Partnering With WIC to Prevent Excessive Weight Gain in Pregnancy
Phase: NA
Conditions: Obesity, Overweight, Pregnancy Related
Sponsor: Temple University

Study Title:   
 
 
Partnering with WIC to Prevent Excessive Weight Gain in Pregnancy 
 
NCT Number:  
 
 
NCT03707834 
Documents Included:  
IRB Approved Protocol with Statistical Analysis Plan 
 
Date of IRB Approval:  
 
09/21/2021  

Protocol #25256  
 
 
 
Page 1 of 31 
IRB Approved September 21, 2021 
1) Abstract of the study 
Institute of Medicine guidelines for weight gain in pregnancy are clear, but evidence-
based treatment approaches are not widely available. This evidence gap is 
particularly pressing for medically vulnerable women - those who are low income 
and often racial/ethnic minorities. These women have the highest rates of obesity, 
but almost no resources to support weight control in pregnancy. Without 
intervention, most will exceed Institute of Medicine recommended gains and incur 
significant morbidity for themselves and their children. There is preliminary data from 
our group supporting the efficacy of digital health platforms for delivering antenatal 
obesity treatment among the medically vulnerable. However, our inexpensive, easily 
scalable approach has not been integrated and tested in real world settings, limiting 
broad reach and dissemination potential. Dissemination considerations are 
especially pressing for socioeconomically disadvantaged and minority populations 
because of these groups’ higher obesity risk, greater potential for experiencing 
obesity-related comorbidities in pregnancy, and limited finances to afford alternative 
treatments. The Women, Infants and Children (WIC) Food and Nutrition Program is 
the leading public health nutrition program for pregnant women and their children in 
the US, and thus, it is in a unique position to meaningfully impact the obesity 
epidemic among the more than 9 million disadvantaged participants it serves 
annually. Yet no demonstrations of effective gestational weight gain interventions 
exist in WIC. We propose a pragmatic trial designed to rigorously test our antenatal 
obesity treatment approach integrated into Philadelphia WIC community clinics. We 
have long-standing relationships with WIC staff and prior experience conducting 
pragmatic clinical trials in under-resourced settings. We will randomize 438 African 
American and Latina Philadelphia County WIC participants with obesity in early 
pregnancy to one of two treatment arms: 1) usual WIC care; or 2) healthy lifestyle 
intervention arm, which includes empirically supported behavior change goals, 
regular self-monitoring text messages with automated feedback, tailored skills 
training materials, and counseling from WIC nutritionists. Our primary outcome is 
prevalence of excessive gestational weight gain; we will additionally examine 
changes in diet and physical activity, health-related quality of life, and rates of 
adverse pregnancy outcomes. We will use the RE-AIM (Reach, Effectiveness, 
Adoption, Implementation, Maintenance) framework to evaluate the intervention’s 
dissemination potential and cost effectiveness in the WIC setting. The proposed 
project will constitute the first systematic translation of a comprehensive antenatal 
obesity treatment program focused on low-income, racial/ethnic minorities, using the 
strengths of mHealth and WIC provider counseling for intervention delivery.  
 
2) Protocol Title 
Partnering with WIC to prevent excessive weight gain in pregnancy  
 
3) Investigator  
Sharon Herring, MD, MPH 
 
4) Objectives 

Protocol #25256  
 
 
 
Page 2 of 31 
IRB Approved September 21, 2021 
a. Primary specific aim: To determine whether the healthy lifestyle program 
lowers the prevalence of excessive gestational weight gain, compared to 
usual WIC care. Primary hypothesis: Participants randomized to the healthy 
lifestyle intervention arm will demonstrate significantly lower prevalence of 
excessive gestational weight gain, compared to those randomized to usual 
WIC care.  
b. Additional aims:  
i. To compare trial arms with respect to changes in diet and physical 
activity, and rates of adverse pregnancy outcomes (including glucose 
intolerance, hypertension, and infant macrosomia). 
 
ii. To utilize the RE-AIM framework to evaluate the intervention’s 
dissemination potential in WIC. We will assess: reach into the patient 
population; effectiveness on outcomes; organizational adoption; 
consistency of implementation; and maintenance of effects on 6- and 
12-month maternal/child postpartum weights.  
 
iii. To quantify the intervention’s cost-effectiveness. 
 
5) Rationale and Significance  
Nearly two-thirds of pregnant women exceed Institute of Medicine (IOM) weight gain 
guidelines.1 Excessive gestational weight gain not only adversely affects the current 
pregnancy – by increasing risk of diabetes and hypertension, cesarean delivery, and 
infant macrosomia – but it also promotes new or persistent obesity in women and 
their children.2,3 Ethnic minority women are at particular risk of greater gains 
because they are more likely to enter pregnancy obese,4 reside in obesogenic 
environments,5 and adopt obesity promoting behaviors (e.g., high caloric intake, 
physical inactivity).6-8 However, these high risk women also suffer from a paucity of 
treatments. Without intervention, the implications are clear: most will exceed 
recommended gains in pregnancy and incur significant morbidity for themselves and 
their children.9,10  
 
We are working to fill this treatment gap. For nearly a decade, our group of 
multidisciplinary researchers has partnered with African American and Latina 
women, primarily those of lower socioeconomic position, to develop innovative 
weight control treatments that: 1) focus on simple, empirically-supported behavior 
change goals, tailored to the target population;11-13 and 2) use low-cost, mobile 
technologies that enjoy high penetration among racial/ethnic minorities (text 
messaging, social media) to deliver intervention content, promote social support, 
and allow for frequent yet convenient, interactive self-monitoring.14 There is 
mounting evidence supporting the efficacy of this approach for delivering 
inexpensive, easily scalable weight control interventions,15-18 particularly in 
pregnancy.19 Our pilot intervention for this proposal cut the proportion of African 
American mothers gaining in excess of IOM guidelines in half.19 While our study had 
high engagement and low attrition, the treatment was implemented in a single 
obstetric clinic using research staff for interpersonal support, limiting broad reach 

Protocol #25256  
 
 
 
Page 3 of 31 
IRB Approved September 21, 2021 
and dissemination potential. We posit that mHealth interventions must be delivered 
with additional counseling from trusted, routine care providers to reliably produce 
clinically significant outcomes and sustain effects.20-24 However, no demonstrations 
of effective gestational weight gain interventions have included brief provider 
counseling as a component. Doing so is a high priority. 
 
The next step is to integrate our promising pilot intervention into the Women, Infants 
and Children (WIC) Food and Nutrition Program, the leading public health nutrition 
program for low-income pregnant women and their children in the US.25 WIC 
provides routine care for nearly 2 million pregnant women annually, yet standard 
care at WIC is inadequate for addressing antenatal obesity.26 Mothers from our pilot 
revealed a need for WIC nutritionist involvement to enhance trust and 
receptivity of our messages. We have spent the past year talking at length with 
WIC nutritionists through focus groups about integrating our interventions into daily 
practice, brainstorming strategies we plan to employ in this proposal.27 For example, 
WIC nutritionists have voiced repeated frustrations about lack of time for patient 
follow-up between antenatal visits, as there is no method in place to maximize 
counseling for those who need it most. We plan to test an approach, grounded in 
theory and our preliminary work that will electronically alert providers if their patients 
are not achieving intervention goals, offering WIC nutritionists scripts for brief, 
tailored strategies to deliver by phone – so to increase efficiency and potentially 
lower costs. 
 
We propose a pragmatic trial design in which we will randomize 438 African 
American and Latina Philadelphia County WIC participants with obesity in early 
pregnancy to either usual WIC care or a healthy lifestyle intervention arm. The 
intervention arm, adapted from our pilot with WIC nutritionist input, is a multi-level, 
systems-change antenatal obesity treatment approach. At the patient level, we 
will provide empirically-supported behavior change goals, self-monitoring text 
messages with feedback, tailored skills training materials, and interpersonal support 
from trusted WIC providers. At the provider level, we will make it easier for WIC 
nutritionists to advise about weight gain in pregnancy by providing electronic patient 
progress reports and counseling recommendations. Our primary outcome is 
prevalence of excessive gestational weight gain. If successful, this approach can 
be quickly scaled to impact the entire WIC program.  
 
6) Resources and Setting  
a. Recruitment Sites: To maximize recruitment, while WIC is conducting visits 
virtually, data queries and phone screening by WIC staff will include 
participants from all 10 of Philadelphia WIC’s community clinic sites.  Once 
sites resume in-person visits, we will resume in-person recruiting.   
i. North Philadelphia WIC Clinic,1300 West Lehigh Avenue, Philadelphia, 
PA 19132 
ii. Olney-Logan WIC Clinic, 5751 N. Broad Street, Philadelphia, PA 
19141 
iii. Aramingo WIC Clinic, 2401 East Tioga Street, Philadelphia, PA 19134 

Protocol #25256  
 
 
 
Page 4 of 31 
IRB Approved September 21, 2021 
iv. South Philadelphia WIC Clinic, 1165 South Street, Philadelphia, PA 
19147. 
v. Northeast WIC Office, 7959 Bustleton Avenue, Philadelphia, PA 
19152. 
vi. Overbrook WIC Office, Overbrook Plaza, Store # 1400, 5610 
Lancaster Avenue, Philadelphia, PA 19131 
vii. Woodland WIC Office, 1741 South 54th Street, Philadelphia, PA 
19143. 
viii. St. Christopher WIC, Nelson Pavilion Bldg, 160 East Erie Avenue, 
Philadelphia, PA 19124 
ix. Lehigh WIC Office, 217-33 West Lehigh Avenue, 2nd Fl. Philadelphia, 
PA 19133 
 
b. Research Procedures Site:  
Assessment visits (combined CORE Screening/Enrollment (CS/EN) >
weeks gestation], end of pregnancy [36-38 weeks’ gestation], 6-months 
postpartum, and 12-months postpartum) will occur over the phone with 
Temple research staff member.  All staff will complete calls from a private 
space. 
 
If public health guidelines allow and participants consent, these calls may be 
conducted as in-person visits at Temple’s CORE office (3223 N. Broad Street, 
Suite 175) or if transportation is an issue, we will conduct these visits at the 
participants’ home.   
 
