Optimizing Health From Pregnancy Through One Year Postpartum: A Sequential Multiple Assignment Randomized Trial (SMART) of Perinatal Lifestyle Interventions
Phase: NA
Conditions: Obesity, Pregnancy Related
Sponsor: University of Pittsburgh

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Study Protocol  
 
 
 
 
 
 
Official Title: Optimizing health from pregnancy through one year 
postpartum: A sequential multiple assignment randomized trial 
(SMART) of perinatal lifestyle interventions  
 
  
 
 
ClinicalTrials.gov ID (NCT number): NCT03069690 
 
 
 
Protocol Date: 11/20/2024 
 
 
 
 

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Scientific Background 
Approximately two-thirds of American women are overweight or obese (OV/OB; BMIs > 25), 
and rates of obesity prior to pregnancy are increasing dramatically. For example, Kim and 
colleagues reported a 70% increase in the prevalence of pre-pregnancy obesity over a 10 year 
period. Rates of gestational diabetes mellitus (GDM), pre-pregnancy hypertension, and 
preeclampsia also have increased since 2000, and women who are OV/OB prior to pregnancy are 
at higher risk for preeclampsia, and gestational hypertension than are normal weight women. 
Prenatal OV/OB, along with weight gain in pregnancy, is related to difficult deliveries, an 
increased likelihood of macrosomia, congenital malformations, and obesity among the children 
born to OV/OB mothers. 
 
Gestational weight gain (GWG) also affects maternal and child health independent of pre-
pregnancy OV/OB. Excessive GWG robustly predicts the amount of postpartum weight 
retention, increases the risk of obstetric complications and is associated with adiposity among 
neonates, children, adolescents, and adults. The Institute of Medicine (IOM)reissued guidelines 
for GWG stratified by pre-pregnancy BMI that recommend GWG between 15 and 25 pounds for 
an overweight woman and 11 to 20 pounds for an obese woman. However, approximately 45% 
of women exceed IOM guidelines for GWG, and rates above 50% and as high as 63% have been 
reported. Moreover, women who begin pregnancy OV/OB are more likely to exceed IOM 
guidelines for GWG than are women with pregravid BMIs in the healthy weight range, and some 
evidence suggests that overweight women are even likelier than obese women to exceed GWG 
guidelines. Thus, although the causes of obesity are multi-factorial, the perinatal period is 
uniquely associated with women’s obesity and offers a critical window for improving maternal 
health. 
 
Perinatal interventions have not succeeded in decreasing GWG or affecting weight at one year 
postpartum. 
Previous interventions to address perinatal weight have attempted either to minimize GWG or 
decrease postpartum weight retention. No intervention has successfully addressed the 
psychosocial and circumstantial changes that relate to maternal self-regulation across the 
transition from pregnancy through the postpartum year. Thus, the sequence of interventions that 
promotes behavior change from pregnancy through the postpartum period to improve weight at 
one year postpartum is unclear. We assert that the transition from pregnancy to postpartum offers 
a unique opportunity to optimize health by one year postpartum and that the optimal strategy of 
prenatal and postpartum interventions to effect maternal health may differ according to the 
amount of weight gained during pregnancy. 
 
Interventions to address GWG have not helped OV/OB women avoid excessive GWG. A limited 
number of controlled studies have examined the efficacy of interventions to prevent excessive 
GWG. Overall efforts to moderate GWG have been unsuccessful or have been modestly 
successful, but only among subgroups of women. For example, Polley found intervention helped 
only women who were normal weight before pregnancy. Similarly, Phelan et al tested the 
efficacy of a lifestyle intervention to decrease the number of women with excessive GWG. In a 
sample of 401 women, a lifestyle intervention that addressed eating and activity and included 
provision of body weight scales and pedometers succeeded in minimizing GWG only with 
women who were normal weight prior to pregnancy. Thus, it appears interventions may succeed 

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in preventing excessive GWG, but not among women who begin pregnancy OV/OB. 
 
Additionally, with the exception of a lifestyle program delivered by nurses in Finnish clinics, 
previous interventions to prevent excessive GWG have been limited in intensity. Interventions 
have been designed to offer a small number of group-based sessions, improve GWG monitoring 
among obstetricians, or provide dietary advice without teaching the behavioral principles 
necessary for longer-term behavior change. To optimize longer-term maternal weight and health 
for women who begin pregnancy overweight, addressing GWG alone may be insufficient, 
particularly through brief contacts. Additional components, intensified interventions or an 
approach to weight over the perinatal period may be necessary to alter longer-term obesity-
related risks, particularly among OV/OB women. 
 
