Helping Moms to be Healthy After Baby
Phase: NA
Conditions: Weight Loss, Diet Modification, Obesity
Sponsor: University of Colorado, Denver

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eiraw 
COMIRB Protocol 
COLORADO MULTIPLE INSTITUTIONAL REVIEW 
BOARD 
CAMPUS BOX F-490    TELEPHONE:  303-724-1055  
Fax:  303-724-0990 
 
 
 
Protocol #: 16-1932 
Project Title: 
Helping moms to be healthy after baby 
 
 
 
Principal Investigator:  
Darcy A. Thompson MD, MPH 
Version Date: 
09/08/2017  
 
 
 
 
  
 
 
Hypotheses and Specific Aims:  
 
This protocol outlines details for both a main study and a Substudy. 
 
Main study hypotheses: 
 
1. The multicomponent novel weight loss intervention delivered in WIC will be feasible and 
acceptable. 
2. This intervention will be associated with a greater weight change over 12 weeks compared to 
control.  
 
Main study aims: 
 
Aim 1: To evaluate the feasibility and acceptability of a multi-component novel weight loss 
intervention delivered in a WIC setting to a population of low-income, predominantly racial/ethnic 
minority, obese, postpartum women.  
 
Aim 2: To evaluate differences in weight change between intervention and control participants to 
determine preliminary intervention efficacy over a 12-week period. 
 
SUBstudy hypotheses: 
 
1. The multicomponent novel weight loss intervention delivered in WIC will be acceptable. 
2. This intervention will be associated with differences in diet, physical activity, and self-efficacy 
compared to control 
 
SUBstudy aims: 
 
Aim 1: To evaluate the acceptability of a multi-component novel weight loss intervention delivered in a 
WIC setting to a population of low-income, predominantly racial/ethnic minority, obese, postpartum 
women.  
 
Aim 2: To evaluate differences in diet, physical activity, and self-efficacy, between intervention and 
control participants to determine preliminary intervention efficacy over a 12-week period. 
 
 

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II. Background and Significance:  
Low-income and minority women are at increased risk for postpartum weight retention (i.e. retaining 
weight after pregnancy) and consequent persistent obesity.1,2 Women who have had children, 
especially racial/ethnic minority women who have had children, have 3 times the risk of obesity 
compared to women who have not had any children.3 Pre-pregnancy obesity is an important 
contributor to postpartum weight retention.4-6 Women who are obese pre-pregnancy are 3-5 times 
more likely to gain weight, rather than lose weight, in the postpartum period than non-obese women.7 
Addressing maternal weight during this time is critical given that obesity places women at increased 
risk for poor health outcomes (e.g. cardiovascular disease) and their offspring at increased risk for 
obesity.8 Addressing maternal weight in the first year postpartum is essential given evidence that 
weight retained beyond this period is usually retained long-term and is an independent risk factor for 
obesity.9  
Effective interventions addressing postpartum weight retention in low-income and racial/ethnic 
minority women are urgently needed. Translation of evidence on weight loss to the postpartum period 
in a community setting is lacking, yet holds great potential. WIC is an ideal location to translate such 
evidence given that WIC, staffed by educators and registered dietitians (RDs), interacts regularly with 
women in the postpartum period, offering nutrition education and supplemental foods.  
Obesity science supports that weight loss interventions should be multi-component with regular points 
of contact.10 Building upon this, we have designed a multi-component intervention that considers the 
demands on women in the postpartum period and utilizes technology for both provider decision 
support and for virtual contact with participants. The intervention will address diet, physical activity, 
and social support through the use of in-person meetings with WIC staff, text messaging, phone 
coaching, and Facebook. In-person meetings with WIC staff will occur monthly in addition to the 
typical quarterly appointments, and will focus on the mother vs. the more common emphasis primarily 
on the infant. HeartSmartMoms, an electronic provider decision support tool, which our team 
previously piloted in a WIC-based intervention (Puma et al, under review), will assist providers in 
using motivational interviewing (MI). MI has been shown to enhance weight loss.11,12 Text messaging 
has also been used to enhance weight loss through the use of motivational messages as well as the 
encouragement of self-monitoring.13 In-between monthly WIC visits, women will receive daily texts. 
Phone coaching will also be available. Finally, women will join a private WIC Facebook group where 
they can receive information from WIC educators and connect with other intervention participants for 
social support. Text messages, phone coaching, and Facebook were endorsed by WIC clients and 
will offer flexibility throughout the day as to when participants engage with intervention components.  
 
 
 
III. Preliminary Studies/Progress Report:   
We conducted 4 focus groups with WIC clients (2 English and 2 Spanish). There was overwhelming 
support for the desire to have additional support for postpartum weight loss in the WIC setting. 
Women liked HeartSmartMoms and thought it could be helpful. Most women were open to having 
WIC visits focused more heavily focused on maternal lifestyle habits.  Women were open to getting 
information via texts, some women wanted phone coaching, and women who used Facebook, liked 
the idea of connecting online with other mothers of young infants enrolled in WIC.  
 

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Co-investigators have experience in weight loss both clinically and in research studies. Dr. Nicklas 
has been involved in multiple studies focused on post-partum weight loss including protocols using 
lifestyle coaching. 14,15  
 
IV. Research Methods 
 
 
A. Outcome Measure(s):   
 
Main study: 
 
Primary: Feasibility and acceptability:  
• We will assess the ease of recruiting women for the study (number enrolled/number 
approached) and attrition from the study.  
• We will also collect data on intervention adherence, including number of women who 
received the entire intervention, number of women who came to visits, use of 
HeartSmartMoms (HSM), participation in self-monitoring, use of phone coaching, and use 
of the Facebook group page. 
 
Secondary:  
• 
Change in weight over 12 week period 
 
 
Substudy: 
 
Primary: Feasibility and acceptability: 
• We will conduct semi-structured interviews with intervention participants at the 12 week 
time point to understand their experience in the intervention and to obtain feedback on 
each component.  
 
Secondary:  
 
• 
Dietary saturated fat, trans fat, total sugars, "added sugars", fruit and fruit juice, vegetable 
intake, glycemic load and glycemic index 
• 
Physical activity 
• 
Self-efficacy related to diet and exercise 
• 
Readiness to change 
• 
Eating stimulus index 
 
B. Description of Population to be Enrolled:   
 
Main study:  
We will be working with low-income, English or Spanish-speaking postpartum mothers enrolled in the 
Aurora WIC clinic.  The Aurora WIC clinic serves predominantly minority women; nearly 70% of 
women are racial/ethnic minorities. To be eligible for WIC, women must be low-income or ≤185% of 
the poverty level.  
 
