In-home Obesity Prevention to Reach Low-income Infants Through Maternal and Social Transmission
Phase: NA
Conditions: Obesity, Obesity, Childhood, Obesity; Familial
Sponsor: University of Southern California

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IN-HOME OBESITY PREVENTION TO REACH LOW-INCOME INFANTS 
 
ID: 1R01HD092483-01 
 
Date: 01/28/21 
 
 
 

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A. SPECIFIC AIMS 
 
More than 40% of children enrolled in federally funded programs are overweight or obese by age 5.1-4 This is 
concerning because obese children have a 70% chance of becoming obese adults.5,6 Unfortunately, extant 
obesity efforts have had a limited impact among low-income underserved children, in part because of limitations 
inherent to existing programs: 1) short duration and low intensity; 2) late timing of implementation, when children 
are already overweight or obese; 3) delivery methods limiting their accessibility and sustainability; and 4) failure 
to address barriers such as a lack of culturally competent and in-language services, poverty, housing instability, 
and access to care, which interfere with healthy lifestyle changes. To address these gaps, we have integrated 
simple, evidence-based nutrition and physical activity components as part of the services already delivered by 
our home visitation partner, Healthy Families America, with the long-term goal to deploy these efforts to Home 
Visitation Programs (HVPs) nationwide. Annually, over 500 publicly and privately funded HVPs provide 
nationwide services to more than 650,000 low-income, underserved infants and their families. The home visiting 
structure is not only an unparalleled model for scalable and sustainable childhood obesity prevention, but it also 
provides a unique opportunity to understand factors related to the intergenerational transmission of obesity in 
families who are most at risk.  
Over the last four years, our transdisciplinary team of researchers, home visiting stakeholders, families, and 
community stakeholders (hereafter referred as the COPE team), has integrated evidence-based nutrition and 
physical activity components into an engaging module that we call COPE: Childhood Obesity Prevention @ 
homE /Contrarrestar Obesidad: Programa para niños En casa. COPE is delivered in English and Spanish as an 
enhancement module to the services of our HVP partner. Our pilot work supports the successful integration, 
feasibility, and preliminary efficacy of COPE.  
The proposed study builds upon the momentum, resources, and research infrastructure of our pilot work to 
test the larger-scale and sustained impact of COPE on infant’s and mothers’ obesity outcomes, and to study key 
mechanisms of maternal and social transmission on infants’ obesity risk. Specifically, 300 low-income 
mothers/infants enrolled in Healthy Families America HVP will be recruited and enrolled in the study, for an 
effective final sample of 200 mothers/infants. Based on standard HVP procedures, mothers/infants will be 
matched to highly trained home visitors (nurses) based on their ethnicity/race and language preferences. Home 
visitors, in turn, will be randomly assigned to deliver the standard HVP curriculum only or the standard HVP 
curriculum + COPE as part of their weekly home visits for two years of HVP services. Comprehensive 
assessments of mothers/infants will be conducted at enrollment and after 6 and 12 months of intervention.  
Specific Aim 1 (maternal and infant outcomes). Test the direct effects of COPE on infants and mothers’ 
weight, metabolic risks, diet/energy intake, and physical activity. This will be accomplished by comparing 
changes in body weight, metabolic markers, and eating and activity-related behaviors between infants/mothers 
across study arms (HVP only vs. HVP+COPE). These results will indicate whether HVP is an effective 
infrastructure for primary and secondary obesity prevention.   
Specific Aim 2 (maternal transmission). Test whether breastfeeding and maternal diet and activity, feeding 
practices, and food insecurity mediate the effect of COPE on infants’ outcomes. This aim will test mechanisms of 
maternal transmission on infants’ obesity risks.  
Specific Aim 3 (social transmission). Aim 3 is two-pronged. Aim 3a tests the direct effect of HVP+COPE 
(vs. HVP only) on the characteristics of the social and community networks that surround mothers and infants 
(i.e., the density, composition, and quality of “health support networks”). Aim 3b tests whether the characteristics 
of social networks mediate the effects of COPE on maternal and infant outcomes. These findings will indicate if 
HVP obesity prevention efforts can alter and/or activate social network mechanisms.  
Secondary Aim. Conduct a real-life economic analysis (costs, cost-savings, and non-monetary benefits) of 
integrating COPE into existing HVPs.  
This proposal addresses the impetus to develop interventions targeting at-risk infants before obesity is 
established. Although maternal-infant interventions are much-needed, they present implementation and 
dissemination challenges, including limitations on compliance and retention, and limited potential for scalability 
and sustainability. Our proposed strategy overcomes these challenges through an innovative solution that 
merges evidence-based nutrition and activity components into an existing, ongoing federally-funded 
infrastructure. The proposed research is timely as the Institute of Medicine, the United States Department of 
Agriculture (USDA), and Health and Human Services (DHHS) extend their recommendations to address key 
factors influencing obesity risk in children from birth to 24 months of age.  
 

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B. SIGNIFICANCE 
 
B.1. Scientific premise and impact. The proposed study tests whether delivering in-home obesity prevention 
as part of an ongoing, sustainable service delivery system (home visitation programs, HVPs) is an effective 
approach for primary (infants) and secondary (mothers) obesity prevention among low-income, underserved 
families. This research is poised to have a substantial impact because the delivery modalities of current obesity 
efforts disproportionally restrict the reach and engagement of children who are most at-risk for obesity, and limit 
the development and generalization of healthy habits in families’ home environment. Our proposed strategy 
overcomes these challenges through an innovative and potentially cost-effective solution that merges evidence-
based key nutrition and activity components into an ongoing federally funded HVP. Our focus on understanding 
maternal and social determinants of intervention effects increases the significance, innovation, and impact of 
this research by identifying key determinants that can be leveraged to prevent childhood obesity in infancy. This 
work will inform maternal and child health public policy initiatives that seek to address the intergenerational 
transmission of obesity efforts. If effective, this intervention can be readily disseminated to other HVPs sites 
nationwide.  
 
B.2. Focus on underserved segments of the population. Although a recent nationally representative study 
found a decline in obesity for children ages 0-5, this was not true for low-income and non-white children.10 In 
fact, 40% of low-income children enrolled in federally-funded programs are overweight or obese by age five.1-4 
In Los Angeles (LA) County there is a strong, positive association between the prevalence of childhood obesity 
and economic hardship.11 Sadly, even the most successful obesity strategies have had limited impact among 
economically disadvantaged families, partly because of their failure to address factors which profoundly affect 
the ability of at-risk families from diverse racial and ethnic backgrounds to adhere to lifestyle changes in real-
world settings.12,13 Initiating and maintaining healthy habits is ubiquitously difficult, especially for families who 
face a multitude of barriers such as a lack of access to linguistically and culturally competent services, poverty, 
housing instability, and food insecurity. These challenges highlight the dire need to re-conceptualize obesity 
prevention as an integral component of universal care, embedded in a comprehensive system of child and 
maternal health services. 
 
B.3. Focus on infant/maternal transmission. Rapid weight gain during the first 4-6 months of life has been 
associated with greater odds of child overweight at age 4-7y,14-16 and in adolescence.14,17-20. Yet, most obesity 
programs focus on school-aged children, when many youth are already overweight or obese, and only a few studies 
have focused on modifying obesity-risk factors in infancy. Child-feeding practices and early nutritional 
experiences play a key role in shaping children’s health behaviors and weight outcomes.21-24 For example, in a 
sample of 718 parents of children ages 3-5y, parents with an indulgent feeding style had children with a higher 
BMI,25 a finding that has been replicated in 177 Head Start families.26 Another potential mechanism by which 
maternal factors might mediate infant outcomes is via breastfeeding. In developed countries, some studies 
suggest that breastfeeding is protective for childhood obesity.27-30 However, not all studies support this view.31-36 
These mixed findings suggest that a range of maternal factors, including mothers’ feeding practices,37-41 mother’s 
energy intake and diet, food insecurity (as it relates to diet), and physical activity may impact child obesity 
outcomes.42-50 Positive changes in maternal health behaviors and food security are not only beneficial for 
mothers’ health, but are also a promising approach to address intergenerational transmission of obesity risk and 
health disparities. The proposed research represents a unique opportunity to test the impact of key maternal 
mechanisms on obesity transmission and whether a comprehensive approach to maternal/infant health can alter 
children’s weight trajectories.51  
 
B.4. Focus on social transmission. Despite evidence that obesity is 
influenced by social networks and social-ecological systems, which 
extend beyond parent-child context, few childhood obesity initiatives have 
translated these concepts into practice. Families are embedded in social 
networks and communities that influence their health behaviors and 
practices through several mechanisms, in particular via social influence 
and social support.52-59 These social factors can ultimately promote or 
impede behavior change and maintenance.60-62 Drawing on social 
influence and social network theories, as well as innovative "network-
mediated interventions" that have been successfully applied in other 
areas of public health,60,62 the promotion of maternal and infant health 
behaviors to prevent childhood obesity ideally involves enhancing Figure 1.  Social network characteristics relevant to 
healthy behavior change 

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families’ social networks so that they support behavior change (Figure 1). The intervention goal is to alter and 
enhance mothers’ social networks so that they provide greater (a) healthy social influence, with a larger proportion of 
individuals in their network who engage in the desired health behaviors and so provide healthy behavior norms, 
modeling, cues, and opportunities;63-65 and (b) health-relevant social support, with an increase in the density of 
relationships that encourage and support healthy behaviors.66,67 Obesity prevention initiatives that explicitly target 
families’ social networks (i.e., their connections to people and organizations) by creating opportunities for meaningful, 
health-supportive relationships to be fostered and maintained, will help to promote healthy behavior change, and has 
the potential to improve the reach, effectiveness, adoption, implementation, and maintenance of family-based 
interventions.62,68 
 
B.5. Focus on sustained implementation and high intervention dosage. Obesity researchers and public 
health decision makers have argued against “diets” and promoted the development of healthy habits for life. Yet 
most (if not all) obesity intervention and prevention programs are generally short-lived (8-12 weeks). We believe 
that the short delivery and low intensity of obesity interventions greatly decreases their potential impact. 
Specifically, the short implementation of interventions/programs is inadequate to cover pivotal feeding and 
eating-related developmental transitions that are not only critical for the development of healthy eating habits, 
but also highly challenging for children and parents (e.g., transition from breast milk, to pureed foods, to solid 
foods).69 Furthermore, the greatest challenge of healthy lifestyle interventions is not to initiate healthy practices 
in families, but to help them maintain healthy behaviors for a prolonged period of time. Even when obesity 
interventions directly plan or address this as part of their curriculum, the maintenance phase rarely (if ever) 
exceeds a few weekly one-hour sessions. This timeline is arguably insufficient to ensure mastery of learned skills 
into lifelong healthy habits.  
 