Interventions to promote postpartum weight loss have not succeeded among lower income 
women. A second approach to perinatal weight management has focused on postpartum weight 
loss and specifically on the prevention of GWG retention. Substantial evidence indicates that 
changes to eating or activity postpartum pose minimal, if any, risk for OV/OB postpartum 
women. Studies examining the effects of diet and exercise on lactation have documented that 
lifestyle changes do not adversely affect breast milk composition, production or quality or infant 
growth and development although OV/OB women may have difficulty initiating or sustaining 
breast feeding. Thus, the potential risks of postpartum weight loss for OV/OB women are 
minimal and offset by potential benefits. 
 
However, in contrast to interventions for GWG, postpartum weight management efforts have 
been modestly successful. Randomized controlled trials for postpartum weight loss have tested 
the efficacy of brief group sessions, mailed correspondence and group sessions coupled with 
individualized phone calls. For example, Ostbye assigned women to an eating and exercise 
intervention or a no treatment control at 6 weeks postpartum and followed women for one year. 
Intervention comprised 18 group classes addressing exercise and eating and 6 individualized 
telephone contacts. Enrollment in the program was readily accomplished and retention rates 
during the postpartum year were excellent, suggesting that OV/OB women are interested in 
postpartum weight management. However, intervention was not associated with weight loss at 
one year. Moreover, attendance at group classes, which predicted weight change, was very low 
(3.8 of 18 classes) and younger, African American and lower income women were less likely 
than older, white, higher income women to participate. Intervention also was delivered 
irrespective of GWG, and questions about the need for additional intervention for women who 
met or failed to meet GWG guidelines remain. 
 
Finally, the limited efficacy of postpartum weight loss interventions may be due to timing. Most 
trials have initiated intervention 6- or 12-months after childbirth, and one recruited women at 6-
weeks postpartum. In summary, previous postpartum weight loss efforts, and our work on health 
behavior change postpartum suggests that, to maximize efficacy, postpartum interventions need 
to engage women from lower socioeconomic groups, be delivered in a fashion that addresses 
postpartum stressors and capitalize on the immediate transition between pregnancy and the early 
postpartum period. 
 
The proposed SMART is innovative as the first effort to evaluate different combinations, or 

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sequences, of intervention across pregnancy and the postpartum period to decrease maternal 
weight and improve health by one year postpartum. Use of a SMART design provides the 
opportunity to test the efficacy of different sequences of intervention during pregnancy, 
postpartum or both, and to collect data on the benefit of adapting this sequence according to 
GWG. SMART and other dynamic treatment approaches have been applied to psychiatric and 
health, conditions including drug use, and adult and child weight loss, but this proposal 
represents the first use of SMART for perinatal weight. Although pregnancy has been called a 
critical period for weight management, there are no data to determine if delivering a lifestyle 
intervention prenatally, postpartum or across the perinatal transition optimizes maternal weight 
and health by one year postpartum. 
 
Moreover, the transition from pregnancy to postpartum provides an ideal period to evaluate the 
utility of GWG as a potential tailoring variable. GWG is routinely documented and easily 
measured in all women. As such GWG would be a pragmatic variable on which to tailor 
treatment sequences. However, there are no data on the efficacy of GWG as a tailoring variable 
for perinatal weight interventions. The proposed SMART design enables us to evaluate the 
optimal sequence and to test the efficacy of different strategies, or combinations of sequences, 
for women who do and do not meet GWG goals. For example, we will compare the strategy of 
starting with HABITpreg and continuing with HABITpost only when GWG exceeds IOM 
guideline to the strategy of no treatment postpartum for women who receive HABITpreg and met 
their GWG goal. Alternatively, maternal weight one year postpartum may be decreased most by 
starting with TAU and receiving HABITpost only if GWG is high. Finally, by stratifying women 
according to pregravid BMI, we will be in a unique position to explore whether a different 
decision rule is more efficacious for a particular weight group. 
 
There is substantial innovation in using interventions to address the different situational and 
psychosocial needs of women during pregnancy and the postpartum year. To date, no 
interventions have successfully addressed the unique sequential challenges presented by the 
perinatal period. We have made adaptations to the content and modality of the lifestyle 
interventions described, HABITpreg and HABITpost, that address conceptually relevant and 
modifiable factors that affect health in either pregnancy or the postpartum period. In 
HABITpreg, designed to address excessive GWG, we include a focus on weight stability given 
that weight gain is expected. In HABITpost, we recognize the increased time demands of infant 
care and include a focus on postpartum sleep given the impact of sleep on mood and weight in 
general and postpartum weight specifically, as well as the use of telephone and home visits as in 
our previous postpartum work. 
 