This population was chosen because they are at high risk for obesity in the postpartum period and 
weight retention and prolonged obesity.   

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Inclusion criteria: 
• Adult woman (≥18 and <50 years old)  
• Enrolled in WIC or with an infant enrolled in WIC; 
• 3-12 months postpartum 
• A pre-pregnancy BMI of 25 - 40 kg/m2 (based on self-reported height and weight prior to 
pregnancy) 
• Postpartum body mass index between 25 and 50 kg/m2 
• English- and/or Spanish-speaking 
• Owns a mobile phone with texting functionality  
o In order to receive texts during the trial 
 
Exclusion criteria:  
• 
Health conditions impacting weight or ability to participate in a weight loss trial  
o 
Pregnancy or planned pregnancy in next 5 months 
o 
Any health problems or undergoing any treatments that might interfere with what 
participant eats or her ability to exercise 
o 
Medical provider recommendation to avoid exercise 
• 
Plans to be in a different geographic area within the next 5 months 
• 
Plans to stop coming to Aurora WIC in the next 5 months. 
• 
Unable to give informed consent; 
• 
Not able to read and understand English or Spanish at an 8th grade level.  
• 
Not willing to create a Facebook account if they do not already have one. 
• 
Asked to follow-up in < 3 months at most recent WIC visit 
 
 
Substudy:  
 
The substudy will have 2 parts – Part A and B.  Part A applies to the lifestyle group from the main 
study and will have 2 phases (1 and 2). This is split into 2 phases so that Phase 2 opportunity and the 
associated financial remuneration of Phase 2, is not known until the 12 week visit. We want a true 
assessment of the participation in the lifestyle intervention as it would be run in WIC, and thus do not 
want participants to stay in the intervention solely for the remuneration in the substudy. Part B applies 
to the observation group in the main study.  
 
Part A Phase 1 
Inclusion criteria: 
o Participant in the lifestyle group in the Main study presenting for baseline visit 
 
Exclusion criteria:  
o None 
 
Part A Phase 2 
Inclusion criteria: 
o Participant in the lifestyle group in the Main study presenting for 12 week visit 
o Participated in Part A Phase 1 
 
Exclusion criteria:  
o None 

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Part B 
Inclusion criteria: 
o Participant in the observation group of the main study presenting for baseline visit 
 
Exclusion criteria:  
o None 
 
C. Study Design and Research Methods   
 
Main study: We propose a pilot randomized controlled trial. We will pilot a multicomponent 
intervention delivered in a WIC setting.  In order to attempt to model the intervention as it would be 
run in WIC, there will be no remuneration for participating other than the small gift ($5) at the 
beginning of the study.  
 
Substudy: Women in the main study will be eligible for this substudy. The substudy is broken into 2 
Parts (A-Lifestyle group from Main study , B- observation Group from Main study). We will ask 
participants to complete a survey and for some a semi-structured interview.  
 
 
Here is an overview of our study process 
 
 
 
 
 
Setting: The study (main and substudy) recruitment/enrollment, intervention delivery and data 
collection will occur at the Aurora WIC clinic. Over a year ago we partnered with WIC and over the 
last year developed this study protocol together, with input from WIC clients. All study activities will 
occur at this site except for data management, some phone/text contact with interested 
individuals/participants, and data analysis.  
 
Participant Recruitment, Screening, and Enrollment:  
 
Main study:  
We will enroll up to 80 women, with a goal of 40 to complete the substudy Part A phase 2 or Part B. 
We will post flyers in the WIC office regarding the study opportunity and WIC staff will wear tags 
about the study (optional for WIC staff to wear)– see Appendix Q and R. 
Recruit-
ment in 
WIC clinic 
by staff 
(screen for 
3 eligibility 
criteria 
using WIC 
chart)
Meet with 
PRA to 
assess 
complete 
eligibility 
and learn 
about 
study
Consent/En
roll-ment
Randomi-
zation
Collect 
Baseline 
Data and 
participate 
in optional 
substudy
Participate in 
12-week 
intervention 
(lifestyle 
group)  or 
control 
(observation 
group)
Outcome 
Measure-
ment (12 
weeks post 
baseline) 
and 
participate in 
optional 
substudy

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The UCD PRA will review the WIC records for upcoming appointments for each day and pre-identify 
those women who are 3-12 months postpartum. She will share the list of those with appointments 
meeting this criteria with the WIC staff, reminding them to introduce the study opportunity to the 
person at the end of the appointment.  
WIC staff will introduce the study to postpartum women at the end of a visit to WIC. Before 
introducing the study to a person, the WIC staff person will screen for 3 eligibility criteria using data 
available to her. 1) Person is 3-12 months postpartum,  2) WIC is not recommending to come back to 
WIC prior to 3 months, and 3) if data is available, person meets current BMI eligibility. If the person 
meets these criteria, the WIC staff member will introduce the study to the person. They will also give 
them the flyer (Appendix C) with more information about the study and the screening questions for 
the person to review(Appendix A.2 page 1 only).  This screening done by the WIC staff member 
ensures that the study is not offered to women who are not eligible based on data already available at 
WIC.  
 
