Disseminating and Implementing A Lifestyle Based Healthy Weight Program in a National Organization
Phase: PHASE3
Conditions: Obesity
Sponsor: Washington University School of Medicine

D&I of a Lifestyle Based Healthy Weight Program in a National Organization 
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Disseminating & Implementing a Lifestyle 
Based Healthy Weight Program in a National 
Organization 
 
 
 
 
Protocol  
 
 
 
 
 
 
Date created (Version 4.4): July 17, 2025 
 
 

D&I of a Lifestyle Based Healthy Weight Program in a National Organization 
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TABLE OF CONTENTS 
 
PROTOCOL ................................................................................................................................................. 1 
A 
INTRODUCTION ............................................................................................................................... 4 
A1 
STUDY ABSTRACT ......................................................................................................................... 4 
A2 
PRIMARY HYPOTHESIS ................................................................................................................... 4 
B 
BACKGROUND .................................................................................................................................. 4 
B1 
PRIOR LITERATURE AND STUDIES .................................................................................................. 4 
B2 
RATIONALE FOR THIS STUDY ......................................................................................................... 6 
C 
STUDY OBJECTIVES ....................................................................................................................... 7 
C1 
PRIMARY AIM ................................................................................................................................ 7 
C2 
SECONDARY AIMS ......................................................................................................................... 7 
C3 
RATIONALE FOR THE SELECTION OF OUTCOME MEASURES ........................................................... 7 
D 
INVESTIGATIONAL AGENT .......................................................................................................... 7 
D1 
PRELIMINARY STUDY ..................................................................................................................... 8 
E 
STUDY DESIGN ................................................................................................................................. 8 
E1 
OVERVIEW OR DESIGN SUMMARY ................................................................................................. 8 
1.a 
Inclusion Criteria ..................................................................................................................... 8 
1.a 
Exclusion Criteria ..................................................................................................................... 9 
1.b 
Participant Recruitment Plans and Consent Process ............................................................... 9 
1.c 
Randomization Method ........................................................................................................... 10 
1.d 
Early Withdrawal of Participants ........................................................................................... 10 
1.e 
When and How to Withdraw Participants .............................................................................. 10 
1.f 
Data Collection and Follow-up for Withdrawn Participants ...................................................... 10 
E2 
DESCRIPTION OF USUAL CARE PAT AND HEALTH INTERVENTIONS ........................................... 10 
2.a 
Description ............................................................................................................................. 10 
2.b 
Usual care description ............................................................................................................ 11 
2.c 
HEALTH description .............................................................................................................. 11 
2.d 
HEALTH dose ......................................................................................................................... 11 
2.e 
HEALTH training curriculum (implementation strategy) ...................................................... 12 
F 
STUDY PROCEDURES ................................................................................................................... 12 
F1 
SCREENING FOR ELIGIBILITY ............................................................................................................ 13 
F2 
SCHEDULE OF MEASUREMENTS ....................................................................................................... 14 
G 
SAFETY MONITORING ................................................................................................................. 16 
G1 
POTENTIAL RISKS ........................................................................................................................ 16 
G2 
SURVEILLANCE AND REPORTING PROCEDURES ........................................................................... 16 
G3 
SAFETY MONITORING PLAN ........................................................................................................ 17 
H 
STATISTICAL PLAN ....................................................................................................................... 17 
H1 
SAMPLE SIZE DETERMINATION AND POWER ................................................................................ 17 
H2 
INTERIM MONITORING AND EARLY STOPPING ............................................................................. 18 
H3 
STATISTICAL METHODS ............................................................................................................... 18 

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H4 
QUALITATIVE METHODS .............................................................................................................. 19 
H5 
MISSING OUTCOME DATA ........................................................................................................... 19 
I 
DATA HANDLING AND RECORD KEEPING ............................................................................ 20 
I1 
CONFIDENTIALITY AND SECURITY ................................................................................................... 20 
I2 
TRAINING ......................................................................................................................................... 20 
I3 
PERFORMANCE MONITORING ........................................................................................................... 21 
J 
STUDY ADMINISTRATION .......................................................................................................... 21 
J1 
COMMITTEES .................................................................................................................................... 21 
J2 
PARTICIPANT STIPENDS OR PAYMENTS ............................................................................................ 21 
J3 
STUDY TIMETABLE .......................................................................................................................... 21 
K 
ATTACHMENTS .............................................................................................................................. 22 
K1 
APPENDIX A. SAMPLE OF HEALTHY EATING & ACTIVE LIVING TAUGHT AT HOME (HEALTH) 
CURRICULAR MATERIALS ......................................................................................................................... 23 
K2 
APPENDIX B. DATA SAFETY AND MONITORING PLAN ................................................................. 28 
 
 
 
 

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A Introduction 
 
A1 Study Abstract 
Excessive weight gain among young adult women age 18-45 years is an alarming and 
overlooked trend that must be addressed to reverse the epidemics of obesity and 
chronic disease. During this vulnerable period women tend to gain disproportionally 
large amounts of weight compared to men and other life periods. Our team developed a 
lifestyle modification intervention Healthy Eating & Active Living Taught at Home 
(HEALTH) that prevented weight gain, promoted sustained weight loss, and reduced 
waist circumference in an effectiveness trial in partnership with Parents as Teachers 
(PAT), a national home visiting, community based organization with significant reach in 
this population. PAT provides parent-child education and services free-of-charge to 
nearly 170,000 families through up to 25 free home visits per year until the child enters 
kindergarten. This study will extend our previous work to evaluate dissemination and 
implementation of HEALTH across three levels (mother, parent educator, PAT site) to 
achieve widespread impact. We will conduct a pragmatic cluster randomized controlled 
trial to evaluate HEALTH and the HEALTH training curriculum (implementation strategy) 
on weight among mothers with overweight and obesity across the US (N= 200 HEALTH; 
N= 200 usual care). Parent educators from 40 existing PAT sites (20 HEALTH, 20 usual 
care) will receive the HEALTH training curriculum through the PAT National Center, 
using PAT’s existing training infrastructure, as a continuing education opportunity. An 
extensive evaluation, guided by RE-AIM, will determine implementation outcomes 
(acceptability, adoption, appropriateness, feasibility, fidelity, and adaptation) at the 
parent educator level. The Conceptual Framework for Implementation Research will 
characterize determinants that influence HEALTH dissemination and implementation at 
three levels (mother, parent educator, PAT site) to enhance external validity (reach and 
maintenance) and population level impact. The findings from this innovative study will 
have significant potential to help reverse the trend of excessive weight gain among 
young adult women, a critical priority target in battling the epidemics of obesity and 
chronic disease, by reaching women with an evidence-based intervention nation-wide. 
B Primary Hypothesis 
The magnitude of the between-group difference in baseline to 24-month change in 
weight will be at least 4.7 kg, with mothers receiving HEALTH gaining less weight than 
those receiving usual care. 
 
C Background 
 
D Prior Literature and Studies 
Among women, early adulthood (18–45 years of age) is a particularly vulnerable 
time period, during which they tend to gain disproportionately large amounts of weight, 

