are struggling the most in their gestational weight gain or postpartum 
weight loss (step 3 of the intervention, after they have not met goals for two sessions in a row). The food 
vouchers and actual food will differ in value, depending on the size of the food item (e.g., a 10-pack of 
oatmeal that is expected to last 5 days). However, we will spend approximately $3.00 for two meal 
replacements per day for these participants. These are not considered gifts nor a form of compensation, 
and are part of the treatment, for those who are struggling with the weight goals the most. 
 
Participants will be encouraged to replace 2 meals with meal replacements and will be advised to consume 
a third meal of conventional foods. We will select meal replacements that meet the nutritional needs of 
pregnant and postpartum women and will provide detailed meal plans that recommend conventional 
foods to be consumed, to ensure a balanced diet appropriate for pregnant and postpartum women. They 
will be advised to use the meal plans as guidance for their third conventional meal or for all meals, if they 
refuse meal replacements at any point. Dr. Harvey, as a registered dietician, will guide the meal 
replacement choices and the Look AHEAD meal plan adaptation.     
• Toolbox: The toolbox will include additional treatment options (e.g., providing exercise videos, lower 
calorie cookbooks, arranging a session with an exercise physiologist/trainer) for participants who need 
assistance in meeting weight, calorie or exercise goals, or coping with challenges in meeting these 
goals.  The toolbox items are not considered a form of compensation, and will be returned to the 
research team. 
• Additional behavioral strategies:  As appropriate, the interventionist will introduce other behavioral 
strategies using adapted Look AHEAD ILI lessons on topics such as stimulus control, social support, and 
combating negative thinking. 
• Trained Interventionists with Military Knowledge: A critical part of any military intervention is the 
ability of the interventionist to understand the culture and the language of the participants. A sentence 
like, “I just got my PCS orders and have to go to the CSS to start paperwork, which will require an OPR 
that my OIC wants by COB Friday, but first I have to take my fitness test,” is the norm. To civilians, this 
appears to be gibberish, but all military personnel know these acronyms because they are part of 
everyday life. Interventionist credibility is extremely important and if the interventionist does not 
understand the common vernacular of an active duty member, they lose credibility. We have addressed 
this with our research staff by ensuring that we have retired military staff available to educate and 
answer any questions our non-military staff might have, and we strive to retain our trained 
interventionists across research projects. Our interventionists have Bachelor’s or Master’s degrees in 
applicable areas (i.e., social work, counseling/psychology, child development, and nursing). As a result, 
we have highly trained interventionists who are very familiar with military culture and experienced in 
delivering behavioral interventions. An interventionist will be paired with a participant at randomization 
and will continue working with the participant throughout the entire intervention, to facilitate social 
support. 
• Treatment Fidelity:  Based on our previous experience with behavioral interventions, we will utilize the 
following quality procedures to help ensure treatment fidelity: 1) detailed intervention protocol 
development; 2) careful interventionist proficiency and ongoing re-training; 3) recording of 10% of 
intervention sessions to provide corrective feedback on protocol adherence; 4) electronic 
documentation of all intervention contacts in the study database to monitor participant exposure to 

 
 
Revised by PR 2019 
11 
treatment; and 5) weekly study meetings to review participants’ adherence to structured protocols 
(based on the process data collected). These study meetings (attended by all interventionists and 
investigators) will also include problem solving related to challenging cases and refining skills. 
 
3.6.2. Data Collection and Processing:  
Measures will be obtained by trained staff who are blinded to treatment assignment. In-person follow-up 
data collection visits will be scheduled at gestational Week 32 and Week 36, as well as at 6-weeks, 6-
months, and 12-months postpartum. If a study participant has moved out of the local area after enrolling in 
the study and continues to be a Tricare beneficiary, with the participant’s permission, research staff will 
collect weight data via the participant’s Body Trace scale uploads and other data instruments through the 
use of paper questionnaires mailed to the participant.  In addition, telephone interventions will continue as 
normal per protocol.  Relevant incentives (e.g., actual diapers given to participants) will be used to obtain 
high retention at all follow-up data collection visits. Incentives will not exceed the maximum amount 
specified by military policy.  The diapers are an incentive and would be provided to a participant who 
attends the following data collection visits: 
Year 1 ($50 limit) 
32 week visit 
Choice of: $15 worth of diapers, 
baby ointment, or wet bag  
36 week visit 
Choice of: $15 worth of diapers, 
baby ointment, or wet bag 
6 week post-partum visit 
Handprint keepsake  ($10) 
Year 2 ($50 limit) 
6 month post-partum visit 
 