A final innovative aspect of the proposed research is the diversity of the proposed sample. 
Previous work on perinatal weight management with women from minority groups or with lower 
incomes has been limited. Although rates of obesity prior to pregnancy have increased among 
women from all backgrounds, African American women had the highest prevalence of obesity in 
a recent survey, and the relationship between parity and weight gain is particularly strong among 
African American women. Lower levels of education also are associated with greater weight 
retention postpartum. Given our previous perinatal health behavior research, we are uniquely 
situated to recruit and retain women of diverse backgrounds and to address questions about the 

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optimal sequence of weight-related interventions for women from minority groups and of lower 
socioeconomic status, who may benefit most. 
 
Study Objectives 
The purpose of this study is to determine the best combination of lifestyle intervention to 
improve maternal weight, health and psychological symptoms at 1 year postpartum. 
 
Specific Aim 1: Determine the combination of prenatal and postpartum lifestyle interventions 
that optimizes maternal weight, cardiometabolic health, depressive symptoms and stress at 12-
months postpartum. 
Hypothesis 1: Women in HABITpreg who are assigned to HABITpost will have improved 
weight and secondary outcomes at 12-months postpartum relative to women who receive only 
HABITpreg or only HABITpost. 
Hypothesis 2: Women who receive only HABITpost will have improved weight and secondary 
outcomes at 12-months postpartum compared to those who receive only HABITpreg or only 
TAUpost. 
 
Specific Aim 2: Determine the optimal combination of interventions based on GWG that 
improves weight, cardiometabolic health, depressive symptoms and stress at 12-months 
postpartum. 
Hypothesis 3: Among women who receive HABITpreg or TAUpreg and gain excessive GWG, 
those who are assigned to HABITpost will have improved weight and secondary outcomes at 12-
months postpartum compared to those in TAUpost. 
Hypothesis 4: Among women who receive HABITpost, women who met GWG goals will have 
improved weight and secondary outcomes compared to those who exceed GWG goals regardless 
of prenatal assignment. 
 
Exploratory Aims: Evaluate the optimal sequence of interventions by prenatal weight. We will 
determine, for example, if the strategy of HABITpreg then HABITpost, regardless of GWG, 
optimizes outcomes for obese women, and if TAUpreg then HABITpost is helpful for 
overweight women only when GWG is excessive. Evaluate the effect of the sequence of 
interventions on infant risk for obesity. 
 
Impact: This SMART is designed to identify the sequence of interventions most likely to 
improve maternal health at one year postpartum. Optimizing the sequence of behavioral 
interventions to address specific needs during pregnancy and the first postpartum year can 
maximize intervention potency and mitigate longer-term cardiometabolic health risks for women 
and their children. 
 
 
Study Design & Methods 
Potential participants will be screened by study staff using a brief self-report format phone 
screening to make sure that they meet eligibility criteria before scheduling the first assessment 
where they will complete the informed consent process. Study staff will obtain verbal consent 
prior to asking the caller any screening questions. 

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If requested and preferred by potential participants, we will send them a link to complete the 
screening questions through webdataxpress. This link to the WDX screening form will also be 
available on our lab website. Individuals will have to consent to the screening process on the site 
before moving on to the screening questions. After answering the screening questions potential 
participants will be presented with different responses depending on eligibility status. 
If ineligible: Thank you for your interest in the HABIT Study. Based on the answers you 
provided in this screener, you are ineligible to participate in our study. We will keep you in mind 
for any future studies. Have a great day! 
If eligible: Thank you for your interest in the HABIT Study. Based on the answers you provided 
in this screener, you are eligible to participate! A member of our team will reach out to you 
within a week or so to schedule an assessment and answer any further questions you may have. 
Have a great day! 
If we need more information to determine eligibility: Thank you for your interest in the HABIT 
Study. A member of our team will reach out to you within a week to discuss your potential 
participation and answer any further questions you may have. Have a great day!” 
 