We will recognize WIC staff efforts to present the study to WIC clients meeting the above criteria by 
giving $5 gift cards. These gift cards will be given on about a weekly basis to WIC staff demonstrating 
active engagement in supporting the study. This includes, but is not limited to those presenting the 
study the most frequently to WIC clients, having a positive attitude about the study, or encouraging 
other WIC staff to help recruit for the study.  
Women interested in learning more will then immediately meet with the PRA. If they cannot meet with 
the PRA, they will be offered times to return to meet with the PRA. An appointment will be set to meet 
with the PRA.  If the WIC staff person making this appointment to meet with the PRA is not on the 
study protocol, then a text reminder will be sent to the interested person the day before their visit with 
the PRA.  The text will be sent through the automated text reminder system used by WIC. No 
identifying information will be shared with the study team. If the person assisting the person in making 
an appointment with the PRA is on the study protocol, then they will offer a phone or text reminder to 
the participant from the study team, asking permission to share their name and phone number with 
the study team.  If the person agrees to this, a text reminder (or phone call if preferred) will be sent to 
the person the day prior to their appointment to remind them about their appointment. This will be 
sent from the study team texting platform. No identifying information will be included in the text. If the 
person does not show up to their scheduled appointment, the study team will send a follow-up text 
asking if the person would like to reschedule the appointment. 
 During the meeting, the PRA will read the prescreening consent (Appendix A.1) and then assess 
eligibility using a series of questions and calculating the BMI after measuring the person’s weight and 
height. (Appendix A.2) The questions  address specific inclusion/exclusion criteria for the main study 
to assess eligibility and suitability for study participation. To ensure confidentiality, we will not record 
any identifiers on the screening questionnaire (Appendix A.2). We will retain the screening 
questionnaires as detailed in the screening consent language (Appendix A.1). The data on these 
sheets will help us to understand why people were not eligible. No identifying information will be 
written on the screening questionnaire 
 
If the person is eligible, the RA will educate the person on the study procedures. To help with 
comprehension, the RA will give the participant a page with more in-depth study information, and a 
consent form (Appendix N and E).  
 
The bilingual (English/Spanish) RA will describe the study in-depth and answer all questions. This will 
occur 1 on 1 or with multiple interested individuals at the same time. After answering all questions, 

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the RA will meet 1 on 1 to address any further questions the person may have about the study.  The 
RA will then read the consent form to the person, who will have their own copy to read along.  The 
consent contains information about the study procedures and risks.  It also recommends that 
participants should check with their medical provider before starting to exercise. We will NOT require 
individuals to bring in a note from their medical provider.  The RA will answer any questions as 
needed.  For those ready, the RA will complete the informed consent process and enroll the person in 
the study. As part of the consent process, participants will be offered to take additional time if needed 
to decide. If they need additional time, they will be asked to call the RA if they decide they are 
interested in participating. If this happens, they will be asked to come meet in person with the RA at 
the WIC office to complete the informed consent process and enroll in the study.  We will stress 
during this informed consent process that participation in our research study is voluntary, that 
subjects may withdraw from the study at any time, and that the investigators reserve the right to 
discontinue the research protocol at any time. A copy of the signed informed consent form will be 
given to each subject. Appendix E is the main study consent form. 
 
The Aurora WIC sees over 700 women monthly. Over 50% of these women report being overweight 
or obese pre-pregnancy. Given these high numbers and the importance of this topic to women in WIC 
(as described by WIC clients during prior stakeholder meetings), we expect to complete enrollment 
within a 2-4 month time period.  
 
Treatment assignment: Following informed consent, women will be randomly assigned to the lifestyle 
group (intervention) or observation group (control). We will use a computer program to randomize 
subjects using block randomization, to ensure equal numbers of intervention and control participants, 
given the small sample size.  We will randomize in blocks of 10 using a random number generator 
where 1= intervention (Lifestyle group) and 2= control (Observation group).  The RA will have sealed 
envelopes labeled and ordered from 1 up. The RA will open the next envelope in order of consenting 
to assign the participant to the intervention or control arm. 
 
Substudy:  
 
The substudy will be broken into 2 parts: Part A for Lifestyle group participants and Part B for the 
Observation group participants.  Data collection varies slightly between these 2 groups as outlined in 
the study procedures.  Only persons participating in the Main study are recruited to be in the 
Substudy.  Screening for eligibility will be done by the PRA based on assigned group in the Main 
study.  Enrollment will occur as follows: 
 
Part A for lifestyle group involves completing 2 phases.  
 
Part A: Phase 1 (labeled Part A.1) involves survey data collection around the time of the Main study’s 
Baseline visit.  This will occur either at the visit when the person is consented into the main study or 
at the baseline visit. After the person is consented into the main study and randomized to the lifestyle 
group, they can then complete data collection for the main study.  Once this is done, they will then be 
offered the opportunity to participate in this substudy. If they are interested, the RA will conduct 
informed consent using the information sheet Appendix F.A.1. 
 

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Part A: Phase 2 (labeled Part A.2) involves survey and interview data collection at the Main study’s 
12 week visit. After completing data collection for the Main study at the 12 week visit, the PRA will 
introduce this study opportunity. If the person is interested, the RA will then complete informed 
consent, using the information sheet Appendix F.A.1., and enroll the person into the study.  
 
These 2 phases will be presented to participants at these different time points in order to ensure that 
the substudy opportunity is not an incentive to participate in the main study.  
 
Part B for the observation group involves survey data collection at both the baseline and 12 week 
visit. This substudy opportunity for data collection at 2 time points will be offered to participants at the 
baseline visit.  If the person is interested, the RA will then complete informed consent, using the 
information sheet Appendix F-B, and enroll the person into the study. 
 
 
Study procedures: 
 
Main study: 
 
In this randomized controlled study participants will be randomly assigned to either an observation 
group  (control) or a Lifestyle group (intervention). Both groups will receive the following:  
 
1. 
Two visits to the WIC office for data collection as described below (Baseline and at 12 weeks). 
2. 
Study visit reminder calls and/or texts either or both ~1 week and ~1-3 days before baseline 
and the 12 week study visit. 
3.  
A small gift (less than $5 in value) at the baseline visit.   
 
For each subject, the time from enrollment to study completion will be approximately 12-20 weeks, 
depending on timing of scheduling of the visits. 
 
Baseline and 12 week study visits and parameters to be measured on all participants: 
 
At the baseline study visit, we expect data collection to take < 30 minutes. We will collect data using a 
survey and anthropometric measurements. 
• 
Survey: We will orally administer the survey (Appendix B) to participants to avoid literacy 
issues that are common in low-income populations. Survey questions will include the following: 
a. Demographics: Maternal age, education level, race, ethnicity, marital status, 
employment status, number of children, age of youngest child (months), ages of 
children at home, and acculturation level.  To measure acculturation, we will use an 
adapted version of the Spanish and English language-use subscales of the 
Bidimensional Acculturation Scale for Latinos. 16  Each subscale contains 5 items about 
language use, with responses ranging from never (1) to always (5). 
b. We will also ask about smoking, formula and breastfeeding, and whether the mother 
has been or is diabetic or prediabetic, mother’s weight before her recent pregnancy, and 
whether she is currently participating in any weight loss programs or is pregnant. 