Choice of: $15 worth of diapers, 
baby ointment, or wet bag 
12 month post-partum visit 
Choice of: $15 worth of diapers, 
baby ointment, or wet bag 
 
3.6.3. Setting:  
Subjects will complete pre-screening, consent and data collection in the OB clinics at WHASC and SAMMC.  
Interventions will be completed via telephone. 
 
3.6.4. Date(s):  
Participants will be involved in study related activities for twenty-one months from the time of enrollment. 
 
3.6.5. Source of Research Material:  
Source of Research Material per Participant (Procedures) 
# Routine 
Care 
# Research 
Driven 
# Total 
Procedures 
Research Project Medical Clearance 
0 
1 
1 
Screening Visit Interview Questions 
0 
1 
1 
Weight 
12 
7 
19 
Height 
0 
5 
5 
Abdominal Circumference 
0 
3 
3 
Contact information 
0 
7 
7 
Demographics 
0 
1 
1 
International Physical Activity Questionnaire 
0 
5 
5 
Breastfeeding Questions 
0 
2 
2 
EPDS Depression Screener 
3 
3 
6 
Military Fitness Test Scores  
0 
2 
2 
Program Evaluation 
0 
2 
2 
Modified Pregnancy-Unique Quantification of Emesis and Nausea 
Index  
0 
2 
2 
Weight Gain Recommendations 
0 
1 
1 

 
 
Revised by PR 2019 
12 
 
3.6.6. Subjects:  
Study participants will be female, active duty military personnel stationed at Joint Base San Antonio. 
 
3.6.7. Inclusion/Exclusion Criteria: 
Inclusion:  
• Participants will be female, DoD Tricare beneficiaries (Active Duty military, retirees and dependents) 
living in the San Antonio, Texas area receiving medical care at Joint Base San Antonio, and at least 
18 years old. 
• Participants must be less than 12 weeks gestation upon recruitment (based on the date of their last 
menstrual period and confirmed by first trimester ultrasound at the first prenatal visit). 
• Participants must be within the normal, overweight, or obese BMI ranges upon Baseline 
measurement. 
• Participants must plan to live in the San Antonio, Texas area for at least 1.5 years. 
 
Exclusion: 
• Participants who have any medical conditions that limit a participant’s ability to engage in changes 
in dietary intake or increases in physical activity, based on the determination of physicians on the 
study team. 
• Participants who have a high-risk pregnancy (i.e., Type I or II diabetes at conception or current 
multiple gestation), based on the determination of physicians on the study team. 
• Participants who smoke at the time of conception (smoking cessation during pregnancy has 
significant benefits for fetal health, but the quitting process can be associated with weight gain and 
thus offers potential study confounds) 
 
3.6.8. Instrumentation:  
• Contact information 
• Demographics: Participants will complete a questionnaire regarding their age, parity, race, and 
ethnicity. 
• Physical Assessment:  
• Weight: At all measurement visits, weight will be recorded in kilograms. Weight will be measured 
on a calibrated digital scale in duplicate, with the participant wearing light clothing and no shoes. 
While we will obtain the mother’s weight at baseline, we will also obtain self-reported pregravid 
weight (before the last menstrual period). The difficulty of anticipating when a final weight should 
be obtained to capture the fullest extent of GWG was considered, and we elected to use an 
approach that afforded two possible weights that would be available for analytic purposes. The 
Week 36 weight will be the primary outcome except for mothers who deliver prior to 36 weeks, in 
which case we will use the Week 32 weight. Thus, we will have a final observation of GWG for all 
participants, regardless of whether they deliver earlier than 36 weeks. 
• Waist Circumference: As an indicator of subcutaneous and visceral abdominal fat, waist 
circumference will be measured (recorded in centimeters) using a non-distensible measuring tape 
and standard protocols for positioning. 
• Height: Height, using a wall-mounted stadiometer, will be recorded in centimeters. BMI will be 
calculated from measured weight and height. 
• Physical Activity: We will assess physical activity, subjectively, using the International Physical Activity 
Questionnaire, as it has been used in other studies of gestational/postpartum weight management, has 
been validated against accelerometry, and has good test-retest reliability. We will also assess physical 

