Leveraging Ongoing Home Visitation Programs to Address Obesity Disparities Among Underserved, Low-Income Mothers and Children
Phase: NA
Conditions: Obesity, Obesity, Childhood, Obesity; Familial
Sponsor: University of Alabama at Birmingham

Leveraging Ongoing Home Visitation Programs to Address 
Obesity Disparities Among Underserved, Low-Income Mothers 
and Children (Obesity Health Disparities Research Center) 
 
Study Protocol & Statistical Analysis Plan 
 
NCT03433456 
 
 
Date of Last Protocol Approval: 02 January 2024 
 
 
Gareth R. Dutton, Endowed Professor of Diabetes Prevention & 
Control, Principal Investigator 
University of Alabama at Birmingham 
Birmingham, AL 35294 
 
Sarah-Jeanne Salvy, Professor of Medicine, Principal 
Investigator, Cedars-Sinai Medical Center, West Hollywood, CA 
90069 

  
Leveraging Ongoing Home Visitation Programs to Address 
Obesity Disparities Among Underserved, Low-Income Mothers 
and Children (Obesity Health Disparities Research Center) 
 
Principal Investigator: Gareth R. Dutton and Sarah-Jeanne Salvy  
Sponsor: NIMHD 
National Clinical Trial (NCT) Identified Number: NCT03433456 
 
Version Number:  v1.0 
02 January 2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

  
 
Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................. 1 
1 
PROTOCOL SUMMARY ............................................................................................................................... 1 
1.1 
Synopsis ................................................................................................................................................ 1 
1.2 
Schedule of Activities (SoA) ............................................................................................................... 2 
2 
INTRODUCTION ............................................................................................................................................ 3 
2.1 
Study Rationale .................................................................................................................................... 3 
2.2 
Background........................................................................................................................................... 3 
2.3 
Risk/Benefit Assessment .................................................................................................................... 5 
2.3.1 
Known Potential Risks ..................................................................................................... 5 
2.3.2 
Known Potential Benefits ................................................................................................ 5 
3 
STUDY DESIGN ............................................................................................................................................. 6 
3.1 
Overall Design ...................................................................................................................................... 6 
3.2 
End of Study Definition ....................................................................................................................... 6 
4 
STUDY POPULATION .................................................................................................................................. 7 
4.1 
Inclusion Criteria .................................................................................................................................. 7 
4.2 
Exclusion Criteria ................................................................................................................................. 7 
4.3 
Screen Failures .................................................................................................................................... 7 
4.4 
Strategies for Recruitment and Retention ........................................................................................ 7 
5 
STUDY INTERVENTION .............................................................................................................................. 8 
5.1 
Study Intervention(s) Administration ................................................................................................. 8 
5.1.1 
Study Intervention Description ....................................................................................... 8 
5.1.2 
Dosing and Administration ............................................................................................ 11 
5.2 
Measures to Minimize Bias: Randomization .................................................................................. 11 
5.3 
Study Intervention Compliance ........................................................................................................ 11 
6 
STUDY INTERVENTION DISCONTINUATION AND SUBJECT 
DISCONTINUATION/WITHDRAWAL .................................................................................................................... 11 
6.1 
Discontinuation of Study Intervention ............................................................................................. 11 
6.2 
Subject Discontinuation/Withdrawal from the Study ..................................................................... 11 
6.3 
Lost to Follow-Up ............................................................................................................................... 12 
7 
STUDY ASSESSMENTS AND PROCEDURES ..................................................................................... 12 
7.1 
STUDY Assessments ........................................................................................................................ 12 
7.2 
Adverse Events and Serious Adverse Events ............................................................................... 13 
7.2.1 
Definition of Adverse Events (AE) ............................................................................... 13 
7.2.2 
Definition of Serious Adverse Events (SAE) .............................................................. 13 
7.2.3 
Classification of an Adverse Event .............................................................................. 14 
7.2.4 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 14 
7.2.5 
Adverse and serious adverse Event Reporting ......................................................... 15 
7.3 
Unanticipated Problems .................................................................................................................... 15 
7.3.1 
Definition of Unanticipated Problems (UP) ................................................................. 15 
7.3.2 
Unanticipated Problem Reporting ................................................................................ 16 
8 
STATISTICAL CONSIDERATIONS .......................................................................................................... 16 
8.1 
Statistical Hypotheses ....................................................................................................................... 16 
8.2 
Sample Size Determination .............................................................................................................. 16 
8.3 
Statistical Analyses............................................................................................................................ 17 
8.3.1 
General Approach .......................................................................................................... 17 

  
8.3.2 
Analysis of the Primary Endpoint(s) ............................................................................ 17 
8.3.3 
Analysis of the Endpoint(s) ........................................................................................... 18 
8.3.4 
Safety Analyses .............................................................................................................. 18 
8.3.5 
Baseline Descriptive Statistics ..................................................................................... 18 
9 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 18 
9.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 18 
9.1.1 
Informed Consent Process ........................................................................................... 18 
9.1.2 
Study Discontinuation and Closure ............................................................................. 19 
9.1.3 
Confidentiality and Privacy ........................................................................................... 19 
9.1.4 
Quality Assurance and Quality Control ....................................................................... 20 
9.1.5 
Data Handling and Record Keeping ............................................................................ 20 
9.1.6 
Protocol Deviations ........................................................................................................ 20 
9.1.7 
Conflict of Interest Policy .............................................................................................. 21 
9.2 
Abbreviations ...................................................................................................................................... 22 
10 
REFERENCES ............................................................................................................................................. 23 
 

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STATEMENT OF COMPLIANCE 
The trial will be conducted in accordance with International Conference on Harmonisation Good Clinical 
Practice (ICH GCP) and applicable United States (US) Code of Federal Regulations (CFR). The Principal 
Investigator will assure that no deviation from, or changes to, the protocol will take place without prior 
documented approval from the Institutional Review Board (IRB), except where necessary to eliminate an 
immediate hazard(s) to the trial subjects. All personnel involved in the conduct of this study have 
completed Human Subjects Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all subject materials will be 
submitted to the local Institutional Review Board (IRB) for review and approval. Approval of both the 
protocol and the consent form must be obtained before any subject is enrolled. Any amendment to the 
protocol will require review and approval by the IRB before the changes are implemented to the study. 
All changes to the consent form will be IRB approved; a determination will be made regarding whether a 
new consent needs to be obtained from subjects who provided consent, using a previously approved 
consent form. 
 