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c. Contact information: We will ask for her name, address, phone numbers, email address, 
and contact information for someone we can call if we cannot reach the participant. We 
will ask her to identify the number she wants to receive texts and the email address 
where we send the Facebook invite, if she is in the Lifestyle group.  
 
 
• 
Anthropometrics: Weight and height measured twice using WIC scales and stadiometer.  
 
  
At the 12 week study visit, we expect data collection to take about 20 minutes, collecting 
anthropometric measurements and some survey data.  
 
Anthropometrics: Weight and height measured twice using WIC scales and stadiometer.  
Survey: We will orally administer the survey (Appendix J) to participants to avoid literacy 
issues that are common in low-income populations. Survey questions will include the following: 
a. Demographics: Maternal employment status. 
b. We will also ask about smoking, formula and breastfeeding, and whether the mother 
has been or is diabetic or prediabetic, and whether she is pregnant. 
 
 
Procedures by Arm of Study (Observation Group (Control) and Lifestyle Group (Intervention): 
 
Observation Group participants:  Women in the observation group will receive usual WIC care, plus 
the opportunity to meet with a WIC RD at the 12 week visit.  Written WIC materials on lifestyle 
recommendations will also be given to all observation group participants at the baseline visit. We will 
connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC 
RD at that time. At the baseline visit, we will give them an information sheet telling them what to 
expect. (Appendix G) 
 
 
Lifestyle group participants: Women in this group will receive typical WIC care plus the below 
described activities. The intervention will last 12 weeks.   
 
Enhanced and more frequent WIC visits: 
• Women will be seen by WIC educators/RDs monthly (at baseline, 4 weeks, and 8 weeks) versus 
the usual every 3 month visit. We will give women an information sheet at the baseline visit telling 
them a little bit about what to expect. (Appendix H) Immediately prior to seeing the WIC staff 
member, the participant will be asked to complete a survey on the iPad using the HeartSmartMoms 
(HSM)app. We previously trialed HSM in a WIC setting in the San Luis Valley. This app helps to 
facilitate quick identification of high-risk behaviors (e.g. high sugar-sweetened beverage intake, no 
vegetable or fruit intake) by asking questions about lifestyle behaviors (diet, physical activity, 
sedentary behaviors, sleep and perceptions of weight, readiness to change). The participant study 
ID number will be used on this app so there is no identifiable information. After filling this in, the WIC 
staff member or PRA will measure the participant’s height and weight, enter it into HSM, and then 
will print out the HeartSmart printout, which identifies the participant’s obesogenic behaviors for the 
WIC educator. The print out will also provide language consistent with motivational interviewing (MI) 
that can be used by the WIC educator to direct client counseling using MI techniques.   The content 
of these visits will be patient-centered, so it will be tailored to each participant, but it will focus on 

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maternal healthy lifestyle behaviors – diet, physical activity, sedentary behaviors, and sleep. 
Educators will use motivational interviewing (MI) to help participants make lifestyle changes.  The 
foundation of treatment of obesity lies in effective counseling of women to motivate healthy 
behaviors. National and state guidelines encourage patient-centered counseling such as MI. WIC 
staff will receive advanced training in MI. Educators will use this technique to help women set goals 
for healthier lifestyle habits, based on standard guidelines for lifestyle behaviors.  WIC staff will ask 
each participant to set goals related to lifestyle change before the end of the visit. Staff will also 
offer educational materials on these topics to participants if applicable. Recommended behavior 
changes will be based on moving participants closer to recommended lifestyle behaviors.    
 
 
Content areas to be covered in 1: 1 counseling, will include:  
• 
MyPlate: This is recommended by the federal government. It helps WIC educators to 
talk about portions and variety or foods.  
• 
Sugar-sweetened beverages: WIC staff will talk about limiting this in the diet.  
• 
Healthy snack options:  This will focus on healthy options for food between meals and 
when on the go. It will touch on quick ways to make a good choice.  
• 
Taking time for self/taking care of yourself: Women will be encouraged to ask for help in 
order to be able to take care of themselves.  
• 
Home environment: Educators will talk about how the food around one influences what 
one eats. For example, if there are no sugary drinks at home, it is easier to avoid them.  
• 
Recipes: Educators will provide recipe ideas for healthy snacks and meals. 
• 
Working and having a healthy lifestyle: Educators will talk about tips for staying healthy 
while working. For example, how planning ahead and having specific foods available 
helps.  
• 
Physical activity: Participants will be encouraged to increase their physical activity 
gradually. They will be given a pedometer and encouraged to increase their amount of 
walking.  Other types of exercise will be chosen by the participant. They will be 
encouraged to choose activities that they enjoy and to gradually increase the amount 
they are doing.    
• 
Goal-setting: This will touch on the importance of setting small and realistic goals for 
changing behaviors.  
• 
Stress-management: This will touch on the importance of managing stress and asking 
for help. It will include some ways to manage stress like asking for help, deep breathing, 
etc.  
The suggested order in which these topics are reviewed is as follows: Baseline visit (physical 
activity, MyPlate), 4-week visit (Healthy snack options, stress-management, home 
environment, taking time for self), and  8-week visit (Sugar-sweetened beverages, working and 
having a healthy lifestyle). All counseling will be patient-centered. This means it will be guided 
by the patient’s problem areas and interests. Hence, in 1:1 sessions not all of the above will be 
covered and other areas relevant to the topic may be addressed, as desired by the participant.    
Educational materials will be used with clients, as appropriate.   Educational materials created 
for this study are included in Appendix O and content from the above areas.  The 3 handouts 
for collaborative  goal setting at each visit (Title of ‘Goals’ on top) include a location for putting 
the participant ID.  After filling in this handout with the WIC educator, a copy will be made and 
the original will be given to the participant. The copy will be kept in order for the educator to 

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review past goals with each this participant at future study visits. Other educational materials 
that are typically used at WIC will also be used in this study, as appropriate.  
 