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making prevention of weight gain an important target for obesity prevention efforts.1-3 
Maternal weight change in young adulthood, often initiated during pregnancy and 
maintained after the postpartum period, can impact obesity risk for the rest of a woman’s 
life.4-6 Data from the most recent NHANES survey show that among adult women, the 
prevalence of obesity in 2011-4 ranged from 12% for Non-Hispanic Asian women to 57% 
among Non-Hispanic Black women,7 indicating the burden of obesity is borne 
disproportionately by some groups. NHANES data also demonstrated that obesity 
increased among women from 2005-6 to 2013-4, but not among men.8 Secular trends 
toward dramatic gains, particularly in young adult women, have been observed in the 
few representative longitudinal studies that have been conducted.1,3,9,10 For example, 
The Coronary Artery Risk Development in Young Adults (CARDIA) study enrolled young 
adults (18-30 years old) in 1985-6; periodic measurements through 1995-6 found 68% of 
white women and 78% of Black women who began the study overweight gained at least 
5 kg over 10 years and 20% and 29% of these respective groups gained excessive (>20 
kg) amounts of weight.2 Reaching young mothers with interventions that can reverse the 
trend of excessive weight gain among young adult women is critical to battling the 
epidemics of obesity and chronic disease. 
Dissemination and implementation (D&I) evidence-based interventions, which 
translate the Diabetes Prevention Program (DPP) into real-world practice, hold promise 
for impacting the secular trends described above, as prevention of weight gain is a 
priority intervention target.3 Follow-up data from the DPP demonstrated the lifestyle 
intervention, targeting improved dietary intake and physical activity, decreased the 
incidence of diabetes by 27% over 15 years in overweight and obese adults with 
impaired glucose tolerance, compared to the placebo group.11,12 Moderate weight loss 
can delay or decrease the risk of developing obesity related diseases, such as 
cardiovascular disease and diabetes,11,13,14 and metabolic studies have found that for 
some outcomes, most of the improvement from a weight loss of up to 15%, come with 
the first 5% of weight lost.14 Improvement in blood pressure can be achieved even with 
as little as 3% weight loss.15-18 In DPP translation studies, Aziz et al. found the 
percentage of participants achieving a 5% weight loss ranged from 20% to 64% across 
interventions.19 While interventions are able to achieve weight loss, they often ultimately 
result in diminished effect and weight regain over time.12,20-27 One study found changes 
in chronic disease risk factors were not different between participants who lost, then 
regained weight compared to those who did not lose weight.28  
Despite efforts to translate the DPP to broader populations,29-33 evidence-based 
interventions often fail to reach young women, who are at high risk for weight gain.34 
Women with young children face time and childcare barriers, which impact participation, 
engagement, and retention; this is of concern as success in programs such as the DPP 
is associated with attendance.35 Discrepancies exist between evidence-based, 
efficacious interventions such as the DPP, and the practical reality of what can be 
implemented in real-world settings.11,36-39 This study will build on our previous work 
embedding core DPP elements into the usual practice of a home visiting program that 
already offers intensive contact over time, and extends this by using PAT’s own staff and 
training infrastructure. This study will also assess the effectiveness of the HEALTH 
training curriculum (the implementation strategy) and the external validity of this 
approach when HEALTH is implemented in real-world sites, critical to ensuring 
sustained impact. 

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D1 Rationale for this 
Study 
Excessive weight gain among young adult women (18-45 years) is an alarming 
and overlooked trend that must be addressed to reverse the epidemics of obesity and 
chronic disease.3 On average, young women gain as much as 0.96 kg per year, for a 
total of 11.9 kg over 10 years.2 Based on large scale epidemiologic studies,9 gaining as 
little as 2.5 to 10 kg can increase a woman’s risk of death from cardiovascular disease 
by 25%. Development of obesity during childbearing years may also lead to its 
intergenerational transfer, heightening the need for interventions to prevent weight gain. 
During this vulnerable period women tend to gain disproportionally large amounts of 
weight compared to men and other life periods.1-3 Evidence-based interventions, such as 
the DPP,12 often fail to reach this population due to time and priority constraints.34 Our 
team developed an intervention that prevented weight gain and promoted sustained 
weight loss in partnership with Parents as Teachers (PAT),40 a national home visiting, 
community based organization with significant reach in this population. PAT provides 
parent-child education free-of-charge to women and families, through up to 24 home 
visits per year that begin prenatally and continue until kindergarten. In 2016, 4,999 
parent educators, in 3,246 sites across all 50 states, conducted >1.7 million home visits 
with nearly 170,000 families.41 
D&I of an evidence-based intervention within PAT can prevent chronic diseases 
such as cardiovascular disease and diabetes among mothers nationwide.11,19,42,43 Since 
HEALTH is embedded within PAT’s existing home visits (without adding visits), which 
provides long-term interaction with the family (from prenatal until the last child in the 
home enters kindergarten),41 it is able to provide a ‘limited content + long-term delivery’ 
approach. This approach supports mothers in making incremental changes in eating and 
physical activity behaviors, and prevents weight gain.44  In an effectiveness trial, 
HEALTH led to a 4.7 kg weight difference between groups, reducing weight by 1.5 kg in 
the intervention group, relative to a 3.2 kg gain in the usual care group over 2 years.40 
Embedding HEALTH within PAT overcomes barriers to participation and reflects the 
United States Preventive Services Task Force (USPSTF) recommendation of 12 
intervention sessions per year.45 Mothers are already motivated to participate in PAT to 
benefit their child. This enables participation in HEALTH, an intervention that prevented 
weight gain, promoted weight loss, and reduced waist circumference (which help prevent 
cardiovascular disease and diabetes)40 and is ready for D&I. 
The proposed study extends our previous work with a Hybrid Type 246 pragmatic 
cluster randomized controlled trial to evaluate D&I of HEALTH across three levels 
(mother, parent educator, PAT site) to achieve widespread impact. First, we will 
determine weight outcomes among 504 overweight/obese mothers (N=200 HEALTH; 
N=200 usual care) when parent educators (~8/site) from 40 PAT sites nationwide (20 
HEALTH, 20 usual care) receive the HEALTH training curriculum (the implementation 
strategy47) through PAT National Center’s existing training infrastructure. From a D&I 
perspective, an evaluation guided by RE-AIM will measure implementation outcomes 
(acceptability, appropriateness, feasibility, fidelity, adaptation).48-50 Further, the 
Conceptual Framework for Implementation Research will guide an assessment of factors 
that influence external validity at multiple levels (mother, parent educator, PAT site) to 
maximize HEALTH D&I.51,52 This innovative study provides the evidence necessary for 
sustainable D&I of HEALTH across PAT’s national network, promoting healthy weight 
and preventing chronic disease on a national scale. 

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E Study Objectives 
 
E1 Primary Aim 
Aim 1. Determine the effectiveness of HEALTH on weight and behaviors among 
200 overweight and obese mothers when disseminated and implemented across 
20 real-world PAT sites. We hypothesize: 
Hypothesis 1.1 The magnitude of the between-group difference in baseline to 24-month 
change in weight will be at least 4.7 kg, with mothers receiving HEALTH gaining less 
weight than those receiving usual care. [primary] 
Hypothesis 1.2 Mothers in HEALTH will improve dietary (e.g., reduce sugar beverages) 
and physical activity (e.g., increase brisk walking) behaviors over 24 months, compared 
to usual care. [secondary] 
Hypothesis 1.3 Relative to usual care, mothers in HEALTH will improve the home food 
environment. [secondary] 
E2 Secondary Aims 
Aim 2. Evaluate the HEALTH training curriculum’s impact on implementation 
outcomes (e.g., acceptability, fidelity), at the parent educator level, when 112 
parent educators (~8/site) are trained by PAT National Center. We hypothesize that 
parent educators receiving the HEALTH training curriculum will: 
Hypothesis 2.1 Deliver HEALTH with fidelity (adherence, quality of delivery, exposure to 
the intervention, and participant responsiveness or involvement). [primary] 
Hypothesis 2.2 Deliver HEALTH as designed, but adapted for content, consistency, and 
intensity. [secondary] 
Hypothesis 1.3 Rate HEALTH acceptable, appropriate, and feasible to implement in 
routine practice. [secondary] 
 
Aim 3. Characterize determinants that influence HEALTH D&I at three levels: 
mother, parent educator, PAT site to enhance external validity (reach and 
maintenance/sustainability). 
Question 3.1 Are the mothers participating in HEALTH representative of typical PAT 
participants? 
Question 3.2 What characteristics of parent educators make them more likely to deliver 
HEALTH with fidelity? 
Question 3.3 Are there characteristics of PAT sites that make them more likely to adopt 
and maintain HEALTH? 
E3 Rationale for the 
Selection of 
Outcome Measures 
Weight change was selected as the main outcome measure as the aim of the study is 
prevention of weight gain. 
F Investigational Agent  
 

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F1 Preliminary study 
In the efficacy study (NIDDK grant no. R18DK089461; registered at 
www.clinicaltrials.gov NCT01567033.), women in the usual care versus intervention 
group were significantly less likely to achieve 5% weight loss at 24 months (11% vs 
26%, p=0.01). At 12 months, there was a 2.8-kg difference in weight between groups 
(p=0.0006), and by 24 months a 4.7-kg difference in weight (3.2 [SD=7.6] kg vs –1.5 
[SD=8.3] kg, p=0.002); group differences in waist circumference were also evident by 12 
months (2.1 [SD=8.4] cm vs –0.7 [SD=9.8] cm, p=0.04) and 24 months (3.8 [SD=10.6] 
cm vs –2.5 [SD=9.1] cm, p=0.005), as were improvements in behavioral outcomes. 
There was no difference in blood pressure between groups.53  
 
G Study Design  
 
G1 Overview or Design 
Summary 
The study includes a Hybrid Type 2 (efficacy/implementation) cluster randomized trial. 
Since parent educators from each PAT site will be trained together (risk for 
contamination) and several research questions relate to the PAT site level, a cluster 
randomized trial is appropriate.54-56 PAT National Center will train educators affiliated 
with 40 PAT sites in HEALTH; among these, 20 will be randomly assigned to receive the 
HEALTH training curriculum (implementation strategy), and 20 will serve as controls, 
delivering usual care PAT. Given the multi-level nature of this study, there are two types 
of participants: 1) mothers and 2) PAT staff 
 
1.a 
Inclusion Criteria  
PAT sites: Sites will be selected from the pool of 3,246 sites to be among the 40 
included in the trial then randomized. To be eligible, sites must report seeing 25 families 
per year, to assure the required number of mothers per site will be able to be recruited 
during the study period. Further, to avoid compromising at PAT site’s ability to complete 
its primary function of delivering PAT by imposing the burden of a study, only sites in 
compliance with the PAT model are eligible. 
 