1 
 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
Title: 
Leveraging Ongoing Home Visitation Programs to Address Obesity 
Disparities Among Underserved, Low-Income Mothers and Children 
(Obesity Health Disparities Research Center) 
Study Description: 
This two-arm, parallel, randomized controlled trial (RCT) tests the 
effectiveness of a simple obesity intervention (HABITS) delivered as part of 
ongoing home visiting services, compared to the existing home visiting 
services without obesity-related content on mothers’ and children’s 
obesity risks. 
Objectives: 
 
The objectives of the study are to compare the effects of treatment on 
children and primary caregivers’ weight outcomes at 6 and 12 months, and 
to compare the effects of treatment on maternal feeding practices, habit 
strength of targeted behaviors, and features of the household 
environment relevant to targeted behaviors at 6 and 12 months. 
Endpoints: 
The primary endpoint is caregiver and child weight at 12-months 
Study Population: 
Participants will be 148 mothers (>50% African American; 100% low 
income) and their children (0–5yo at baseline) enrolled in a home visiting 
program in central Alabama. 
Phase: 
N/A 
Description of Study 
Intervention: 
The HABITS intervention focuses on habit formation and modifications of 
food and activity cues in the home to support habit formation. Habit 
formation is focused on improving five behaviors: 1) fruits/vegetables, 2) 
fried foods, 3) sugar-sweetened beverages, 4) physical activity and 5) self-
monitoring. 
Study Duration: 
12-months 
Subject Duration: 
12-months 
 
 

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1.2 
SCHEDULE OF ACTIVITIES (SOA) 
 
 
Baseline/Enrollment 
6-months 
12-months 
Demographics 
X 
 
 
Medical history changes 
 
X 
X 
Caregiver anthropometrics 
(weight, height) 
X 
X 
X 
Child weight 
X 
X 
X 
Home food and activity 
environment (Home Food 
Assessment; HFA and Home 
Inventory Describing Eating 
and Activity Development; 
H-IDEA) 
X 
X 
X 
Habit strength (Self-
Reported Habit Index; SRHI) 
X 
X 
X 
Food and Activity Frequency 
Survey (Modified from 
NHANES) 
X 
X 
X 
Personal Health 
Questionnaire Depression 
Scale (PHQ-8) 
X 
X 
X 
 
 
 
 
 
 
 

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2 
 
INTRODUCTION 
 
2.1 
STUDY RATIONALE  
Low-income and racial/ethnic minority adults and their young children are especially at-risk of obesity,1 
and the lack of access to evidence-based obesity efforts further contributes to these disparities.2,3 Even 
the most successful obesity prevention strategies have had limited success among under-resourced 
families, partly because effective obesity interventions are neither accessible nor tailored to address 
families’ poverty, limited education, lack of access to healthier foods and other barriers affecting the 
ability of these families to adhere to lifestyle changes in real-world settings.2,3 While conventional 
weight management interventions are typically comprehensive, addressing a breadth of nutrition, 
activity, and behavioral topics,31-33 there are a few key behaviors (e.g., self-monitoring of weight, 
consistent physical activity) that have been consistently associated with long-term weight 
management.4-8 As such, focusing on helping families develop healthy habits around a few key behaviors 
may be an effective, more efficient approach to weight management. Further, this type of simplified, 
targeted approach may be particularly well-suited for under-resourced, overburdened families.9 This 
type of simpler, more targeted intervention focusing on the mastery of a few, simple behaviors is 
consistent with a habit-formation paradigm, which focuses on frequently and consistently engaging in a 
target behavior in response to a specific cue until that behavior becomes automatic.9,34-38  Given that 
habit-formation and automaticity rely on repeated engagement in the target behavior in response to 
consistent contextual cues, it is necessary that such an intervention include modification of cues in the 
household environment, where most food is consumed among US families, in order to support the 
development and maintenance of targeted healthy behaviors. Thus, the proposed study is focused on 
implementing an obesity-prevention intervention that prioritizes the habit-formation of a few behaviors 
from multi-component, evidence-based obesity interventions while addressing relevant cues in the 
home environment to support habit-formation of targeted behaviors. The current intervention is 
embedded within an ongoing federally funded home visiting program, which provides an ideal 
infrastructure for engaging historically underserved caregivers and their children within their homes. By 
embedding the study intervention into an existing home visiting program, dissemination and scalability 
of the study intervention (if effective) is feasible. 
 