The baseline, 4-week, and 8-week visit with WIC staff will be combined visits with the WIC educators 
and RDs.  
In-between WIC visits: 
 
 We will offer 3 methods of contact between in-person WIC visits. 
• Text messages to motivate and prompt self-monitoring: We will send a text to participants 2-7 times 
a week.  
o Content: We will use adapted content from a texting program developed at Denver 
Health that was an adaptation of the Diabetes Prevention Program tailored for low-
income individuals.13   This content related to healthy lifestyle behaviors including diet 
and exercise. We will send the message in the language requested by the participant.  
We will also send a weekly message asking participants to send us their average 
weekly step count from their pedometer and their weight. Self-monitoring is known to 
promote weight loss.17 
 
 
Text content will be brief and will sometimes include a link to the facebook page. Topics 
will include: 1) Eating less fat and fewer calories, 2) Exercise, 3) healthy eating out  4) 
recipe modifications 5) Healthy Eating, with variety and balance, 6) motivation, and 7) 
sending in their weight and weekly step average. 
• 
Example texts:  
o Try to substitute high fat food for lower fat food, like using ground turkey 
instead of ground beef, or drink low-fat milk instead of whole. 
o Spread calories over the day by eating regular meals and snacks, and by 
planning ahead. How you eat is important, not just what you eat. 
o We tend to underestimate our portions! Did you know that a serving of 
meat (fish, chicken, beef, or pork) is the size of deck of cards? 
o Walking is a great activity. All you need is a pair of good walking shoes. If 
this is a new activity for you, start with a few minutes per day of gentle 
walking and slowly increase. 
o Change is hard, but a healthy lifestyle is worth it- start with little changes 
and gradually work up. You can do it! 
 
 
o Texting Platform: We will use an online texting platform to automate outgoing text 
messages.  These will be sent to cellphones via the internet platform. We will not 
include any identifying information in the text messages. In case of incoming text 
messages from participants, a WIC staff member will oversee incoming text messages.  
An automated response to these incoming messages will be set up to say something 
like “Thanks for replying to us! No one can answer your message immediately, but we 
will get to it as soon as possible”.  The PI or WIC staff member will review incoming 
messages Monday through Friday (once every other day) and respond as needed. 
 
• Facebook Group: We will develop a private Facebook group page. This will be moderated daily by a 
bilingual WIC staff member (trained WIC educator with back up from a WIC RD) who will post 

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information on healthy lifestyle behaviors (based on national guidelines and WIC materials similar to 
in 1:1 counseling sessions described above) and answer questions posted by participants, should 
they arise. The moderator posts will be in both English and Spanish, and respondents can respond 
in their preferred language. We will also encourage group support amongst the participants. 
Evidence suggests mothers find support in mother-focused Facebook group pages.18  
i. The PI or a co-I will be the administrator for the group. This allows her to reassign the 
moderator role if needed, ensure the group is private, and control the appearance of the 
group page.  
ii. The WIC staff member will be the moderator of the Facebook group. This means she 
will have the ability to post things on the page, approve or deny membership to the 
group, approve or deny posts, remove posts and comments on posts, remove and block 
people from the group. She will make the site private, only accessible to those receiving 
an email invite to join. Participants will be sent an invite to join the group.  Participants 
will see who else is a member of the group, but no one else will see who is a member of 
the group. If a study participant would like to join the group under a pseudonym to 
protect confidentiality, they will be allowed to do this, if they tell us their Facebook name 
(pseudonym). We will need to know their Facebook name to ensure only participants in 
the study are using the private Facebook group page. Members can interact with other 
members in the Facebook group through the Facebook page. The WIC staff member 
will remove posts deemed inappropriate or not helpful. 
iii. We will observe all activity on the private Facebook group page, number and content of 
posts.   
  
• Phone coaching: Phone coaching is an effective method to support weight loss in postpartum 
women.19 We will text women weekly to remind them of the option of speaking with a WIC educator 
about lifestyle changes in between WIC visits. Women will be asked to call in to schedule a time to 
speak with the coach. During these appointments, participants will speak with the WIC educator or 
RD on their lifestyle goals and healthy lifestyle behaviors – similar to topics outlined above for in 
person WIC visits. Motivational interviewing techniques will be used.  We expect calls will last 10-15 
minutes and can occur daily M-F as needed by the participant, at a time convenient to both parties.   
 
 
 
 
 
 
Pregnancy: These interventions are acceptable for the postpartum time period and would not be 
expected to cause harm if a subject becomes pregnant. If a subject becomes pregnant during the 
study, all research activities will stop and she will be excluded from the study at that point. These 
subjects will be excluded as they would affect study data and because pregnancy may require 
different care.  
 
 
 
Participant study activities: Below is a table of all study activities, described for observation group 
and lifestyle group participants in the main study. 
 

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Baseline 
Week 1 
Week 2 
Week 3 
Week 4 
Week 5 
Week 6  
Week 7 
Week 8 
Week 9 
Week 10 
Week 11 
Week 12 
All participants  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data collection – in-clinic 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
Lifestyle Group participants 
only 
 
 
 
 
 
 
 
 
 
 
 
 
 
In-clinic intervention visits 
using HeartSmartMoms and 
lifestyle coaching using 
motivational interviewing 
X 
 
 
 
X 
 
 
 
X 
 
 
 
 
Outgoing texts 2-7/week 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Facebook group participation 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Pedometer use 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Weekly send in weight and 
step count 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Weekly phone coaching 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Please note: We will do our best to schedule visits 4 , 8 and 12 weeks after the baseline visit. 
However, given possible scheduling conflicts, we will allow a 2 week window around each of the 
visits. 
 
 
Contacting participants for their study visits:  
We will contact participants to schedule future study visits (baseline, 4, 8 and 12 weeks for lifestyle 
group participants and baseline and 12 weeks for observation group participants) by phone/text in 
order to schedule these visits. If we are unable to reach them by phone/text, we will use email and 
mail. Additionally, during the consent process, we will get permission from subjects to contact a family 
member or friend if we are having trouble getting in touch with the subject at any point in the study. 
We will use these methods if phone, text, mail, email do not work. Participants will also get text 
reminders about upcoming visits.  If participants fail to show up for an appointment, we will contact 
them to reschedule.  
 