Assessments: All participants will complete assessments at 16 weeks of pregnancy or less (T0), 
Between 32 and 40 weeks (T1), at 6 months postpartum (T6) and 12 months postpartum (T12). 
Assessments will be conducted by research assessors. Assessments will take place at Magee-
Womens Hospital and each assessment should take 1-2 hours to complete. Assessments will 
consist of the following: (Questionnaires and a schedule of assessments are attached and 
described below) 
 
Height, weight & waist circumference. Height will be measured with a stadiometer at study 
enrollment (T0). Weight will be measured using a calibrated digital scale at all assessment 
timepoints. Women will be measured in street clothes without shoes. Prepregnancy body mass 
index (BMI) will be calculated as (weight in kg)/(height in m2). The use of self-reported 
pregravid weight is common in studies of gestational weight gain and accurate within 1-2 kg. 
Repeated measurements of weight will also be abstracted from medical charts during pregnancy. 
Waist circumference will be measured at T0, T6 and T12. This will be taken using a tape 
measure marked in centimeters and placed at the level of the umbilicus. The average of two 
consecutive measurements will be used. 
 
Gestational weight gain and excessive gestational weight gain. Gestational weight gain (GWG) 
will be calculated as final weight before delivery minus prepregnancy weight. GWG will be 
defined as excessive according to IOM guidelines based on initial prepregnancy BMI. Both the 
categorical (yes/no) variable representing GWG above the IOM guideline for the woman’s 
prepregnancy BMI, and the total amount of GWG will be used as dependent variables. Because 
the length of gestation is a potential confounder of GWG, we will abstract delivery date from 
women’s medical charts and calculate gestational length. 
 
Demographic information. Information including age, race, ethnicity, income, educational 
background, employment status, health insurance status and marital status will be collected at T0 
and updated at T1, T6 and T12. 
 

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Self-reported mood. Women will complete the Center for Epidemiological Studies-Depression 
Scale (CES-D) to assess current depressive symptomatology. The CES-D was selected because it 
appears to be less sensitive than other depression scales to somatic symptoms that may be 
common postpartum. Thus, the CES-D provides a useful repeated measure during pregnancy and 
the postpartum period. Responses on the CES-D will be carefully reviewed, and women who 
endorse extreme scores will be contacted for further evaluation and referral if necessary. This 
questionnaire will be completed at all 4 assessments. The Edinburgh Postnatal Depression Scale 
(EPDS) will be given at all 4 timepoints. This measure of depression specifically looks at 
postnatal depression. Participants will read 10 statements and for each one choose which of four 
possible responses is closest to how she has been feeling during the past week. Anxiety will be 
measured by the State Trait Anxiety Inventory (STAI). 20 questions are rated on a 4 point scale 
with higher scores indicating higher anxiety. This questionnaire will be completed at all 
timepoints. 
 
Sleep quality. The Pittsburgh Sleep Quality Index will be given at all timepoints to assess sleep 
quality. 
 
Sleep chronotype. A modified version of the Munich ChronoType Questionnaire (MCTQ) will 
be used at all timepoints to assess sleep chronotype. This self report questionnaire has questions 
designed to collect more detailed information on sleep patterns. 
 
Sleep health. The RU_SATED 4.0 Sleep Health Scale will assess participants' multidimensional 
sleep health at all timepoints (Baseline, T0, T1, T6, and T12). It is a 6-item measure that assesses 
sleep over the past month. 
 
Infant sleep. The Brief Infant Sleep Questionnaire - Revised (BISQ) Short Form will be used to 
assess infant sleep patterns at T6 and T12. The BISQ is a parent-completed measure of infant 
and toddler sleep. The BISQ assesses start of the bedtime routine, bedtime, sleep onset latency, 
night waking frequency, night waking duration, longest stretch a child remains asleep, total 
nighttime sleep, nap duration, and total amount of time a child sleeps in a 24-hour period. Higher 
scores on the BISQ indicate better sleep. 
 
Stress. Perceived stress will be assessed using the Perceived Stress Scale(PSS). The PSS is a 14-
item scale designed to assess the degree to which an individual appraises situations as stressful. 
This questionnaire will be given at all assessments. 
 
Impulsivity. The UPPS-P Impulsive Behavior Scale will be used as a general measure of 
impulsivity. The UPPS-P is a 59-item measure that assesses five facets related to trait 
impulsivity. The items comprising the measure consist of Likert scale response options. 
Participants will complete select subscales that have a total of 33 questions. The Barratt 
Impulsiveness Scale will be used to assess the personality/behavioral construct of impulsiveness. 
This questionnaire has 30 questions rated on a 4 point scale. Both of these questionnaires will be 
completed at T0, T1 and T6. Another measure of impulsivity that participants will complete at 
each timepoint is the Consideration of Future Consequences Scale. This is a self-report 
questionnaire that comprises 14-items measuring a tendency to consider future consequences of 
behavior. 