2.2 
BACKGROUND  
Obesity and health-related disparities persist among socioeconomically disadvantaged adults and 
children. Although a nationally representative study found a decline in obesity for children ages 0-5, this 
was not true for economically disadvantaged children.10 In fact, 40% of low-income children enrolled in 
federally-funded programs are overweight (≥85th BMI percentile) by age five, with an obesity (>95th 
percentile) prevalence of 16.3% among low-income 2-4yo children in Alabama.11-14  Similarly, low-
income women and those with less education are disproportionately affected by obesity.1 Even the 
most successful obesity reduction/prevention strategies have had limited impact among under-
resourced families, partly because effective obesity interventions are neither accessible nor tailored to 
address families’ poverty, limited education, lack of access to healthier foods and other barriers 
affecting the ability of these families to adhere to lifestyle changes in real-world settings.2,3  
 
Maternal behaviors and the home environment are likely key pathways of obesity risk in early 
childhood.15,16 Maternal factors such as mothers’ diet and feeding practices are instrumental in shaping 
children’s health behaviors and weight outcomes.17-21 Similarly, a variety of factors within the home 
environment have also been associated with healthful dietary behaviors. For instance, both household 

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food availability (foods present in the house) and accessibility (whether available foods are in a form or 
location that facilitates their consumption, such as fruit on the counter) are associated with children’s 
dietary intake and weight status.22-24 Since health behaviors developed in early childhood influence 
habits and weight trajectories across the lifecourse,17,18,25-30 interventions are needed to address these 
pathways early in the child’s development. These findings support our effort to explicitly tackle maternal 
factors as well as the home environment as key determinants of children’s weight trajectories. 
 
Simple, targeted interventions focused on habit-formation may be efficient and effective. While 
conventional family-based obesity interventions comprehensively address nutritional, physical activity, 
and behavioral topics,31-33 only a handful of behaviors (e.g., self-monitoring of weight, consistent 
physical activity, regular eating patterns) have been consistently, and empirically, associated with long-
term weight management.4-8 Thus, helping individuals develop healthy habits around a few key 
behaviors may be as effective and more efficient for impacting energy balance and weight management 
than addressing a wide-ranging set of topics. A simplified approach targeting a select number of 
behaviors may be particularly well-suited for under-resourced settings and populations.9 This approach 
is also consistent with the growing literature supporting habit-formation for weight management.9,34-38 
Habit-formation interventions focus on frequently and consistently enacting a target behavior within a 
certain context or in response to a specific cue until the behavior reaches automaticity.9,34-38 Once habits 
are well-established (i.e., automatic), then they become less reliant on intentional control or awareness 
and more resistant to competing demands (e.g., mental fatigue, negative affect).38 A handful of studies 
suggest that habit-formation interventions focused on select energy-balance behaviors (e.g., reducing 
fat, increasing daily steps, consuming low-energy dense snacks, controlling portions, decreasing intake 
of sugar-sweetened beverages, reducing sitting time) are feasible and result in greater weight loss than 
usual care when delivered in primary care9,34,39 and are effective in improving parental feeding practices 
(i.e., increased provision of fruit/vegetables and healthy snacks, decreased serving of sweetened drinks) 
for children ages 2-6yo.40 
 
Helping families modify their home environment may facilitate habit-formation. Since habit-formation 
and automaticity rely on the repetition of a behavior in response to consistent contextual cues, it is 
imperative to address the cues in the individuals’ personal and household environment that are 
conducive to the development and maintenance of targeted healthy habits. Modification of household 
cues to support behavior change- such as increasing the availability of washed and cut fruits/vegetables 
and the visibility of cues to promote physical activity, or removing energy-dense foods from the home or 
storing in inaccessible locations- is grounded in the principles of “choice architecture”, which posits that 
our environment ultimately determines the choices we make (i.e., breakfast choice is determined by 
breakfast options available).41-44 Two recent trials examined the effectiveness of modifications in the 
participants’ household environment on weight management.45,46 Treatment resulted in significant 
weight loss in these predominantly White, well-educated samples, 45,46 and outcomes seemed 
particularly promising for women and other adults living in the household.47 However, less is known 
about the utility of these household environmental modifications for addressing obesity in underserved 
and low-income women and their children. 
 
The proposed study leverages an established home visiting program to deliver an in-home obesity 
intervention to underserved mothers and children who would otherwise not receive these services. 
Consistent with a capacity building approach, we aim to extend the curriculum and mission of an 
ongoing home visiting program to address obesity and related health disparities among low-income 
women and children (see also48). Home visiting programs are embedded in a comprehensive system of 
child and maternal health designed to optimize child development and prevent adverse outcomes.49-53 

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These programs are effective in improving children’s physical and psychosocial health, immunization 
rates, breastfeeding, and overall cognitive and social development.47,53-70 The home visiting 
infrastructure is ideal to address obesity among underserved mothers and children because it: (1) 
already engages low-income families at a critical point in the intergenerational transmission of obesity; 
(2) provides in-home services to address ecologically relevant cues and promote generalization to the 
family environment;71,72 (3) removes many of the barriers of outpatient programs (e.g., transportation, 
childcare need); (4) provides services for an extended period of time to ensure mastery of skills and 
behaviors; and (5) is already implemented in urban and rural areas nationwide,58,68,73,74 which would 
facilitate future dissemination and scalability. To date, however, there has been no comprehensive 
effort to address maternal-child obesity as part of these home visiting services. 
 
2.3 
RISK/BENEFIT ASSESSMENT   
 
2.3.1 KNOWN POTENTIAL RISKS  
This study involves providing a health behavior intervention to low-income mothers or primary 
caregivers and children; therefore, the use of children as participants is inherent to the nature of this 
protocol. If a mother becomes pregnant during the course of the study, we decided not to exclude or 
discontinue her from the study, as the habit behaviors pose no risk and are likely beneficial to her as well 
as her unborn child but are also primarily aimed at providing healthy options for the child in the study. 
The study intervention, which is aimed to improve health behaviors of mothers or primary caregivers 
and children, is considered low-risk. Additionally, because the study assessments only involve completion 
of interviews, surveys, vitals, and home food assessments, there is still less than minimal risk to 
participants. There is a low risk of emotional or psychological discomfort from participants answering 
personal questions about their eating and activity behaviors. There is also a possible minimal, mild, and 
temporary risk for physical overexertion due to exercise from increased walking and physical activity.  To 
protect the rights and welfare of these participants, they will be assured that their regular home visiting 
services will in no way be affected by their decision to participate, or not participate, in the study. While 
we are offering financial incentives to mothers or primary caregivers, these incentives are modest and 
are only intended to compensate for time completing assessments.  
 