 
 
Revised by PR 2019 
13 
activity objectively using the Actical accelerometer. Participants will be asked to wear the 
accelerometer for 7 days, including 2 weekend days and 3 weekdays. 
• Weight Gain Recommendations:  We will assess knowledge of weight gain recommendations at the 
Baseline visit, before randomization. One previous study has shown the gestational weight gain 
expectations, in a civilian population, predicted actual pregnancy weight gain; however, it is not certain 
whether this finding will replicate in a military population. 
• Feeding Practices:  Participants will be asked whether their child is being breastfed, partially breastfed 
(supplemented daily with formula or milk), or fully formula fed and whether solid foods are eaten daily. 
In addition, the duration of breastfeeding will be assessed.  Breastfeeding status will also be used to 
calibrate postpartum calorie goals. 
• Depression: Screening for depression at the first prenatal visit, 28 weeks gestation and at the 6-weeks 
postpartum visit is standard practice by the WHASC and SAMMC obstetric clinics using the Edinburgh 
Postnatal Depression Scale. We will obtain these scores from the participants’ medical record. In 
addition, we will assess depression at the 6-weeks, 6-months and 12-months postpartum data 
collection visit, so we will be able to examine whether our results vary based on the presence of 
depression. 
• Fitness Test Scores: We will obtain the final pregravid and the first postpartum fitness test score from 
active duty participants to be able to examine the impact of the interventions. 
• Program Evaluation: Program satisfaction will be assessed to offer insight into program acceptability as 
well as barriers and facilitators to participation in each intervention arm. We will adapt the treatment 
satisfaction measure we are currently using in our “Fit Blue” study to evaluate acceptability and 
examine feedback on specific intervention aspects, which will inform program refinement and future 
implementation.  
• Medical Outcomes and Health Care Utilization: Pregnancy-related medical outcomes will be obtained 
from the participant’s medical record and will include: maternal (e.g., gestational diabetes, 
preeclampsia) and fetal conditions; type of delivery; Apgar score; gestational age at delivery; and birth 
weight and length of the infant. Length-for-age, weight-for-age and weight-for-length Z-scores will be 
calculated using the Center for Disease Control and Prevention (2000) reference data. Health care 
utilization (counts of ambulatory visits by type [physician, imaging, lab, other] and hospital/NICU 
admissions, hospital days) for mother and child will also be captured. 
 
4.0. Human Subject Protection: 
 
4.1. Recruitment:  
Participants will be recruited through presentations from research staff and advertisements located in the 
OB clinics at WHASC and SAMMC as well as other appropriate areas of JBSA.  Persons interested in 
learning more about the study may call the study phone number, or can request a call back or email 
through the website or in person event. We plan to use flyers, business cards, posters, newspaper, word-
of-mouth, and electronic advertisements in base bulletins.  Advertisements will include a phone number by 
which to reach study personnel for more information. 
 
4.2. Consent Processes:  
No study specific procedures will be performed without a written and signed informed consent document 
and HIPAA Authorization.  Participants who do not demonstrate the ability to understand or the 
willingness to sign the written informed consent document will be excluded from study entry.   
  
 
 

 
 
Revised by PR 2019 
14 
4.3 Participation Compensation:  
Subjects will not be paid for participation in this study, however they will receive incentives, such as 
diapers, diaper ointment, wet bag, and a handprint keepsake for attending data collection visits as 
described in section 3.6.2. 
 