7) Prior Approvals 
WIC is strongly supportive of our efforts (see updated approval letter attached from 
WIC). 
 
8) Study Design 
a. Recruitment Methods: Up to 600 women will be recruited and consented for 
this study.  We plan to enroll and randomize a total of 438 participants (219 
per arm).  Based on prior studies (Herring PI, Protocol #20227, “The effects of 
an electronically-mediated, pregnancy and postpartum, behavioral 
intervention program on changes in weight and cardiometabolic biomarkers: 
Healthy4Baby” NIH K23HL106231-01 and Herring PI, Protocol #22201, 
“Targeting pregnancy-related weight gain to reduce disparities in obesity: a 
randomized control trial” HRSA R40MC26818), we will likely need to recruit 
and screen approximately 40% more women than our randomization target 
(as we anticipate no-shows to baseline visits).   
 
b. Recruitment via advertisements and flyers: Study advertisements will be 
used and are attached. Subjects will be deemed eligible for screening by 
completing a phone screen with a WIC staff member. The phone screen will 
include questions related to determining if the subject meets the study’s initial 
inclusion and exclusion criteria (see section 8e below for inclusion/exclusion 

Protocol #25256  
 
 
 
Page 5 of 31 
IRB Approved September 21, 2021 
criteria).  Research staff will devote time daily to fielding phone calls, 
scheduling study subjects for screening visits, and conducting screening 
visits.  
 
c. Recruitment via WIC’s electronic patient database: Potential participants 
for this clinical trial will include patients identified through WIC’s electronic 
patient database, using the eligibility criteria described in the 
inclusion/exclusion criteria section below. We will target patients who are 
seen at the WIC sites described in the recruitment site section above (6a). Dr. 
Kilby, WIC Executive Director, has provided an updated letter of support for 
this study and its recruitment approach (see approval letter attached to this 
protocol). We’ve used a similar approach in previous studies. We are 
requesting a HIPAA waiver in order to identify potentially eligible patients via 
WIC’s electronic patient database. 
i. Criteria used to develop the computable phenotype: 
1. Age in years (>= 18 years) 
2. &XUUHQWO\SUHJQDQWZHHNV¶JHVWDWLRQZLWKLQGD\VRIWKH
data query 
3. %0,NJPZLWKLQGD\VRIWKHGDWDTXHU\ 
 
ii. Once a list of patients is generated using this phenotype by WIC staff, 
an IRB-trained WIC staff member Gloria Lobato, Lauren Brennan, or 
Sam Nash will text message or call identified patients in English and/or 
Spanish and explain the purpose of the study, assess interest, and 
evaluate eligibility (see WICProvider/Phone screen for script and 
eligibility questionnaire).  All Spanish speaking participants will be 
screened by Gloria Lobato, who is bilingual. Participants who are 
initially eligible after phone screening (see inclusion/exclusion criteria 
below) will be scheduled for a combined CS/EN call or visit where they 
will be immediately consented in English or Spanish for the study by 
Temple study staff (note, all study visits for Spanish speaking 
participants will be administered by Alberly Perez, who is bilingual). 
1. Text messaging will be managed by above WIC staff. Phone 
numbers and participant information will be given to Temple 
staff only after participant agrees. Sample English text 
messages are: 
a. "Hi! WIC is working with Temple University on a new 
program to improve women's health. If you’re interested, 
please let us know when we can call you!" 
b. "Hi! We just tried to call to let you know that WIC is 
working with Temple University on a new program to 
improve women's health. If you’re interested, please let 
us know when we can call you again!" 
2. Sample Spanish text messages are: 

Protocol #25256  
 
 
 
Page 6 of 31 
IRB Approved September 21, 2021 
a. "¡Hola! WIC está trabajando con la Universidad de 
Temple en un programa nuevo para mejorar la salud de 
las mujeres. Si está interesada, ¡por favor avísenos 
cuándo podemos llamarla!"  
b. "¡Hola! Nosotros intentamos llamarle para informarle que 
WIC está trabajando con la Universidad de Temple en un 
programa nuevo para mejorar la salud de las mujeres. Si 
está interesada, ¡por favor avísenos cuándo podemos 
llamarla de nuevo!" 
 
iii. Participants can contact the WIC staff/study team at any time if they 
wish to opt out of further contact regarding this trial and no further 
contact will be made.  In that case, they will be reminded that they can 
contact WIC staff/study team at any time to learn more about the study 
if they change their mind. Refreshing the patients meeting the 
computable phenotype criteria will occur every 30 days after the initial 
data query.  This refresh will capture newly identified patients for future 
recruitment. Only WIC staff will be given WIC client information until 
potential participants agree (via phone) to be contacted by Temple 
staff.  
 
iv. All participants will be emailed or mailed a copy of the consent prior to 
their CS/EN call.  During the CS/EN call or visit, staff will use Redcap 
to facilitate the process of consenting electronically. The link will be 
emailed or texted to the participant during the phone call or visit. 
Participants will then have to electronically sign the Informed Consent 
Form, HIPAA Authorization, and the Medical Record Release forms 
(prenatal, delivery, infant, and WIC). In the instance that Redcap is not 
working, we will continue to consent over the phone. The staff member 
consenting will sign for themselves, send a copy of the consent to the 
participant, and create a note-to-file explaining why the subject signed 
the consent on a different day. 
 
v. Once consented in-person or during the CS/EN call, maternal height 
and weight will be measured or self-reported by the participant to 
ensure participants fall within the BMI eligibility range (see 
inclusion/exclusion criteria).  
 
vi. They will then complete questionnaires (assessing sociodemographics, 
medication intake, psychosocial factors, health insurance, income, 
hospital and outpatient visits, quality of life, and executive functioning) 
read out-loud by Temple study staff to minimize literacy demands. 
Additionally, research staff will administer the ASA24 dietary recall 
during the combined CORE Screening/Enrollment visit or call (a tool 
that assesses participant dietary intake over the previous 24 hours).  

Protocol #25256  
 
 
 
Page 7 of 31 
IRB Approved September 21, 2021 
 
vii. Participants will then be enrolled and randomized 1:1 per computer-
generated assignments in REDCap to healthy lifestyle intervention (A0; 
n=219) or usual WIC care (SC; n=219). Randomization will be stratified 
on weight status (overweight vs. obesity) and ethnicity (African 
American vs. Latina).  Dr. Herring and her staff will be blinded to group 
assignment until participants reach randomization. Participants who 
choose not to participate, or who are ineligible, will be referred back to 
their WIC providers/Obstetricians for health/nutrition information. 
 
viii. If a call is needed/requested (e.g. due to Covid-19 restrictions on in-
person vists), upon completion of the combined CS/EN call, 
participants will be sent via UPS a BodyTrace scale to use for weight 
at each time point. Additionally, they will be sent paper copies of their 
signed Informed Consent Form, the HIPAA Authorization, and the 
Medical Record Release forms (prenatal, delivery, infant, and WIC) 
   
d. Inclusion and Exclusion Criteria 
i. Inclusion Criteria:  All participants must meet all of the following criteria 
at screening 
1. Women at least 18 years of age 
2. 0HDVXUHG%0,EHWZHHQNJP 
3. Self-identify as African American or Latina  
4. Philadelphia WIC participant 
5. *HVWDWLRQDODJHZHHNV¶E\ODVWPHQVWUXDOSHULRG 
6. Willingness to receive study texts  
7. Own a cell phone with an unlimited text messaging plan 
8. Able to participate in light to moderate physical activity (walking) 
9. Participants must be willing to comply with all study-related 
procedures 
10. Participants must be able to read and write fluently in English or 
Spanish 
 
ii. Exclusion Criteria:  If participants meet one of the following criteria, 
they will be excluded. 
1. Prior bariatric surgery 
2. Pre-existing medical condition and/or medication that could 
influence weight (e.g., diabetes, HIV, thyroid disorder, bulimia, 
anorexia, gallbladder disease)  
3. Diagnosis contraindicating weight control (e.g., hyperemesis 
gravidarum) 
4. Shared phone 
5. Multiple pregnancy (e.g., twins) 
6. Current and/or previous participant of our Temple-led obesity 
treatment interventions in pregnancy or the postpartum period 

Protocol #25256  
 
 
 
Page 8 of 31 
IRB Approved September 21, 2021 
7. Serious or unstable medical or psychological conditions that, in 
the opinion of the investigator, would compromise the subject’s 
safety for successful participation in the study  
 
e. Study Timelines 
i. The duration of a subject’s participation in the study: Approximately 18 
months. Participants will be followed for one year after delivery. 
 
ii. The duration anticipated to enroll all subjects: approximately 30 
months. 
 
iii. The estimated date that the investigators will complete the study: 
December, 2023. 
 