In our preliminary work providing these services, mothers or primary caregivers did not report increased 
burden from participating in this program. Participants receiving the obesity prevention curriculum were 
just as likely to meet the benchmark areas defined by Health Resources and Services Administration for 
evaluating the conventional home visiting program, which suggests that the additional obesity 
prevention content did not detract from the existing services or over-burden participants receiving the 
combined program. Also, participants were 27% less likely to discontinue home visiting services when 
they received the combined home visiting + obesity prevention curriculum as compared to those 
receiving the conventional program alone in our prior preliminary work. 
 
2.3.2 KNOWN POTENTIAL BENEFITS  
By targeting children and their mothers or primary caregivers, the current intervention has the potential 
to improve maternal behaviors and outcomes while also addressing the intergenerational transmission of 
obesity by testing whether maternal factors and home environment mediate children’s outcomes. The 
intervention has the potential to reduce obesity and risk factors associated with obesity for participating 
mothers or primary caregivers and their children and targets a specific population that carries a 
disproportionate burden of obesity. This initiative represents a unique opportunity to increase access to 

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obesity treatment/prevention services by leveraging an ongoing home visiting infrastructure that provides 
family-oriented services to families most at risk for health and obesity disparities. This partnership greatly 
improves the potential to disseminate cost-effective and sustainable evidence-based obesity efforts on a 
larger scale. This 12-month intervention will provide important information about the effectiveness of this 
intervention delivered within the home environment of low-income families. Finally, if the program 
intervention is deemed successful, the program can easily be implemented in conjunction with hundreds 
of other similar home visiting services to reduce the impact and prevalence of obesity on low-income 
families and children throughout Alabama and other states. 
 
3 
STUDY DESIGN  
 
3.1 
OVERALL DESIGN 
 This is a cluster randomized trial in which home visitors (n=18 anticipated) employed by our partner 
(First Teach Home Visiting Program) will be randomly assigned to deliver the home visiting standard 
curriculum with or without HABITS (n=9 home visitors in each arm). 
 
Caregivers with a child 0-5 years of age who are enrolled in the First Teacher Home Visiting program and 
who have completed their initial 90-day home visiting program benchmark testing will constitute our 
initial recruitment pool (>50% African American, 40% White, <10% other/multiple race). First Teacher 
Home Visiting Program enrolls caregivers with young children in their free and voluntary services 
through community outreach. In order to be eligible for home visiting services, families must have a 
social risk factor such as poverty, social isolation, lack of material and social support, lack of 
transportation and limited education and literacy. 
 
Home visitors will approach their families who are potentially eligible to introduce the study, gauge 
interest, and screen interested families for eligibility. Designated study staff determine of families are 
eligible based on the completed screening form and inclusion/exclusion criteria. Home visitors are 
informed of family’s eligibility and notify the family. Eligible families are then introduced to a blinded 
study assessment worker who schedules the enrollment and baseline visit. 
 
Assessment workers (who are distinct from home visitors and masked to group assignment) will bre 
responsible for completing informed consent, enrolling caregiver-child dyads into the study, and completing 
Visit 1 (baseline), Visit 2 (6-month), and Visit 3 (12-month) assessments.  
 
After completing Visit 1 (baseline) assessment procedures, families will be told by their home visitor which 
study arm they have been allocated to, for those in the HABITS intervention arm (i.e., home visiting standard 
curriculum with HABITS) will begin receiving the HABITS intervention at their home visits for 12-months. 
 
3.2 
END OF STUDY DEFINITION 
While Primary Completion will be defined as the date of the last 12-month assessment data collection of 
the last participant, the End of Study will be the date that caregiver-child benchmark data and home visit 
completion data have been received from our home visiting program partner, as these data will provide 
necessary covariates for the conduct of our statistical analyses and are needed to ensure the study does 
not affect family services 
 

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4 
STUDY POPULATION 
 
4.1 
INCLUSION CRITERIA 
Families enrolled in home visiting will be invited to participate in the study, with limited exclusion 
criteria. Caregiver-child dyads will be eligible to participate regardless of weight status because the 
targeted health behaviors are relevant and beneficial for all caregivers and children. Improvements in 
maternal behaviors (regardless of weight status) may further reduce children’s obesity risk. To be 
included, caregiver-child dyads will have to meet the following inclusion criteria: 
• 
Caregiver enrolling in the trial is 18 years of age or older 
• 
Child is 0-5 years of age 
• 
Child has at least 1 year of eligibility remaining in the home visiting program 
• 
Family has completed their first 90-days in the home visiting program 
 
4.2 
EXCLUSION CRITERIA 
• 
Child has a current or prior history of a feeding or growth disorder 
• 
Caregiver has lost a significant amount of weight (>15 pounds) in the past 6 months unrelated to 
childbirth 
 
4.3 
SCREEN FAILURES 
Caregiver-child dyads who do not meet study inclusion criteria will be informed of this decision by their 
parent educator and reassured that their family will still be in the home visiting program and this will 
not change the quality of the services and care you receive. 
 
4.4 
STRATEGIES FOR RECRUITMENT AND RETENTION 
Individuals who are enrolled in the First Teacher Home Visiting program and who have completed their 
initial 90-day home visiting program benchmark testing will constitute our initial recruitment pool. 
Home visitors will approach their families who are potentially eligible to introduce the study, gauge 
interest, and screen interested families for eligibility. Designated study staff determine of families are 
eligible based on the completed screening form and inclusion/exclusion criteria. Home visitors are 
informed of family’s eligibility and notify the family. Eligible families are then introduced to a blinded 
study assessment worker who schedules the enrollment and baseline visit. 
 