B.6. Focus on home visitation programs: an untapped opportunity to address childhood obesity. 
Consistent with a capacity building approach, we aim to extend the 
existing curriculum and mission of HVPs to address the important gaps 
reviewed above (see also Figure 2 and our concept paper70). The 
outcomes of the proposed research combined with our HVP partnership 
is likely to have national implications. Over 500 publicly and privately 
funded HVPs provide services to more than 650,000 low-income, 
underserved children and their families in the U.S. annually. HVPs are 
embedded in a comprehensive system of child and maternal health 
service that is designed to promote optimal child development and 
prevent adverse outcomes.71-75 Randomized controlled trials (RCTs) 
show that high-quality HVPs can effectively improve children’s physical 
and psychosocial health such as birth outcomes, breastfeeding, 
immunization rates, and overall cognitive and social development.75-93  
Although some HVPs provide basic information on infant nutrition, 
there has been no comprehensive, and sustainable effort to address 
childhood obesity prevention, nutrition, and physical activity as part of 
their services. This may be because the initial focus of HVPs, 40 years 
ago, was to decrease the incidence of low birth weight.94,95 The current 
high prevalence of overweight and obesity among HVPs children is likely to prompt a new national mandate that 
HVPs address childhood obesity prevention as a part of their services. This highlights the pressing need to re-
conceptualize the mission and capabilities of HVPs to address obesity prevention for all children. The HVP 
structure is ideal to address obesity prevention among underserved families for many reasons (see also 70):  
a. HVPs have been in place for more than 40 years, with $1.5 billion annual investment from the Affordable Care 
Act,96 which speaks to the sustainability of the services provided.  
b. They provide culturally and linguistically tailored in-home services, which removes barriers to accessing the 
program (e.g., transportation, childcare), promotes the generalization of skills to the home environment, and 
enables ethnically and racially diverse families to access culturally competent health services.  
c. HVPs have existing partnership with Women, Infants and Children (WIC) programs nationwide.  
d. HVPs already address many barriers to healthy lifestyles such as unemployment, family conflict and violence, 
housing instability, and neighborhood characteristics. 
e. The free and voluntary weekly home visits begin during pregnancy or shortly after birth, and continue until 
the child reaches 2-5 yo, depending on the HVP model. The extensive timeframe for service delivery makes 
it possible to reinforce health knowledge, skills, and behavioral habits. 
– COPE – 
Obesity efforts have limited impact among 
underserved, low-income children at risk for 
obesity. 
Obesity prevention should be: Initiated in 
infancy, delivered in home, & embedded in an 
infrastructure serving at-risk families.  
The home visiting model is ideal to provide 
scalable and sustainable early childhood 
obesity prevention. 
COPE will integrate obesity prevention into 
ongoing home visiting services 
Figure 2. Scientific Premise & Impact of COPE. 

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f. 
Support, referral, and advocacy is central to the HVP model of delivery, facilitating families’ development of 
social and community networks that support health outcomes.  
g. The widespread presence of HVPs across the US, and established infrastructures in nationwide urban and 
rural areas,80,91,97,98 are critical for the scalability of services across the United States.  
h. The model is likely to be cost-effective as obesity prevention would be delivered as part of an existing 
infrastructure, with the potential to improve child health and reduce societal costs.  
 
B.7. Feasibility of delivering obesity prevention as part of HVPs’ services. Over the last four years, our 
transdisciplinary COPE team has integrated established nutrition and physical activity components and 
activities9,99-104 into a culturally sensitive, language specific, and community-forming model of implementation 
that we call COPE (see Intervention arms below). COPE does not target weight loss; rather it focuses on 
preventing the development of childhood obesity through the promotion of healthy behaviors in all mothers and 
infants/children from diverse racial and ethnic backgrounds, regardless of weight status.  
Drs. Salvy & de la Haye secured two pilot grants (CTSI [Salvy, #8UL1TR000130] and NIH Johns Hopkins 
Global Obesity Prevention Center [de la Haye, # 5U54HD070725-03]) and completed the following activities: 
1. Obtained IRB approval and developed all study material.  
2. Consolidated our partnership with Cyd Wessell, the National Director of Healthy Family America (see letters 
of support), laying the groundwork to enable the dissemination of COPE to other sites nationwide.  
3. Publish the concept paper outlining the rationale and scientific premises underlying our initiative (see 70)  
4. Manualized evidence-based nutrition and activity guidelines into educational material and hands-on activities 
that are culturally sensitive (e.g., recipes adapted to families’ preferences) and community engaging (e.g., 
leveraging resources and social networks endogenous to the community through community gardening and 
communal cooking activities) to meet the needs and desires of HVP families.  
5. Trained home visitors to implement COPE using science-based content and social-experiential approaches 
to elicit change talk and patient-centered goals; trained recruitment and data collection staff. 
6. Integrated COPE into the curriculum of our HVP partner in Antelope Valley (a chapter of Healthy Families 
America in Antelope Valley, CA), and delivered the module in English and Spanish.  
7. Evaluated recruitment procedures and retention rates, and documented characteristics of the families’ social 
networks that could be targeted to optimize healthy changes.  
8. Enrolled our target pilot sample of 50 HVP mothers/infants and randomized families to receive HVP 
curriculum with or without COPE for 6 months to test the feasibility of integrating COPE into HVP services 
(see Preliminary findings below).  
9. Formed our COPE Community Advisory Board (families, Antelope Valley Partners for Health home visitors, 
stakeholders, physicians), which provides feedback on the project every 6 months.  
 
Preliminary data: Baseline characteristics and social networks. Mothers (average age = 25 years) in 
our pilot sample were 70% Hispanic/ Latino, 13% African American, 8% White, 5% American Indian/Alaskan, 
and 4% mixed/other race. All were low-income and were receiving federal support through WIC. Mothers’ social 
connections were predominantly family and household members, who were the key providers of health-related 
support. Mothers were somewhat socially isolated from their broader 
community: they reported few connections to same-age friends, 
spouses/romantic partners (<50%), or other (non-family) community 
members. Specific characteristics of mothers’ social networks were 
identified as potential barriers to healthy behavior change. For example, 
having a larger proportion of social ties who were female or who lived 
in the same household, and a smaller proportion of friends, was 
associated with poorer health indicators (i.e., greater gestational weight 
gain, pre-pregnancy and baseline BMI; greater soda intake; and less 
fruit and vegetable intake). These findings have informed the proposed 
study design, which aims to alter and enhance mothers’ social networks 
so that they are more supportive of healthy behavior change. For 
example, the proposed intervention will foster new social connections 
to peers in their community who can provide support and serve as 
healthy role models.  
0
200
400
600
800
1000
1200
1400
1600
1800
2000
baseline
6mo
control
cope
Energy Intake (Kcal)  
Figure 3. Effects of COPE on maternal 
energy intake. 

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Preliminary data: infant and mother outcomes. To date, our pilot study has collected and processed 
outcome measures among 25 children and mothers who have completed 6 months of intervention. Children’s 
weight velocity was 18% lower in COPE than in the control group (0.61 + 0.1 kg/month vs 0.75 + 0.1 kg/month), 
although this difference was not statistically significant. Interestingly, 
there were no group differences in infants’ energy intake at baseline or 
at 6-month, which raises the possibility that maternal factors, such as 
breastfeeding and maternal diet account, at least in part, for infants’ 
weight trajectories. This hypothesis will be tested in the proposed study.  
As part of this pilot study, we also assessed maternal energy intake 
(Figure 3) and consumption of sugar-sweetened beverages (Figure 4) 
as we hypothesize that these variables impact children’s obesity 
outcomes (as outlined in Aim 2). Mothers’ food intake was assessed via 
24-hour food recalls and converted into energy intake (Kcal) by a 
research assistant blind to group assignment. These preliminary trends 
that suggest an improvement in maternal dietary intake in COPE vs. 
control are promising. 
 
B.8. Theoretical Framework. Our overarching model promotes maternal 
healthy weight, healthy family behaviors and home environment, and 
supportive family and community social networks, as key pathways affecting 
child outcomes during the important developmental period of infancy/early 
childhood.105,106 This theoretical framework and underlying scientific premise 
informs our specific intervention model (Figure 5). Our approach is based on 
the Ecological Systems Theory, Family Systems Perspective and on the Life 
Course Perspective. These frameworks provide the rationale for targeting the 
maternal and social mechanisms to initiate, reinforce, and maintain healthy 
behaviors in infancy/early childhood. The Ecological Systems Theory and 
Family and Community Systems perspective emphasize the need to consider 
the impact of individual, family, community, and societal factors on health and 
social outcomes.107 Social networks, which include parent-child dyads as well 
as other family, friends, and important individuals and organizations, exert 
influence on obesity and related behaviors that should be harnessed.108 Finally, the Life Course Perspective 
underpins our focus on the intergenerational transmission of health behavior, the importance of intervening 
during critical life stages, and addressing differential exposures to risk / protective factors at key points across 
the lifespan contribute to health disparities.109-113  
 
B.9. Innovation. This study is both theoretically and clinically innovative in:  
1. Focusing on primary prevention of childhood obesity by targeting infancy to promote the development of 
healthy habits for life in culturally sensitive ways.  
2. Using an existing infrastructure that is providing culturally-, family-, and community- oriented services to a 
high-risk segment of the population to address the limitations of current childhood obesity efforts, and 
focusing on scalability, sustainability and cost effectiveness, all of which are critical issues to consider for the 
delivery of health services. 
3. Testing key social and maternal mechanisms in the intergenerational transmission of obesity, and thus 
evaluating whether changes maternal behavior and social networks affect infant outcomes and ultimately 
contribute to childhood obesity prevention. 
4. Providing weekly in-home obesity prevention to optimize the generalization of skills and behaviors in the 
family environment, and to modify the home environment. 
 