WIC benefits:  WIC administration of benefits to participants in this study will be as follows.   
Observation Group: No changes for the Observation group participants. 
Lifestyle Group:   Standard practice at WIC is to administer benefits to WIC clients for the time 
period between visits. In other words, if a WIC client is scheduled to be seen in 3 months, then she 
would receive 3 months of benefits. If she is asked to be seen in 1 month, she will receive one 
month of benefits.  We plan to mirror this in the Lifestyle group.  Participants in the lifestyle group 

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will receive benefits for the length of time between scheduled visits – 4 weeks. We clearly outline 
this in the consent form.  If a person fails to show up for a visit, and we are unable to reach them 
before the time when their previously administered benefits expire or they drop out of the study, 
then WIC will change the benefits to receive the amount they would have received if they were not 
in the study.  In other words, if a participant in the Lifestyle group would have received 3 months of 
benefits if she was not enrolled, and she fails to show up to her 4 week visit and we cannot reach 
her or she opted to drop out, then WIC will give her the other 2 months of benefits she would have 
expected to receive prior to that 3 month visit. WIC clients use EBT cards, so benefits can be 
uploaded from WIC without the participant coming in.  With these methods, we will mirror WIC 
standard practice and ensure participants do not experience undue burden as a research 
participant.   
 
Substudy: 
 
The substudy will be 2 parts – Part A(Lifestyle – 2 phases) and Part B (Observation group). 
 
Part A: Phase 1 (Lifestyle Group): After enrollment into the substudy Part A, Phase 1, the RA will 
orally administer a survey (Appendix I) to participants to avoid literacy issues that are common in low-
income populations. We expect data collection to take  30-45 minutes. Participants will receive a $25 
gift card for their participation. Survey questions will include the following: 
a. Diet Survey: We will use the Block Fat/Sugar/Fruit/Vegetable Screener which takes 10-
12 minutes to complete and is available in English and Spanish.20 This is a publically 
available questionnaire. This screener contains 55 questions. Portion size is asked for 
32 food items. A series of "adjustment" questions ask about usual intake of low-
fat/trans-fat free or low-carbohydrate/low-sugar versions of various foods. Analysis 
produces estimates of saturated fat, trans fat, total sugars, "added sugars" (in 
sweetened cereals, soft drinks, and sweets), fruit and fruit juice, vegetable intake, 
glycemic load and glycemic index. The bilingual research assistant will orally administer 
this. Data will provide estimates on dietary saturated fat, trans fat, total sugars, "added 
sugars" (in sweetened cereals, soft drinks, and sweets), fruit and fruit juice, vegetable 
intake, glycemic load and glycemic index.  The Block booklets will be mailed to the 
company for analysis. The only identifier on each booklet will be the participant study ID 
number.  
b. Pregnancy Physical Activity Questionnaire: We will use a slightly adapted version of the 
Pregnancy Physical Activity Questionnaire  (PPAQ) Chasan-Taber L, Schmidt MD, 
Roberts DE, Hosmer D, Markenson G, Freedson PS.  Development and Validation of a 
Pregnancy Physical Activity Questionnaire. Med Sci Sports Exer 2004 36(10):1750-
1760.   
c. Self-efficacy regarding diet and exercise: some items are from another study 
(unpublished) and some are from http://sallis.ucsd.edu/measure_selfefficacy.html 
d. Eating Stimulus Index: http://europepmc.org/abstract/med/19699840 
e. Perceived Stress Scale: A Global Measure of Perceived Stress,  Author(s): Sheldon 
Cohen, Tom Kamarck and Robin Mermelstein Source: Journal of Health and Social 
Behavior, Vol. 24, No. 4 (Dec., 1983), pp. 385-396 
f. Readiness to Change: Items are from another study 
 
Part A: Phase 2: 

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At the 12 week visit, after enrollment into the substudy Part A, Phase 2, the RA will orally administer a 
survey (Appendix K) to participants to avoid literacy issues that are common in low-income 
populations. She will then conduct the semi-structured interview (Appendix D). The semi-structured 
interview will ask for participant perspective on the lifestyle program and their participation. (See 
Appendix D) This part of the interview will be audiorecorded.  
 We expect data collection to take overall 60-90 minutes. Participants will receive a $35 gift card for 
their participation. Survey questions will include the following: 
a. Diet Survey: We will use the Block Fat/Sugar/Fruit/Vegetable Screener which takes 10-
12 minutes to complete and is available in English and Spanish.20 This is a publically 
available questionnaire. This screener contains 55 questions. Portion size is asked for 
32 food items. A series of "adjustment" questions ask about usual intake of low-
fat/trans-fat free or low-carbohydrate/low-sugar versions of various foods. Analysis 
produces estimates of saturated fat, trans fat, total sugars, "added sugars" (in 
sweetened cereals, soft drinks, and sweets), fruit and fruit juice, vegetable intake, 
glycemic load and glycemic index. The bilingual research assistant will orally administer 
this. Data will provide estimates on dietary saturated fat, trans fat, total sugars, "added 
sugars" (in sweetened cereals, soft drinks, and sweets), fruit and fruit juice, vegetable 
intake, glycemic load and glycemic index.  The Block booklets will be mailed to the 
company for analysis. The only identifier on each booklet will be the participant study ID 
number.  
b. Pregnancy Physical Activity Questionnaire: We will use a slightly adapted version of the 
Pregnancy Physical Activity Questionnaire  (PPAQ) Chasan-Taber L, Schmidt MD, 
Roberts DE, Hosmer D, Markenson G, Freedson PS.  Development and Validation of a 
Pregnancy Physical Activity Questionnaire. Med Sci Sports Exer 2004 36(10):1750-
1760.   
c. Self-efficacy regarding diet and exercise: some items are from another study 
(unpublished) and some are from http://sallis.ucsd.edu/measure_selfefficacy.html 
d. Eating Stimulus Index: http://europepmc.org/abstract/med/19699840 
e. Readiness to Change: Items are from another study 
 