9) Study Procedures and Data Analysis 
a. Data collection: This section reviews the types of data that will be collected, 
stored, and analyzed to meet the scientific goals of the study. Trained 
research staff will collect assessments for participants in intervention and 
usual care arms at multiple time points (Table 1). Our evaluation protocol will 
be similar to the ones we have used successfully in prior trials. If 
transportation is an issue, we will conduct visits at participants’ homes.  
b. We will additionally abstract data from participants’ WIC records and obstetric 
charts, including 24-28 week oral glucose tolerance test (OGTT) results, 
prenatal weights, and infant birth weight at delivery. We have used this 
pragmatic approach to collect high-quality data from medical records in prior 
studies.19,28 A detailed study timetable and list of all procedures at each visit 
are shown below: 
Table 1: Summary of types of data collected 
Measure 
WIC/Phone 
Screening 
Time point 
CORE 
Screening/ 
Enrollment 
(CS/EN) 
Baseline 
36-weeks’ 
Gestation 
 
Follow-up 1 
6-Mo 
Postpartum  
 
Follow-up 2 
12-Month 
Postpartum 
  
Follow-up 3 
Screening Eligibility Form 
X 
 
 
 
 
Informed Consent 
 
X 
 
 
 
Questionnaires 
 
X 
X 
X 
X 
Maternal Weight 
 
X 
X 
X 
X 
Maternal Height 
 
X 
X 
X 
X 
Infant Weight 
 
 
 
X 
X 
Infant Length 
 
 
 
X 
X 
ASA-24: 24-Hour Recall of Food 
Intake 
 
X 
X 
 
 
Maternal Medical Record Review 
 
X 
X 
X 
X 
WIC Medical Record Review 
 
X 
X 
X 
X 

Protocol #25256  
 
 
 
Page 9 of 31 
IRB Approved September 21, 2021 
 
i. Questionnaires. Participants will complete several questionnaires at 
each time point (by phone or in-person, depending on participant 
preference and/or Covid-19 restrictions on in-person visits): Core 
Screening/Enrollment (CS/EN), 36-38 weeks’ gestation (end of 
pregnancy), 6 months postpartum, and 12 months postpartum. All 
questionnaires will be read out-loud by study staff to minimize literacy 
demands. These questionnaires will contain the following items (with 
data collected and stored in REDCap): 
1. Psychosocial measures: Using previously validated 
questionnaires (merged into a single screening and follow-up 
survey), participants will self-report: 1) food security via the 6-
item USDA survey, 2) health literacy via the BRIEF: Health 
Literacy Screening Tool, 3) quality of life via the Short Form 12 
or SF-12, and 4) questions about housing stability.  
2. Economics: A variety of variables related to health insurance, 
work productivity, income, and hospital and outpatient visits will 
be collected to assess the cost-effectiveness of the intervention. 
3. Sociodemographics: A variety of variables will be collected via 
self-report, including age, parity, marital status, smoking history, 
and education. 
4. Concomitant medications and adverse events: At all visits, 
medications added/adjusted and adverse events will be 
recorded.   
5. Infant feeding: Infant feeding behaviors and beliefs will be 
assessed from questions adapted from the Infant Feeding Style 
Questionnaire at 6 month and 12 month postpartum visits.  
6. Executive functioning: Participants’ executive functioning will be 
assessed using the BRIEF-A (Behavior Rating Inventory of 
Executive Function) at CS/EN. 
7. Patient-provider interactions: This will be assessed at the 36-
week (end of pregnancy) visit and the 6-month postpartum visit 
via the MOR: Mothers on Respect Index and the MADM Scale: 
Mothers Autonomy in Decision Making. 
 
ii. Weight and height. Maternal weight will be measured at each time 
point either in-person or using a BodyTrace scale that will be sent to 
the participant after completion of the combined CS/EN call or visit.  
Height will be measured in-person or self-reported during the 
combined CS/EN call or visit. 
   
iii. Infant weight and length. With the participant’s optional consent, we 
will have them sign medical record release forms to get their infant’s 
weight and length from their pediatrician. These will be used to 

Protocol #25256  
 
 
 
Page 10 of 31 IRB Approved September 21, 2021 
approximate measures at 6-months and 12-months of age and assess 
maintenance of intervention effects on infant weight/length.  
 
iv. 24 Hour Dietary Recall (ASA-24). Measures of dietary intake via 
electronic 24-hour recalls administered at combined CS/EN call or visit 
and at the end of pregnancy visit. More details are provided in the data 
analysis section below. 
 
v. Medical record review. With the participant’s consent, we will extract 
information about her medical history to confirm eligibility, health 
problems and weight during pregnancy, delivery records, and 
postpartum records.  
 
WIC record review. With the participant’s consent, we will extract 
information about nutritional topics/issues discussed at WIC visits 
occurring during the study period. We will extract maternal and infant 
weight and height data collected at WIC visits during the study period. 
We will also extract any changes to participants’ address(es) and 
phone number(s) collected at WIC. 
 
c. Treatment: This section reviews the two treatment arms in the study.   
i. Eligible volunteers will be randomly assigned by Temple study staff, 
with use of a random-number generator in RedCap, to a treatment 
group consisting of either usual WIC care (SC) or an individual, healthy 
lifestyle intervention (AO) that consists of: 1) empirically supported 
behavior change goals; 2) self-monitoring of behavioral diet goals and 
weight gain via text messages with automated feedback; 3) tailored 
skills training materials; and 4) WIC nutritionist counseling. 
 
ii. Description of SC: Participants assigned to the WIC usual care arm will 
receive usual care offered to pregnant women at WIC. Per WIC 
protocol, participants will be strongly encouraged to schedule routine 
prenatal care visits with their obstetricians, who will be informed of the 
patient’s participation (but not randomization assignment) via letter 
(included in the original submission). We will ensure that WIC 
providers have access to self-help materials (e.g., brochures from the 
American College of Obstetricians and Gynecologists [ACOG]) and 
quarterly trainings on obesity treatment updates). Additionally, all 
participants randomized to SC will receive self-help materials compiled 
from American College of Obstetricians and Gynecologists [ACOG].  
 
iii. Description of AO: In addition to usual WIC care described above, 
participants in the AO arm (or Healthy Lifestyle Group) will receive a 
multi-component, theory- and evidence-based antenatal obesity 
treatment. Rooted in Social Cognitive Theory, our intervention is 

Protocol #25256  
 
 
 
Page 11 of 31 IRB Approved September 21, 2021 
designed to enhance mothers’ self-efficacy and intrinsic motivation for 
weight-related behavior change through goal setting and self-
monitoring (self-regulatory processes), behavioral skills training 
(mastery experiences), interpersonal support (social persuasion), and 
social modeling strategies.30-32 Also integrated is a Social Ecological 
Approach that highlights the complex interplay among individual-, 
family-, and community-level factors.33,34 Thus, treatment emphasizes 
changing behavior across multiple spheres of influences and various 
settings (e.g., expanding an individual’s nutrition knowledge, effectively 
dealing with constraints of income and access, modifying the home 
environment). 
1. Behavior change goals: Our treatment focuses on adhering to 
a set of simple behavior change goals that directly/indirectly 
modify energy balance, chosen for their relevance to the target 
population, ease of self-monitoring, concreteness, and empirical 
support for weight control.11,35-39 Our behavioral goals have 
proven efficacy, even in resource constrained settings.15-19,28 
During the combined CS/EN call, all participants in the AO 
group will receive 3 behavior change goals: 1. Limit starchy 
foods like white rice, mac & cheese, white bread, and potatoes 
to no more than 1 a day; 2. No sugary drinks; 3. Eat at least 1 
green veggie a day. From our skills training library, videos will 
be immediately texted that focus on “how” to reach each goal 
rather than simply “what” to change and provide an orientation 
to the program. To foster novelty yet maximize behavioral habit 
formation, we will rotate participants’ goals at 8-week intervals, 
aiming for repetition to achieve automaticity.40,41 The second 
group of goals are: 1. No greasy foods; 2. Limit your sweet and 
salty snacks like chips, cookies, ice cream, and cake to no more 
than 1 baby-sized snack a day; 3. Eat at least 1 fruit a day. All 
participants will alternate between the two goal groups at 8 
week intervals until they complete their end of pregnancy visit. 
To facilitate goal attainment, participants will receive a water 
bottle, measuring bowls and spoons, a magnetic shopping list, 
and a cookbook after completion of t the combined CS/EN call. 
 

Protocol #25256
Page 12 of 31
IRB Approved September 21, 2021
2. Interactive self-monitoring text messages: Regular self-
monitoring is one of the most efficacious behavior change 
strategies,42 though adherence notoriously wanes over time.43
Texts are inexpensive to develop, simple to tailor, and 
immediately scalable. Greater self-efficacy and satisfaction is 
observed when text messages are encouraging and 
motivational in obesity treatment trials, with the use of 
testimonials from peers for 
support and tailored 
recipes/tips for concrete
ideas.44-46 We developed a 
robust texting system that 
incorporates these strategies 
that will be adapted for use 
in the proposed study. Fully 
automated monitoring 
texts matched to each 
participant’s current 
behavior change goals will 
be sent 2 times weekly, at 
the time of her choosing. 
Once a participant enters her data, she will receive immediate 
personalized self-monitoring feedback through text 
messaging to reinforce successes and/or offer motivational 
strategies (see example from Healthy Babies). We will 
additionally send intervention participants text message 
prompts to self-weigh weekly using study provided scales 
from BodyTrace. These scales transmit weight data directly 
through the cellular network. Progress will be displayed via links 
to web-based graphs that participants (and WIC nutritionists) 
can easily access to visualize gestational weight gains. We 
have used BodyTrace scales in several studies with >90% 
compliance for self-weighing.28,48,49 
3. Tailored skills training materials: Tailored materials can 
enhance the personal relevancy of interventions, provide cues 
to action, and increase engagement.50 We will offer intervention 
participants’ skills training content that corresponds to their 
assigned behavior change goals via videos and text messages 
sent 3 times weekly (frequency of texts was determined with 
input from Healthy Babies participants and review of mHealth 
literature, suggesting that informational texts should not be 
delivered daily).51-53 We have a library of materials that have 
been adapted for this study, with topics including (but not limited 
to): negotiating barriers; stress reduction; eating out; serving 
sizes; and engaging social support – all designed for mothers 

Protocol #25256  
 
 
 
Page 13 of 31 IRB Approved September 21, 2021 
from resource constrained settings with low-literacy levels 
(example skills text: “Craving something sweet? Instead of 
grabbing junk, eat applesauce, yogurt, or a fruit cup. Ur baby 
will thank u -”). We created ~1 minute videos including 
messages from WIC nutritionists and narratives from previous 
study participants, providing role models with information about 
cost and community resources to increase receptivity.  All 
materials will be available in English and Spanish, with specific 
content tailored to ethnicity (either African American or Latina), 
to offer relevancy to all participants enrolled. 
 