 C. APPROACH 
This research is designed to integrate and leverage our team’s expertise (Table 1), as detailed in the Personnel 
Justification section, Multiple PI Plan, and Biosketches.  
 
C.1. Design overview. Table 2 depicts the logic model of the proposed study, and demonstrates its scientific rigor. 
Healthy Families America home visitors (see Intervention arms below for their qualifications) will be randomized 
to deliver the HVP curriculum with or without COPE for 12 months (standard HVP duration). Mothers/infants will 
be recruited and enrolled on a rolling basis over 24 months (study months 6-30), and  
COPE 
Mothers 
Infants 
Social 
Networks 
 Aim 1 
 
 
 
Aim 2 
Aim 1 
Aim 3a
 Aim 3b 
 Aim 3b 
Figure 5. Intervention model. 
0
10
20
30
40
50
60
70
80
baseline
6mo
control
cope
Figure 4. Mothers’ soda consumption. 
% of mothers consuming soda daily 

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matched to a home visitor 
based on race, ethnicity 
and language 
preferences. Assessment 
of mothers and 
 infants will be conducted 
by assessment workers 
(who are blind to study 
assignment) at enrollment, 
and after receiving 6 and 
12 months of services. ** 
The 
assessment 
of 
participants after they ceased to receive services for a given period of time (i.e., “true” follow-up) is impossible 
because of the ongoing nature of HVP services. We believe that asking home visitors to withhold the delivery of 
the COPE material to allow for a “no COPE” period would be unrealistic in terms of potential contamination, and 
also create an uncomfortable situation for families and HVP staff.  
 
Table 2. Logic Model COPE 
SITUATION: More than 40% low-income children enrolled in federally funded programs are overweight or obese by age 5. Obesity efforts have 
limited impact among underserved, low-income children, at risk for obesity. 
INPUTS 
OUTPUTS 
OUTCOMES 
• Existing HVP infrastructure 
• Funding 
• Evidence-based nutrition, activity, and 
behavioral components; Research and 
education expertise; Pilot study evidence 
• Partnership (academia, service systems, 
stakeholders, families, community 
organizations) 
• Community Advisory Board (CAB) 
• Training and intervention curricula 
• Input from childhood obesity experts 
ACTIVITIES 
Implementation of COPE: Nutrition, 
Physical activity, Psychosocial Support 
and Behavioral Change, Healthy home 
environment, Support and Community 
Connectedness, Social-experiential activities 
PARTICIPANTS 
• 200 mothers/infants enrolled in HVP 
• Home visitors, directors and 
stakeholders 
SHORT AND MEDIUM TERM 
• Healthier infant feeding practices and 
breastfeeding; Healthier home environment; 
Healthier diet and physical activity for mothers 
and infants; Social connections supporting 
health; Improvement in child diet and physical 
activity  
LONG-TERM 
• Lowered obesity incidence and health 
disparities among children involved in HVPs; 
Reduced costs of obesity and related diseases 
ASSUMPTIONS 
• Personal, family and structural factors influence the outcomes of childhood 
obesity prevention.  
• HVP infrastructure provides a scalable, sustainable, cost-efficient delivery 
model for obesity prevention.  
• Combining didactic and social experiential learning is necessary to engage 
and mobilize families and children. 
• Supportive social networks are pivotal to sustain healthy change 
EXTERNAL FACTORS 
• Underserved families lack access to opportunities and 
resources that facilitate healthy behaviors (e.g., poverty, food 
deserts). 
• Social and community contexts can support or create barriers 
to healthy behaviors. 
• HVPs do not currently address childhood obesity, and home 
visitors are not trained to address obesity risks. 
EVALUATION AND OUTCOMES: Aim 1 (maternal and infant outcomes). Test the direct effects of COPE on infants and mothers’ weight, metabolic and 
behavioral trajectories. Aim 2 (maternal transmission). Test the hypothesis that mothers’ weight, diet and behavioral outcomes (activity, feeding 
practices, and food insecurity) mediate the effect of COPE on infants’ outcomes. Aim 3 (social transmission). Aim 3a tests the direct effect of 
COPE on maternal networks. Aim 3b tests whether the characteristics of maternal networks mediate maternal and infant outcomes.  Secondary 
Aim. Conduct a real-life economic analysis (costs, cost-savings and non-monetary benefits) of integrating COPE into existing HVPs. DELIVERABLES: 
Scientific/academic (journals and conferences) and non-academic outlets (online media; meeting with stakeholders). 
 
C.2. Technical merits of our study approach. Our formative and pilot work made it possible to refine issues 
related to the technical merit and scientific rigor of our study approach. Intervention dosage. By providing our 
program components via weekly in-home services initiated in infancy and maintained for a sustained period of 
time (12 months), we resolve many limitations of existing obesity prevention programs. The proposed model of 
delivery makes it possible to: (1) cover key child developmental periods for healthy eating and activity; (2) deliver 
the material gradually, over a sustained period of time, to avoid burdening families and home visitors; (3) guide 
parents to implement changes in their homes to promote generalization and address ecologically relevant cues 
related to habit formation, (4) and ensure that the skills and knowledge gained are reinforced and mastered to 
promote long-term maintenance. Treatment fidelity. Intervention fidelity encompasses integrity (interventions 
are implemented according to established procedures) and differentiation (interventions are distinct from one 
another).114 Our preliminary findings suggest that our strategies are effective in preserving integrity and differentiation: 
(1) Comprehensive assessment of the standard HVP curriculum to avoid content overlap. (2) Home visitors 
Table 1. Expertise of team members 
Salvy 
de la 
Haye 
HFA 
Chandler
-Delaney 
Goran 
Chou 
Galama 
Infants and early childhood obesity/nutrition 
x 
 
x 
x 
x 
 
 
Home visitation services 
 
 
x 
 
 
 
x 
Family-based behavioral obesity 
interventions 
x 
 
 
 
 
 
 
Underserved, racial/ethnic populations and 
culturally/linguistically tailored interventions 
 
 
x 
x 
x 
 
x 
Multilevel interventions for behavior change 
x 
x 
 
 
 
 
 
Social network measurement and analysis 
 
x 
 
 
 
 
 
Longitudinal modeling of multilevel data  
 
x 
 
 
 
x 
 
Cost analyses of childhood prevention 
efforts 
 
 
 
 
 
 
x 

8 
 
complete rigorous training to learn the HVP curriculum and meet the requirements of Healthy Families America 
(the HVP model we are partnering with). They receive weekly supervision to review progress and address issues. 
(3) Home visitors delivering COPE receive a 2-day initial training and annual refresher courses from Dr. Salvy 
and the onsite Health Families America dietitian and nutritionist, with scripted manuals and materials. Dr. Salvy 
further reviews 25% of the sessions to monitor fidelity. (4) Weekly supervisions (home visitors) and bi-annual 
focus groups (families, home visitors, and Community Advisory Board) are conducted to review progress, dosage 
and timing of delivery, and provide the opportunity to resolve problems or issues encountered. (5) Intervention 
components are delivered in the home or at specified community-run settings (e.g., community garden), and meetings 
and supervisions with home visitors implementing different arms are held on separate days (at Antelope Valley Partners 
for Health) to minimize the risks of contamination. COPE supervision is embedded in the weekly supervision home 
visitors already receive to monitor their services. Potential burden or weakening of HVP curriculum. Potential 
concerns related to adding material to the existing HVP curriculum include (1) diluting or weakening HVPs’ 
outcomes in other areas (e.g., parenting skills, maternal depression), and (2) increasing the burden on HVP staff 
and families. Our formative evaluation and pilot work indicate that these concerns are unfounded. COPE was 
designed collaboratively with our HVP partners (who are experienced in integrating new enhancement modules 
into the HVP curriculum) so that it would complement other program goals. For instance, home visitors report 
that COPE cooking and tasting activities are used to strengthen mother-child bonding and parenting skills (a 
standard HVP benchmark area). HVP directors also found no differences between HVP+COPE and HVP only 
families on HVPs’ benchmark areas set by the Health Resources and Services Administration (i.e., maternal and 
newborn health; child abuse and neglect and emergency department visits; crime or domestic violence; family 
economic security; and coordination and referrals for other community resources and support). Concerns that 
COPE may overly burden families and lead to greater attrition was also not supported, as the dropout rate was 
considerably lower among mothers in the HVP+COPE group than among mothers in the HVP only group in our 
pilot study. These findings suggest that the addition of COPE does not weaken other HVPs’ targeted outcomes, 
or overly burden families and home visitors. We will continue to monitor these outcomes throughout the 
implementation.  
 