Part B: After enrollment, the RA will orally administer a survey (Appendix I) to all participants. We 
expect data collection to take 30-45 minutes. Survey questions will include:  
a. Diet Survey: We will use the Block Fat/Sugar/Fruit/Vegetable Screener which takes 10-
12 minutes to complete and is available in English and Spanish.20 This is a publically 
available questionnaire. This screener contains 55 questions. Portion size is asked for 
32 food items. A series of "adjustment" questions ask about usual intake of low-
fat/trans-fat free or low-carbohydrate/low-sugar versions of various foods. Analysis 
produces estimates of saturated fat, trans fat, total sugars, "added sugars" (in 
sweetened cereals, soft drinks, and sweets), fruit and fruit juice, vegetable intake, 
glycemic load and glycemic index. The bilingual research assistant will orally administer 
this. Data will provide estimates on dietary saturated fat, trans fat, total sugars, "added 
sugars" (in sweetened cereals, soft drinks, and sweets), fruit and fruit juice, vegetable 
intake, glycemic load and glycemic index.  The Block booklets will be mailed to the 
company for analysis. The only identifier on each booklet will be the participant study ID 
number.  
b. Pregnancy Physical Activity Questionnaire: We will use a slightly adapted version of the 
Pregnancy Physical Activity Questionnaire  (PPAQ) Chasan-Taber L, Schmidt MD, 
Roberts DE, Hosmer D, Markenson G, Freedson PS.  Development and Validation of a 

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Pregnancy Physical Activity Questionnaire. Med Sci Sports Exer 2004 36(10):1750-
1760.   
c. Self-efficacy regarding diet and exercise: some items are from another study 
(unpublished) and some are from http://sallis.ucsd.edu/measure_selfefficacy.html 
d. Eating Stimulus Index: http://europepmc.org/abstract/med/19699840 
e. Perceived Stress Scale: A Global Measure of Perceived Stress,  Author(s): Sheldon 
Cohen, Tom Kamarck and Robin Mermelstein Source: Journal of Health and Social 
Behavior, Vol. 24, No. 4 (Dec., 1983), pp. 385-396 
f. Readiness to Change: Items are from another study 
 
Then at the 12 week visit, the RA will orally administer a survey (Appendix K) to all participants. We 
expect data collection to take 30-45 minutes. Survey questions will include:  
a. Diet Survey: We will use the Block Fat/Sugar/Fruit/Vegetable Screener which takes 10-
12 minutes to complete and is available in English and Spanish.20 This is a publically 
available questionnaire. This screener contains 55 questions. Portion size is asked for 
32 food items. A series of "adjustment" questions ask about usual intake of low-
fat/trans-fat free or low-carbohydrate/low-sugar versions of various foods. Analysis 
produces estimates of saturated fat, trans fat, total sugars, "added sugars" (in 
sweetened cereals, soft drinks, and sweets), fruit and fruit juice, vegetable intake, 
glycemic load and glycemic index. The bilingual research assistant will orally administer 
this. Data will provide estimates on dietary saturated fat, trans fat, total sugars, "added 
sugars" (in sweetened cereals, soft drinks, and sweets), fruit and fruit juice, vegetable 
intake, glycemic load and glycemic index.  The Block booklets will be mailed to the 
company for analysis. The only identifier on each booklet will be the participant study ID 
number.  
b. Pregnancy Physical Activity Questionnaire: We will use a slightly adapted version of the 
Pregnancy Physical Activity Questionnaire  (PPAQ) Chasan-Taber L, Schmidt MD, 
Roberts DE, Hosmer D, Markenson G, Freedson PS.  Development and Validation of a 
Pregnancy Physical Activity Questionnaire. Med Sci Sports Exer 2004 36(10):1750-
1760.   
c. Self-efficacy regarding diet and exercise: some items are from another study 
(unpublished) and some are from http://sallis.ucsd.edu/measure_selfefficacy.html 
d. Eating Stimulus Index: http://europepmc.org/abstract/med/19699840 
e. Readiness to Change: Items are from another study 
 
Participants from the observation group will receive at the 12 week visit a $50 gift card for their 
participation.  
 
 
Overview of data collection: 
 
Data to be collected from study participants and when the data are to be collected  
 
Variable 
Baseline 
Visit 1 
 
4 week visit 
(Lifestyle 
group only)  
8 week visit 
(Lifestyle 
group only) 
12 
week 
visit 
Main study 
 
 
 
 
Demographics Questionnaire  
X 
 
 
 

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Smoking status 
X 
 
 
X 
Breastfeeding history 
X 
 
 
X 
Health questions 
X 
 
 
X 
Weight 
X 
X 
X 
X 
Height 
X 
 
 
 
Substudy 
 
 
 
 
Block Fat/Sugar/Fruit/Vegetable 
Screener 
X 
 
 
X 
Pregnancy Physical Activity 
Questionnaire 
X 
 
 
X 
Self-efficacy re: diet and exercise 
X 
 
 
X 
Eating Stimulus Index 
X 
 
 
X 
Perceived Stress Scale 
X 
 
 
 
Readiness to change 
X 
 
 
X 
Semi-structured interview on 
participant perspective on the 
acceptability of the intervention 
(lifestyle group participants only) 
 
 
 
X 
 
 
D.   Description, Risks and Justification of Procedures and Data Collection Tools: 
 
 
 
Study procedures are listed below with related risks and justifications. 
 
Main study: 
 
Surveys:  We will orally read survey questions to participants and responses.   It may be tiring 
answering questions in our survey. Also, a participant may feel discomfort answering questions of a 
personal nature, but subjects can always choose not to answer any question. 
 
Anthropometric measurements: We will measure heights and weights using WIC clinic scales and 
stadiometers. Participants may feel uncomfortable being weighed. 
 
Lifestyle coaching:  At the baseline, 4 and 8 week visits, intervention-arm participants will receive 
lifestyle coaching from WIC staff as described above. Participants may feel uncomfortable filling in the 
HeartSmartMoms survey, or answering lifestyle questions with the WIC staff.  They may feel 
uncomfortable setting lifestyle behavior goals.  Given that WIC staff will be using a patient-centered 
approach with motivational interviewing, this discomfort should be reduced.  Motivational interviewing 
is a critical aspect of behavior change in weight loss intervention focused on behavior change.  
 
Using a pedometer: Intervention participants will be asked to use a pedometer – clicked onto their 
clothing.  Participants may find using a pedometer uncomfortable. They may find discomfort in seeing 
their step counts.  We will educate participants on how to use the pedometer, to help ensure comfort. 
We will also counsel participants on how step counts can be helpful and to set realistic goals using 
this device.  
 
Exercise: Lifestyle coaching will encourage exercise because it is an important part of weight loss 
interventions. There are risks associated with exercise. Exercise may cause sweating, fatigue, or 

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feeling out of breath. It is also possible that participants could develop soreness or injuries from 
increased exercise. Exercise can rarely cause abnormal heartbeats, chest pain, passing out, heart 
attack, stroke, or death, which are extremely rare events. 
 