Mothers: As a pragmatic trial, it is important that study participants closely match the 
usual case load for PAT; inclusion criteria have been selected accordingly.57 For 
inclusion in the analytic sample, participants must be 18-45 years of age, overweight or 
obese (BMI 25-45 kg/m2), English or Spanish speaking, participating or willing to 
participate in PAT at a participating PAT site for 2 years, and able to give informed 
consent for participation.  
 
PAT staff: All parent educators at sites participating in the study will be invited to 
participate. If parent educators elect not to receive the HEALTH training curriculum (the 
implementation strategy), they will still be allowed to consent to the study and participate 
in the survey; if they decline to consent to the study and participate in the survey, 
educators will still be allowed to receive the training; however, mothers on these 
educators’ case loads will not be eligible for the study. 

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1.a 
Exclusion Criteria  
Mothers: Women who are currently pregnant, fewer than 6-months postpartum, or 
planning to become pregnant in the next 24 months; are unable to speak English or 
Spanish; and/or are unable to engage in a walking program will be excluded.  
 
PAT staff: at least 18 years of age 
1.b 
Participant Recruitment Plans and Consent Process 
Mothers: Our plan to recruit participants mirrors routine PAT ‘rolling’ recruitment 
throughout the year. Parent educators may provide study fliers or emails to families 
(parent educators commonly provide materials to families). If the PAT site is hosting an 
event at which study consent might occur and measures might be taken, parent 
educators might provide flyers or emails about these events as well. Interested families 
will either call the number on the flyer or indicate their interest to the parent educator; the 
parent educator will send the names of mothers who express interest in additional 
information to the research team who will coordinate an outreach/screening call or text. 
Screening and data collection procedures will be will be conducted with a data collector. 
Data collectors could be a local study team member who calls from (for screening calls) 
and/or travels from St. Louis (for in person screening and/or measurement) to the site or 
an individual hired locally to complete data collection. Data collectors will screen 
potential participants by phone or at site events to ascertain self-reported height and 
weight, to determine eligibility. If eligible based on self-report, the data collector will 
consent the participant to a baseline visit and schedule this baseline visit. At the baseline 
visit, the informed consent process will occur before baseline data collection, with the 
data collector. These visits may occur in the woman’s home, some other location she 
prefers (e.g., library, doctor’s office, PAT site), or at PAT site events. As data collection 
will occur electronically, the participant will have the opportunity to review the consent 
information on the electronic data collection device (i.e., tablet) before initiating data 
collection and receive a paper copy of the document, however, we have requested a 
waiver of documentation of consent. The data collector will also measure height and 
weight to confirm eligibility based on BMI. Those found to be ineligible and those not 
providing consent will continue with PAT visits, but will not be part of the study (will not 
participate in any study measures). To minimize the possibility of coercion or undue 
influence during the consent process, mothers will have as much time as needed to 
decide about participation, and the data collector will remind them that their PAT 
services will not be affected by their decision to participate or not. 
 
PAT staff: When a site agrees to participate in the study, all parent educators will be 
made aware of the opportunity to participate in the study through a flyer and/or email 
message and/or announcement at a staff meeting or training. If the parent educator is 
interested in participating, they will contact the research team by email. Site leaders may 
also provide a list of educators along with their contact information. The research team 
will reach out to parent educators by phone and email to conduct informed consent and 
send the information sheet by email. To minimize the possibility of coercion or undue 
influence during the consent process, parent educators will have as much time as 
needed to decide about participation, and the research team will remind them that 
participating will not affect their employment.  

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1.c 
Randomization Method 
PAT sites will be randomly assigned to HEALTH or usual care via a dynamic 
randomization scheme,58 in which percent of low-income and number of families served 
will be considered so that we achieve similar distributions in both arms of the study. The 
first 12 sites will be randomized to HEALTH or usual care arms in a 1:1 ratio within five 
site pairs where two sites are matched closely on total size and percent of low-income 
families. There are two sites that cannot be matched; for these two sites, several 
possible randomizations will be elicited in a 1:1 ratio and the randomization that best 
maintains the overall balance (on total size and percent of low income families) between 
the two treatment groups will be selected. Subsequent sites will use a dynamic 
randomization scheme, the details of which will be determined when those sites are 
recruited. Again, they will be randomized to best maintain the overall balance (on total 
size and percent of low-income families) between the two treatment groups. 
1.d 
Early Withdrawal of Participants  
Mothers: Participants who decide they would no longer like to participate in the study are 
free to withdraw at any time; they may continue with PAT visits, but will not be part of the 
study (will not participate in any study measures). 
 
PAT staff: Participants who decide they would no longer like to participate in the study 
are free to withdraw at any time; this will not affect their employment, but they will not be 
part of the study (will not participate in any study measures). 
1.e 
When and How to Withdraw Participants  
Should a participant (mother or PAT staff) wish to withdraw from the study, they can do 
so at any time by completing the withdrawal letter, found in the Participant section of the 
Human Research Protection Office website at http://hrpo.wustl.edu (or use this link: 
https://hrpo.wustl.edu/participants/withdrawing-from-a-study/) or requesting that the 
Investigator send a copy of the letter. 
1.f 
Data Collection and Follow-up for Withdrawn Participants  
Participants (mother or PAT staff) who decide to withdraw will not participate in any 
additional measurement or follow-up. 
 
G2 Description of usual 
care PAT and 
HEALTH 
interventions 
 
2.a 
Description  
 
Given the national scale of PAT and the considerable variability between sites 
and participants, PAT curricula are primarily hands on, including dynamic interactions 
and role-playing. This allows for adaptation at the level of the mother-parent educator 
relationship, where the parent educator is able to tailor the program to meet the mother’s 
context.49,59 Section 2.d provides additional detail. 

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2.b 
Usual care description  
 
Participants at usual care PAT sites will receive the Foundational (usual care) 
curriculum that uses a strength-based, solution-focused model.60 It includes 60-minute 
home visit plans60 that focus on 1) rapport building (e.g., reflective questions to get to 
know the family such as “What did you notice about your child’s development?”), 2) 
development-centered parenting (e.g., comparing and ordering for math skills), 3) 
parent-child interaction (e.g., measuring dried beans), 4) family well-being (e.g., address 
needs in the family’s physical and emotional environment such as “Who do you think 
supports your child to be happy and successful?”), and 5) closing/reinforcement and 
follow-up plans (e.g., feedback on goals, praise for success). The frequency and number 
of visits are based on the family’s needs and preferences.  
 