C.3. Participants. Participants will be low-income mothers/infants (6mo at 
enrollment) who are already receiving services from our HVP partner (Figure 6). 
Thus, study enrollment does not require that we recruit more families than our 
HVP partner is already enrolling. Mothers are enrolled in HVP services through 
outreach and screening pre-partum, in English or Spanish, at community health 
centers and hospitals. In order to be eligible mothers must meet a number of (but 
not all) risk criteria (e.g., low-income, housing instability). Enrolled mothers are 
matched to a home visitor (nurse) based on culture and language. Recruitment. 
Assessment workers (distinct from home visitors delivering services) who enroll 
families into services will introduce the study to mothers and obtain written 
consent. They will clarify with mothers that their refusal to participate in the study 
will not affect their receipt of any other services provided by the HVP. In our 
experience, families feel comfortable refusing if they are not willing to participate. 
Mothers/infants will be ineligible if they have any of the following conditions: 
eating disorders (e.g., bulimia nervosa), schizophrenia, and obesity-related 
syndrome (e.g., Prader Willi). Participants enrolled in a weight-loss program will 
be ineligible. Based on our pilot work, we expect to recruit 70% Hispanic/Latino, 
13% African American, 8% White, 5% American Indian/Alaskan, 4% mixed 
race. Retention. We have learned a great deal about retention through our pilot work. For instance, most attrition 
from HVP services occurs in the first six months of services. Therefore, to maximize retention, mothers will be 
invited to participate in the study after six months of home visits. The unique relationship between home visitors 
and mothers facilitates subsequent retention, as many of these mothers are socially isolated and home visitors 
are important confidants and supports. We will use multiple strategies that are effective for high-risk populations 
to further retain the study sample: (1) gift cards of $25 at each data collection, with all incentives paid after each 
assessment; (2) frequent contacts to maintain engagement and foster open communication; (3) quarterly 
newsletters to update subjects about study activities; (4) acknowledging birthdays and milestones; (5) reminder 
phone calls the day before the weekly visits and assessment sessions. Randomization. Randomization will be 
at the level of home visitors, who deliver the HVP (cluster randomization). Home visitors who serve mothers that 
are participating in the proposed study will be randomly assigned to deliver either HVP only or HVP+COPE. 
Potential concerns with randomizing by home visitors are feasibly addressed in this study. First, the likelihood of 
Families eligible for HVP in the region  
(n=4000) 
Enrolled families eligible for the study 
(n=3200-3600) 
Effective sample after attrition 
(n=200) 
Families recruited and enrolled 
(n=300) 
HVP only 
(n=100) 
 HVP + COPE 
(n=100) 
Figure 6. Enrollment flow 

9 
 
bias is reduced due to the homogenous population enrolled in HVPs (e.g., income, ethnicity/race). Second, to 
reduce contamination, the training and supervisions of home visitors assigned to each arm will be held on separate 
days. All analyses will control for home visitor work experience (number of years in HVP). 
 
C.4. Intervention Arms (Table 4).  
HVP curriculum. Our HVP partners are two of 400 
nationwide Healthy Families America (HFA) sites/chapters, 
housed at Antelope Valley Partners for Health and the 
Antelope Valley Children’s Bureau. The HFA model meets the 
DHHS criteria for an “evidence-based early childhood home 
visiting 
service 
delivery 
model” 
(See 
http://homvee.acf.hhs.gov). HFA services begin prenatally 
and continue until children are 2-5yo depending on the HVP 
model. The curriculum focuses on strengthening parent-child 
relationships and family functioning, promoting positive child 
development, and linkage to community resources (e.g., medical providers, financial/housing assistance, 
childcare, substance abuse treatment, community programs). HFA accredited home visitors (Nurses) are 
matched to families on cultural background and language (English or Spanish), to provide culturally sensitive 
services. Home visitors are selected because of their personal characteristics (e.g., non-judgmental, 
compassionate, ability to establish a trusting relationship), their experience working with culturally diverse 
communities, and their skills to do the job. HFA home visitors are expertly trained and experienced in handling 
situations encountered while working with at-risk families. They receive training in cultural competency, 
substance abuse, reporting child abuse, domestic violence, and linkage to services in their community. Home 
visiting staff also receive intensive training specific to their role (e.g., identifying at-risk families, standardized 
assessments, phlebotomy, mental health referrals, promoting preventive health care, utilizing creative outreach 
efforts, establishing and maintaining trust with families, building upon family strengths, developing individual 
family support plans, teaching parent-child interaction, managing crises). Staff also receive weekly supervision, 
ongoing developmental training, and have limited caseloads (10-15 families) to meet their families’ needs. 
COPE is a culturally sensitive, language specific, and community-forming model of implementation to deliver 
key nutrition, activity and feeding practice components as part of HVP services in a way that is engaging for 
families. COPE key components are summarized in Table 4, and outlined in detail below. Although 
mothers/infants are the focus of HVPs and COPE, visits are delivered in the home and, as is standard practice 
with HVPs, will engage other household members if possible (e.g., spouse).  
1. Maternal nutrition. Home visitors teach mothers to prepare and store foods they receive from WIC and the 
Food Bank, and to gradually build healthier nutrition and activity goals congruent to their cultural practices and 
ethnic specific food palate: (a) increasing intake of vegetables and fruits (≥5 servings/day of fruits and vegetables) 
and integrating nutrient-dense ingredients in their families’ meals/recipes; (b) limiting intake of high-saturated fat 
and sugar in modifying families’ favorite recipes (the material is adapted to families’ cultural and personal 
preferences); (c) eliminating sugar-sweetened beverage intake, supported by the provision of information and 
activities on sugar content, long-term effects of high sugar consumption, importance of drinking water, and 
impact of advertising;115-121 (d) teaching healthy portion sizes using different visual activities.  2. Infants/young 
children nutrition. The curriculum promotes sustained breastfeeding for the first two years and the gradual 
integration of complementary feeding (pureed and age-appropriate solid foods) that support healthy eating for 
infants. Mothers learn about feeding/eating developmental stages and transitions, and healthy feeding7-9,122 
practices to promote: (a) responsiveness to child hunger and fullness cues; (b) the consumption of nutrient-
dense foods (as opposed to energy-dense); (d) the transition to structured schedule for meals/snacks from 
complementary feeding; and (d) the use of non-food related child soothing techniques. Mothers also learn 
strategies to address neophobia,123,124 such as repeated multi-sensory (i.e., smell, touch, taste) exposures to 
nutrient-dense novel foods,125 gradual texture shaping, parents/caregivers modeling, and involvement of children 
in food selection and preparation; and strategies to handle meal-related tantrums (e.g., redirection, positive 
reinforcement of appropriate behaviors).126,127 3. Maternal/child physical activity. Although there is no 
unequivocally accepted guidelines for the number of minutes children 0-2yo should be active each day,128 the 
DHHS has summarized recommendations from the National Association for Sport and Physical Education, 
the American College of Sports Medicine, and the National Institutes of Health: (a) daily planned physical 
activities, including tummy time, that safely support the infant’s developmental milestones (e.g. head and neck 
self-support, rolling, floor sitting, kicking, crawling, reaching and grasping for objects, etc.); (b) engage in 30 
Table 4. Interventions components 
 
HVP  
COPE 
Maternal/infant health 
x 
 
Child physical and social development 
x 
 
Crime and domestic violence 
x 
 
Child abuse and neglect 
x 
 
Family economic stability 
x 
 
Breastfeeding 
x 
x 
Maternal nutrition 
 
x 
Physical activity and play 
 
x 
Infant nutrition/feeding practices 
 
x 

10 
 
minutes of supervised but unstructured physical activity each day; and (c) avoid being sedentary for more than 
60 minutes at a time, except when sleeping. The American Academy of Pediatrics (A.A.P.) Expert Committee 
further suggests limiting screen time.129 COPE is premised on the above guidelines in addition to CDC guidelines 
for adults (150 minutes of moderate intensity physical activity/week). COPE teaches parents to make activity/play 
a daily habit for their entire family by exploiting lifestyle activities (e.g., taking the stairs, walking to the shop). 
Home visitors help parents design activities around their local environment, schedule, and preferences, and to 
optimize their use of safe spaces. Parents are provided with information about resources and free group activities 
conducive to physical activity (e.g., parks, walking clubs, outings, etc.), and classes they can take with their 
children and with other HVP families. The curriculum emphasizes the importance of parents co-engaging in 
activities with their children to set a good example through modeling and to provide opportunities for their children 
to be physically active. 
 
COPE delivery format. Our formative work and pilot research indicates that didactic and experiential 
approaches are needed to help families adopt behaviors that will promote their child’s health.  
 1. Didactic education focuses on in-home individualized coaching to help mothers implement changes in their 
“natural environment”. A strong emphasis is placed on gradual goal setting in which mothers set objectives for 
their own and/or their children’s weekly activity and diet (e.g., decreasing by “x” the number of sugar-sweetened 
beverages) and on parent modeling healthy behaviors (i.e., co-engaging in healthy behaviors with their children). 
Parents are taught behavior management and cognitive-behavioral strategies to change cues in their home 
environment. Mothers receive individual coaching to gradually eliminate high-energy dense foods from the home 
environment, and to modify the home to make it more conducive to exercising (e.g., removing 
computer/televisions from sleeping areas).129 2. Social experiential activities (Table 5) were selected in response 
to: our theoretical framework that emphasizes social network influences; our pilot work that highlights existing 
social network barriers to behavior change; and families’ desire to learn through hands-on, social activities. 
These activities are already built into the service infrastructure at Antelope Valley Partners for Health, are 
integrated across all key content areas of COPE, and will be promoted to participants in the intervention arm 
(but not to participants in the control arm) by their home visitor. Participation by study participants will be 
monitored and recorded by activity staff. One central purpose of the communal activities is to foster new, yet 
sustainable social and community connections that will provide increased healthy behavior role models and 
social support for mothers. This will 
be achieved through activities that 
provide a context for repeated social 
connection among consistent groups 
of 
COPE 
participants 
in 
their 
neighborhoods, 
and 
through 
activities designed to foster group 
learning, discussion, and shared 
experiences that are aligned with the 
individual didactic learning in home. 
These social activities are similar to 
those delivered as part of the 
National Institute of Food and 
Agriculture’s Expanded Food and 
Nutrition Education Program.130   
 