4.4. Assent Process: N/A 
4.5. Benefits:   
Participants may increase their knowledge about healthy eating and physical activity.  However, there is no 
guarantee or promise of direct benefit for subjects participating in the study. 
 
4.6. Risks:   
All study procedures involve only minimal risks to subjects.  Since regular exercise will be encouraged, 
some people may experience some muscle soreness. There are no major risks associated with taking 
measurements (height, weight, and waist circumference), taking a health history or collecting 
questionnaire data. There is, however, the potential risk of loss of confidentiality. Although, we do not 
anticipate that any study related procedures would increase a participant’s risk of suffering from 
emotional distress or having thoughts of suicide, study procedures are in place so that research staff can 
respond appropriately if this should occur (see section 4.9 for description of Study Procedures for 
Distressed Participants). 
 
4.7. Costs: N/A 
 
4.8. Safeguards for Protecting Information 
The research consents and study related documents will be stored in a locked cabinet in a locked room.  All 
research data including participant demographics will be kept in an electronic database, which will be 
encrypted, double password protected and the access will be restricted.  The research database, consents, 
and study related documents will be securely maintained for six years after the closure of the study. The 
research data will not be utilized for further research activity beyond the protocol stipulations without 
additional IRB approval. 
 
Identifiable research data will be entered electronically into a database housed at UTHSC via a secure 
connection using Cisco VPN client.  The data will be encrypted, double password protected, and access will 
be restricted.  The research database will be managed and maintained at UTHSC.  Upon completion of the 
study protocol, UTHSC will destroy paper forms and links according to IRB procedures. 
 
4.9. Safeguards for Protecting Subjects: 
The principal investigator will be responsible for the protocol safety monitoring.  The PI will make study 
documents readily available for inspection by the local IRB and oversight staff for confirmation of the 
study data. 
 
Study procedures for distressed participants were developed for research staff to follow in the event that 
a participant is suffering from emotional distress or having thoughts of suicide.   
 
Several precautions have been taken to both limit the likelihood of participants suffering from a significant 
psychological event and in the unlikely event that one occurs, we have established appropriate steps for 
the Counselor to follow in order to get the participant help. 
 
 
 

 
 
Revised by PR 2019 
15 
A. PRESCREENING FOR DISTRESS 
1. All prospective participants are pre-screened by a military medical provider who both screens the 
participants in person and reviews their electronic medical record.  Specifically, all prospective 
participants are asked whether they have any “Emotional or psychiatric conditions (depression, 
schizophrenia)”asked on the HEALTHY PREGNANCY Research Project Medical Clearance Form. 
 
2. Additionally, all patients (including the enrolled participants) at OB orientation and at 6-weeks 
postpartum are administered the 10-item Edinburgh Postnatal Depression Scale (EPDS) as a part of 
routine pregnancy care.  Responses indicating an increased likelihood of depression are addressed by 
the prenatal care procedures at the medical facility.  Please see attached SAMMC Standard Operating 
Procedure 36 and WHASC Operating Instruction 44-11.   
1. At 6-months and 12-months postpartum the research staff will administer the Edinburgh Postnatal 
Depression Scale during in-person data collection visits.  
a. If the participant scores a 10 to 12 on the EPDS, the participant is possibly experiencing 
depression. 
b. If the participant scores a 13 or greater on the EPDS, the participant is likely experiencing 
depression. 
c. Both these situations should be brought to the attention of a mental health professional. 
i. Participants will be referred to the Behavioral Health Optimization Program (BHOP) at the 
WHASC Family Health Clinic.  BHOP can be reached by phone at 292-1159; same-day 
appointments are also offered. 
ii. The BHOP service is available to all active duty members. BHOP providers are authorized to 
document visits in AHLTA so that the encounter notes are available to other authorized 
users. 
2. If the following response is endorsed by the prospective/enrolled participant, the Counselor will 
probe briefly for more information about the circumstances of their distress, including potential 
suicidality. 
a. Critical responses are: 
i. Item 10 (“The thought of harming myself has occurred to me”): Responses 1 (“Yes, quite 
often”) and 2 (“Sometimes”). 
b. The Counselor will ask whether the participant has a plan to harm herself (to act on her suicidal 
thoughts) by asking: 
i. Do you have thoughts about suicide? 
ii. If yes, do you have a plan to hurt yourself? 
  