The unique relationship between home visitors and mothers facilitates retention. Many of these 
caregivers are socially isolated and home visitors are important sources of support. We will also use 
strategies (implemented with participants in both intervention arms) that we have found effective for 
retention: (1) providing gift cards of $100 at each data collection for all caregivers, with all incentives 
paid after each assessment; (2) ensuring frequent contacts with all participants to maintain engagement 
and foster open communication; (3) sending holiday newsletters to update participants about study 
activities; (4) acknowledging birthdays and milestones; (5) providing reminder phone calls before 
assessment sessions; and (6) seeking contact information of relatives or friends to be able to reach 
participants. 
 

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5 
STUDY INTERVENTION 
 
5.1 
STUDY INTERVENTION(S) ADMINISTRATION 
 
5.1.1 STUDY INTERVENTION DESCRIPTION 
 
Table 1 outlines the components of the two study arms. 
Table 1. Components of each study arm 
 
 
 
Standard home 
visiting 
(Control Group) 
Standard home visiting + 
HABITS 
(Intervention Group) 
Early childhood education and school readiness 
X 
X 
Parenting 
X 
X 
Socioemotional development (e.g., regulate 
emotion & behavior, develop empathy) 
X 
X 
Physical development (e.g., immunization; motor 
skills) 
X 
X 
Limit fried foods 
 
X 
Limit sugar-sweetened beverages 
 
X 
Increase daily steps 
 
X 
Increase non-starchy vegetables and fruits 
 
X 
Self-monitoring of weight and target behaviors 
(caregivers only) 
 
X 
 
Standard home visiting curriculum. Our partner home visiting program, First Teacher Home Visiting 
Program meets the Department of Health and Human Services (DHHS) criteria for an evidence-based 
early childhood home visiting service delivery model (http://homvee.acf.hhs.gov). Caregivers and 
children receive monthly or bi-monthly visits and they are provided with a set of carefully developed 
curriculum, books and materials designed to strengthen children's cognitive skills, early literacy skills, 
social/emotional and physical development. These voluntary services are free of charge for mothers and 
children (ages 0-5 years) most at risk of disparities because of poverty, social isolation, lack of material 
and social support, lack of transportation and limited education and literacy. 
 
HABITS curriculum (Intervention). HABITS focuses on healthy weight of all mothers, regardless of 
baseline weight status, and on preventing obesity through the promotion of healthy behaviors in early 
childhood. Accordingly, HABITS addresses habit-formation of four behaviors relevant to mothers and 
children: (1) limit fried foods; (2) limit sugar-sweetened beverages (SSB); (3) increase daily steps; and (4) 
increase fruits and vegetables (Table 2). These behaviors are consistently associated with long-term 
weight management, are amenable to habit formation, and have health benefits for all mothers and 
children, regardless of weight status (i.e., eating fruits and vegetables as substitutes for energy-dense 
fried foods benefit everyone, not only obese individuals). HABITS also addresses mothers’ self-
monitoring of weight and targeted behaviors to support habit-formation of eating/activity behaviors. 
Regular self-weighing and completion of food/activity records are associated with program adherence 
and successful weight management. 
 

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HABITS is also ecologically relevant in strategically modifying contextual cues in the home environment 
(choice architecture) to support habit-formation of targeted behaviors (e.g., acquiring and preparing 
fruits and vegetables is a prerequisite to automatically consuming fruits and vegetables). Specifically, the 
intervention targets three features of choice architecture relevant to the 5 behaviors targeted by 
HABITS: (1) availability (i.e., items exist in the home regardless of whether they are readily visible or 
accessible), (2) accessibility (i.e., items are easily retrievable, ready to use/eat, located within reach), and 
(3) visibility (i.e., items are easy to see on countertop, or when opening the refrigerator, freezer or 
cupboard in the case of foods/beverages; or visible by the door or other location in the case of walking-
related stimuli/cues and self-monitoring materials). 
 
Table 2. HABITS target behaviors, scientific premises and intervention description 
Scientific premise 
Intervention 
Behavior #1: Limit fried foods 
Fried foods are energy-dense and 
contain a large amount of saturated 
fat. Higher consumption of high-
saturated fat is associated with greater 
weight gain and poorer health.  
Habit-formation: Mothers will be provided corrective feedback and instruction 
to recognize fried foods, adopt alternative cooking methods, and modify their 
favorite recipes. Didactic learning and recommendations will be supported by 
experiential, hands-on and learn-by-doing practice activities involving both 
mothers and children. Food selection and cooking methods will then be repeated 
until mastery and automaticity are reached. Similar habits will be shaped, 
practiced, and repeated to address food selection outside the home. Home 
environment: The foods available at home and knowledge of cooking methods 
are key determinants of mothers’ and children’s food choices. Mothers will be 
encouraged to avoid bringing pre-made fried foods into the home, limiting access 
to ingredients necessary for frying foods, and promoting access to recipes and 
ingredients for alternative cooking methods.  
Behavior #2: Limit sugar-sweetened beverages (SSB) 
Higher SSB consumption, which may 
lead to excess energy intake, is 
associated with greater weight gain 
and 
poorer 
health. 
Guidelines 
recommend that adults limit their SSB 
consumption and that fruit juice be 
limited to <4 ounces/day for children 
under the age of 3.  
Habit-formation: Mothers will be taught to decrease SSB consumption for 
themselves and their child by making water consumption a habit (e.g., 
consuming water at every meal) and providing alternative non-sweetened 
beverages. Home environment: Mothers will be taught to avoid buying or 
storing SSB at home. When SSB are present in the home, mothers will identify 
an inconvenient/inaccessible/hidden location for  storage.  
Behavior #3: Increase daily steps  
Guidelines recommend adults engage 
in 150 minutes of moderate intensity 
physical activity/week. Walking is 
easily performed and does not require 
specific skills or equipment. Walking 
10,000 steps/day is consistent with 
~60 minutes 
of 
brisk 
walking. 
Guidelines for infants (6-12 months): 
daily planned activities, like tummy 
time, 30 minutes/day of supervised but 
free play, and the opportunity to crawl 
and move around. Toddlers & 
Preschoolers (1-3 years): active for at 
Habit-formation: Mothers will be given pedometers and instructed to work 
towards accumulating 10,000 steps/day in making walking a habit in response to 
family-relevant cues and contexts. Mothers will receive corrective feedback to 
help them recognize contextual cues eliciting lifestyle activities. For example, 
“stairs” or “talking on the phone” will become cues eliciting “walking up the stairs” 
or “pacing while on the phone”. Mothers will be coached to make children’s 
activity/play a daily habit integrated in the family routine and in response to daily 
habitual cues or contexts (e.g., 10-min of play after breakfast). Home 
environment: Lack of resources and safety are salient barriers to physical 
activity. The choice architecture of the larger family environment (home & 
neighborhood) will be addressed in helping mothers design and select activities 
around their local environment, schedule, and preferences, and to optimize their use 
of safe spaces. Mothers will be provided with information about resources and 