2.c 
HEALTH description  
 
Participants at HEALTH (intervention) sites receive the Foundational curriculum + 
evidence-based lifestyle change strategies to prevent weight gain and promote weight 
loss embedded within and delivered as part of home visits. The HEALTH intervention is 
guided by PAT’s strength-based, solution-focused model and a socio-ecologic approach 
recognizing the protective and interactive influences on women across multiple 
levels.61,62 
A detailed sample of the curricular materials unique to the HEALTH intervention 
are included in Appendix A. In addition to the usual care PAT curriculum content, goal 
setting related to healthy weight, and the importance of parental modeling of healthy 
eating and physical activity are incorporated throughout the discussion and visit. Content 
mirrors the structure of the Foundational curriculum described above, but is enhanced to 
embed lifestyle change as the following example illustrates: 1) rapport building (e.g., 
reflective questions to get to know the family such as “What did you notice about your 
child’s development + What did you notice about your families eating?”), 2) 
development-centered parenting (e.g., comparing and ordering for math skills + healthy 
portion size), 3) parent-child interaction (e.g., measuring food in appropriate portion 
size), 4) family well-being (e.g., address needs in family’s physical and emotional 
environment such as “Who do you think supports your child to be happy and successful? 
+ What could you do at home to make it easier to eat healthier portions?”), and 5) 
closing/reinforcement and follow-up plans (e.g., feedback on goals, praise for success). 
Other objectives include skill building and strategies to address: reduction of high-sugar 
beverages, substituting healthy for unhealthy foods, portion control, and eating patterns. 
Physical activity goals encourage a total of 150 minutes (2.5 hours) of moderate-
intensity exercise (e.g., brisk walking) and/or lifestyle activity per week.63 HEALTH 
participants will be provided pedometers, allowing them to track and self-monitor their 
steps.  
2.d 
HEALTH dose  
 
Intervention dose. HEALTH may be delivered over 24 months via a (1) core and 
(2) maintenance phase. Modeled after the Diabetes Prevention Program (DPP)11,12,25 
and various effective DPP adaptations,31,33 the visits begin with greater frequency, and 

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taper. HEALTH was effective with families receiving, on average, 23 visits over two 
years, with 39% of families receiving <15 visits, 36% of families receiving ≥25 visits, and 
15% receiving >30. Consistent with PAT practice, the frequency and number of visits are 
determined by the family’s needs and preferences, therefore the dose structure for 
HEALTH is flexible. A sample number of visits is provided in Table 1, but will likely differ 
by family (as was the case in the effectiveness trial) so that each family gets what they 
need in terms of content, number of visits, and visit frequency. The core phase (months 
1-6) is the most intense and structured phase, delivered via ~13 home visits. During this 
phase, participants are taught basic information about healthy eating and physical 
activity and are given the opportunity to practice related behavioral skills during home 
visits (see lesson topics and examples in Table 1). During this time the parent educators 
and mothers learn how to best work together to achieve study goals. The maintenance 
phase (months 7-24) reinforces lessons learned in the core phase while assisting 
participants in focusing on issues of relevance and problem-solving via 10 home visits. 
As PAT is designed to be a universal program,44 HEALTH was also designed to be 
universal; for example, while the HEALTH program stresses reducing sugar-sweetened 
beverage intake, parent educators tailor this to the specific types of beverages women in 
different cultures drink (e.g., sodas, Kool-Aid, Agua Fresca, orangeade).  
 
2.e 
HEALTH training curriculum (implementation strategy)  
 
We will use PAT’s existing infrastructure to deliver our implementation strategy, the 
HEALTH training curriculum.47 This includes:  
Training materials used in the HEALTH effectiveness trial and developed with the 
input of PAT National Center, will be formulated into the type of curriculum manual PAT 
parent educators are accustomed to receiving.  
PAT parent educators will be trained to deliver HEALTH through a specialty 
training delivered by PAT National Center. In preparation for the current proposal, we 
worked with PAT National Center to harmonize the HEALTH training curriculum with the 
organization’s usual practice and training infrastructure. The protocol may be delivered 
through an interactive training that includes seven components: 1) HEALTH background 
and rationale, 2) guidelines for healthy weight behaviors, 3) overview of the HEALTH 
protocol, 4) the importance of the mother’s lifestyle and influence on child weight and 
development, 5) role-play practice sessions with other parent educators, 6) instruction 
on the use of self-monitoring tools and 7) feedback from trainers. Consistent with PAT 
training protocols we have successfully implemented,64-66 HEALTH educators must 
complete a posttest reflecting training objectives. A pretest will be available to frame 
training. Trainees must receive ≥90% correct on the posttest before delivering the 
intervention to participants. 
Ongoing consultation will include ‘booster’ sessions, consistent with PAT 
‘communities of practice’. PAT educators may receive training and supervision by the 
research coordinator (dietitian and PAT parent educator) and by a parent educator with 
experience in similar trials. Parent educators may receive continuing education credits 
(required by PAT for all parent educators) for participating in the HEALTH training 
curriculum. 
 
H Study Procedures  

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H1 Screening for 
Eligibility 
Mothers: Screening for mothers will occur in two phases. First, data collectors (study 
team members) will screen potential participants by phone to ascertain self-reported 
height and weight, to determine eligibility. If the mother is eligible based on this 
screening, they will be offered a baseline visit. These visits may occur in the woman’s 
home, some other location she prefers (e.g., library, doctor’s office, PAT site), or at PAT 
site. At this visit, the data collector will assess height and weight to assure the mother’s 
BMI is within the eligibility range. The procedures for these participants are outlined in 
Figure 1. Given in-person procedures are not possible during COVID-19 physical 
distancing, alternate procedures are outlined in Appendix C. 
 
 
 
PAT staff: as there are no exclusion criteria, no screening is required. The procedures 
for these participants are outlined in Figure 2. 
 

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H2 Schedule of 
Measurements 
Mothers: The flow of participants is outlined in Figure 1. After the mother consents to 
study participation, the data collector will conduct baseline measures (i.e., 
anthropometry, blood pressure, behavior measures, home environment measures); data 
collection is summarized in Table 1 (below). Data collectors will conduct anthropometry 
and blood pressure measures and mothers will be asked to complete surveys for data 
collection. Data collection will occur again at 12 and 24 months (conducted by the data 
collector at all time points). As randomization will be at the PAT site level, data collection 
will be the same for both HEALTH and usual care with one exception. Mothers will be 
asked to complete an acceptability survey along with their 12 and 24 month measures. 
Given in-person procedures are not possible during COVID-19 physical distancing, 
alternate procedures are outlined in Appendix C. 
During home visits, parent educators may (with participant consent) record the visits so 
that fidelity to and adaptations from the intervention can be monitored.  
 
Table 1. Summary of Measures 
 
Acronym 
SC 
BL 
M12 
M24 
Time point 
 
 
 
 
 
Day (window, ± days from randomization) 
 
 
≤180 
 
 
Day (window, ± weeks from BL) 
 
 
 
365±90 
730±90 
MOTHER-LEVEL DATA 
 
 
 
 
 
Telephone Screening (self-report HT, WT → consent) 
 
● 
 
 
 
Demographic and Socio-Economic Characteristics 
DEM 
 
● 
 
 
 
 
 
 
 
 
Anthropometrics 
Height 
HT 
 
● 
 
 
Weight 
WT 
 
● 
● 
● 
Blood Pressure 
BP 
 
● 
● 
● 
Waist Circumference 
WC 
 
● 
● 
● 
Safety monitoring (excessive weight loss - >15%) 
 
 
 
● 
● 
Behavior 
NHANES Dietary Screener Questionnaire (from 
 
 
● 
● 
● 

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HEALTH) 
IPAQ 
(http://uacc.arizona.edu/sites/default/files/ipaq_english
_telephone_short.pdf) 
 
 
● 
● 
● 
Home Environment 
 
Kegler_2014_The influence of home food 
environments on eating behaviors of overweight and 
obese women 
 
 
● 
● 
● 
HEALTH Effectiveness Trial Items (SES, 
race/ethnicity, norms) 
 
 
● 
● 
● 
 
 
 
 
 
 
Individual Parent-Level Satisfaction Measure (RE-AIM 
measure: acceptability) 
 
 
 
● 
 
 
 
 
 
 
 
Testing performed by the data collectors; respondent self report 
 
 
Mothers in the HEALTH group will be purposively selected to be representative 
of those with varying (high, middle, low) scores on the quantitative measures for 
acceptability (acceptability survey). Interviews will be completed by phone, and will be 
digitally recorded. We anticipate interviews to assess implementation outcomes 
(acceptability, appropriateness, and feasibility) will last 45-60 minutes.  
Mothers will receive PAT services throughout the 24 months, consistent with PAT 
practice; mothers served by sites randomized to HEALTH will receive PAT from parent 
educators trained in the HEALTH curriculum, and those served by usual care PAT sites 
will receive usual care PAT. Once final data collection occurs at 24 months, no additional 
follow-up will occur. 
 