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Eating. The Eating Disorder Examination Questionnaire (EDE-Q) is a self-report version of the 
Eating Disorder Examination. The EDE is an interview designed to assess the complete range of 
psychopathology and behaviors related to disordered eating. Participants will complete the Three 
Factor Eating Questionnaire, which contains three empirically derived factors with good internal 
consistency in nonclinical samples. The restraint factor reflects conscious thoughts and 
purposeful behaviors to control food intake. Disinhibition reflects a tendency to relinquish 
control over food intake in response to environmental or emotional stimuli. The final factor is 
hunger. Both of these questionnaires will be completed at all timepoints. In addition, participants 
will also complete 2 dietary food recalls at each assessment. The study will utilize the Automated 
Self-Administered 24-hour (ASA24) Dietary Recall System to collect information about what 
participants ate in the prior 24 hours. At each timepoint participants will complete 2 separate 24 
hour food recalls. The first at their in person assessment and another other one over the phone 
within the next couple weeks. At the end of the 12-month follow-up recalls interviewers will ask 
participants LOC questions (attached in question 2). The Perceptions about Eating and Weight 
during Pregnancy will be administered during T0 and T1 assessments. This questionnaire will 
measure eating and weight concerns and potential misconceptions about eating and weight 
specific to pregnancy. The Power of Food Scale (PFS) will be complete at each assessment 
timepoint. This is used to assess appetite for palatable foods and document the psychological 
impact of living in environments with an abundance of palatable foods. The Eating Pathology 
Symptoms Inventory (EPSI) will assess body image dissatisfaction and eating pathology 
symptoms in this study at T12 only. 
 
Weight Bias- The Weight Bias Internalization Scale (WBIS-M) will be used at all timepoints. 
This measure contains 11 questions on weight bias that are rated on a 7-point Likert scale. 
 
Physical activity- The Pregnancy Physical Activity Questionnaire (PPAQ) will be used to assess 
activity during each assessment. The PPAQ is a self-report measure of physical activity which 
evaluates the duration, frequency, and intensity of physical activity amongst pregnancy women. 
As an additional, objective, measure of activity, participants will be asked to wean an activity 
tracker for a period of time at each assessment timepoint. 
 
Appetite and feeding. The Adult Eating Behaviour Questionnaire (AEBQ) will be used to 
measure the appetitive traits of our participants. The AEBQ is a self report questionnaire with 35 
item rated on a 5 point scale. Participants will complete this questionnaire at each assessment. 
The Baby Eating Behaviour Questionnaire (BEBQ) will be used to measure the appetites of our 
participants’ infants. Mothers will report their child’s appetite by answering 18 questions rated 
on a 4 point scale. This questionnaire will be completed at the T6 assessment. A questionnaire 
about the participant’s intent to breastfeed will be administered at their T1 assessment and at T6 
and/or T12 they will complete a questionnaire about their experience with breastfeeding their 
baby. The Child Eating Behaviour Questionnaire (CEBQ) will be completed during the T12 
assessment to measure the appetites of our participants’ child. Participants will complete this 35 
item scale reporting on their 1 year old child. 
 
Health information. We will collect, via questionnaire, interview format and medical record 
review, information about use of medications, including psychiatric medications, use of other 

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treatments for weight, and the presence of medical conditions (e.g., gestational diabetes) at each 
assessment. We also will collect information about parity and current family composition (i.e., 
number of children and adults living in the home) as well as current and past pregnancy data via 
questionnaire. Information about current smoking status and history of smoking will be collected 
using a self-report questionnaire. The same questionnaire will also ask about past and current 
alcohol use. An investigator designed Cannabis Use Questionnaire will be used to evaluate 
current and past cannabis use. This measure will be used at all timepoints. Medical record 
review. Research assessors will look at participants' medical charts to extract physician measured 
weights, verify that they are having a singleton pregnancy, delivery date, and medical history 
during the pregnancy (e.g. current and preexisiting medical conditions, medications, and other 
treatments being pursued). We will also use participant's medical records to facilitate counseling 
sessions by looking up or verifying their next obstetric appointment date and time. 
 