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least 1 hour/day (2-3 hours or more is 
better), and avoid sitting or lying down 
for >1 hour at a time, except when 
sleeping. Young children (4-6 years): 
at least 1 hour/day of physical activity 
(up to several hours) and avoid sitting 
or lying down for >2 hours at a time, 
except when sleeping. 
free group activities conducive to physical activity (e.g., parks, walking clubs, 
outings), and classes they can take with their children and other home visiting 
families. We also consider mothers as key social contributors of children’s choice 
in providing access and opportunities for their children to be physically active.  
Behavior #4: Increase intake of non-starchy vegetables and fruits 
Fruits and vegetables are low in 
energy density, high in fiber, and 
generally contain more nutrients than 
other food groups. Eating low-energy 
dense  fruits and vegetables daily as 
substitutes for high energy-dense 
alternatives can help individuals feel 
satisfied while reducing overall energy 
intake.29,30 Most children and adults 
eat fewer fruit and vegetable servings 
than are recommended, and children 
are more likely to consume  fruits and 
vegetables 
if 
these 
foods 
are 
introduced early. The most simplified 
version 
of 
the 
USDA's 
recommendation is to fill half of the 
plate with fruits and vegetables for 
every meal and each snack. This 
simple visual guideline does not 
require any counting or measuring of 
food.  
Habit-formation: Mothers will be instructed to consistently consume fruits and 
non-starchy vegetables as snacks (cue/ context) and to provide non-starchy 
fruits and vegetables at every meal (cue/ context).  To do so, mothers will learn 
to (1) recognize snacks and meals as contextual cues eliciting fruits and 
vegetables consumption, and (2) prepare/cook/store non-starchy fruits and 
vegetables for themselves and for their young children. Corrective feedback from 
home visitors will be supported by learn-by-doing, hands-on activities such as 
taste tests and food preparation, cooking and storing demonstrations involving 
both mothers and children to promote multi-sensory exposure and increase 
children’s acceptance of novel fruits and vegetables. Home environment: 
Families enrolled in home visiting programs receive assistance from WIC and 
the food bank. These organizations help promote fruits and vegetables 
availability for mothers and their young children. However, lack of exposure and 
knowledge on how to prepare and store these foods are critical constraints 
influencing these mothers and children’s nutritional choices. Home visitors will 
work with mothers to ensure that the fresh, frozen, and/or canned fruits and 
vegetables they receive from WIC and the food bank are properly prepared, 
readily available, highly visible, and easily accessible in the home (e.g., prepared 
for convenience). Proper food preparation and storage (e.g., freezing) can also 
reduce food waste of perishable fruits and vegetables and ensure that families 
have fruits and vegetables available throughout the month. For example, cooking 
and freezing meals containing fruits and vegetables ensure availability despite 
financial constraints near the end of the month. 
Behavior #5: Self-monitoring of weight and targeted behaviors (mothers only) 
Grounded in self-regulation theory, 
self-monitoring of weight and related 
behaviors (e.g., food intake) provides 
immediate 
feedback, 
allows 
for 
corrective 
actions, 
and 
are 
foundational components of evidence-
based weight management programs. 
Regular self-weighing and completion 
of food/activity records are associated 
with 
program 
adherence 
and 
successful weight management.  
Habit-formation: Mothers will receive simplified self-monitoring forms with 
instruction to record weight and HABITS behaviors daily: number of fried foods, 
SSB, steps, and F/V servings. They will practice monitoring with their home 
visitors who will provide corrective feedback. Mothers will be instructed to weigh 
themselves at the same time each day in the same context (e.g., in the bathroom 
after brushing teeth). Similarly, they will be instructed to pair dietary self-
monitoring with meals/snacks and to write down their step counts before bed 
(cue/context). Home environment: Mothers will be encouraged to place scales 
in highly visible and accessible locations, in close proximity to cues eliciting other 
well-established behaviors (e.g., beside the toilet). Mothers will be instructed to 
keep their self-monitoring checklist with them to ensure tracking occurs in close 
temporal proximity with the target behavior. Additional tips will be discussed, 
such as taking a picture of one’s meal for later recording when necessary. With 
support and guidance from home visitors, posting of weight and target behavior 
graphs in visible locations (e.g., bathroom mirror, refrigerator door) to monitor 
progress will also be encouraged. 