C.5. Measurements. HVP Assessment Workers (registered nurses who can draw blood) who enroll families into 
standard HVP services, have been trained to screen and recruit eligible families for the proposed project. They 
will administer the assessments (English or Spanish; Table 6) in the families’ homes or at the HVP clinic (as 
needed) at baseline/enrollment, and after 6mo and 12mo of services. Home visitors will be trained to gather 
interim (objective) weight measurements for the purpose of generating more frequent data points, triangulated 
with the assessment workers’ measurements. 
Medical and family history. A thorough family history and physical examination will be conducted at baseline. 
We will collect demographic data, including socioeconomic status (education, income, eligibility for SNAP). 
Infant growth & waist trajectories. Weight will be measured on a digital scale (Tanita) accurate to the nearest 
5g. Length will be measured to the nearest 0.1 cm using an infanto-meter using the standardized WHO approach, 
Table 5. Description of COPE experiential and communal activities 
Communal 
cooking 
Advance meal preparation to promote home cooking using foods from WIC/food 
bank, and decrease reliance on fast-food. Gatherings are lead by Nadia Sigaran 
(Site Culinary Program Coordinator) and take place in the Wellness Homes 
operated by our partner (Resources & Environment section).  
Community 
gardening 
Mariposa master gardeners teach parents/children gardening techniques 
(planting, growing and harvesting fruits and vegetables). Gardens are located 
on Wellness Homes’ grounds. Families tend local gardens with other families.  
Food 
management 
Classes to improve food resource management practices such as purchasing, 
selecting, or otherwise obtaining; preparing; and storing foods to increase 
sustained availability of healthy foods throughout the month. This material is 
delivered in local grocery stores and markets.  
Mobile food 
demos 
Food demonstrations hosted in neighborhood farmers markets to provide 
convenient and accessible cooking and food preparation demonstrations using 
fresh products from local farmers markets.   

11 
 
including use of staff training modules. Weight 
and length will be used to calculate weight-for-
length 
and 
weight-for-age 
z-scores 
(WHO 
Standards), as recommended by the CDC for 
children <24 mos. Infant growth rates will be 
examined as the change in WLZ from baseline to 
follow up (12mo) Waist circumference will be 
measured at the umbilicus (nearest 1-mm) using 
a non-stretch measuring tape.  
Infant diet & activity. To fully capture infants’ diet 
(e.g., breastfeeding, use of formula, fruits/ 
vegetables, fat/sugar intake), we will use multiple 
tools. Diet recall. .Mothers will be interviewed 
about their infants’ intake of fruits, vegetables, 
friend foods, and sugared beverages. Mothers will 
complete items from the Diet and Behavior 
Questionnaire (DBQ)132 of the National Health and 
Nutrition 
Examination 
Survey 
to 
capture 
breastfeeding/feeding history and introduction to 
formula and solid foods. Infants’ activity. Because of validity issues related to accelerometry in infants/young 
children, we opted to capture time engaged in sedentary activities and structured/unstructured physical activity. 
Mothers will report their child’s activities (e.g., tummy time,).133-135  
 
Infants and maternal biomarkers for metabolic risks. Blood will be drawn at the Antelope Valley Partners for 
Health office by Assessment workers with phlebotomy certification, at baseline  for mothers only. Mothers: Blood 
will be drawn by Assessment Workers who will make a maximum of 3 attempts to draw the blood during the first 
visit. If the first attempt is not successful, mothers will be invited to return on another day for a second (and final) 
attempt. Plasma will be stored at -70°C for analysis. Biomarkers of type 2 diabetes risk, lipids, and inflammatory 
markers. CRP will be measured using the Millipore Multiple assay kit at the USC DORI Core Laboratory. Lipids 
will be assayed using Vitros Colorimetric assays (Johnson & Johnson Clinical Dinostics Rochester, NY) for 
cholesterol, triglycerides and HDL-cholesterol. Sitting blood pressure (mothers) using auscultation and heart rate 
will be measured on the right arm after a 5-minute rest. Three readings of blood pressure and heart rate will be 
obtained and the average of the last two last will be recorded. 
 
Maternal weight & waist circumference. Weight and height will be measured by Assessment Workers in 
participants’ homes using an electronic scale (Model BWB-800S, Tanita, Portage, MI) and stadiometer (Model 
PE-AIM-101, Perspective Enterprises) according to standard procedures.140 Subjects will remove shoes, belts, 
and heavy outerwear and empty pockets. We will measure height in duplicate and if measurements are not 
within 0.5 cm, we will obtain a third measurement. The mean of all measurements will be used to calculate BMI. 
Waist circumference will be measured at the umbilicus to the nearest 1 mm using a non-stretch measuring tape. 
Maternal obesity prior to pregnancy will be derived from pregravid BMI (recall during pregnancy at recruitment). 
Gestational weight gain will be defined as the last weight obtained before delivery minus the pregravid recalled 
weight or the weight recorded at the first prenatal visit during the first trimester using electronic medical record 
data. 
 
Maternal diet & activity. Mothers’ dietary intake and activities will be assessed using several items from 
NHANES (2017), including intake of fruits and vegetables, fried foods, and sugary-sweetened beverages, and 
time mothers engage in moderate physical activity.  
Maternal social networks & support. Using egocentric social network methods141 and EgoWeb software 
(http://www.rand.org/methods/egoweb.html, developed with PI de la Haye), we will assess the characteristics of 
the social actors (people, organizations) and relationships that surround mothers.142,143 Using standard name 
generator items,143,144 participants are asked to identify 20 important adults in their lives, and then report on the 
attributes of each person (demographics, health attributes/behaviors) and types of relationships they share. 
Relationship characteristics of interest include how they know the person (e.g., family, friend from a community 
program, etc.), frequency of interaction, and provision of support for health behaviors (e.g., encouragement for 
or co-engagement in specific behaviors)52,53,145. Social Support measures from the PROMIS database will be used 
to assess emotional and instrumental support, and social isolation. Egocentric network data is used to compute 
network composition variables (e.g., proportions of family/friends in the network), and variables that represent 

12 
 
important network structures (e.g., sparse or dense support). Respondents will also be asked about health-
related relationships (e.g., information seeking, support) they have with community organizations. Social network 
analysis (SNA) will be used to compute summary statistics for each mother’s network, such as the proportion of 
network members that engage in regular exercise or that provide health-relevant support, and the density of 
supportive relationships.147   
Maternal food insecurity. The U.S. Adult Food Security Survey Module148 is an 18-item, three-stage design 
with screeners. Each stage consists of characteristic conditions and experiences of food insufficiency to meet 
the basic needs of household members, and of the behavioral responses of household members to these 
conditions. We will test if scores mediate the effect of COPE on infants’ outcomes, as energy intake and weight 
are related to food insecurity.42-50  
 
C.6. Analytic Plan.  
General strategy. Three waves of data will be collected (baseline/enrollment, 6 and 12- months of 
intervention). Analyses will be carried out according to the intention-to-treat rule consistent with standard practice 
in most clinical trials. We will conduct standard statistical diagnosis and descriptive statistics of demographic and 
background variables, and examine frequencies for reasonableness, sparseness (categorical data) and non-
normality (continuous variables) of the data. Missing data will be addressed using multiple imputation and/or full 
information maximum likelihood estimation. Psychometric properties of the study scales will be investigated to 
ascertain appropriate validity and reliability. Preliminary analyses will test group equivalence on baseline 
characteristics. Categorical methods of analysis (e.g., cross tabulations, chi-square) will be used for discrete data 
while t-tests will be used for continuous data to test the comparability of the prevention arms. Factors found to be 
different at baseline will be adjusted for in subsequent analyses. The following covariates will be entered in all 
analyses: home visitor, home visitor experience (years), number of visits, household composition, race/ethnicity, 
acculturation, mother’s age, medical history/gestational diabetes, post-partum depression. 
Social network analysis (SNA). Network data will be analyzed using SNA packages in R (e.g., SNA, igraph) 
to produce visualizations and statistics that summarize the characteristics of each mothers’ network. We will 
compute the following network statistics: the proportion of network members that provide specific types of health 
relevant support, and that engage in specific health behaviors; and the density of supportive relationships within 
each network (i.e., the number of supportive relationships among network members that are reported, as a 
proportion of the total number of possible supportive relationships where all network members provide 
support).149,150 These statistics will be computed for each assessment period (as well as change statistics across 
periods), and included in the analyses, as described below. 
Statistical Models Aims 1-3. Our conceptual model includes three types of variables: Intervention arms 
(HVP vs. HVP+COPE) and covariates, mediators, and outcome variables. We will use multiple statistical 
procedures tied to the analytic objectives of each of our specific aims, including generalized linear modeling, 
path analysis and structural equation modeling (SEM) approaches. To control for potential cluster effect due to 
home visitors as families are nested with visitor, statistical models will be developed based on multilevel path 
analysis to test direct and indirect (or mediational) effects hypothesized in the model.151,152 The models involve 
two levels with mothers or children as Level-1 units and visitors as Level-2 units treated as a random effect. With 
multilevel path modeling approach, the covariance matrix to be analyzed can be properly decomposed into 
individual- and group-level covariances to account for the clustering effect due to visitor nesting effect of the 
data. The multilevel path model can involve all variables from the family level in the analysis. The model can also 
incorporate distal predictors and mediators from the visitor-level (Level-2) and outcomes from family-level (Level-
1) data. The aims of the proposed study focus on the Level-1 units. Following Bentler-Weeks153 modeling 
notation, the path model can be expressed as: =β+, with all exogenous (distal) variables defined as  and 
all endogenous (mediators and final outcomes) variables as . The parameters in β and  matrices can be 
specified according to the hypotheses of each Aim. Models to be developed are discussed in greater detail below 
for each Aim. Mplus software154 will be used model estimation and evaluation. 
Aim 1 (maternal/infant outcomes). Change in weight-related outcomes over the 2-year implementation is the 
primary outcome comparison. We will use multilevel regression models adjusting for clustering effect of home visitors 
to compare differences in the main outcomes across time by intervention arm. Regression model can be treated as 
a special case of path model without mediators. These regression models will include all participants, who have at 
least 2 measurements, regardless of when the measurements are taken, increasing the follow-up of study participants 
and statistical power. Specific measures relevant to Aim 1 are maternal and children weight-related measures. 
These models will allow the evaluation of intervention effects on, for example, child growth trajectory and activity, and 
mother BMI, metabolic, and behavior outcomes. Investigation of the main effects of COPE on outcomes will be 
conducted at each follow-up. Baseline outcome measures will be treated as covariates to control for potential 