PAT staff: The flow of participants is outlined in Figure 2. After PAT staff consent, those 
at sites randomized to HEALTH may be trained in the HEALTH training curriculum 
through PAT’s existing training infrastructure. Staff at sites randomized to usual care will 
continue to provide usual care PAT, and will be able to receive the HEALTH training 
curriculum at the end of the study. Staff at both sites will be asked to record visits with 
study participants so that fidelity to and adaptations from the intervention can be 
monitored and to complete visit checklists after each visit with a participating mother 
documenting visit content.  
Staff at all sites will be asked to complete surveys to assess implementation 
outcomes (acceptability, adoption, appropriateness, feasibility, fidelity, and adaptation). 
Staff at sites randomized to the HEALTH training curriculum will be asked to take the 
surveys at enrollment/randomization (before training) and again after training. Parent 
educators in usual care sites will also be asked to complete the measures at baseline, 
upon enrollment into the study. Both sets of educators will be asked to complete the 
measures at the end of the intervention period, before the usual care sites receive the 
HEALTH training curriculum. Usual care parent educators will complete a final round of 
surveys after they receive the HEALTH training curriculum.  
PAT staff will be purposively selected to be representative of those with varying 
(high, middle, low) scores on the quantitative measures for acceptability to be invited to 
participate in qualitative data collection. Interviews will be completed by phone and will 
be digitally recorded. We anticipate interviews to assess implementation outcomes 
(acceptability, appropriateness, and feasibility) will last 45-60 minutes. Parent educators 
will complete interviews after conducting HEALTH with at least three families. Following 
this final data collection, no additional follow-up will occur.  
 

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I SAFETY MONITORING 
The study will monitor participant safety.  One aspect of this monitoring is to evaluate 
potential participants at screening to determine whether it is safe for them to participate 
in the interventions.  
 
I1 
Potential Risks 
 
This study is minimal risk as defined by 45 CFR 46.102: “the probability and 
magnitude of harm or discomfort anticipated in the research are not greater in and of 
themselves than those ordinarily encountered in daily life or during the performance of 
routine physical or psychological examinations or tests”. Therefore, we anticipate no 
psychological, social or legal risks beyond those of participation in minimal-risk research 
in general.  
Participants may find some of the questions in the questionnaire assessments 
embarrassing. They may be uncomfortable having their height, weight, waist 
circumference, and blood pressure measured.  
A potential risk to study participants is loss of confidentiality. 
I2 
Surveillance and 
Reporting 
Procedures 
This study does not involve a drug intervention, device intervention, or highly invasive 
data collection procedure. However, recognizing that unanticipated events can occur in 
the course of any study, even a minimal risk study, the following reporting protocols will 
apply. 
This study will collect the following information for events that occur during the conduct 
of study activities (i.e., collection of study data or home visits):  
• 
unanticipated (i.e., unexpected) and related adverse events (possibly related or 
definitely related to study participation) and  
• 
unanticipated problems that may involve risk to participants or study staff, but do 
not necessarily result in an adverse event (i.e., harm).  
These will be monitored using two mechanisms: 
1. Events (Possible AEs) observed (e.g., discomfort with measures, elevated blood 
pressure) by members of the study team (i.e., data collectors or parent 
educators) will be reported directly to the project coordinator. Team members will 
report a detailed description of the possible adverse event including the 
participant ID number, who reported the event to HEALTH staff; who witnessed 
the event; when, where, how the event occurred; and any action taken in 
response. The information will be conveyed by email. The project coordinator, in 
collaboration with the PI will (1) determine if the event qualifies as an AE, (2) 
follow-up as appropriate, and (3) report AEs in the REDCap database (the 
following will be reported in the REDCap database for AEs: AE description with 

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dates, actions taken in response, and event classifications including final status, 
expectedness, relatedness, and severity) and to the IRB/DSMB (as appropriate). 
2. Weight will be annually monitored as mothers are weighed at 12 and 24 months 
to be sure that weight loss is not excessive. Should a mother lose greater than 
15% body weight over a 12 month period a member of the study team or PI will 
reach out to the participant and administer Eating disorder Screen for Primary 
care [ESP], a screening for eating disorder. Appropriate referral will be made if 
the screen is positive.  In addition, those that gain over 15% body weight over a 
12 month period a member of the study team or PI will reach out to the 
participant to refer her to her health care professional. 
Mothers who become ineligible over the course of the study (i.e., due to 
pregnancy) will be withdrawn from the study. 
I3 
Safety Monitoring 
Plan 
 
A Data Safety and Monitoring Board (DSMB) will oversee study implementation. 
Further details on the Data Safety and Monitoring Plan and the Data Safety Monitoring 
Board are located in Appendix B. 
 
J Statistical Plan  
 
J1 Sample Size 
Determination and 
Power 
We are confident the tabulated computations that led to our decision to randomize 40 
sites (20 to each arm) are, if anything, conservative. Tabulations are based on weight at 
24 months as the primary outcome and are for two-sided tests at the 0.05 significance 
level.  
 
Table 2:  Number of subjects required in each PAT site for two-sided tests at the 
0.05 level of significance. 
 
# PAT 
sites per 
group 
 
 
Power 
Between 
group 
difference 
Intraclass correlation coefficient 
 
0.01 
 
0.02 
 
0.05 
 
 
 
 
 
 
19 
0.8 
4 
6 
6 
7 
0.9 
4 
8 
8 
11 
 

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The table entries (Table 2, above) are the required sample size per cluster completing 
data collection for power values of .8 and .9; for ICC values of .01, .02, .and 05; for 19 
PAT sites per group, and for between group differences of 4 between-group difference in 
the baseline to 24-month change in body weight that can be detected. Prior data from 
the HEALTH effectiveness trial found the standard deviation of the change in weight 
from baseline to 24 months was 8.3 kg. To be conservative, the computations assume 
an increased value of 10 for the standard deviation. The computations also assume 7 
mother will complete 24 months of follow-up at each of 19 PAT sites. The number 
actually enrolled will be increased to 10 mothers (to account for a potential dropout rate 
of 30%) and 40 sites (20 per arm). Based on the above parameter assumptions, Table 3 
indicates that to achieve a power of 0.8 with 19 PAT sites per group and an intraclass 
correlation coefficient as high as 0.05, the between-group difference in the change in 
weight from baseline to 24 months would have to be 4. Since the HEALTH study saw a 
24-month decrease in weight of 1.5 (+/- 8.3) kg in the intervention group and a 24-month 
increase of 3.2 (+/-7.6) kg in the control, we are confident the target of 19 PAT sites per 
group with 7 mothers providing 24-month data is sufficient. We emphasize these 
computations are conservative because they allow for more variability (i.e., assume a 
larger standard deviation) than was observed in HEALTH, and because our analysis will 
add power by including data on the dropouts who do not provide 24-month data but who 
do provide data at 12 months. 
J2  Interim Monitoring 
and Early Stopping 
Data from the study will be monitored on a continuous basis by the PI and research 
team. The PI, along with the research team. The PI and all Co-I’s and research 
coordinators will meet every 3 months or as needed to review progress and issues. All 
serious adverse events (SAEs), adverse events (AEs), and anthropometric values will be 
reviewed by the investigators on an ongoing basis. 
 
The Data and Safety Monitoring Board (DSMB) will have overall responsibility for 
monitoring the emerging results. The focus of the DSMB will be on safety issues, 
recruitment, retention, protocol adherence and data quality and timeliness. The DSMB 
will meet at least twice each year and more frequently if needed.  
 
We have no outcome-based rules for participant termination (i.e., no participant will be 
terminated simply based on poor response to the intervention). The only anticipated 
circumstances under which a participant would be terminated from study participation 
would be if we, or the NIH or DSMB, determine that it would not be safe for the 
participant to continue. In addition, per IRB requirement, participants may withdraw from 
the study early if they decide they are no longer interested in participating. 
J3 Statistical Methods  
 
Initial analyses will use t-tests and chi-square tests to compare baseline 
characteristics across groups. If continuous variables do not satisfy the normality or 
equal variance assumptions of the t-tests, we will explore data transformations and, if 
appropriate transformations cannot be identified, may employ Wilcoxon’s test.  
The primary analysis outcome, weight change between visits, was compared 
between intervention groups using a linear mixed-effect model with repeated measures. 
The model included a fixed effect for intervention group, time point, and the intervention 

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by time point interaction with a random effect for participants nested within site In 
addition, we may employ models that adjust for covariates (e.g., income), if these are not 
balanced by randomization. The covariance structure will be determined after evaluating 
correlation coefficients across time and assessing both Akaike’s Information Criterion 
and Bayesian information Criterion.  
Secondary continuous outcomes will be analyzed with the same mixed-effect 
model. If model assumptions of normality are violated, data will be rank-transformed 
prior to analysis. The secondary binary outcome will be assessed using a binomial 
generalized estimating equation (GEE) model repeated measures, while secondary 
ordinal outcome (physical activity category) will be analyzed using a multinomial GEE 
model with repeated measures. Due to the multiple comparisons, only the primary 
endpoint—weight change from baseline to 24 months—will be reported as an 
unadjusted comparison. All other p-values will be adjusted for multiple comparisons 
using the Benjamini-Hochberg linear step-up procedure to control the false discovery 
rate across comparisons. Participants with missing data for all outcomes after baseline 
were excluded. Participants with at least one follow-up measurement (i.e., 12-month, 24-
month, or both) were included in the analyses. 
Mixed-effect analyses will also be conducted for subgroups. A per protocol analysis will 
also be conducted for participants completing at least four home visits . Least squares 
means with 95% confidence intervals will be report for changes from baseline. No 
adjustment for multiplicity will be applied to the confidence interval widths. 
 