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5.1.2 DOSING AND ADMINISTRATION 
Families in both groups receive home visits with their home visitors at least monthly, but in most cases 
two home visits are completed per month. Due to the COVID-19 pandemic, some home visits may need 
to be completed remotely by telephone or video calls. Information on the frequency of completed home 
visits (dates of completed visits) and type of visit (in-person or remote visit) will be documented by 
home visitors as part of their standard home visiting responsibilities. 
 
Home visitors randomized to the HABITS intervention group will be instructed to contact their families 
weekly between home visits by text, telephone, or video call to briefly check-in with the caregiver about 
how they are doing with their HABIT and work with the caregiver (as needed) to briefly problem-solve 
challenges. Home visitors will be instructed to document the date and type (text, telephone, video call) 
of every check-in completed with families. 
 
5.2 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION 
Randomization will be at the level of the home visitors (cluster randomization). Home visitors (n=18) will 
be randomly assigned to deliver the home visiting standard curriculum with HABITS (n=9 home visitors) 
or without HABITS (n=9 home visitors). The likelihood of bias related to cluster randomization (i.e., by 
home visitors) is reduced because all mothers are low-income with a relatively equal number of African 
American and White mothers. To reduce the risk of contamination between treatment arms, the 
training and supervisions of home visitors assigned to each arm of the trial will be conducted separately 
(i.e., to prevent sharing of HABITS material with home visitors assigned to deliver the control arm). 
 
5.3 
STUDY INTERVENTION COMPLIANCE 
Home visitors randomized to deliver the HABITS intervention will complete a weekly checklist 
documenting all study-related intervention contacts with participants. As part of these checklists, home 
visitors will report the type of contact (home visit in-person, home visit by telephone, home visit by 
video call, or weekly check-in between home visits). For each home visit completed, home visitors will 
report the topics discussed and time spent discussing each topic. 
 
6 
STUDY INTERVENTION DISCONTINUATION AND SUBJECT 
DISCONTINUATION/WITHDRAWAL 
 
6.1 
DISCONTINUATION OF STUDY INTERVENTION 
Participants will continue to receive the study intervention for the 12-month trial, as long as they remain 
in the home visiting program. The study intervention may be discontinued for a participant if a clinical 
adverse event (AE) or other medical condition or situation occurs such that continued participation in 
the study intervention would not be in the best interest of the subject.  
 
6.2 
SUBJECT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Subjects are free to withdraw from participation in the study at any time upon request. 
An investigator may discontinue or withdraw a subject from the study for the following reasons: 
 

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• 
Significant study intervention non-compliance  
• 
If any clinical adverse event (AE) or other medical condition or situation occurs such that 
continued participation in the study would not be in the best interest of the subject 
Subjects who sign the informed consent form and are randomized but do not receive the study 
intervention may be replaced.  Subjects who sign the informed consent form, and are randomized and 
receive the study intervention, and subsequently withdraw, or are withdrawn or discontinued from the 
study, will not be replaced. 
 
6.3 
LOST TO FOLLOW-UP 
A subject will be considered lost to follow-up if he or she fails to return for 2 scheduled visits and is 
unable to be contacted by the study staff.  
 
The following actions must be taken if a subject fails to be available for a required study visit: 
• 
The site will attempt to contact the subject and reschedule the missed visit and counsel the 
subject on the importance of maintaining the assigned visit schedule and ascertain if the subject 
wishes to and/or should continue in the study. 
• 
Before a subject is deemed lost to follow-up, the investigator or designee will make every effort 
to regain contact with the subject (where possible, 3 telephone calls and, if necessary, a certified 
letter to the subject’s last known mailing address or local equivalent methods). These contact 
attempts should be documented in the subject’s study file.  
• 
Should the subject continue to be unreachable, he or she will be considered to have withdrawn 
from the study with a primary reason of lost to follow-up. 
 
7 
STUDY ASSESSMENTS AND PROCEDURES 
 
7.1 
STUDY ASSESSMENTS  
All caregiver-child dyads in the study will complete three (3) assessments: 1) Visit 1 (baseline) at the 
start of the study, 2) after 6 months (Visit 2), and 3) after 12 months (Visit 3). Blinded assessment staff 
(assessment workers) will work with families to complete these assessments. Assessments may be done 
completely in-person at a family’s home, a combination of over the phone and in-person, or all remotely 
with no in-person, physical contact. The visits will include surveys and other measures described below: 
• 
Intake and Demographics Survey (Visit 1 only): Asks questions about age, education, income 
level, race, medical history. 
• 
The Physical Activity Readiness Questionnaire [PAR-Q] (Visits 1 and 2): Assesses health and 
ability to do physical activities. If there are any concerns about a caregiver’s ability to participate 
in the walking and movement section of the Habits program, they may be asked to see a doctor 
about their health before taking part in this section of the program. They will still be able to 
participate in other parts of the program.75 
• 
Behavior Rating Inventory of Executive Function for Adults [BRIEF-A) (All 3 visits): Caregivers will 
complete this validated questionnaire that asks about attention and how they react to different 
situations.76 
• 
Medical Changes Survey: (Visits 2 and 3): Caregivers will be asked to report any medical or 
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• 
Self-Report Behavioural Automaticity Index [SRBAI] (All 3 visits): A four-item automaticity scale 
that assesses automaticity of HABITS target behaviors for the caregiver and for the caregiver 
encouraging the child to engage in each target behavior.77 
• 
Weight measurements (All 3 visits): Mothers’ and child’s weight will be measured in duplicate 
using an electronic scale (Model BWB-800S, Tanita, Portage, MI) according to standard 
procedures.78 
• 
Height measurements (All 3 visits): Caregiver height will be measured in duplicate using a 
portable stadiometer (Seca 213, Perspective Enterprises) according to standard procedures.78 
When a height measurement is not possible (due to COVID-19 restrictions), caregivers will be 
asked to self-report their height. 
• 
Patient Health Questionnaire-8 [PHQ-8] (All 3 visits): Assesses caregiver’s thoughts and feelings 
over the last two weeks.79 
• 
Food and Activity Frequency Survey (All 3 visits): To best capture maternal feeding practices 
related to behaviors targeted by HABITS, mothers will complete modified versions of the 
Children’s Dietary Questionnaire80 and Diet and Behavior Questionnaire (DBQ)81 of the National 
Health and Nutrition Examination Survey. These instruments will be modified to focus on the 
eating behaviors targeted by HABITS: SSB, fried foods, and fruits and vegetables. 
• 
Home Food and Activity Environment Assessment (All 3 visits): A modified version of the Home 
Food Assessment (HFA) and Home-Inventory Describing Eating and Activity Development 
(Home-IDEA) adapted to HABITS target behaviors will be used by assessment workers to assess 
accessibility and visibility of fruits, vegetables, fried food, SSB, and activity-related stimuli/cues 
(e.g., stroller). Items are coded as “yes” or “no” on availability. Both instruments have been 
validated in the homes of families with children. The Home Food and Activity Environment 
Assessment may be completed in-person in the family’s home or (if needed to abide by COVID-
19 safety guidelines) by telephone.82-85 
 