4. WIC provider counseling: There is evidence that WIC 
counseling is trusted,54-56 yet WIC nutritionists find it difficult to 
adequately address gestational weight gain at routine visits.27 
Our treatment is designed to encourage a patient-centered 
counseling approach (e.g., responsive to individual preference, 
needs, and values) while at the same time overcome barriers, 
including: time constraints (by supplying progress reports and 
brief recommendations); failure to follow-up in-between visits 
(which will be largely automated); and fear of causing offense 
(which will be resolved through role play and group discussion). 
There is strong support for integrating our intervention into WIC 
care (see letter from initial IRB submission). Participants will 
have monthly to bimonthly study-related phone calls from a WIC 
nutritionist (aka, WIC Champion, Gloria Lobato) to set goals, 
overcome challenges, and give participants new information 
about diet and activity while they are in the program. These calls 
will last 15- 30 minutes and will be audiotaped (for training and 
feedback). Additionally, if participants agree, they will also 
receive in-person support at their regularly scheduled WIC visits 
every 2-3 months. While WIC is conducting visits virtually, we 
will not be using this approach. To inform counseling, we will 
supply the WIC champion with coaching protocols for new goal 
assignment calls that will be adapted from our prior pregnancy 
and postpartum weight control trials during study start-up. The 
goal assignment calls will take place in 8 week intervals for each 
participant. Additionally, the WIC champion will be notified when 
a participant in this group is -0.3kg from her weekly maximum 
IOM recommended weight gain targets or above57 and the WIC 
champion will be asked to call these participants within 48 hours 
using adapted problem solving call scripts to enhance 
motivation for behavior change, deliver in-depth skills training, 
engage in problem solving, and provide social support. We will 
set a call ceiling of 1, 15-30 minute call monthly so to not 
overburden providers, but instead harness a potentially 

Protocol #25256  
 
 
 
Page 14 of 31 IRB Approved September 21, 2021 
important opportunity for impacting behavior change and 
ensuring safety.  
 
5. Facebook and Instagram. In keeping with our strategy in prior 
studies, supplemental skills training materials, links to videos, 
and/or contests with prizes will be posted daily on an optional 
private Facebook (FB) group that participants will be invited to 
join at baseline. We chose to incorporate FB because data 
suggest a strong link between social influence and healthy (or 
risky) behaviors, particularly among young adults,58 which we 
and others have leveraged through FBs unique communication 
features (e.g., frequent messaging/posts to increase exposure 
to weight-related skills; reciprocal interactions through instant 
messaging and/or FB “pokes” for persuasion).59,60  Philadelphia 
WIC providers actively use FB to promote local programs and 
communicate with current patients, and thus, we do not 
anticipate difficulty maintaining/moderating our group page. To 
ensure confidentiality, this group will be completely private, have 
a generic name, and will not appear on profile pages. Evidence 
from Healthy4Baby and Healthy Babies and other studies using 
social networking sites within mHealth/eHealth interventions 
demonstrate efficacy for their use with obesity treatment.18,19,61-
65  Due to feedback from participants, we additionally added an 
optional private Instagram profile to allow participants to interact 
with other participants in the program and to learn new tips 
about staying healthy.  
 
d. Data Analyses: 
i. Primary outcome. The primary outcome is the proportion of 
women with excessive gestational weight gain, defined as the 
proportion of mothers exceeding weekly Institute of Medicine (IOM) 
weight gain targets (>0.32 kg/week for BMI 25-29.9 kg/m2; >0.27 
NJZHHNIRU%0,NJPRYHUWKHVWXG\SHULRGIURPHQUROOPHQWWR
end of pregnancy).57 Total gestational weight gain will be calculated as 
the difference between weight in kilograms measured at 36-38 weeks’ 
gestation (end of pregnancy) and weight at the baseline visit (in the 
first trimester or early second trimester of pregnancy). Weight in clinical 
gowns, without shoes, will be recorded in duplicate by trained staff 
using high-quality, calibrated SECA digital scales. We will also use 
BodyTrace scales for patients seeking a remote option (and/or during 
restrictions to in-person visits during the Covid-19 pandemic) that will 
be sent to the participant after completion of the combined CS/EN call. 
In the rare case that a mother delivers her infant before 36-38 weeks’ 
gestation, we will abstract her last prenatal weight from her obstetric 
chart and call her within 2 weeks of delivery to administer our follow-up 

Protocol #25256  
 
 
 
Page 15 of 31 IRB Approved September 21, 2021 
survey. We expect to abstract weights in <10% of mothers based on 
previous experiences with the target population, Height will be 
measured to the nearest 0.1 cm using a calibrated stadiometer at 
participants’ in-person baseline assessments or via self-report via 
phone.  
 
ii. Secondary and patient-centered outcomes. 
1. Dietary intake will be measured using the Automated Self-
Administered 24-hour (ASA24) dietary assessment tool, a web 
application developed by NCI.69 We will collect one 24-hour 
dietary recall during combined CS/EN visit or call and during the 
end of pregnancy visit. Data are summarized as intake of micro- 
and macronutrients, food groups, and dietary patterns. ASA24 
has been validated against more expensive, time-consuming 
tools.71 We have experience using this measure in diverse 
groups.48,49   
 
2. Disorders of glucose tolerance (mild hyperglycemia, 
gestational diabetes) will be identified through routine glycemic 
screening as part of usual obstetric care between 24-28 weeks’ 
gestation. Standard care dictates that venous blood is sampled 
for glucose 1 hour after a 50-gram oral glucose load. If the 
JOXFRVHUHVXOWLVPJG/WKHSDUWLFLSDQWZLOOEHUHIHUUHGIRU
a 100-gram fasting 3-hour OGTT. Normal 3-hour OGTT glucose 
results include: <95 mg/dL at baseline, <180 mg/dL at 1 hour, 
<155 mg/dL at 2 hours, and <140mg/dL at 3 hours.77 In this 
study, we will define glucose intolerance in 2 ways: 1) 1-hour 
2*77YDOXHVPJG/PLOGK\SHUJO\FHPLDDQGWZRRU
more abnormal values from the 3-hour OGTT (gestational 
GLDEHWHV*OXFRVHYDOXHVPJG/DUHDVVRFLDWHGZLWK
adverse pregnancy outcomes and have been used by us and 
others to define milder states of glucose intolerance.78-80 We 
have used this pragmatic approach to collect high-quality OGTT 
data in prior studies with almost no (<5%) missing values.81  
 
3. Infant birth weight will be abstracted from delivery records. 
0DFURVRPLDZLOOEHGHILQHGDVLQIDQWELUWKZHLJKWJUDPV
We will calculate sex-specific birth weight for gestational age 
percentile based on US national data.83 To evaluate intervention 
safety, we will examine the proportion of small-for-gestational 
age (SGA) infants by group (e.g., those with birth weights <10th 
percentile for gestational age). 
 
4. Sociodemographics and medical history. Participants will 
self-report age, adverse childhood experiences, food security, 
race/ethnicity, parity, income and employment, education level, 

Protocol #25256  
 
 
 
Page 16 of 31 IRB Approved September 21, 2021 
health status, tobacco use, household size, and marital status. 
We will abstract medical history from obstetric records, including 
comorbidities and prenatal/delivery complications. 
 
5. RE-AIM outcomes. We will use the RE-AIM framework to 
evaluate dissemination potential.84  
 
Reach will be evaluated in several ways. First, we will work 
with our WIC colleagues to identify the total number of eligible 
participants enrolled at WIC during the period of recruitment. 
Next, we will evaluate the proportion of the eligible WIC 
population who: 1) are reached by our study activities; 2) are 
interested in participation; 3) enroll; and 4) are excluded from 
participation. Lastly, we will assess the representativeness of 
our sample by comparing the sample’s demographic features to 
that of the target population. 
Effectiveness will be assessed via our primary, secondary 
and patient-centered outcomes. 
Adoption is a measure of potential intervention uptake by 
WIC. We will quantitatively assess number of provider referrals 
for study entry.  
Implementation will be examined on both the participant 
level and the WIC provider level. At the participant level, we will 
measure intervention engagement via: 1) number of responses 
to self-monitoring text prompts, text response time, and the 
type/frequency of texted videos viewed; 2) type/frequency of FB 
or Instagram posts and/or likes; and 3) number/duration of WIC 
provider visits and calls completed. Relying on an approach by 
Olson and colleagues, we will examine the extent to which level 
of engagement is associated with gestational weight gain.85 We 
will also evaluate the consistency of the intervention across 
different patient/provider subgroups. At the WIC provider level, 
we will examine process data stored in our web application and 
perform chart reviews to assess documentation of weight-
related counseling to measure intervention delivery fidelity.  
Maintenance of weight change will be assessed at 6- and 
12-months postpartum. We will determine the proportion of 
women in each treatment group at (+/- 0.9kg) or below early 
pregnancy weight by 6 months and 12 months postpartum. 
While observational data repeatedly suggest that excessive 
gestational weight gain is the strongest predictor of postpartum 
adiposity,3 few studies have evaluated this relationship in the 
context of a clinical trial. With participant consent, we will 
additionally abstract their infant’s weight and length from their 
pediatrician visits. These will be used to approximate measures 
at 6-months and 12-months of age and assess maintenance of 
intervention effects on infant weight/length. 

Protocol #25256  
 
 
 
Page 17 of 31 IRB Approved September 21, 2021 
 
iii. Data analysis plan:  
1. Primary aim. We will use Fisher’s exact test (for raw 
intervention effects) as well as multivariable logistic regression 
(for adjusted intervention effects), testing the effect of treatment 
group on the odds of excessive gestational weight gain while 
simultaneously adjusting for covariates discovered to be 
unbalanced between the trial arms at baseline. We will consider 
interaction effects of treatment by relevant baseline predictors 
when needed, (e.g., age, parity, BMI, and gestational age at 
enrollment), to evaluate the assumption of equal intervention 
effects between the 2 arms with respect to these covariates. 
Data will be analyzed using an intention-to-treat (ITT) approach 
where subjects are analyzed according to their treatment 
assignment at randomization, regardless of level of 
engagement. Since an ITT analysis is planned, 2 methods are 
proposed for accounting for missing data. First, multiple 
imputation methods will be used to estimate weight at 36-38 
weeks’ gestation based on intermediate outcomes, mediating 
variables, and data collected on subjects with complete follow-
up.87,88 A second approach will utilize model-based analyses 
with direct maximum likelihood methods.89 
Additionally, to take advantage of the longitudinal nature of 
this study, we will treat weight as a continuous measure, 
employing an advanced mixed-effects modeling approach to 
estimate individual and mean weight trajectories over time by 
treatment group. We will supplement weights collected by 
research staff with available electronic health record prenatal 
weight data abstracted from WIC and/or participants’ obstetric 
records; we and others have found that the absolute agreement 
between research and prenatal clinic measured weights is 
extremely high, providing strong support for exchangeability.90,91 
Benefits of this modeling approach include: 1) ability to 
accommodate all available measured prenatal weight data; 2) 
allowance for varying and/or unequally-spaced intervals 
between measurements; and 3) high variability in the number of 
longitudinal assessments expected across subjects. 
Longitudinal trajectories could be modeled using splines or 
kernel density.92 They will allow for an unbiased estimation of 
the overall intervention effect on gestational weight gain to 
better understand non-linear, dynamic changes in weight over 
time.  
 