J4 Qualitative Methods  
 
The digital recordings from interviews will be transcribed. Two researchers will 
analyze the transcripts. For the adaptation analysis, coding will be guided by the work of 
Wiltsey Stirman et al.59,68 using a combination of deductive and emergent coding.69 For 
all other analyses, after reviewing the research questions,70,71 team members will read 
five transcripts using the first draft of a codebook. Each coder will systematically review 
the data and organize each statement into categories that summarize the concept or 
meaning.72 Once these transcripts are coded, they will be discussed to ensure accuracy 
of the codebook and inter-coder consistency. The codebook will be edited as needed 
prior to coding the remaining transcripts. All transcripts will be analyzed by two coders in 
NVivo11.73 Themes from coded transcripts will be summarized and highlighted with 
exemplary quotes.  
J5  Missing Outcome 
Data 
Missing values will be examined carefully to determine their causes and potential 
impact on subsequent analyses. We will evaluate whether data are missing at random. 
For data that are missing at random, we will conduct some analyses involving mixed 
models. In these analyses, missing values are dealt with in a natural manner, in that 
existing values are analyzed, and no observations are deleted due to missing values. In 
addition, we will conduct analyses where we do multiple imputation of missing values in 
a way that biases towards the null. Finally, we will conduct sensitivity analyses which 
assume that data are missing at random, to see how this impacts our results. Loss to 
follow up and missing and incomplete data will be monitored closely by the DSMB, to 
solve potential issues of missing data before there is a substantial impact on the results. 
For data collected as responses to questionnaires, all forms will be reviewed for 

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completeness before the participant leaves the study visit. Data entry will be 
accomplished quickly so that missing values may still be retrieved.  
Under intention-to-treat principles, all participants will be included in the analysis. 
Where appropriate, analyses involving mixed models may be used such that all existing 
values are analyzed, and no observations are deleted due to missing values. Sensitivity 
analyses under various assumptions regarding the missing data will be conducted to 
confirm the robustness of the results. 
 
K Data Handling and Record Keeping  
 
K1 Confidentiality and 
Security 
 
Data collected during measurement visits (using a tablet) will be collected using 
REDCap, a mature, secure web application for building and managing online surveys 
and databases (http://projectredcap.org/), using data entry screens developed by the 
statistical data analyst that include range checks (e.g., to warn the user if continuous 
variables are outside the range). Data collection directly into an online survey or a tablet 
mobile application will reduce errors in transferring data from paper to computer. 
Random checks of data collection activities will assure reliability. We will also include 
bivariate checks (e.g., weight for height).  
 
All data will be maintained in the strictest confidence. Electronic data will be held in 
secure format in password-protected computer records. Data will be identified only by 
study number. A log of study number and identifying data and hard copy will be kept by 
the investigators in a locked file cabinet or secure electronic folder.  
 
All data will be treated confidentially, and the participants' names and identities will 
not be disclosed in any published reports. Data security will be maintained using 
password protection and the standard two-key requirement of HIPAA. The automated 
backup procedures of our Division of Biostatistics will ensure no data is lost. 
 
K2 Training  
All study team members will receive training in proper conduct of human subjects 
research. For data collectors conducting screening and measuring outcome data, the 
study team will conduct training on study procedures. Training will include methods for 
screening potential participants for eligibility, securing and verifying informed consent, 
and completing on-site assessments of anthropometrics, blood pressure, and surveys. 
Depending on the number of families served by the PAT site the previous year, we may 
hire 1-3 data collectors near each site. To ensure accuracy and appropriate inter-
assessor agreement, multiple data collectors hired per site may complete duplicate 
measures on practice individuals.  
Parent educators at sites randomized to HEALTH will also complete human 
subjects training. They will review materials provided by the Human Research Protection 
Office and complete the required quizzes, which will be returned to the research 
coordinator; she will then provide the results to the Human Research Protection Office 
for inclusion of the parent educator as a study team member. 

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K3 Performance 
Monitoring  
An important outcome of the study is to monitor parent educator fidelity to the HEALTH 
intervention. Careful fidelity monitoring through evaluation of visit audio recordings and 
visit checklists will be conducted. 
 
L Study Administration 
 
L1 Committees 
Oversite for the study will include a Data and Safety Monitoring Board (DSMB). A 
chairperson and three members have agreed to serve on the DSMB, and a draft charter 
has been drafted. Before the study can begin, the protocol must be approved by the 
committee. Any subsequent major changes to a study’s protocol must also be approved 
by the DSMB Chair.   
The focus of the DSMB will be to assure that the safety of research participants is 
appropriately monitored and the validity and integrity of the data are ensured. The DSMB 
will meet at least twice each year and more frequently if needed (to be defined in the 
charter). Recommendations by the committee can include protocol modification or early 
termination for unexpected safety problems. Recommendations are made to the PI and 
disseminated to the NHLBI and IRB. 
 
L2 Participant Stipends 
or Payments  
There are several types of incentives in the study. Participating mothers will receive $20 
for each research visit (baseline, 12-months, and 24-months). As the visit checklists are 
extra reporting for research purposes, parent educators (HEALTH and usual care) may 
receive $10 incentives for each visit checklist completed. Parent educators participating 
in surveys about implementation outcomes and context may receive $30 gift cards at 
each time-point. Mothers, parent educators, and site leaders participating in qualitative 
interviews may receive $30 incentives. 
L3  Study Timetable 
After initial study set-up (Table 3), the collaborative planning phase, IRB approval, and 
site recruitment and randomization (during August to December 2018), we will begin 
delivering the HEALTH training curriculum to sites randomized to the HEALTH arm 
between December 2018 and February 2019. We will begin recruiting mothers in 
February 2019. With a rolling recruitment, we anticipate recruitment will continue until 
year 3. This schedule will allow adequate time to finalize analysis, write manuscripts, 
and disseminate our findings.  

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M  Attachments  
 
 
 
 

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M1 Appendix A. Sample 
of Healthy Eating & 
Active Living Taught 
at Home (HEALTH) 
Curricular Materials 
 
 

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Each visit will include review of previous topic and goal setting  
 
HEALTH Topic  
Intent 
Prompts/questions 
Core Visits (1st 4-6 months - ideally every visit with family) 
1. Welcome to 
HEALTH and 
goal setting ) 
Welcome to HEALTH. 
Establish rapport and discuss the benefits of 
participation. 
Provide an opportunity to set HEALTH goal(s) 
by using the SMART method. 
Why did you want to participate in this study? 
What are your thoughts about health or being healthy? 
What do you want to learn or hope to learn about being healthy? 
Have you set any goals for yourself? Are you willing to set any goals 
during your time of participation?  
2. Healthy 
beverages 
Build skills in reading labels to discuss sugar 
content and calories in various beverages.  
Explore the effects of sugary drinks on health.  
Assist parents in discovering tips to drink more 
water. 
When you are thirsty, what do you drink? 
What are your favorite drinks? 
Do you ever drink water? If so, how much? How often? 
Do you know how many grams of sugar are recommended for our 
daily consumption?  
How many teaspoons of sugar are in a 20oz soda? 
3. Being active: 
a way of life  
Make the connections between physical activity 
and healthy living. 
Identify barriers to being active.  
Brainstorm ways to be active. 
What are your thoughts about being active? 
Is there anything that makes it hard for you to be active? 
Tell me about any activity that you do.  
What about activities for your children? 
Do you track your steps? If so, how do track your steps or what do you
use? 
4. Self-
monitoring 
Explore the topic of self-monitoring. 
Increase parent’s awareness of their actions and 
how to track their behaviors. 
Have you ever tracked what you have eaten or drank? If so, why? 
Do you track your weight? If so, how often? 
How do you feel about tracking yourself? 
5. Portion Size  
Discuss components of my plate. 
Learn recommendations for appropriate 
portions.  
Build skills in choosing healthy portions. 
What size plates do you use during meals?  
When it is time to eat, who puts the food on the plates and how do 
they decide how much? 
What do meals usually consist of? (protein, starch, veg, etc.) 
When someone wants more food, what happens? 
6. Cope with 
triggers  
Provide an opportunity to learn about food cues 
and ways to change them.   
What makes you want to eat? 
How often do you eat? 
How can you make changes to things around your home to make it 
easier for your family to eat healthier? 
7. Eat well away Assist parents in developing basic principles for 
What places do you frequent when you eat away from home? 