13 
 
baseline differences. Effects of COPE will be evaluated first at each follow-up assessment point. Longitudinal 
analyses with all follow-up points (6 and 12 months) will then be conducted to examine profiles across time to 
investigate the effects of program conditions on trends of outcome measures.  
Aim 2 (maternal transmission). To estimate the mediational effects of maternal transmission, multilevel 
path models will be developed and evaluated per our hypotheses. The model specification will be guided by our 
conceptual model treating Intervention program as the distal variables along with demographic variables to affect 
mother’s weight, diet and behavior as mediators, which in turn may influence infants’ outcome. While the 
intervention program will be at the Level-2 unit, all other variables included in the multilevel path models will be 
Level-1 variables obtained from mothers and children. Using breastfeeding and maternal diet on infants’ weight 
trajectories as an example, the mediation mechanism of maternal transmission can be expressed by the process: 
COPE→ breastfeeding * maternal diet→ weight. The path model will allow the test of both the direct effect of 
COPE on infant weight trajectory and its indirect effect on through breastfeeding and maternal diet. 
Aim 3 (social transmission). A multilevel path model similar to the one described in Aim 2 will be specified. 
Mediators can be specified in a process to more appropriately represent the mechanism of social transmission. 
For example, the model can contain a sequence of influences such as: COPE→ density of social network 
support→ maternal outcomes→ infant outcome. A direct effect of social network on infants’ outcomes can also 
be specified to investigate if social network has direct and indirect effect on infants’ outcomes.  
Power Analysis Aims 1-3 (Figure 7). A total of 30 home visitors will be recruited and randomized to HVP 
or HVP+COPE. With an average of 13 families served by each visitor, a total of 300 families will be invited to 
participate in the proposed study over 12 months. Based on our pilot work and existing HVP data,94,95,155-157 we 
expect a retention rate of 75% of families, which will result in a final sample of 200 mothers/infants. We have 
calculated power using G*Power158 based on an effective sample of N=200 for the main weight related outcomes 
with the design of repeated measurement. All tests use a two-sided alpha level of .05. Our pilot study showed a 
small to medium effect size of .4 (Cohen’s d) on our main outcome of children’s weight velocity and smaller effect 
on energy intake at 6 months post-test. No previous study has investigated the long-term (12 months) delivery 
of in-home obesity prevention on 0-2yo children’s growth trajectory, diet and activity. However, an in-home 
intervention compared to outpatient pediatric counseling 
resulted in a large effect size of 1.64 (Cohen’s d) for 
changes in zBMI at 12 months, among obese 2-5yo 
children.159,160 To account for potential large clustering 
effect at the home visitor level, we assume the intraclass 
correlation (ICC) of .05 to .1 161 with inflation factors (1+(n-
1)*ICC) of 1.4 to 1.8, respectively.162 After taking inflation 
factor into account, our proposed sample size of 200 will 
have enough power to detect medium effect sizes based 
on Cohen’s f163 between .17 and .20. More comprehensive 
path model will be specified in each aim for model 
evaluation and hypothesis testing. We are aware of the 
sample size limitation and will be cautious in the number of 
variables and the size of the model involved. We used the 
hypothesis-testing framework of RMSEA164 to estimate 
power of model fitting in our study. With  = .05, a null hypothesis RMSEA of .00 (almost exact fit for path model), 
an alternative hypothesis RMSEA of .08 (criterion of not acceptable models) and degrees of freedom (size of the 
model) ranging from 10 to 15, the range of statistical power for a sample size of 300 is between .83 and .93. We 
will have sufficient power to detect small to medium effect of a set of pre-selected parameters associated with 
mediators and outcomes with sample size of 200.165 
Secondary Aim (Real-life economic analysis). We will document the costs of adding COPE to HVP’s 
services through cost logs and interviews with HVP directors. We will consider the costs of labor (the time home 
visitors spent in training and in administering COPE, times their wage rate) and of materials (training and 
intervention manuals for home visitors), and evaluate how these costs can be absorbed through the ongoing 
funding from the Affordable Care Act. We will calculate infants and mothers’ weight, metabolic, and behavioral 
trajectories and how they differ by child gender, household structure, and other observables. These analyses 
will be conducted at two levels. First, we will calculate the cost-effectiveness of HVP+COPE (vs. HVP only) by 
comparing the cost of adding COPE per unit of improvements in weight, metabolic, or behavioral outcomes with 
the cost per unit of improvement in these outcomes vs. alternative obesity programs with similar aims (e.g., 
prevention delivered in outpatient settings). This will provide a measure of the effectiveness of COPE vs. 
Figure 7. Required sample size by effect size 

14 
 
alternative interventions. We will rely on an extensive review of the literature to obtain estimates of costs and 
improvements associated with such alternative programs. Second, in the absence of long-term data, simulation 
models are often used to predict long-term outcomes and/or evaluate the cost-effectiveness of healthcare 
interventions. We have developed a simulation model to predict BMI trajectories and associated medical 
expenditures over the life cycle (e.g., 166). The model utilizes data from the Medical Expenditure Panel Survey 
(MEPS) to model yearly changes in BMI and healthcare costs associated with each possible initial BMI state. 
The model was validated using data from the National Health and Nutrition Examination Survey (NHANES). This 
work shows that reducing by 10% the risks of overweight/obesity (BMI ≥ 85th percentile) in ages 2-18 is 
associated with reductions in direct medical costs between $2,830 (men) and $3,000 (women) in adulthood. 
Reducing obesity risks by 25% is associated with savings of $5,860 and $6,022 in adult men and women 
respectively. We will use this model to predict reductions associated with long-term BMI and medical care 
expenditures over the life cycle and compare these to costs associated with COPE. 
 
C.7. Timeline 
 
Table 7. Timeline of planned research activities 
Research Task 
Month of Study 
6 
12 
18 
24 
30 
36 
42 
48 
54 
60 
Convene weekly research meetings (key personnel) 
 
 
 
 
 
 
 
 
 
 
CAB meetings 
 
 
 
 
 
 
 
 
 
 
In-person training of home visitors and refresher courses 
 
 
 
 
 
 
 
 
 
 
Delivering COPE as part of HVP services  
 
 
 
 
 
 
 
 
 
 
Recruitment /enrollment /baseline assessment 
 
 
 
 
 
 
 
 
 
 
33% sample 
 
 
 
 
 
 
 
 
 
 
66% sample  
 
 
 
 
 
 
 
 
 
 
      100% sample 
 
 
 
 
 
 
 
 
 
 
Assessments (based on rolling enrollment) 
 
 
 
 
 
 
 
 
 
 
6-month assessment 
 
 
 
 
 
 
 
 
 
 
18-month assessment 
 
 
 
 
 
 
 
 
 
 
Data entry and data cleaning 
 
 
 
 
 
 
 
 
 
 
Interim analyses and preliminary reports and publications 
 
 
 
 
 
 
 
 
 
 
Manuscript preparation and research dissemination  
 
 
 
 
 
 
 
 
 
 
Clinical and community dissemination 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
C.8. Deliverables. The most appropriate scientific outlets will be journals dedicated to obesity (International 
Journal of Obesity, Pediatric Obesity) and general nutrition and public health (Pediatrics, American Journal of 
Public Health, American Journal of Clinical Nutrition). We will also target specialized (Obesity Society, 
International Network for Social Network Analysis) and general conferences. Study findings will be disseminated 
to our HVP partners, Community Advisory Board and key stakeholders, and utilized to refine our existing 
curriculum and protocol for future dissemination. 