Mindfulness. To assess mindfulness, the Mindfulness Attention Awareness Scale (MAAS) will 
be used. This scale contains 15 items rated on a 6 point scale and it has been shown to be valid 
and reliable. Participants will completed this measure at each of the 4 timepoints. 
Body Surveillance. Participants will complete a subscale of the Objectified Body Consciousness 
Scale (OBCS) to measure body surveillance, which closely matches self-objectification, or the 
“habitual monitoring of the body’s outward appearance”. This subscale contains 8 questions on a 
7 point Likert scale. Participants will complete this measure at each of the 4 timepoints. 
 
Food insecurity- Food insecurity will be measured using an investigator edited version of the 
U.S. Household Food Security Survey Module. This questionnaire will be given at all assessment 
visits. 
 
Discrimination. The Major Experiences and Everyday Discrimination Scales include 19 
interviewer administered questions. The Major Experiences subscale includes 9 questions about 
employment, housing, 
and education; the Everyday Discrimination subscale includes 10 questions about interactions 
with others (e.g., respect, harassment). Reasons for discrimination (e.g., race, gender, religion) 
are assessed. This interview will be administered at all timepoints. 
 
Adverse childhood experiences will be measured using the BRFSS Adverse Childhood 
Experience (ACE). The measure was edited to also include some questions of emotional and 
physical neglect. This questionnaire will be given at T12. 
 
Measure of behavior change- An investigator designed measure of behavior change will be used 
at all timepoints. This measure contains 44 questions which were designed to evaluate topics 
addressed throughout HABIT treatment such as exercise, eating, sleep and social support. 
 
Program evaluation- The program evaluation form is an investigator designed questionnaire to 
allow HABITpreg and HABITpost participants to give feedback on the study intervention. They 
are able to rate how helpful the program was, how much they enjoyed the program, and provide 
written feedback/suggestions. The form includes questions about their experience with the virtual 
format of the intervention during COVID-19. The measure will be given to pregnancy 
intervention participants at the T1 assessment and postpartum intervention participants at the T6 

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assessment. 
 
Blood draw. Participants will be asked to provide a blood sample to measure 
glucose/insulin/insulin resistance and lipids/inflammation. Levels of estrogen and progesterone 
will also be measured. To gather this information, up to about 2-3tb of blood will be collected by 
a qualified individual contracted through the Magee CTRC. This will be done at all of the 
assessments. If women are unable to attend their assessment at Magee CTRC we will send a 
trained phlebotomist to their home to complete the blood draw. 
 
Infant data: We will conduct medical chart reviews to obtain infant height, weight, and medical 
history during their first year of life, in accordance with the study procedures for participating 
women. We will also collect data on the infant gut microbiome using stool sample kits in 
accordance with procedures from the Center for Medicine and the Microbiome (CMM). At their 
2-6 week postpartum visit, mothers will be provided with fecal sample collection kits and 
instructed to collect infant fecal samples, then mail them in pre-paid approved envelopes to the 
CMM. We will ask participants to complete 4 subscales of the Infant Behavior Questionnaire 
Revised (IBQ-R) at T12. This survey is designed to measure temperament in infants. 
 
Safety alerts: We will ask participants at each follow-up (T1, T6 and & T12) about any medical 
events occurring between visits. Individuals enrolled in the ancillary study will also answer these 
questions at their T2 visit. Any medical events discussed will be logged on an interview form 
labeled with the participant's ID number. 
 
COVID-19 Information: We will ask participants about any COVID-19 positive tests they had 
while they were in the study. Additionally, they will be asked if they received the COVID-19 
vaccine. This interview form will be completed at their final assessment timepoint (12 months 
postpartum). 
 
Intervention: 
By study design participants will be randomized twice over the course of their participation. 
Once at enrollment and again at the time of their second assessment which coincides with the 
end of their pregnancy. After completing the baseline assessment (T0), participants will be 
randomized to either the HABIT intervention during pregnancy or to usual care. Usual care 
consists of the care that pregnant woman usually receive from their obstetric and other providers. 
All women in the study will continue to receive the care they usually receive. Those in usual care 
will not receive any extra treatment from the study team. If they are randomized to treatment 
they will be assigned a coach and will immediately get started with their first session. Treatment 
during pregnancy will consist of up to 10 in person sessions lasting approximately 20-30 
minutes. These sessions will take place at their regularly scheduled OB appointments, at our 
research building, or a nearby location. Participants in the HABITpregnancy group will also 
receive texts and phone calls between sessions. HABIT will focus on weight, physical activity, 
eating and psychosocial issues. Intervention goals will emphasize adherence to healthy behaviors 
rather than absolute weight goals. Specifically, women will receive consultation about nutritional 
balance, dietary guidelines for pregnant women and advice to maintain an optimal rate of weight 
gain according to prepregnancy BMI. Women will use self-monitoring forms to identify and 
modify cues for unhealthy behaviors. Beliefs about body weight and eating during pregnancy 