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from home 
healthy eating out. 
Practice how to apply these principles at the 
type of restaurant the participant frequents. 
How often do you eat fast food? (daily, weekly, etc.) 
If you eat out, are there ways to make healthier choices? 
8. Meal 
planning  
Provide an opportunity for parents to brainstorm 
meals that their family eats. 
Identify ways to make the meals healthier.  
Practice planning and charting the meals.  
How does your family decide what to eat at a meal? 
Are there things that make it hard to plan meals? 
If you are able to plan a meal, what makes that work for you? 
Are you able to make a meal out of the essential foods you have at 
home?  
Follow up Visits (at least monthly) 
9. Cook More  
Make the connection between cooking at home 
and improving one’s own health. 
Discuss practical tips to encourage more 
cooking at home.  
Explore low calorie options to favorite 
menus/recipes.  
How do you feel about cooking? 
Do you cook at home? If so, how often do you cook? 
Does anything prohibit you from cooking? 
What are the kid(s) doing when you are cooking? 
What changes can you make in order to prepare healthier foods at 
home? 
10. Healthy 
snacking 
Begin to learn appropriate portions by exploring 
nutrition label for common foods. 
Build skills in measuring out appropriate portions 
of food.  
Discuss healthy snack options.  
What do you consider a snack? 
Do you snack? If so, how often do you snack? 
What snacks do you give your children? 
Where do you eat your snacks? 
Can we look at a typical food that you consider a snack? 
11. Family Meals  Learn the benefits of eating meals as a family 
unit.  
Discuss strategies to eat meals together.  
Plan and coordinate family meals without 
distractions (TV). 
How do you feel about sitting down to eat together as a family? 
Where do you eat meals?  
Who is present for meals? 
Are there any distractions while eating? 
 
12. Ways to eat 
less calories  
Identify ways to reduce calories. 
Discuss strategies to better eating. 
Develop goals for high calorie food to be 
changed. 
 
What are some foods that you think are problematic? 
Why do you feel these are problematic? 
What do you think of when you hear the word calories?  
Are you aware of your caloric intake or do you count calories daily? 
Are you capable of making healthy food choices?  
13. Find time for 
fitness 
Provide an opportunity for parents to identify 
positive cues to be active at home. 
How do you find time to be active? 
How much time are you active? 
What can you do at home to be active? 
What type of activities do you do with your kids? 

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14. Problem 
solving 
Learn the steps to problem solving.  
Discuss barriers to making changes.  
Practice the steps to problem solving. 
What problems have you encountered while striving to be healthy? 
What issue do you want to problem solve? 
15. Get support 
Explore examples of problematic social cues 
and helpful social cues.  
Identify strategies for coping with social events – 
parties, vacations, holidays, etc. 
When you are working towards your goal how do other people effect 
your progress?  
What are the positives and what makes it hard? 
How can you overcome the negative in order to get more positive 
support? 
16. You can 
manage 
stress 
Provide an opportunity for parents to discuss 
and identify stressors in their life. 
What causes you stress?  
When you are stressed, what do you do? 
When you are stressed, do you tend to eat or drink? 
How does stress effect you physically? 
17. Healthy 
breakfast 
Improve the understanding of breakfast and how 
eating breakfast is beneficial to overall health. 
Identify strategies to eat a healthy breakfast. 
Do you have time to eat breakfast? 
How often do you and your children eat breakfast? 
What happens if you don’t eat breakfast? 
What do you eat or drink for breakfast? 
What are healthier options you could have for breakfast? 
18. Healthy 
routines 
Brainstorm and discuss routines in everyday life. 
Explore ways to make routines a healthy part of 
life. 
What routines do you have? 
Do you have any regular eating routines? 
What about any fitness routines? 
What about any snack routines? 
What about any mealtime routines? 
19. Food labels 
Build skills in reading nutrition-fact labels. 
Make the connection between the information 
from the labels and making healthy food 
selections. 
Do you read food labels? 
If so, what do you look at? 
Do you make purchases based on the nutrition information from the 
food labels? 
What are you most concerned with regarding the food labels? 
20. Jump start 
your activity 
plan 
Provide an opportunity for parents to 
acknowledge and identify barriers to meeting 
their goals. 
Review the steps to problem solving. 
Where are you with the progress of your activity goals? 
Have you met any of your activity goals? 
What has helped it you meet your activity goals? 
What has made it hard to meet your activity goals? 
21. Take charge 
of your 
Recognize and identify negative thoughts.  
Assist parents in learning how to talk back to 
Tell me the positive changes you have made. 
What are things you tell yourself to encourage your positive behavior? 

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thoughts/Wa
ys to avoid 
burnout 
negative thoughts with positive thoughts.  
Encourage parents to get back up and on track 
after a slip. 
What strategies have worked for you when you feel discouraged? 
22. Shopping 
Identify strategies for healthy shopping.  
Build skills in creating lists to grocery shop for 
planned meals. 
Who does the grocery shopping for the family? 
How often do you go to the grocery store? 
Do you have a strategy for grocery shopping? 
What pulls your attention when you are at the grocery store? 
What influences what you purchase at the grocery store? 
23. Stay 
motivated 
Review the participant’s progress and develop a 
plan for improvement. 
Discuss the importance of motivation and ways 
to stay motivated.  
Develop action plans for common barriers. 
What have you been able to accomplish so far? 
What motivated you?  
How did you deal with any distractions that arose? 
What helped you stay on track with your goals? 
What will you continue to do to stay healthy? 
 
 
 
 

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M2 Appendix B. Data 
Safety and 
Monitoring Plan 
 
 
 
 

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Data and Safety Monitoring Plan 
To assure that the safety of research participants is appropriately monitored and the 
validity and integrity of the data are ensured, we have defined operating procedures to 
regularly review data and outcomes. We have developed a Data and Safety Monitoring 
Plan that is commensurate with the scope of the research project. Therefore, 
considering minimal potential risks of this trial the plan operating procedures include the 
following: 
 
Description of Monitoring Entities 
The Principal Investigator (PI) is responsible for oversight of all aspects of the trial 
including safety and the inclusion of other reviewers does not relieve the investigator’s 
responsibility. However, additional oversight will be provided by a Data and Safety 
Monitoring Board (DSMB). 
 
Description of Plan for Interim Analysis and Reporting 
Monitoring responsibilities include examination of safety, study protocol, data collection, 
and outcomes for the potential for adverse outcomes. We have appointed a DSMB. This 
board will evaluate the progress of the trial, including periodic assessments of participant 
risk versus benefit, safety, and other factors that can affect study outcome (to be 
described in detail in the DSMB Charter) annually and ad hoc as necessary. In 
accordance with the DSMB Charter and the determination made at the initial DSMB 
meeting, and at the discussion of the Chair, data will be provided to the DSMBat least 
annually. In the event of the identification of or potential for an adverse event, the PI will 
immediately notify the DSMB and the IRB. 
 
Description of Plan for Assuring Data Accuracy, Data Security, and Protocol 
Compliance 
The study has developed plans to assure data accuracy, data security, and protocol 
compliance. All study team members will receive training in data accuracy and security 
procedures. Study staff are required to notify the project manager and PI of suspected 
protocol deviations, and provide an explanation, within 24 hours of awareness (Monday-
Friday). After review, the PI will categorize protocol deviations as either major (has the 
potential to negatively impact the rights, safety, or welfare of participants or others or the 
scientific validity of the study), or minor, and will track all deviations. For minor 
deviations, the staff member responsible for the deviation will be notified. If it is evident 
that the protocol is misunderstood, clarification will be provided. Repeated occurrence of 
a minor deviation may be classified as a major deviation. Major deviations will prompt 
the PI to requesting a written explanation from the responsible staff member. The project 
manager, as needed, and the PI will communicate with study personnel to confirm that a 
process is in place to ensure that further protocol deviations of similar kind do not recur. 
Review of all protocol violations will be a standard component of study team meetings. 
The study team will report major deviations to the IRB within 10 working days of the PI’s 
awareness; if a major deviation results in SAE, the IRB will be notified within one 
working day of the PI’s awareness. 
 