15 
 
PROTECTION OF HUMAN SUBJECTS 
 
A. Participants 
This comparative effectiveness research involves the enrollment of 300 mothers/infants for a final effective 
sample of 200 mothers and their infants (age 6mo at enrollment).  
Inclusion of women. Women are represented by mothers and female infants, which will be about half of the 
infant sample. Based on our projected effective sample of 200 mothers and their 200 infants (N=400), we 
anticipate that 75% of our sample will be women (100 children + 200 mothers = 300).  
Inclusion of racially and ethnically diverse families.  The families enrolled in the Home Visiting Program 
(HVP) from which the sample is drawn is culturally, racially and ethnically diverse, reflecting the population of 
low-income families enrolled in home visiting services in the Antelope Valley, CA area. Based on our HVP partner 
(Healthy Families America site in Southern California: Antelope Valley Partners for Health and Children’s 
Bureau) clients’ demographics and on our pilot work, we anticipate the following ethnic and racial distribution: 
70% Hispanic/ Latino, 13% African American, 8% White, 5% American Indian/Alaskan, and 4% mixed/other 
race.  
It is important to note that Health Families America (HFA) home visitors are matched to families based on 
language and cultural background. Home visitors are rigorously trained to understand, acknowledge, and respect 
families’ cultural differences. Home visitors are selected because of their personal characteristics (i.e. non-
judgmental, compassionate, ability to establish a trusting relationship, etc.), their experience working with 
culturally diverse communities, and their skills to do the job.  
Inclusion of children. Infancy and early childhood are important developmental periods given that nearly 
one-third of American children two years and older are already overweight or obese167-169 and these rates are 
even higher among low-income children of color. Once obesity is established, it is difficult to reverse,170 and 
obesity in childhood and adolescence are independent risk factors for adult obesity.6 Children develop eating 
and activity habits in the context of their family, and parents influence the child’s health trajectories through their 
own behaviors (e.g., modeling) and through the shared family environment. This proposal addresses the impetus 
to develop interventions targeting at-risk infants before obesity is established, to avoid the significant public 
health implications associated with obesity by reducing lifelong health struggles for at-risk individuals and 
reducing financial burdens for the society as a whole. The services and obesity module being evaluated in this 
proposed research involve the provision of home visiting services to infants/children and their mothers. 
Therefore, a number of the outcomes that will be measured as part of the proposed research will involve children. 
Specifically, children will be represented by the 200 infants that will be the offspring of the mothers, as well as 
mothers who are 18 years of age or younger. A significant proportion of mothers enrolled in home visiting 
services (50%) are ≤18 years of age. Based on our pilot data, we expect the total number of participants ≤18 
years of age at enrollment will be: 200 infants + 100 mothers = 300.  
The research team is well trained and experienced in conducting research in children. Dr. Salvy (MPI) is a 
Clinical Psychologist with expertise in pediatric and child psychology, and she has been a member of the 
children’s Institutional Review Board (IRB) for several years at the Women and Children’s Hospital in Buffalo, 
NY. She will ensure the quality of the treatment implementation. The involvement of minors as participants in 
this research is in compliance with all subparts of 45 CFR Part 46 as well as with Federal laws and regulations. 
Sources of materials. Data will be used specifically for research purposes and held in strict confidence. 
Data from human subjects include:  
• Clinical evaluation and medical history via questionnaire/interview; 
• Demographic information, via questionnaire (mothers) 
• Anthropometry: body weight, waist circumference, height (mothers/infants) 
• Blood pressure (mothers) and blood samples (mothers/infants); 
• Variables derived from dietary intake, via recall interviews (mothers as respondents for themselves and for 
their infants);  
• Physical activity via interview/recall (infants) and accelerometers (mothers);  
• Social networks and support via questionnaires (mothers); 
• Maternal feeding style & practices via questionnaire (mothers); 
•  Maternal food insecurity via questionnaire (mothers); 
 
Records. Mothers’ pre-pregnancy weight and infants’ birth weight will be obtained from our HVP partner. All 
other data used for this study will be collected during the implementation of the study protocol. 
 
B. Potential Risks/Adverse Events and Procedures Used to Minimize the Risks 
For purposes of monitoring and reporting adverse events, the following definitions will be used:  

16 
 
Adverse event (AE): any untoward medical occurrence that may present itself during treatment or 
administration of an intervention, and which may or may not have a causal relationship with the treatment. 
Adverse events could arise from the study (e.g., breach of confidentiality) or could arise because of the 
population under study (e.g., a mother reports extensive use of drugs). 
Serious adverse event (SAE): Any medical occurrence that results in death; is life-threatening; requires 
inpatient hospitalization or prolongation of existing hospitalizations; creates persistent or significant 
disability/incapacity, or a congenital anomaly/birth defect. Such an event could include suicidal ideation or 
attempted drug overdose or withdrawal, etc. 
Adverse events monitoring. Each participant (mother and infant) will be evaluated for any adverse events. 
All events will be graded by their attribution (unrelated to protocol; or possibly, probably, or definitely related to 
protocol). Any event reported to the Principal Investigators or to designated research associates by the subjects 
or Antelope Valley Partners for Health nursing and medical staff, which also meets the event criteria, will be 
carefully documented in a report submitted to the IRBs. The report will include a description of the event; when 
and how it was reported; any official charts, records, or documentation to corroborate the event or the reporting 
of the event; and an action plan to prevent future occurrences. All adverse events will be graded as mild, 
moderate, or severe. Any severe and/or unanticipated adverse event will be immediately reported to the IRBs 
(within 48 hours of occurrence or recognition) and NIH. All adverse events will be summarized annually and 
submitted to the IRBs and NIH. Any action resulting in a temporary or permanent suspension of this study (e.g., 
IRB actions) will be reported to the NIH.  
Physical risks. There are minimal physical risks added from participating in this study. All lifestyle dietary 
and physical activities suggested are in line with national guidelines. Recommended physical activities are low 
impact and unlikely to create discomfort for participants.  
Psychological risks. Though none of the questionnaires contain items that are particularly sensitive, 
personal, or potentially upsetting, it is possible that a participant may become upset thinking about some of the 
questions or topics in this study. Trained assessors will be conducting the assessment sessions to address any 
potential incident. All participants will be informed that they are free to refuse to answer any particular questions 
or questionnaires. They will also be informed that they can withdraw from the study at any time without penalty. 
Staff will immediately report any AEs connected to the implementation of the intervention to Drs. Salvy and de 
la Haye who will keep a log of AEs and SAEs. Drs. Salvy and de la Haye will file a written report within 24 hours 
of being notified to the IRB, whether the event relates to the project or not. As part of this process, members of 
the IRB committee review the event and determine whether the event is directly related to project procedures so 
that it can be determined whether procedures need to be modified to avoid a similar AE in the future. Whether 
the event is related to the project, we will keep a log to provide information about all AEs in annual progress 
reports to the IRB and NIH. Drs. Salvy and de la Haye will monitor outcomes for AEs, and outcome information 
will be entered into a log for inclusion in reports to the IRB and NIH.  
Social risks. There are no social risks for participating in this study. 
Legal/other risks. None. 
Postpartum depression. The Edinburgh Postnatal Depression Scale (EPDS)171 is used to assess 
postpartum depression at enrollment into home visiting services. Maternal depression will be assessed again 
prior to study enrollment. Mothers who show signs of severe postpartum depression will be closely monitored 
and provided additional referrals and resources as needed. The Safety Officer, Dr. Paul Round, is a physician 
at the Antelope Valley Clinic. Dr. Round oversees the physical and psychosocial safety and well-being of families 
enrolled in home visiting services. The decision to include/exclude mothers with postpartum depression will be 
taken on a case-by-case basis with the counsel of one of the PI (Dr. Salvy, Psychologist), Antelope Valley 
Partners for Health directors, the Safety Officer (Dr. Round, DO) and our CAB (which includes mental health 
professionals and Dr. Paul Simon, MD). We believe that some mothers may benefit from engaging in positive 
and reinforcing activities such as cooking and lifestyle activities. Physical activity has been shown to improve 
moods and alleviate symptoms of depression.  
Trauma and domestic violence. If we suspect that mothers are victims of intimate partner violence, either 
through completion of the questionnaires or through mother report or staff observation, we will implement the 
following procedures: (1) we will make mothers aware of resources available to them in their communities, such 
as shelters; (2) we will work with mothers to develop a safety plan for addressing violence and seeking shelter; 
(3) we will ascertain risk to the child. If we suspect that the child has been abused or witnessed domestic violence, 
we will make a report to child protective services. We will work closely with the home visitor and our HVP partner 
to coordinate efforts in the best interests of the mother and child. Mothers who are victims of domestic violence 
will not be dropped from the study. 

17 
 
Suicidal behavior. As we will be measuring depression in mothers, we will potentially identify participants 
who are suicidal. We follow the Substance Abuse and Mental Health Services Administration SAFE-T: Suicide 
Assessment Five-Step Evaluation and Triage approach to determining risk and clinical response. The five steps 
are Identify Risk Factors, Identify Protective Factors, Conduct Suicide Inquiry, Determine Risk Level/Intervention, 
and Document (which includes intervention and follow-up).  As per Practice Guidelines, we will estimate suicide 
risk as Low, Moderate, or High. All potentially suicidal mothers will be provided an emergency plan with numbers 
to call, including local hospital emergency rooms, suicide hotlines, and home visitor contacts. Each plan will be 
individually tailored to the needs and resources of the mother. Family members will be incorporated into the plan. 
We will be available to home visitors and our HVP partner to work with them as to how to proceed if their clients 
present with suicidal behavior. Home visitors also have ready access to supervisors in their agencies to help 
them respond to mental health needs, and some of the agencies run separate mental health programs, thereby 
providing additional resources for home visitors in conjunction with project staff. Mothers who experience 
psychiatric emergencies such as suicidal behavior will not be dropped from the study.  
Alternative treatments. Parents who do not want to receive the nutrition and physical activity module (i.e., 
COPE), will receive the standard home visitation program curricula. 
 
C. Recruitment and Retention 
Participant recruitment. Low-income mothers and their infants (N=300, for a final effective sample of 200) 
will be participants in the study. Active participants will be low-income mothers and their infants (6mo-old at 
enrollment) drawn from mothers who are enrolled in HVP services at the Healthy Families America site/chapter in 
Antelope Valley, CA. Home visitors providing the HVP services will introduce the study to mothers, and study 
Assessment Workers will obtain written consent. Home visitors will clarify with mothers that their refusal to participate 
in the study is not affecting the services they provide. In our experience from our pilot research, families feel 
comfortable to refuse if they do not wish to participate. Of note, 90% of families receiving Healthy Families America 
HVP services choose to enroll in enhancement studies when offered (i.e., when a module is added to the core 
curriculum and evaluated). These rates are consistent with our pilot work.  
Inclusion/exclusion criteria. Participants will be ineligible if either parent and/or child have a Dx of eating 
disorders (e.g., Anorexia Nervosa), Schizophrenia or Obesity-related syndrome (e.g., Prader Willi). Participants 
enrolled in a weight-loss program will be ineligible.  
Retention. Using conservative estimates, we anticipate that 25% of mothers enrolled will drop out of home 
visiting services over the 12-month study. Consequently, we will oversample at enrollment (N=300) to ensure an 
effective sample of 200 mothers and infants. We have learned a great deal about retaining mothers through our 
prior pilot studies. We attribute retention in part to our persistent efforts and abilities of the HVP home visitors, 
but also believe that there are unique features of home visited mothers that facilitate retention in a research 
study. For example, many of these mothers are socially isolated, and opportunities to exchange with their home 
visitor can be highly rewarding for mothers. We will use multiple strategies to retain the sample over the 
12months of the implementation and assessments. We will rely on approaches widely used in studies of high-
risk populations: (1) a gift card in the amount of $25 at each data collection, with all incentives paid after each 
assessment/data collection regardless of whether they complete the study; (2) frequent contact with participants 
to maintain engagement because we believe that open communication between the team and participants is 
critical; (3) quarterly newsletters to update participants about study activities; (4) acknowledging birthdays; (5) 
participants are given a reminder phone call the day before the weekly visits and assessment sessions (or on 
Fridays for Monday assessment sessions). 
Informed consent procedure. Informed consent, approved by the appropriate IRB, will be obtained by 
Antelope Valley Partners for Health assessment workers who are trained by our research team. All mothers that 
are enrolled in HFA’s HVP services by Antelope Valley Partners for Health and Children’s Bureau will receive a 
detailed explanation of the protocol, including any potential benefits and risks (in English or Spanish). Mothers 
will be required to sign the consent form (in Spanish or English) and provide consent for their infants. Only 
participants from whom consent is obtained will be involved in the study. Signed consents will be kept in the 
participants’ files in locked filing cabinets. Each participant will receive a copy. 
Waiver. No waiver or modification of consent is being requested from the IRB. 
 