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will be addressed and effects of physical activity on body weight, health, and mood will be 
included. Mood will be monitored by the EPDS questionnaire to help tailor individualized 
treatments. To help facilitate treatment, participants who need them will be provided with smart 
phones and Bluetooth enabled scales. Participants who are assigned to usual care will not have 
regular contact with study staff. 
After participants complete the T1 assessment towards the end of their pregnancy they will again 
be randomized to either receive HABIT treatment postpartum or to receive usual care. All 
participants will be randomized again. Usual care consists of the care they would usually receive 
from their OB and other providers. All women will continue to receive this care, however, those 
assigned to usual care will not receive any additional treatment from the study. If participants are 
assigned to HABITpostpartum they complete a separate intervention of over the 24 weeks 
immediately following delivery. Treatment will consist of 12 biweekly sessions completed over 
the phone or in person. In person sessions will be done at the participant’s home or another 
convenient location. Additionally, participants will receive calls and texts between sessions. 
Mood will be monitored by the EPDS questionnaire to help tailor individualized treatments. All 
participants will continue to receive their standard postpartum care from their medical team. 
Counseling sessions during pregnancy and postpartum will be conducted by research project 
staff that has, at least, masters level or equivalent degrees. Counselors will be trained by Dr. 
Levine prior to the start of the project. To help facilitate treatment, participants who need them 
will be provided with smart phones and Bluetooth enabled scales. Treatment materials are 
attached to the end of this application. 
Treatment sessions will be audio taped for supervision. 
 
All newly enrolled participants and any previously enrolled participant that has not yet delivered 
her baby will be invited to participate in the ancillary study. Women who agree to participate in 
the ancillary study will complete additional assessments at each HABIT timepoint and an 
additional assessment between delivery and 4 weeks postpartum. During these assessments they 
will complete the following: 
 
Impulsive phenotypes. Participants will complete a battery of computer tasks to measure 
impulsivity. These tasks include the Go/No-Go Task- A computerized task in which stimuli are 
presented continuously and individuals must make a motor response for the go stimulus and 
withhold a motor response for the no-go stimulus. Stroop Color-Word Test- A computerized task 
in which individuals are required to name the color of a written color word while inhibiting the 
impulse to read the word itself. Delay Discounting Task- a computerized task in which 
individuals choose between smaller, immediate monetary rewards and larger, delayed monetary 
rewards. Wisconsin Card Sorting Test- a computerized task in which individuals have to match a 
target card with one of four category cards under changing conditions. Before completing these 4 
computerized tasks, participants will complete a shortened practice round of the Go/No-Go Task 
and the Stroop Color-Word Test. During this practice round, participants will be encouraged to 
"go faster" when they are responding too slowly. In addition to these computer tasks, participants 
will also complete the Consideration of Future Consequences Scale which is a self-report 
questionnaire that comprises 14-items measuring a tendency to consider future consequences of 
behavior. 
 
Eating behaviors. Participants will complete the self reported Power of Food Scale to assess 

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appetite for palatable foods and document the psychological impact of living in environments 
with an abundance of palatable foods. 
 
All of these measures will be given at each HABIT timepoint as part of the ancillary study. In 
addition, participants will complete one additional visit outside of the regular HABIT timeline. 
This assessment will occur in the early postpartum period. In addition to the measures just 
described participants will be weighed, complete demographic and other questionnaires that are 
completed as part of HABIT (described above). 
 
Participants will be asked to complete 3 follow up assessments. They will complete an 
assessment at the end of their pregnancy (T1), 6 months postpartum (T6) and at 12 months 
postpartum (T12). Individual components of these assessments are described in detail above. 
 
Participants enrolled in the ancillary study will complete one additional follow-up assessment 
outside of the HABIT schedule. This early postpartum assessment (T2) will be completed 
between delivery and 4 weeks postpartum. Individual components of this assessment is described 
in detail above. 
 