A. STUDY PROCEDURES FOR PARTICIPANT DISTRESS, IN-CLINIC OR VIA TELEPHONE 
 
1. MILD TO MODERATE DISTRESS (NO THOUGHTS OR INTENT OF HARM TO SELF OR OTHERS) 
a. During the in-clinic visits or via telephone, if the participant reports mild to moderate stress 
(but no suicidal thoughts or morbid ideations such as thoughts of wanting to be dead), the 
participant will be asked to make an appointment with primary obstetric provider or primary 
care provider.  The patient will also be provided a listing of community resources and 
encouraged to seek help.   
b. Counselor will help the participant develop an action plan to be seen by a mental health 
professional should their distress persist over multiple sessions or worsen.   
c. Counselor will document the conversation and support materials provided. 
d. Continued distress without professional assistance and support can be a reason to 
temporarily or permanently withdraw the participant from the GWG or PPWL Intervention 
protocol. Due to safety concerns, notification of withdrawal from the study based on 
continued distress will result in formal notification of the participant’s command.  

 
 
Revised by PR 2019 
16 
 
2. SEVERE DISTRESS AND THOUGHTS OR INTENT OF HARM TO SELF OR OTHERS WITH NO 
INTENT OR PLAN Participant reports suicidal thoughts or thoughts of harming others but no 
intent or plan. 
a. Counselor will develop an action plan to get help from a mental health professional.  This 
conversation with the participant and the action plan will be documented.  
b. Counselor will follow-up in two business days to ensure that the participant has an 
appointment with mental health scheduled.   
c. Counselor will also inform the participant that if their condition worsens the following 
emergency resources are available: 
1) Mental Health Clinic in WHASC (open for Walk-Ins during duty hours: 210-292-7361) 
2) SAMMC Emergency Department: 210-916-0808 
3) Crisis Hotline call: 1-800-273-TALK 
 
3. SEVERE DISTRESS AND PLANS OR CLEAR INTENT TO HARM SELF OR OTHERS  
a. Participant reports suicidal thoughts or thoughts of harming others and intent or plan. 
b. Once a participant endorses suicidal intent the counselor will attempt to keep them on the 
phone.   
c. Whether the Counselor – Participant contact is by phone or in-person, the Counselor will 
attempt to maintain contact with the participant, identify the location of the Participant and 
maintain verbal contact until help arrives. 
d. Counselor will contact another staff member and indicate they have an emergency and 
direct them to call the appropriate emergency number (911; Lackland Command Post:  210-
671-4225; Security Forces: 210-671-3030; Ambulance: 210-292-7331; SAMMC Police Duty Officer 
210-916-4141) and provide an address.     
e. Counselor will document the conversation with the prospective participant and all actions 
taken. 
 
B. DOCUMENTATION OF ADVERSE EVENTS 
1. Incidences of EPDS scores greater than or equal to 10 may be documented as adverse events.   
2. In the event of an adverse event, the participant should be followed to resolution of   the event, 
or to its stabilization. 
 
4.9.1. Minimizing Risks:  
 
This study follows evidence-based lifestyle recommendations for weight management and improving 
health, including diet change and regular exercise. If followed according to program guidelines, no adverse 
medical conditions are expected to result from the research activities. 
 
 
There are no major risks associated with taking measurements (i.e. height, weight, and waist 
circumference), taking a health history or collecting questionnaire data. There is, however, the potential 
risk of loss of confidentiality. Every effort will be made to keep participant information confidential as 
described in Section 4.8. In the event that questions asked make participants feel uncomfortable, they may 
refuse to answer and may take a break at any time during a study visit. However, we are not collecting any 
information that would in any way jeopardize participants’ careers 
 
Any significant new findings developed during the course of this research project, which may impact upon 
the safety and efficacy of the procedure or treatment under study and consequently influence 
participants’ willingness to continue participation, will be provided to them. 
   