Weight Loss: The intervention will encourage weight loss. With a reduction in caloric intake, 
participants may experience hunger and fatigue.  Sometimes people experience constipation, 
nausea, abdominal discomfort or diarrhea from diet changes.  Headaches, trouble sleeping, changing 
in mood or psychological stress can also occur. Weight loss may occur too rapidly resulting in 
weakness and fatigue. Lifestyle coaching will counsel on gradual weight loss. WIC staff will be 
checking weights in intervention participants every 4 weeks and can counsel participants if weight 
loss is too rapid. The most serious but very rare side effect of reduced calorie diets is gallstone 
formation, which usually only occurs with extremely low fat diets, which will not be recommended in the 
intervention.  WIC educators will have the support of WIC RDs for all participants. Study investigators 
are experienced in appropriate weight loss. 
 
 
Changes in WIC benefits: Being asked to come in to WIC more frequently and having your WIC 
benefits given to you in 1 month amounts may cause you and your family stress and added burden.  
 
Confidentiality: The Principal Investigator and her staff will take all reasonable measures to protect 
the confidentiality of each subject’s records and data. Subject data will be referenced by number only. 
Research data on paper will be kept in a secured file cabinet in a secured office area. Research data 
kept online will be kept secure and confidential through password protection. Data will be stored in 
RedCap and on a secure University server. Data kept on HeartSmartMoms will have participant ID 
number, but no other identifiable information. 
 
Substudy: 
 
Surveys:  We will orally read survey questions to participants and responses.   It may be tiring 
answering questions in our survey. Also, a participant may feel discomfort answering questions of a 
personal nature, but subjects can always choose not to answer any question. 
 
Confidentiality: The Principal Investigator and her staff will take all reasonable measures to protect 
the confidentiality of each subject’s records and data. Subject data will be referenced by number only. 
Research data on paper will be kept in a secured file cabinet in a secured office area. Research data 
kept online will be kept secure and confidential through password protection. Data will be stored in 
RedCap. Audiorecordings will be stored on a secure University server. Data kept on 
HeartSmartMoms will have participant ID number, but no other identifiable information. 
 
 
    
E.   Potential Scientific Problems:  This is a pilot intervention that has never been trialed before. 
It is based on information gathered from WIC staff, WIC leadership, WIC clients and is based on 
evidence from other settings. However, because it has never been trialed before, we may find 
significant feasibility and acceptability issues leading to significant attrition, making it impossible to 
complete Aim 2 for the main and substudies.   Given that this is a feasibility trial, with a small sample 

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size, we may also not have enough power to detect differences between intervention and control 
participants if the differences are small.  
 
 
F.   Data Analysis Plan:   
 
Aim 1: To evaluate the feasibility and acceptability of a multi-component novel weight loss 
intervention delivered in a WIC setting to a population of low-income, predominantly racial/ethnic 
minority, obese, postpartum women.  
 
 
• The RA will transcribe the audiorecorded responses to open-ended questions posed to participants 
and WIC staff on acceptability. We will use a thematic analytic approach to analyze the data. After 
reading and discussing all responses amongst team members, we will create a list of codes. We will 
then use an iterative process to revise codes as needed and identify main themes. We will use a 
software program (Atlas.ti) for coding.  We will assess the ease of recruiting women for the study 
(number enrolled/number approached) and attrition from the study. We will also calculate the 
intervention adherence measures, including number of women who received the entire intervention, 
number of women who came to all visits, participation in self-monitoring, use of phone coaching, 
and use of the Facebook page.  For the Facebook page, we will count the number of 
posts/individual and categorize the content based on the type of content we see.  
 
 
Aim 2: To evaluate differences in diet, physical activity, self-efficacy, eating stimulus, and weight 
change between intervention and control participants to determine preliminary intervention efficacy 
over a 12-week period. 
 
 
• 
We will conduct a univariate analysis of variables to evaluate for baseline group differences, 
distributions, and outliers for demographic, lifestyle and infant feeding variables. Student t-tests 
will be used to test for differences between intervention and control groups in change in weight 
(baseline to 12 wks) and in lifestyle habits using a 2-tailed alpha=0.05 for statistical significance.  
Dr. Thompson will conduct the analysis in consultation with the Child Health Research 
Biostatistical Core. 
 
Sample Size: This is a feasibility trial, hence, we will not be powered to detect all clinically significant 
findings. The sample size was chosen based on the sample needed to achieve Aim1. The sample 
size is 40 (20 intervention and 20 control). We are asking for a sample size in the application up to 80 
in case we have a large number of individuals enroll but not participate in the substudy. Given that 
this is a feasibility trial, we are unsure how difficult recruitment will be.   
 
 
G.  Summarize Knowledge to be Gained:  We will learn whether the proposed intervention is 
feasible and acceptable, which will inform future efforts to design weight loss interventions in WIC 
settings. If it is feasible and acceptable, then this will support the need to evaluate this intervention 
on a larger scale. Findings from Aim 2 will help us to understand whether the intervention has an 
impact on lifestyle changes and weight.  Again, this is important for understanding whether we 
should evaluate this intervention on a larger scale, and will inform sample size estimates for future 
work.  

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5. 
Greene GW, Smiciklas-Wright H, Scholl TO, Karp RJ. Postpartum weight change: how much of the weight gained 
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Whitaker RC. Predicting Preschooler Obesity at Birth: The Role of Maternal Obesity in Early Pregnancy. 
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West DS, DiLillo V, Bursac Z, Gore SA, Greene PG. Motivational Interviewing Improves Weight Loss in Women 
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Armstrong MJ, Mottershead TA, Ronksley PE, Sigal RJ, Campbell TS, Hemmelgarn BR. Motivational interviewing 
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Fischer HH, Fischer IP, Pereira RI, et al. Text Message Support for Weight Loss in Patients With Prediabetes: A 
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Nicklas JM, Zera CA, England LJ, et al. A web-based lifestyle intervention for women with recent gestational 
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Nicklas JM, Skurnik G, Zera CA, Reforma LG, Levkoff SE, Seely EW. Employing a Multi-level Approach to Recruit 
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20. 
https://nutritionquest.com/assessment/list-of-questionnaires-and-screeners/.