2. Additional aims. We will use parallel strategies to those 
described above for secondary and patient-centered outcomes. 

Protocol #25256  
 
 
 
Page 18 of 31 IRB Approved September 21, 2021 
If continuous data are not normally distributed, log or square-
root transformation will be considered. We will control for 
confounders and evaluate effect modification as needed. RE-
AIM outcomes will be analyzed in an exploratory fashion. 
Additional analyses investigating the mediating influence of 
dietary and physical activity changes will use bootstrapping for 
standard errors to estimate the direct, indirect, and total 
effects.93-95 
 
3. Cost-effectiveness. We will conduct the cost-effectiveness 
analysis from both the societal perspective (payer and 
participant) and a third party payer’s perspective using an 
Activity Based Costing approach. We will identify the key 
activities that drive overall costs, and assign all labor, materials 
and supplies, and contracted services costs to these activities 
using intervention tracking forms that have been successfully 
applied in prior studies.96-98 All costs will be valued at market 
rates. We will also identify which costs are sunk (e.g., software 
development) costs and which are incremental costs; only the 
latter will be used in analysis. Participant time spent on 
intervention activities (excluding time costs for physical activity 
and other behavioral modification) will be tracked via surveys at 
assessment visits, and these costs will be monetized based on 
the average hourly wage of participants (or an imputed wage for 
those not working). These surveys will also include questions 
from the Medical Expenditure Panel Survey to identify 
differences in healthcare utilization across arms.99  
Once all costs are properly accounted for, we can derive an 
average incremental cost of healthy lifestyle intervention relative 
to WIC usual care. Although data does not exist on long term 
outcomes of mothers and children as a function of gestational 
weight gain to support a comprehensive cost effectiveness 
analysis in terms of costs per quality adjusted life years saved, 
we will report the incremental cost per unit reduction in 
prevalence of excessive gestational weight gain. We will 
compare this estimate to interventions targeting similar 
outcomes.100-102 We will present results for the base case and 
for reasonable ranges of key parameter values. These 
estimates will prove useful to decision makers who may be 
interested to fund the intervention. 
 
4. Power and sample size. Sample size estimates were 
determined to ensure power for detecting differences in trial 
arms on the primary study outcome, the proportion of women 
with excessive gestational weight gain. We used results from 

Protocol #25256  
 
 
 
Page 19 of 31 IRB Approved September 21, 2021 
our own preliminary studies along with published data from 
earlier trials in obese pregnant women to approximate our ability 
to detect differences in weight gain between trial arms. In our 
pilot study, Healthy Babies, 37% of intervention participants 
gained in excess of IOM guidelines compared to 66% of usual 
care.19 We recognize, however, that our pilot study’s sample 
size was small, and thus, we have made a more conservative 
assumption for the power analysis in this proposal – 15% 
difference between healthy lifestyle intervention and usual WIC 
care arms (e.g., prevalence of 40% in the intervention arm vs. 
55% in usual care) – based on data that includes a range of 
between-group differences, from 12% to 30%.15,49 Sample sizes 
of 186 per arm will provide power of at least 0.8 with a 2-sided 
alpha of 0.05. If the difference is 20% (e.g., 40% vs. 60%), the 
power will be at least 0.96. Conservatively assuming we will 
lose 15% for miscarriage or loss to follow-up, the required 
sample size is 219 subjects per arm or 438 total.  
 
10) 
Withdrawal of Subjects 
Participation in this study is completely voluntary.  Participants may refuse to 
participate or stop participation in this study at any time and it will not affect their 
present or future care at WIC or Temple University. 
 
11) 
Privacy & Confidentiality 
Information about study subjects will be kept confidential and managed according 
to the requirements of the Health Insurance Portability and Accountability Act of 
1996 (HIPAA).  Those regulations require a signed subject authorization 
informing the subject of the following:  
x What protected health information (PHI) will be collected from subjects in 
this study 
x Who will have access to that information and why 
x Who will use or disclose that information 
x The rights of a research subject to revoke their authorization for use of 
their PHI.  
In the event that a subject revokes authorization to collect or use PHI, the 
investigator, by regulation, retains the ability to use all information collected prior 
to the revocation of subject authorization.  For subjects that have revoked 
authorization to collect or use PHI, attempts should be made to obtain permission 
to collect at least vital status (i.e. that the subject is alive) at the end of their 
scheduled study period. 
 
Subjects will be identified only by a coded identification number.  No names will 
be used on any source documents.  Data entered into the database for analysis 
in RedCap (which is stored on Temple University’s HIPAA secure servers) will 
contain only the subject identification numbers. Source documents will be stored 
in a locked file at CORE during active data collection and analysis. Only IRB and 

Protocol #25256  
 
 
 
Page 20 of 31 IRB Approved September 21, 2021 
Good Clinical Practice (GCP) trained staff will have access to individually 
identifiable information under supervision of the PI. The privacy, security, and 
durability of accumulated personal health information are of paramount 
importance. Specifically: physical access to computing resources (hard drives, 
servers, networking equipment) is secure, audited, and restricted to skilled, IRB- 
and GCP-trained personnel; virtual access (login and system administration) is 
encrypted, audited, and limited to skilled personnel; all software and servers are 
reachable only via a virtual private network (VPN); and all communication 
between our software’s application programming interface (API) and third-party 
software is encrypted using SSL. 
 
All surveys and measures will be administered in a private room – either at 
CORE, WIC, from a staff member’s home, or in the patient’s home – to allow 
patients to feel that their answers are private or confidential.   
 
Study staff will communicate with participants via text message. In the Healthy 
Lifestyle Group, staff will also communicate with participants by phone.  
Intervention participants will be asked to weigh themselves on a cellular- 
connected scale. To send and receive phone calls and text messages, and to 
store study information and weights, we use companies such as Twilio, Google 
Cloud Platform, and BodyTrace. These companies will take measures to keep 
information safe on their servers (such as keeping the data encrypted), but no 
system is completely safe. This information is also included in the participant 
consent. 
 
12) 
Risks to Subjects 
a. Potential Risks: 
Few risks or discomforts are anticipated or likely in this study. Participants 
may become uncomfortable when talking about their height or weight. It is 
assessed that these risks are small. All data will be collected over the 
phone with staff in a pirvate room during the call.  
 
Participants may be uncomfortable answering questions (e.g., about 
demographics, dietary intake, or health-related quality of life). To minimize 
any discomfort by participants, staff members will be hired who have 
experience interacting with pregnant women. Additional instruction 
regarding appropriate interactions will be provided by the PI. When 
possible, questionnaires will be administered on mobile phones, tablet, or 
computer, with the use of audio to minimize social desirability bias and 
literacy demands. Further, participants who indicate being uncomfortable 
or appear to be uncomfortable will be given the opportunity to withdraw 
their participation at any time throughout the study. Discomfort will also be 
minimized by informing participants that all data will only be labeled with 
an identification (ID) number and only appropriate research staff will have 
access to this number. 
 

Protocol #25256  
 
 
 
Page 21 of 31 IRB Approved September 21, 2021 
The healthy lifestyle intervention itself presents few risks to participants. 
The intervention will encourage weight gain as recommended by ACOG 
and the Institute of Medicine during pregnancy based on BMI.76, 85 Their 
recommendations have been evaluated and are part of the standard of 
care for pregnant women. Women will be encouraged to participate in 
physical activity and eating behaviors that are associated with the best 
outcomes for mother and fetus. Recommendations for physical activity 
and nutrition will not differ from established public health 
recommendations. There is a small risk of muscle sprains, other soft 
tissue injuries, or bone injuries from exercise; however, participants will be 
given information about proper stretching techniques and the importance 
of a warm-up and cool-down period to minimize injury. 
 