Description of Mechanism for Reporting Adverse Events and Unanticipated 
Problems 
Due to the minimal risk nature of the study, problems and adverse events are unlikely. 
However, the PI is responsible for reporting adverse events. Upon notification or 
observation of an adverse event, the PI will immediately notify the IRB and the program 
officer at NHLBI via telephone and email. Subsequent updating communications will take 

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place as necessary. Secondly, a detailed written description of the event and outcome 
will be sent to the DSMB, IRB, and NHLBI, including standard form reporting. 
Additionally, the DSMB and NIH will be informed of any actions taken by the IRB. The 
IRB and NHLBI will be notified of recommendations made by the DSMB. Annual 
progress reports to the DSMB, IRB, and NHLBI will summarize any adverse event and 
outcome. 

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M3 Appendix C.  
 
HEALTH D&I (R01HL143360): Implications of COVID-19-Expanding for long-term 
data collection 
Our team initially put in place temporary methods to allow for recruitment/enrollment and 
follow-up data collection to occur during COVID-19. However, these were designed to be 
temporary, and therefore did not incorporate collection of important secondary outcomes 
(i.e., blood pressure, waist circumference). Expanding on the plans to resume 
recruitment, enrollment, and follow-up data collection of our study in the context of 
COVID-19 requires additional changes to the study components noted below.  
- 
Screening and Consent 
- 
Participant Enrollment & Baseline Data Collection 
- 
Post Visit Data Collection 
- 
Intervention delivery and tracking 
Noting that this study takes place across 40 sites, each of which operates differently, we 
anticipate this as a starting place for sites currently prepared to implement these 
protocols. We propose the following modifications: 
 
Screening and Consent 
Pre-COVID Procedures 
Data collectors screened potential participants by phone or at site events to ascertain 
self-reported height and weight, to determine eligibility. If eligible based on self-report, 
the data collector consented the potential participant to an in-person baseline visit and 
scheduled this visit. It is at this in-person visit that the potential participant completed the 
consent process with the data collector and was given a hard copy of the consent 
document. There was no signed consent, but after the consent was reviewed, the data 
collector documented the consent process in RedCap.  
COVID Procedures and Changes 
The screening process will proceed as before with only the phone/video call option 
available (e.g. Zoom, FaceTime, Microsoft Teams, and Google Duo). If a potential 
participant screens as eligible, we will email or mail the potential participant the consent 
document. We will verify the participants email address by i) either encrypting the email 
with the consent attached or ii) by sending a confirmation email that does not include 
any PHI or study materials first and then sending the consent after confirmation, 
confirming they have received the consent document. Once the participant has received 
the consent documentation, we will complete the consent process over the phone. Due 
to the COVID-19 pandemic, data collectors will not be able to visit with potential 
participants in person, but will schedule a time for a second phone/video call 
conversation.  
A scale, automated blood pressure cuff, and tape measure for assessing waist 
circumference will be sent to and stored local to the site. If the participant agrees to 
participate in the study, the study team will reach out to a PAT staff member (i.e., the 
participant’s parent educator and/or the site leader) to coordinate data collection, check 
in on the availability of the equipment, and reinforce safety procedures as needed. 
Based on the preference from the site, this will proceed through one of 2 options: 
1. Drop-off method: A PAT staff member or data collector (Wash U employee 
previously hired near the study site to assist with data collection) will drop-off and 
pick up data collection materials (i.e., scale, automated blood pressure cuff, and tape 

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measure) at her home. The PAT staff member or data collector will sanitize the 
materials using the wipes provided by the research team just before dropping them 
off and after picking them up. Ideally, these will be coordinated with planned trips to 
the home to drop of PAT-related materials (e.g., handouts, materials for activities 
during personal visits/group connections) or personal visits. 
2. Site method: The data collection materials will be maintained at the site, and a 
private room will be available, where the mother can go to use the equipment. The 
site will follow COVID procedures per the protocols the site has established (these 
differ across sites based on conditions in the local community). If possible, this will 
be coordinated with a trip the mother was already planning to the PAT site. 
In both cases, the PAT staff member will receive an incentive of $20 per data collection 
visit, which equates to $10 per dropping off or setting up the equipment before the visit 
and $10 for picking up or taking down the equipment after the visit, for their time and 
effort. 
 
Participant Enrollment & Baseline Data Collection 
Pre-COVID Procedures 
After data collectors completed the consent process, they measured the participant’s 
blood pressure and then gathered data to verify eligibility and enroll eligible participants 
into the study. This data consists of gathering their height and weight, to verify eligibility 
by ensuring the participant’s measured (as opposed to self-reported)-BMI is in the 
eligible range. If the participant’s eligibility is confirmed additional data collection 
includes: waist circumference and a survey that the participant completed in RedCap.  
 
COVID Procedures and Changes 
1. An approved scale, automated blood pressure cuff, and tape measure for 
assessing waist circumference will be mailed to each site. Once the PAT staff 
member or data collector has dropped off the scale, blood pressure cuff, and 
tape measure or the mother is situated in the private room at the PAT site we will 
either: 
a. Complete modified data collection via video call, in which we will i) see 
the participant stand on the scale; ii) use the automated blood pressure 
cuff; and iii) encircle her waist with the tape measure; these will be 
recorded entered live in REDCap. 
b. If the participant is not able to complete a video call, she will complete the 
data collection by phone, and will receive instructions by the research 
team on (i) how to take a weight on the scale, (ii) take a photo of weight 
with her personal device (e.g., phone, ipad), (iii) remove their location 
tags, and (iv) send a photo of their ID number and weight on the scale, 
the reading on the blood pressure cuff, and the location on the tape 
measure to the research team which does not include any identifying 
factors (e.g. face, location, or name).  
For all mothers, we will walk the participant through the process of setting up 
the scale, using the blood pressure cuff, and using the tape measure (e.g., 
locating the correct spot for assessing waist circumference). Further, we will 
utilize their self-reported height to calculate their BMI and ensure eligibility. 
Weight will be assessed first, as this is used to confirm eligibility. If the mother 

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is eligible, the remainder of the measures (blood pressure and waist 
circumference) will be completed.  
2. The study team member will then conduct the RedCap Survey through the video 
call or over the phone.  
Once the mother has completed data collection, the PAT staff member or data collector 
will collect the materials (i.e., scale, automated blood pressure cuff, and tape measure), 
sanitize them using the wipes provided by the research team, and stored local to the 
site. If the drop-off method is being used the pickup will ideally be coordinated with 
planned trips to the home to drop of PAT-related materials (e.g., handouts, materials for 
activities during personal visits/group connections) or personal visits.  
 
Post Visit Data Collection 
Pre-COVID Procedures 
Given the ongoing nature of the COVID-19 impacts, enrolled participants will be 
reaching their first post (12-month) and possibly second (24-month) data collection visit. 
Our current data collection procedures are similar to participant enrollment procedures. 
The data that is gathered in the post data collection visits include: weight, blood 
pressure, waist circumference and a survey in RedCap. 
 
COVID Procedures and Changes 
As Data Collectors are no longer able to travel to gather certain data points from the 
participant, the following changes will be needed to continue the post data collection 
process.  
1. Using the same data collection materials as enrollment/baseline and the same 
procedure (i.e., Drop-off/ pick up method or Site method):  
a. Complete modified data collection via the same procedures noted above 
for baseline (with the exception of self-reported height) 
2. We will then conduct the RedCap Survey over the phone or video call.  
 
For data collection at all time points, we will increase the amount of the participant 
incentive from $20 to $30, due to the increased time and effort on the part of the 
participant. 
 
We recognize the dynamic nature of the pandemic situation. If a PAT staff member or 
data collector is not able to drop equipment off at the participant’s house or the mother is 
not able to travel to the PAT site, we will revert to the procedures we used in the initial 
months of the pandemic (beginning in mid-March), which involved mailing a scale with 
instructions to the participant’s home and scheduling a time for follow-up.  
 
 
Intervention delivery 
Consistent with the D&I focus of the study, we will follow each site’s practice regarding 
whether and how visits continue (e.g., virtual, phone, in person). Recognizing the 
dynamic nature of the situation, we will coordinate with PAT National Center regarding 
data they are collecting at the site level in terms of what types of visits are being offered 
as well as what site leaders and parent educators indicate. Parent educators also still 
have the option to complete visit records for visits conducted virtually with mom’s 

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enrolled in the study. The visit record form now has an item to indicate how the visit was 
conducted (i.e., in person vs virtual (phone/video conference). 
 
Additional challenges 
As we resume data collection at additional sites, and as sites who have not yet begun 
data collection start this process, we anticipate we may need to add additional options. 
We will communicate with sites about the process which will work best for them and if 
needed, request modifications accordingly. 
 
 
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