 
 
Revised by PR 2019 
17 
4.9.2. Vulnerable Populations:  Pregnant women 
 
4.9.3. Clinical Care:  
As all participants will be female active duty military members and DoD TRICARE beneficiaries, medical 
care (if needed) is provided at no cost through their Military Treatment Facility (MTF). 
  
4.9.4. Injury Compensation:  N/A 
 
4.9.5. Data Safety Monitoring: 
The trial will be conducted in compliance with this protocol, International Conference on Harmonization 
(ICH) Guidelines for Good Clinical Practice (GCP), and any applicable national and international regulatory 
requirements. The principal and associate investigators will be monitoring all aspects of the study in 
accordance with the appropriate regulations in order to:  
1) Ensure protection of study subjects, compliance with the protocol, and accuracy and completeness 
of records. 
2) Verify the prompt reporting of all data points, including reporting Serious Adverse Events (SAEs) 
and checking availability of signed informed consent, 
 
Note: A Data Safety Monitoring Plan (DSMP) will be developed for this study and the Data Safety 
Monitoring Board (DSMB) will meet yearly to review participant safety. 
 
5.0. Alternatives:   
Alternatives include not participating in the study, consulting with their Primary Care Provider (PCP) or OB 
clinician to assist them with weight management efforts, or self-monitoring of dietary intake and physical 
activity to achieve weight management during pregnancy and postpartum.  Meal replacements may also 
be bought at local stores. 
  
6.0. Data Analysis:  
We will analyze changes in weight and abdominal circumference, as well as data based on other measures 
from baseline, gestational Week 32 and Week 36, as well as at 6-weeks, 6-months, and 12-months 
postpartum. 
 
6.1. Outcome Measures:  
The primary study outcomes will be a comparison of GWG from baseline to the final gestational weight 
(either week 32 or week 36, depending on the delivery date) as well as a comparison of weight loss from 6-
week postpartum to 12-months postpartum for the 3 intervention arms. 
 
6.2. Sample size estimation/power analysis:   
The study aims to enroll 755 (with the intent for 450 subjects completing the study) participants, 150 
participants in each group.  This distribution will provide a diverse representation within each intervention 
group and will provide the necessary information for data and power analysis. 
 
6.3. Statistical Analysis:  
All of the analyses will be performed with SASv9.4. Data will be examined for distributional normality and 
outliers prior to any analyses. Descriptive statistics will be generated for all variables of interest included in 
the analysis, overall and by treatment arm. Univariate comparisons will consist of t-test, chi-square test, 
ANOVA, and their respective non-parametric counterparts if needed, for continuous/categorical variables 
respectively. Primary analyses will be intention-to-treat, without regard to intervention adherence. We will 
use multivariable linear ANCOVA-like regression models for continuous outcomes, to model and compare 

 
 
Revised by PR 2019 
18 
the GWG (Hypothesis 1) and PPWL (Hypothesis 2), in the 3 arms. Using these models, treatment effects will 
be estimated and tested by comparing change in group-specific means at the final prenatal visit and 12-
months postpartum conservatively adjusting for baseline differences (which will be minimal by virtue of 
randomization) and in the case of hypothesis 2 for 6-weeks postpartum weight differences. 
Randomization validity will be assessed by comparing arms on baseline measures using chi-square tests, 
ANOVAs and other appropriate tests. If imbalances are found, we will consider adjusting the between-
group analyses for potential confounders. 
 
6.4 Number of Subjects:   
Number of subjects planned for 
WHASC/SAMMC 
Enrolled in full study 
755 to result in 
450 completing the full study 
TOTAL NUMBER OF SUBJECTS (nation-wide/study-wide):___755___ 
 
7. Duration of Study:  Approximate duration of the study: 72 months 
 
8.  Local and External Support Services:  A letter of support from the 59th MDW Commander is attached. 
 
9.  Intramural (GME) and Extramural Funding Support:   
The National Institute of Diabetes and Digestive and Kidney Diseases provided extramural funding for this 
study. 
 