Additionally, there is a small risk of loss of privacy due to the Facebook 
group and/or Instagram profile. All study participants have 3 different 
options for the manner in which they join the Facebook group, each 
corresponding to the level of privacy they wish to have: Option 1) 
Participants can choose to link their own existing private Facebook 
account with the private Facebook group, allowing other study participants 
to see all of the content on their individual Facebook page; Option 2) 
Participants can choose to link their own existing private Facebook 
account with restrictions to the private Facebook group, allowing other 
participants to see only the content on their individual Facebook pages 
that they permit them to view; Option 3) Participants can choose to create 
an alias Facebook account exclusively for joining the intervention, 
prohibiting the other participants from accessing any of the content on the 
individual Facebook pages that they maintain for personal, private use. It 
is important to recognize that non-members will not be able to view the 
group or obtain group membership. The primary purpose of the Facebook 
group is to enhance weight-related support and mentoring through online 
postings (videos, links and contests), “likes”, and Facebook mail. 
Participants will be told that they should use their discretion with the 
amount and extent to which they share sensitive information to the other 
members of the group. For Instagram, there are two options: Option 1) 
Participants can use their own existing Instagram profile to follow the 
private study Instagram profile; Option 2) Participants can choose to 
create an alias Instagram account exclusively for following the study 
Instagram profile, prohibiting other participants from accessing any of the 
content on their individual Instagram profile that they maintain for 
personal, private use. Study staff will review and respond to any 
comments made or messages sent on both social media platforms to 
dispel misinformation, provide support, and monitor progress, distress 
and/or side effects from the program. 
 
b. Protection Against Risk: 

Protocol #25256  
 
 
 
Page 22 of 31 IRB Approved September 21, 2021 
i. Planned procedures for minimizing or protecting against potential 
risks. Information about study subjects will be kept confidential and 
managed according to the requirements of the Health Insurance 
Portability and Accountability Act of 1996 (HIPAA). Subjects will be 
identified only by a coded ID number. No names will be used on any 
source documents. Data entered into the database for analysis will 
contain only the subject ID numbers. Source documents will be stored 
in a locked file cabinet in a secure location on Temple’s Health 
Sciences Campus. Only the PI and Project Director will have access to 
participant contact information (e.g., name, phone number, postal 
address and/or email address). The web application used by WIC staff 
and Facebook platform will be maintained by a qualified vendor (Louis 
Clotman Design, LLC) and be fully compliant with HIPAA guidelines 
for patient privacy and data security. The vendor will comply with 
current data security standards as they evolve (also see Privacy 
addressed in section 11 above). 
 
ii. Additional protections for pregnant women and their fetuses. 
There is minimal risk to both mother and fetus – the intervention will 
encourage weight gain as recommended by ACOG and the Institute of 
Medicine during pregnancy based on BMI. Their recommendations 
have been evaluated and are part of the standard of care for pregnant 
women. Women will be encouraged to participate in physical activity 
and eating behaviors that are associated with the best outcomes for 
mother and fetus. Recommendations for physical activity and nutrition 
will not differ from established public health recommendations. 
 
iii. Additional plans for ensuring medical or professional intervention 
in the event of adverse effects to the subjects. It is not anticipated 
that there will be any adverse events. However, in the unlikely event 
that an adverse event does occur, the PI (Sharon Herring MD) will be 
notified immediately and any intervention will be handled directly by the 
PI (in consultation with Marisa Rose MD, Co-Investigator and 
Obstetrician/ Gynecologist, and Emily Oken MD, Professor of 
Population Medicine and Nutrition at Harvard Medical School). Dr. 
Rose is the designated medical monitor for the study; Dr. Oken is the 
lead Safety Officer. Both physician-scientists have a high degree of 
understanding about the potential risks involved with modifying 
antenatal diet and physical activity. All adverse events will be reported 
within a timely manner to the Temple University IRB. All IRB guidelines 
on reporting and monitoring adverse events and data will be followed 
strictly. Participants will be immediately referred to their obstetric 
providers if any clinical problems (including physical and emotional 
issues that do not qualify as an adverse event) are detected. Drs. 
Herring and Rose will also be available to assist participants and staff 
with clinical questions/concerns over the entire study period. 

Protocol #25256  
 
 
 
Page 23 of 31 IRB Approved September 21, 2021 
 
iv. Provisions to Monitor the Data to Ensure the Safety of Subjects. 
Annually, we will generate a summary report for Dr. Oken’s (safety 
officer) review, including: description of recruitment and retention 
status; tables showing enrollment and demographics; and tables 
showing adverse events. In the present study, we expect that most, if 
any, reported complications will result from activities unrelated to the 
intervention.    
 
13) 
Potential Benefits to Subjects 
a. Potential Benefits to Research Participants and Others: 
Potential benefits for intervention study participants include improved lifestyle 
and a reduction in maternal/fetal adiposity and cardiometabolic risk. An 
additional benefit for some participants may be personal satisfaction in being 
part of a study that may have major public health implications for the 
community. Of particular importance is the fact that this project aims to 
provide an intervention in a culturally appropriate and sustainable manner. 
However, no benefit from participation can be guaranteed.   
 
b. Risks to the Subjects are Reasonable in Relation to the Anticipated 
Benefits:   
Risks to subjects are minimal and therefore reasonable in relation to the 
anticipated benefits to the research subjects and society as a whole. 
 
14) 
Costs to Subjects 
If participants agree to take part in this research, they will receive $100 after 
completing all CS/EN questionnaires and being officially enrolled (to reimburse 
participants for time and travel). All enrolled participants will also receive a diaper 
bag and a scale to weigh themselves at each study time point after their CS/EN 
call. Mothers in the intervention group will have a water bottle, measuring bowls 
& spoons, and a cookbook included in their bag. Enrolled participants will 
additionally receive $75 after completion of their 36-week gestation call, and $50 
after completion of their 6-month and 12-month postpartum calls. Total 
compensation for completing all assessments will be $275.00 (for both groups). 
Participants will either be texted or emailed VISA e-gift cards (preferred method) 
or mailed plastic VISA gift cards at the end of each visit.  Participants in the 
intervention group will also be eligible to win a monthly raffle prize, valued 
between $75.00 and $100.00. Intervention participants will receive 1 raffle entry 
for each monitoring text they send. Monthly raffles will be held (run by study staff) 
on the last day of every month and winners will be contacted via text message.  
Septa passes will also be provided for transportation (if needed).  
 
15) 
Informed Consent  
All subjects for this study will be sent a consent form via e-mail or mail prior to 
the combined CS/EN call or visit.  During the initial call/visit, study staff will 
review the Informed Consent describing this study and providing sufficient 

Protocol #25256  
 
 
 
Page 24 of 31 IRB Approved September 21, 2021 
information for subjects to make an informed decision about their participation in 
this study.  The consent form is submitted with this protocol for review and 
approval by the IRB.  The formal consent of a subject, using the IRB-approved 
consent form must be obtained before that subject is submitted to any study 
procedure.   
 
Consent will be obtained electronically via Redcap prior to any study procedures 
being completed. Study staff will be trained to consent patients and provide a 
detailed explanation of all procedures, risks, and benefits. 
 
Additionally, participants will be sent or given paper copies of their signed 
Informed Consent Form, the HIPAA Authorization, and the Medical Record 
Release forms (prenatal, delivery, infant, and WIC) 
 
16) 
Non-English (Spanish) Speaking Subjects 
Bilingual research staff have/will translate all study material (e.g. informed 
consent, HIPAA Authorization, medical record release, intervention content).  All 
study visits and WIC champion calls for Spanish speaking participants will be 
administered by bilingual staff.  
 
17) 
Vulnerable Populations 
Additional protections for pregnant women and their fetuses is described in 
Section 12 (above). 
 
18) 
Sharing of Results or Incidental Findings with Subjects 
The study is registered on clinicaltrials.gov. Results of the study will be 
summarized on clinicaltrials.gov once the trial ends.  
 
 

Protocol #25256  
 
 
 
Page 25 of 31 IRB Approved September 21, 2021 
References 
 
1. 
Truong YN, Yee LM, Caughey AB, Cheng YW. Weight gain in pregnancy: does 
the Institute of Medicine have it right? Am J Obstet Gynecol. 
2015;212(3):362.e361-368. 
2. 
Goldstein RF, Abell SK, Ranasinha S, et al. Association of Gestational Weight 
Gain With Maternal and Infant Outcomes: A Systematic Review and Meta-
analysis. Jama. 2017;317(21):2207-2225. 
3. 
Herring SJ, Rose MZ, Skouteris H, Oken E. Optimizing weight gain in pregnancy 
to prevent obesity in women and children. Diabetes Obes Metab. 2012;14(3):195-
203. 
4. 
Flegal KM, Kruszon-Moran D, Carroll MD, Fryar CD, Ogden CL. Trends in Obesity 
Among Adults in the United States, 2005 to 2014. Jama. 2016;315(21):2284-
2291. 
5. 
Lovasi GS, Hutson MA, Guerra M, Neckerman KM. Built environments and 
obesity in disadvantaged populations. Epidemiologic Reviews.31:7-20. 
6. 
Schmidt M, Affenito SG, Striegel-Moore R, et al. Fast-food intake and diet quality 
in black and white girls: the National Heart, Lung, and Blood Institute Growth and 
Health Study. Arch Pediatr Adolesc Med. 2005;159(7):626-631. 
7. 
Marshall SJ, Jones DA, Ainsworth BE, Reis JP, Levy SS, Macera CA. 
Race/ethnicity, social class, and leisure-time physical inactivity. Med Sci Sports 
Exerc. 2007;39(1):44-51. 
8. 
Ervin RB, Ogden CL. Consumption of added sugars among U.S. adults, 2005-
2010. NCHS data brief. 2013(122):1-8. 
9. 
Gould Rothberg BE, Magriples U, Kershaw TS, Rising SS, Ickovics JR. 
Gestational weight gain and subsequent postpartum weight loss among young, 
low-income, ethnic minority women. Am J Obstet Gynecol. 2011;204(1):52.e51-
11. 
10. 
Headen IE, Davis EM, Mujahid MS, Abrams B. Racial-ethnic differences in 
pregnancy-related weight. Adv Nutr (Bethesda). 2012;3(1):83-94. 
11. 
Herring SJ, Nelson DB, Davey A, et al. Determinants of excessive gestational 
weight gain in urban, low-income women. Womens Health Issues. 
2012;22(5):e439-446. 
12. 
Herring SJ, Henry TQ, Klotz AA, Foster GD, Whitaker RC. Perceptions of low-
income African-American mothers about excessive gestational weight gain. 
Matern Child Health J. 2012;16(9):1837-1843. 
13. 
Reyes NR, Klotz AA, Herring SJ. A qualitative study of motivators and barriers to 
healthy eating in pregnancy for low-income, overweight, African-American 
mothers. J Acad Nutr Diet. 2013;113(9):1175-1181. 
14. 
Smith A. U.S. Smartphone Use in 2015. 
http://www.pewinternet.org/2015/04/01/us-smartphone-use-in-2015/. 2015. 
Accessed Accessed December 15, 2014. 
15. 
Bennett GG, Herring SJ, Puleo E, Stein EK, Emmons KM, Gillman MW. Web-
based weight loss in primary care: a randomized controlled trial. Obesity (Silver 
Spring). 2010;18(2):308-313. 