During the social restrictions placed due to COVID-19 we will be doing assessments remotely 
with already enrolled participants. The same assessments will be completed that are typically 
completed in our office. However, we are adding in 1 additional questionnaire (uploaded below) 
to assess how well the ancillary computer tasks worked for them on their device. The answers to 
this questionnaire will help us interpret this data that was collected in a different way. 
 
During the COVID-19 shutdown of in person research we will consent new participants into the 
study remotely. In order to get a baseline weight, study staff may drop off a study scale outside a 
participant's home or another convenient location in order to get a baseline weight. The scales 
will be picked up at a later date outside of their home. Staff will have no direct contact with the 
participants. In addition, we will ask participants for any available self reported blood work 
results that match with the blood work that we typically get at baseline assessments. If recent 
results are available in medical records we will send the participant an additional medical release 
to pull that information. 
 
Eligibility Criteria  
Women will be eligible if they: (1) have a prenatal BMI ≥ 25; (2) are at or before 17 weeks and 4 
days of gestation; (3) are English speaking and (4) have a singleton pregnancy. We considered an 
upper limit to BMI. However, given the paucity of data on weight outcomes for women with 
BMIs >35, we elected not to limit BMI but will randomize women in two strata according to 
BMI (25-29.9 vs. ≥30). Similarly, parity may impact perinatal weight, but intervention goals are 
similar for primagravidae and multiparous women. Thus, we will recruit women regardless of 
gravida and parity, and include these variables as covariates in all analyses. 
 
With the approval of modification #20: (5) Identify as Black or Multiracial Black 
 
Infants will be eligible for medical record and microbiome data collection if (1) mothers' are 

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enrolled into HABIT after MOD16020497-12 or (2) if we are able to reconsent their mothers' 
during the T1 or T2 timepoints. 
 
Statistical Considerations 
First, we will use descriptive statistics and graphic displays to identify outliers, missing data and 
patterns of attrition, and to guide decisions about the use of transformations to satisfy the 
normality assumption. Next, demographic variables and baseline measures will be compared 
between HABITpreg and TAUpreg and between HABITpost and TAUpost using two-sample t- 
or Wilcoxon rank sum tests for continuous variables and chi-square or Fisher’s exact tests for 
categorical variables. Data from women who have become pregnant again or for whom 
pregnancy did not result in a live birth will be excluded. 
 
To utilize the longitudinal data collected, linear mixed-effect models will be the primary analytic 
tool. Mixed-effect models are useful for longitudinal datasets that contain missing observations, 
as anticipated in this study, under the assumption of missing at random (MAR). The MAR 
allows a relationship between missingness (e.g., drop-outs, missed assessments) and outcome 
through their mutual relationship to other covariates, such as treatment sequences or pre-
pregnancy weight status. No residual relationship between missingness and outcome is required 
once covariates are taken into account. However, we also will examine patterns of missingness, 
and report the average effect over different missing patterns if necessary. In each mixed-effect 
model, we will include group, time, group by time interaction, and the stratification factor, pre-
pregnancy BMI (≥30 or <30) as fixed terms. Subject will be included as a random term to 
account for repeated measures from the same subject. Different covariance structures will be 
compared to determine the best model fit. 
 
There are 8 sequences or combinations of intervention in this SMART, which we use to define 
group for hypothesis testing. Time also is a generic factor, and the number of levels will depend 
on the outcome being modeled. For example, for weight, mood and stress, time will be a linear 
term beginning at baseline, and a quadratic term will be added to the model if necessary. For 
other outcomes, time will be a factor with 4 levels (baseline, end of pregnancy, and 6- and 12-
months postpartum). We also will evaluate the need to control for the effects of potential 
confounds such as race, age, socioeconomic status (fixed covariates) as well as breastfeeding, 
smoking status and physical activity (time-varying covariates). If the coefficients for groups or 
group by time interactions are significant, planned contrasts will evaluate groups on weight and 
related outcomes at 6- and 12-months postpartum. Additionally, we will create a binary variable 
for 5% weight loss and use generalized mixed-effect models with the logit link to compare 
groups on proportions with 5% loss at 6- and 12-months postpartum.  
 
Finally, to fully utilize a SMART design, and to evaluate the utility of using GWG as a tailoring 
variable, we will explore what the optimal strategy is and for which participants. A dynamic 
strategy is a decision rule about which intervention is best initially and what intervention 
follows, depending on the response status. The proposed deisgn produces HABITpreg and TAU 
during pregnancy, and women who do and do not meet IOM guidelines for GWG each have 
HABITpost and TAU postpartum, resulting in the 8 possibilities sequences.