D. Protection Against Risk 
 
 
Safety reviews. The PIs will review the safety and progress of this study on a monthly basis. The PIs and 
the IRBs will review this protocol on a continuing basis for subject safety and include results of the review in the 
annual progress reports submitted to NIH. The annual reports will include a list of adverse events and address: 
1) whether adverse event rates are consistent with pre-study assumptions; 2) reasons for dropouts from the 

18 
 
study; 3) whether all participants met entry criteria; and 4) whether continuation of the study is justified on the 
basis that additional data are needed to accomplish the stated aims of the study.  
It is also important to note that Healthy Families America home visitors are expertly trained and experienced 
in handling situations they encounter while working with at-risk families. All home visitors receive extensive 
training in cultural competency, substance abuse, reporting child abuse, domestic violence, drug-exposed infants 
and children, and linkage to services in their community. Home visiting staff further receive intensive training 
specific to their role (i.e., assessment, home visitation, identifying at-risk families, completing standardized 
assessments, phlebotomy, mental health referrals, promoting preventive health care, securing medical homes, 
immunizations, utilizing creative outreach efforts, establishing and maintaining trust with families, building upon 
family strengths, developing individual family support plans, determining the safety of the home, teaching parent-
child interaction, managing crisis situations, etc.). Staff further receive weekly supervision, ongoing 
developmental training, and have limited caseloads (10-15 families) to meet families’ needs. 
 
Monitoring plan. The study’s data safety and monitoring plan will entail several components, overseen 
Principal Investigators (Drs. Salvy and de la Haye):  
1. All University of Southern California (USC) and University of Alabama at Birmingham IRB policies and 
continuous reporting requirements will be followed in conducting the proposed study. Any actions taken by 
the IRB as part of its continuing review will be immediately reported to NIH.   
2. The PIs will implement and monitor procedures to ensure that each mother provides informed consent and 
that all data remains confidential. This will also include a rigorous data management protocol to optimize 
data entry, accuracy/checking, and retrieval. Data will be stored in password-protected files accessible only 
to the investigators and staff under their supervision. In the database, only an ID code number will identify 
subjects. A list linking names and other identifiers with their ID codes will be stored in a separate file with a 
separate password. All original paper surveys and case report forms will be stored in locked file cabinets. 
The PIs will review all data collection forms for completeness and accuracy of the data and for protocol 
compliance. In the case of a breach of confidentiality or other adverse event, the Principal Investigators will 
report the event to the IRB and the appropriate NIH officials, and appropriate procedural changes will be 
implemented to prevent future breaches or adverse events.  
3. An internal committee comprised of the projects’ Principal Investigators (Dr. de la Haye will serve as the chair 
of the committee and Dr. Salvy will act as clinical training and supervisor chair) and the On-Site Project 
Director (Michelle Kiefer at Antelope Valley Partners for Health) will meet quarterly to assess: participant 
recruitment, accrual, and retention; data quality and timeliness; participant risk versus benefit; and the 
development of external conditions that could potentially affect the study.  Significant problems or adverse 
events will be reported immediately to the USC and UAB IRBs, NIH, or FDA (if relevant).   
4. As part of their training for the study, all personnel who will interact with subjects will receive instruction in 
the completion of an adverse event reporting form. In response to any adverse event, these forms will be 
completed promptly and returned to the corresponding study team supervisor, who in turn will report the 
information to the Principal Investigators.   
5. An external Data Safety Monitoring Board (DSMB), not connected to USC, UAB or the research project, will 
convene twice annually, via teleconference, to review the progress of the study, ensure adequate recruitment 
of minority subjects, and to monitor safety concerns.  Key members of the research team will co-participate 
in the conference calls.  The DSMB will consist of five to-be-named individuals from outside USC: (1) a home 
visitation program consumer (parent, most likely a mother) (2) a child services advocate; (3) a layperson; (4) 
a home visitation program stakeholder; (5) a health disparities researcher and (6) a mental health 
professional. The DSMB will meet by phone conference two times within each of the project’s 5 years. Their 
function will be to review the progress of the study, ensure adequate recruitment of minorities into the sample, 
and monitor the study with respect to the safety and well-being of the research patients.   
6. Safety officer. Dr. Paul Round, DO is a pediatrician at the Antelope Valley Community Clinic. Dr. Round will 
serve as safety officer on this project to ensure the protection, safety and satisfaction of mothers and staff 
throughout the many facets of the project. Dr. Round will serve as contact-person to family participants, 
service providers, and all project staff to report problems or areas of concern regarding project 
implementation for resolution with investigators. 
 
Additional protections for pregnant women, human fetuses, and neonates involved in research. This 
study involves parents and their infants (6mo at enrollment). This research does not involve women who are 
pregnant. If a mother becomes pregnant during the study, she will continue to receive HVP services, but she will 
not be involved in the study. 
 

19 
 
Potential benefits of the proposed research to human subjects and others. The potential benefits of 
this study include better management of postpartum weight-loss among mothers involved in home visitation 
programs and healthier growth trajectories for their infants. This study will also help researchers and 
professionals understand how home visitation programs can be used as a vehicle for early childhood obesity 
prevention. Participants will benefit by receiving a nutrition and physical activity module at no cost. Thus, the 
benefits of this project to the individual and society greatly outweigh the risks. 
 
Importance of the knowledge to be gained. HVPs serve at-risk families, including low socioeconomic 
status (SES) and minority families, who are also at the highest risk of obesity. HVPs currently address multiple 
areas of mother and child health and development,71,72,74,75,172 but they have yet to be tested as a viable and 
effective infrastructure for obesity prevention in early childhood. The proposed study seizes an untapped 
opportunity to test this potentially cost-effective, scalable and sustainable model of obesity prevention. This 
represents a unique opportunity to test an innovative model of care for childhood obesity. Findings will inform 
health policies at local, state, and federal levels, as home visitation programs are already implemented in many 
U.S. urban and rural areas and serve a large proportion of low-SES and minority families. Building a healthy 
lifestyle intervention into this infrastructure makes it possible to reach families who are most at risk for poor 
nutrition, a first step toward decreasing disparities. This research is particularly timely with stable funding for HVPs 
from the Affordable Care Act.91  
 
Risk-to-benefit ratio. The risks to the participants are minimal and procedures are in place to reduce the 
risk and minimize the impact of adverse events. The potential gains of this project, including the adoption of 
healthier behaviors for mothers and their infants, healthier growth trajectories for children at high-risk for 
overweight/obesity, and the evaluation of a model for obesity prevention through existing home visitation 
programs, outweigh the risks. 
 
E. ClinicalTrials.gov Requirements 
The project will be registered in ClinicalTrials.gov no later than 21 days after the first subject is enrolled. Reporting 
of summary results information (including adverse events) will be reported no later than 1 year after the 
completion date. The ClinicalTrials.gov registry number (also known as NCT number), brief lay public title, and 
a certification that all required submissions to ClinicalTrials.gov were completed will be provided in progress 
reports.  The PIs (Dr. Salvy at UAB and de la Haye at USC) will assume responsibility for these aspects of the 
trial.  
 
 

20 
 
MINORS AS RESEARCH SUBJECTS 
The research team is well trained and experienced in conducting research in children. Dr. Salvy (MPI) has been 
trained in Pediatric and Child Psychology and she has been a member of the children’s Institutional Review 
Board (IRB) for several years at the Women and Children’s Hospital in Buffalo, NY. She will ensure the quality 
of the treatment implementation. The involvement of minors as participants in this research is in compliance with 
all subparts of 45 CFR Part 46 as well as with Federal laws and regulations. 
 
 

21 
 
INCLUSION OF WOMEN AND MINORITIES 
Women are represented by mothers and female infants, which will be about half of the infant sample. Based on 
our projected effective sample of 200 mothers and their infants (N=400), we anticipate that 75% of our sample 
will be women (100 infants/children + 200 mothers = 300). The families enrolled in the Home Visiting Program 
(HVP) from which the sample will be drawn is diverse, reflecting the population of low-income families enrolled 
in home visiting services in the Antelope Valley, CA area. Based on our HVP partner (two Healthy Families 
America sites in Southern California: Antelope Valley Partners for Health and Children’s Bureau) clients’ 
demographics and on our pilot work, we anticipate the following ethnic and racial distribution: 70% Hispanic/ 
Latino, 13% African American, 8% White, 5% American Indian/Alaskan, and 4% mixed/other race. It is important 
to note that Health Families America (HFA) home visitors are matched to families based on language and cultural 
background. Home visitors are rigorously trained to understand, acknowledge, and respect families’ cultural 
differences. Home visitors are selected because of their personal characteristics (i.e. non-judgmental, 
compassionate, ability to establish a trusting relationship, etc.), their experience working with culturally diverse 
communities, and their skills to do the job.  
 
 
 
 
 
 
 
 
 
 

22 
 
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