Protocol #25256  
 
 
 
Page 26 of 31 IRB Approved September 21, 2021 
16. 
Bennett GG, Foley P, Levine E, et al. Behavioral treatment for weight gain 
prevention among black women in primary care practice: a randomized clinical 
trial. JAMA Intern Med. 2013;173(19):1770-1777. 
17. 
Bennett GG, Warner ET, Glasgow RE, et al. Obesity treatment for 
socioeconomically disadvantaged patients in primary care practice. Arch Intern 
Med. 2012;172(7):565-574. 
18. 
Herring SJ, Cruice JF, Bennett GG, Davey A, Foster GD. Using technology to 
promote postpartum weight loss in urban, low-income mothers: a pilot randomized 
controlled trial. J Nutr Educ Behav. 2014;46(6):610-615. 
19. 
Herring SJ, Cruice JF, Bennett GG, Rose MZ, Davey A, Foster GD. Preventing 
excessive gestational weight gain among African American women: A randomized 
clinical trial. Obesity (Silver Spring). 2016;24(1):30-36. 
20. 
Levine DM, Savarimuthu S, Squires A, Nicholson J, Jay M. Technology-assisted 
weight loss interventions in primary care: a systematic review. J Gen Intern Med. 
2015;30(1):107-117. 
21. 
Appel LJ, Clark JM, Yeh HC, et al. Comparative effectiveness of weight-loss 
interventions in clinical practice. N Engl J Med. 2011;365(21):1959-1968. 
22. 
Rose SA, Poynter PS, Anderson JW, Noar SM, Conigliaro J. Physician weight 
loss advice and patient weight loss behavior change: a literature review and meta-
analysis of survey data. Int J Obes (Lond). 2013;37(1):118-128. 
23. 
Criss S, Oken E, Guthrie L, Hivert MF. A qualitative study of gestational weight 
gain goal setting. BMC Pregnancy Childbirth. 2016;16(1):317. 
24. 
Yeo S, Walker JS, Caughey MC, Ferraro AM, Asafu-Adjei JK. What 
characteristics of nutrition and physical activity interventions are key to effectively 
reducing weight gain in obese or overweight pregnant women? A systematic 
review and meta-analysis. Obes Rev. 2017;18(4):385-399. 
25. 
Johnson P, Betson D, Blatt L, Giannarelli L. U.S. Department of Agriculture, Food 
and Nutrition Service, Office of Policy Support. National- and State-Level 
Estimates of Special Supplemental Nutrition Program for Women, Infants, and 
Children (WIC) Eligibles and Program Reach in 2014, and Updated Estimates for 
2005–2013. Alexandria, VA: September 2017. 
26. 
Cates S, Capogrossi K, Sallack L, et al. U.S. Department of Agriculture, Food and 
Nutrition Service, Office of Policy Support. WIC Nutrition Education Study: Phase I 
Report. Alexandria, VA2016. 
27. 
Carp JE, Wallen JJ, Herring SJ. Women, Infants, and Children providers’ 
perceptions of managing obesity during pregnancy: A qualitative study Obesity 
(Silver Spring). 2017;25(11):Supplement 2, S71. 
28. 
Foley P, Steinberg D, Levine E, et al. Track: A randomized controlled trial of a 
digital health obesity treatment intervention for medically vulnerable primary care 
patients. Contemp Clin Trials. 2016;48:12-20. 
29. 
Chasan-Taber L, Fortner RT, Hastings V, Markenson G. Strategies for recruiting 
Hispanic women into a prospective cohort study of modifiable risk factors for 
gestational diabetes mellitus. BMC Pregnancy Childbirth. 2009;9:57. 
30. 
Bandura A. Social foundations of though and action: a social cognitive theory. 
Englewood Cliffs, NJ: Prentice-Hall, Inc; 1986. 

Protocol #25256  
 
 
 
Page 27 of 31 IRB Approved September 21, 2021 
31. 
Bandura A. Self-efficacy: the exercise of control. New York, NY: W H 
Freeman/Times Books/Henry Holt & Co; 1997. 
32. 
Bandura A. Health promotion from the perspective of socia cognitive theory. 
Psychology and Health. 1998;13(4):623-649. 
33. 
Breslow L. Social ecological strategies for promoting healthy lifestyles. Am J 
Health Promot. 1996;10(4):253-257. 
34. 
Stokols D, Allen J, Bellingham RL. The social ecology of health promotion: 
implications for research and practice. Am J Health Promot. 1996;10(4):247-251. 
35. 
Mozaffarian D, Hao T, Rimm EB, Willett WC, Hu FB. Changes in diet and lifestyle 
and long-term weight gain in women and men. N Engl J Med. 2011;364(25):2392-
2404. 
36. 
Stuebe AM, Oken E, Gillman MW. Associations of diet and physical activity during 
pregnancy with risk for excessive gestational weight gain. Am J Obstet Gynecol. 
2009;201(1):58.e51-58. 
37. 
Chuang CH, Stengel MR, Hwang SW, Velott D, Kjerulff KH, Kraschnewski JL. 
Behaviours of overweight and obese women during pregnancy who achieve and 
exceed recommended gestational weight gain. Obes Res Clin Pract. 
2014;8(6):e577-583. 
38. 
Harris A, Chilukuri N, West M, et al. Obesity-Related Dietary Behaviors among 
Racially and Ethnically Diverse Pregnant and Postpartum Women. J Pregnancy. 
2016;2016:9832167. 
39. 
Chasan-Taber L, Schmidt MD, Pekow P, Sternfeld B, Solomon CG, Markenson G. 
Predictors of excessive and inadequate gestational weight gain in Hispanic 
women. Obesity (Silver Spring). 2008;16(7):1657-1666. 
40. 
Cleo G, Isenring E, Thomas R, Glasziou P. Could habits hold the key to weight 
loss maintenance? A narrative review. Journal of Human Nutrition & Dietetics. 
2017;30(5):655-664. 
41. 
Lally P, Van Jaarsveld C, Potts HW, Wardle J. How are habits formed: Modelling 
habit formation in the real world. European Journal of Social Psychology. 
2010;40:998-1009. 
42. 
Foster GD, Makris AP, Bailer BA. Behavioral treatment of obesity. Am J Clin Nutr. 
2005;82(1 Suppl):230S-235S. 
43. 
Acharya SD, Elci OU, Sereika SM, et al. Adherence to a behavioral weight loss 
treatment program enhances weight loss and improvements in biomarkers. 
Patient preference & adherence. 2009;3:151-160. 
44. 
Woolford SJ, Barr KL, Derry HA, et al. OMG do not say LOL: obese adolescents' 
perspectives on the content of text messages to enhance weight loss efforts. 
Obesity (Silver Spring). 2011;19(12):2382-2387. 
45. 
Soltani H, Furness PJ, Arden MA, et al. Women's and Midwives' Perspectives on 
the Design of a Text Messaging Support for Maternal Obesity Services: An 
Exploratory Study. Journal of Obesity. 2012;2012:835464. 
46. 
Partridge SR, Allman-Farinelli M, McGeechan K, et al. Process evaluation of 
TXT2BFiT: a multi-component mHealth randomised controlled trial to prevent 
weight gain in young adults. Int. 2016;13:7. 

Protocol #25256  
 
 
 
Page 28 of 31 IRB Approved September 21, 2021 
47. 
Thakkar J, Kurup R, Laba TL, et al. Mobile Telephone Text Messaging for 
Medication Adherence in Chronic Disease: A Meta-analysis. JAMA Intern Med. 
2016;176(3):340-349. 
48. 
Steinberg DM, Bennett GG, Askew S, Tate DF. Weighing every day matters: daily 
weighing improves weight loss and adoption of weight control behaviors. J Acad 
Nutr Diet. 2015;115(4):511-518. 
49. 
Steinberg DM, Tate DF, Bennett GG, Ennett S, Samuel-Hodge C, Ward DS. The 
efficacy of a daily self-weighing weight loss intervention using smart scales and e-
mail. Obesity (Silver Spring). 2013;21(9):1789-1797. 
50. 
Skinner CS, Campbell MK, Rimer BK, Curry S, Prochaska JO. How effective is 
tailored print communication? Ann Behav Med. 1999;21(4):290-298. 
51. 
Huberty JL, Buman MP, Leiferman JA, Bushar J, Hekler EB, Adams MA. Dose 
and timing of text messages for increasing physical activity among pregnant 
women: a randomized controlled trial. Transl Behav Med. 2017;7(2):212-223. 
52. 
Finitsis DJ, Pellowski JA, Johnson BT. Text message intervention designs to 
promote adherence to antiretroviral therapy (ART): a meta-analysis of randomized 
controlled trials. PLoS ONE. 2014;9(2):e88166. 
53. 
Whittaker R, Matoff-Stepp S, Meehan J, et al. Text4baby: development and 
implementation of a national text messaging health information service. Am J 
Public Health. 2012;102(12):2207-2213. 
54. 
Kim LP, Koleilat M, Whaley SE. A Qualitative Study to Examine Perceptions and 
Barriers to Appropriate Gestational Weight Gain among Participants in the Special 
Supplemental Nutrition Program for Women Infants and Children Program. J 
Pregnancy. 2016;2016:4569742. 
55. 
Anderson CK, Walch TJ, Lindberg SM, Smith AM, Lindheim SR, Whigham LD. 
Excess Gestational Weight Gain in Low-Income Overweight and Obese Women: 
A Qualitative Study. J Nutr Educ Behav. 2015;47(5):404-411.e401. 
56. 
Mercado A, Marquez B, Abrams B, Phipps MG, Wing RR, Phelan S. Where Do 
Women Get Advice About Weight, Eating, and Physical Activity During 
Pregnancy? J Womens Health (Larchmt). 2017;26(9):951-956. 
57. 
Institute of Medicine. Weight gain during pregnancy: reexamining the guidelines. 
Washington, DC May 2009. 
58. 
Laranjo L, Arguel A, Neves AL, et al. The influence of social networking sites on 
health behavior change: a systematic review and meta-analysis. J Am Med Inform 
Assoc. 2015;22(1):243-256. 
59. 
Kim SJ, Marsch LA, Brunette MF, Dallery J. Harnessing Facebook for Smoking 
Reduction and Cessation Interventions: Facebook User Engagement and Social 
Support Predict Smoking Reduction. J Med Internet Res. 2017;19(5):e168. 
60. 
Weiksner GM, Fogg BJ, Liu X. Six Patterns for Persuasion in Online Social 
Networks.  In Proceedings of the 3rd international Conference on Persuasive 
Technology (Oulu, Finland, June 04 - 06) 2008. 
61. 
Napolitano MA, Hayes S, Bennett GG, Ives AK, Foster GD. Using Facebook and 
text messaging to deliver a weight loss program to college students. Obesity 
(Silver Spring). 2013;21(1):25-31. 
62. 
Willcox JC, Wilkinson SA, Lappas M, et al. A mobile health intervention promoting 
healthy gestational weight gain for women entering pregnancy at a high body 