10. Conflict of Interest:  
If you or any investigator participating in the repository has, or anticipates having, any income from or 
financial interest in: the sponsor of the repository protocol, the supporting organization, or the company 
that owns/licenses the technology being studied, contact the WHASC IRB.  A “Conflict of interest exists if 
an employee’s position or authority may be used to influence or make decisions that lead to any form of 
financial or personal gain for that employee or for his or her family which includes spouse or dependent 
children.”   [NOTE: A conflict of interest or even the appearance of conflict calls into question the 
judgment or actions of the investigator in areas that affect the rights and welfare of research subjects and 
the integrity of the research process.  At its worst, conflict of interest may endanger lives, e.g., not only 
those of the immediate research subjects under study, but those of future patients treated on the basis of 
biased research results.] 
 
 
a. Financial Conflict of Interest: None 
 
b. Personal Conflict of Interest: None 
 
c. Current Off-Duty Employment: None 
 
11.  Use of an Investigational New Drug, use of a Drug for a non-FDA approved purpose, use of an 
investigative device or use of a placebo:   
This research uses an Investigational New Drug 
 
 
 
 
 
[] YES [x] NO 
This research uses a FDA approved drug for a non-FDA approved purpose                                      [] YES [x] NO 
This research uses an Investigational Device      
 
 
 
 
 
[] YES [x] NO 
This research uses a placebo. 
                                                                                    
 
[] YES [x] NO 
 
 
 
 
 
 

 
 
Revised by PR 2019 
19 
12.  Medical Research Area for the Study:  (Pick as many as appropriate) 
[] Analytical Chemistry 
[] Anatomy 
[] Anesthesiology 
[] Biochemistry 
[] Cardiovascular Surgery 
[] Cardiology 
[] Cell Biology 
[] Dentistry 
[] Dermatology 
[] Dietetics 
[] Electrophysiology 
[] Endocrinology 
[] Emergency medicine 
[] Gastroenterology 
[] General Surgery 
[] Hematology 
[] Histology 
[] Immunology/Allergy 
[] Infectious Disease 
[] Microbiology 
[] Molecular Biology 
[] Neonatology 
[] Neurology 
[] Neurosurgery 
[] Nursing 
[x] OB/GYN 
[] Occupational Medicine 
[] Occupational Therapy 
[] Oncology 
[] Ophthalmology 
[] Oral/Maxillofacial Surgery 
[] Orthopedics 
[] Pathology 
[] Pediatrics 
[] Pharmacology 
[] Physical Therapy 
[] Mental Health 
[] Radiology/Imaging 
[] Urology 
[x] Wellness 
[x] Other (state):  Prevention, Behavioral 
 
13. Attachments: 
1. Informed Consent Document 
2. HIPAA Authorization Document 
3. Letter of Support - 559 MDW/CC 
4. Letter of Support- Fitness Center 
5. Letter of Support- SAMMC Dept. of OB/GYN 
6. Letter of Support- WHASC Women’s Health Services 
7. Extramural Funding Support Document 
8. Medical Clearance Letter 
9. Self-screener form 
10. Screening Visit Interview Questions form 
11. Contact information form 
12. Demographics form 
13. Physical Assessment Form (screening, baseline & follow-up visits) 
14. International Physical Activity Questionnaire  
15. Infant Feeding Questionnaire 
16. Edinburgh Postnatal Depression Scale 
17. Program Evaluation 
18. Participant Lesson Outline 
19. Recruitment electronic/newspaper advertisement 
20. Data Safety Monitoring Plan (DSMP) 
21. Form A-2 
22. Form A signature sheet 
23. Research Involving Pregnant Women, Human Fetuses, and/or Neonates Form 
24. Modified-Pregnancy-Unique Quantification of Emesis and Nausea (Modified-PUQE) 
25. Moms Fit2 Fight Pamphlet 
26. Superheroes Flyer 
27. Time is Running Out Flyer 
28. Business Card 
29. Weight Gain Recommendations