Protocol #25256  
 
 
 
Page 29 of 31 IRB Approved September 21, 2021 
mass index: the txt4two pilot randomised controlled trial. BJOG: An International 
Journal of Obstetrics & Gynaecology.124(11):1718-1728. 
63. 
Merchant G, Weibel N, Patrick K, et al. Click "like" to change your behavior: a 
mixed methods study of college students' exposure to and engagement with 
Facebook content designed for weight loss. J Med Internet Res. 2014;16(6):e158. 
64. 
Joseph RP, Keller C, Adams MA, Ainsworth BE. Print versus a culturally-relevant 
Facebook and text message delivered intervention to promote physical activity in 
African American women: a randomized pilot trial. BMC Women's Health. 
2015;15:30. 
65. 
Chang T, Chopra V, Zhang C, Woolford SJ. The role of social media in online 
weight management: systematic review. J Med Internet Res. 2013;15(11):e262. 
66. 
Krukowski RA, West DS, DiCarlo M, et al. Are early first trimester weights valid 
proxies for preconception weight? BMC Pregnancy Childbirth. 2016;16(1):357. 
67. 
Whitaker RC. Predicting preschooler obesity at birth: the role of maternal obesity 
in early pregnancy. Pediatrics. 2004;114(1):e29-36. 
68. 
Thorn B, Tadler C, Huret N, et al. WIC Participant and Program Characteristics 
2014. Prepared by Insight Policy Research under Contract No. AG-3198-C- 
 
11-0010. Alexandria, VA: U.S. Department of Agriculture, Food and Nutrition 
Service;2015. 
69. 
Subar AF, Kirkpatrick SI, Mittl B, et al. The Automated Self-Administered 24-hour 
dietary recall (ASA24): a resource for researchers, clinicians, and educators from 
the National Cancer Institute. J Acad Nutr Diet. 2012;112(8):1134-1137. 
70. 
Thompson FE, Dixit-Joshi S, Potischman N, et al. Comparison of Interviewer-
Administered and Automated Self-Administered 24-Hour Dietary Recalls in 3 
Diverse Integrated Health Systems. Am J Epidemiol. 2015;181(12):970-978. 
71. 
Schatzkin A, Kipnis V, Carroll RJ, et al. A comparison of a food frequency 
questionnaire with a 24-hour recall for use in an epidemiological cohort study: 
results from the biomarker-based Observing Protein and Energy Nutrition (OPEN) 
study. International Journal of Epidemiology. 2003;32(6):1054-1062. 
72. 
Ozemek C, Kirschner MM, Wilkerson BS, Byun W, Kaminsky LA. Intermonitor 
reliability of the GT3X+ accelerometer at hip, wrist and ankle sites during activities 
of daily living. Physiological Measurement. 2014;35(2):129-138. 
73. 
Chasan-Taber L, Freedson PS, Roberts DE, Schmidt MD, Fragala MS. Energy 
expenditure of selected household activities during pregnancy. Research 
Quarterly for Exercise & Sport. 2007;78(2):133-137. 
74. 
Chasan-Taber L, Schmidt MD, Roberts DE, Hosmer D, Markenson G, Freedson 
PS. Development and validation of a Pregnancy Physical Activity 
Questionnaire.[Erratum appears in Med Sci Sports Exerc. 2011 Jan;43(1):195]. 
Med Sci Sports Exerc. 2004;36(10):1750-1760. 
75. 
van Hees VT, Renstrom F, Wright A, et al. Estimation of daily energy expenditure 
in pregnant and non-pregnant women using a wrist-worn tri-axial accelerometer. 
PLoS ONE. 2011;6(7):e22922. 
76. 
St-Onge M, Mignault D, Allison DB, Rabasa-Lhoret R. Evaluation of a portable 
device to measure daily energy expenditure in free-living adults. Am J Clin Nutr. 
2007;85(3):742-749. 

Protocol #25256  
 
 
 
Page 30 of 31 IRB Approved September 21, 2021 
77. 
Gynecologists. ACoOa. Committee opinion number 504: screening and diagnosis 
of gestational diabetes mellitus. . Obsetrics and Gynecology. 2011;118(3):751-
753. 
78. 
Carpenter MW, Coustan DR. Criteria for screening tests for gestational diabetes. 
Am J Obstet Gynecol. 1982;144(7):768-773. 
79. 
Facco FL, Grobman WA, Kramer J, Ho KH, Zee PC. Self-reported short sleep 
duration and frequent snoring in pregnancy: impact on glucose metabolism. Am J 
Obstet Gynecol. 2010;203(2):142.e141-145. 
80. 
Scholl TO, Sowers M, Chen X, Lenders C. Maternal glucose concentration 
influences fetal growth, gestation, and pregnancy complications. Am J Epidemiol. 
2001;154(6):514-520. 
81. 
Herring SJ, Nelson DB, Pien GW, et al. Objectively measured sleep duration and 
hyperglycemia in pregnancy. Sleep Med. 2014;15(1):51-55. 
82. 
Peters JC, Wyatt HR, Foster GD, et al. The effects of water and non-nutritive 
sweetened beverages on weight loss during a 12-week weight loss treatment 
program. Obesity (Silver Spring). 2014;22(6):1415-1421. 
83. 
Oken E, Kleinman KP, Rich-Edwards J, Gillman MW. A nearly continuous 
measure of birth weight for gestational age using a United States national 
reference. BMC Pediatr. 2003;3:6. 
84. 
Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health 
promotion interventions: the RE-AIM framework. Am J Public Health. 
1999;89(9):1322-1327. 
85. 
Graham ML, Strawderman MS, Demment M, Olson CM. Does Usage of an 
eHealth Intervention Reduce the Risk of Excessive Gestational Weight Gain? 
Secondary Analysis From a Randomized Controlled Trial. J Med Internet Res. 
2017;19(1):e6. 
86. 
Centers for Disease Control growth charts. http://www.cdc.gov/growthcharts. 
Accessed January 26, 2017. 
87. 
Rubin D. Multiple imputation for nonresponse in surveys. New York, NY: John 
Wiley & Sons; 1987. 
88. 
Carpenter J, Kenward M. Multiple imputation and its application. West Sussex, 
UK: John Wiley & Sons; 2013. 
89. 
Little RJA, Rubin D. Statistical analysis with missing data, second edition. 
Hoboken, NJ: John Wiley & Sons; 2002. 
90. 
Leo MC, Lindberg NM, Vesco KK, Stevens VJ. Validity of medical chart weights 
and heights for obese pregnant women. EGEMS (Wash DC). 2014;2(1):1051. 
91. 
Vesco KK, Karanja N, King JC, et al. Efficacy of a group-based dietary 
intervention for limiting gestational weight gain among obese women: a 
randomized trial. Obesity (Silver Spring). 2014;22(9):1989-1996. 
92. 
Fitzmaurice GM, Laird NM, Ware JH. Applied longitudinal analysis, second 
edition. Wiley; 2011. 
93. 
Shrout PE, Bolger N. Mediation in experimental and nonexperimental studies: 
new procedures and recommendations. Psychol Methods. 2002;7(4):422-445. 
94. 
Preacher KJ, Hayes AF. Asymptotic and resampling strategies for assessing and 
comparing indirect effects in multiple mediator models. Behav Res Methods. 
2008;40(3):879-891. 

Protocol #25256  
 
 
 
Page 31 of 31 IRB Approved September 21, 2021 
95. 
MacKinnon DP, Lockwood CM, Hoffman JM, West SG, Sheets V. A comparison 
of methods to test mediation and other intervening variable effects. Psychol 
Methods. 2002;7(1):83-104. 
96. 
Finkelstein EA, Kruger E, Karnawat S. Cost-Effectiveness Analysis of Qsymia for 
Weight Loss. Pharmacoeconomics. 2015;33(7):699-706. 
97. 
Dong D, Tan A, Mehta JS, Tan D, Finkelstein EA. Cost-effectiveness of osteo-
odonto keratoprosthesis in Singapore. Am J Ophthalmol. 2014;157(1):78-84.e72. 
98. 
Jakicic JM, Tate DF, Lang W, et al. Effect of a stepped-care intervention approach 
on weight loss in adults: a randomized clinical trial.[Erratum appears in JAMA. 
2012 Jul 11;308(2):136]. Jama. 2012;307(24):2617-2626. 
99. 
http://meps.ahrq.gov/mepsweb/. Accessed Accessed January 26, 2016. 
100. Clifton RG, Evans M, Cahill AG, et al. Design of lifestyle intervention trials to 
prevent excessive gestational weight gain in women with overweight or obesity. 
Obesity (Silver Spring). 2016;24(2):305-313. 
101. Kolu P, Raitanen J, Puhkala J, Tuominen P, Husu P, Luoto R. Effectiveness and 
Cost-Effectiveness of a Cluster-Randomized Prenatal Lifestyle Counseling Trial: A 
Seven-Year Follow-Up. PLoS ONE. 2016;11(12):e0167759. 
102. Redman LM, Gilmore LA, Breaux J, et al. Effectiveness of SmartMoms, a Novel 
eHealth Intervention for Management of Gestational Weight Gain: Randomized 
Controlled Pilot Trial. JMIR MHealth and UHealth.5(9):e133.