Caregiver-Child benchmark data and home visit completion data will be collected from the First Teacher 
Home Visiting Program to ensure the study does not affect family services. For this, First Teacher Home 
Visiting Program will provide us with their assessments that are done as part of the standard First 
Teacher Home Visiting Program yearly evaluations. These questionnaires are not part of our study 
assessments.  
 
7.2 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
   
7.2.1 DEFINITION OF ADVERSE EVENTS (AE) 
Adverse event means any untoward medical occurrence associated with the use of an intervention in 
humans, whether or not considered intervention-related (21 CFR 312.32 (a)). 
 
7.2.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE)  
An adverse event (AE) is considered “serious” if, in the view of either the investigator or sponsor, it 
results in any of the following outcomes: 
• 
Death 
• 
A life-threatening adverse event (of note, the term “life-threatening” refers to an event in which 
the subject was at risk of death at the time of the event, rather than to an event which 
hypothetically might have caused death if it were more severe) 
• 
inpatient hospitalization or prolongation of existing hospitalization 

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• 
a persistent or significant incapacity or substantial disruption of the ability to conduct normal 
life functions 
• 
or a congenital anomaly/birth defect. 
 
Important medical events that may not result in death, be life-threatening, or require hospitalization 
may be considered serious when, based upon appropriate medical judgment, they may jeopardize the 
subject and may require medical or surgical intervention to prevent one of the outcomes listed in this 
definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment 
in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient 
hospitalization, or the development of drug dependency or drug abuse. 
 
7.2.3 CLASSIFICATION OF AN ADVERSE EVENT 
7.2.3.1 SEVERITY OF EVENT 
For adverse events (AEs), the following guidelines will be used to describe severity:  
• 
Mild – Events require minimal or no treatment and do not interfere with the subject’s daily 
activities.  
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a subject’s usual daily activity and may require systemic drug therapy 
or other treatment. Severe events are usually potentially life-threatening or incapacitating.  Of 
note, the term “severe” does not necessarily equate to “serious.” 
 
7.2.3.2 RELATIONSHIP TO STUDY INTERVENTION 
All adverse events (AEs) must have their relationship to study intervention assessed by the clinician who 
examines and evaluates the subject based on temporal relationship and his/her clinical judgment. The 
degree of certainty about causality will be graded using the categories below. In a clinical trial, the study 
product must always be suspect.  
 
• 
Related – The AE is known to occur with the study intervention, there is a reasonable possibility 
that the study intervention caused the AE, or there is a temporal relationship between the study 
intervention and event. Reasonable possibility means that there is evidence to suggest a causal 
relationship between the study intervention and the AE. 
• 
Not Related – There is not a reasonable possibility that the administration of the study 
intervention caused the event, there is no temporal relationship between the study intervention 
and event onset, or an alternate etiology has been established. 
 
7.2.3.3 EXPECTEDNESS  
The Principal Investigator will be responsible for determining whether an adverse event (AE) is expected 
or unexpected.  An AE will be considered unexpected if the nature, severity, or frequency of the event is 
not consistent with the risk information previously described for the study intervention. 
7.2.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 

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The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
study personnel during study visits and interviews of a study subject presenting for medical care, or 
upon review by a study monitor. 
 
All AEs including local and systemic reactions not meeting the criteria for SAEs will be captured on the 
appropriate Adverse Event Reporting form. Information to be collected includes event description, time 
of onset, Principal Investigator’s assessment of severity, relationship to study intervention, and time of 
resolution/stabilization of the event. All AEs occurring while on study must be documented 
appropriately regardless of relationship. All AEs will be followed to adequate resolution. 
 
Any medical condition that is present at the time that the subject is enrolled will be considered as 
baseline and not reported as an AE. However, if the study subject’s condition deteriorates at any time 
during the study, it will be recorded as an AE.  
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed. AEs characterized as intermittent require documentation of 
onset and duration of each episode. 
 
The Study Coordinator will record all reportable events with start dates occurring any time after 
informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of 
study participation.  At each study time point, the Study Coordinator will inquire about the occurrence 
of AE/SAEs since the last assessment. 
 
7.2.5 ADVERSE AND SERIOUS ADVERSE EVENT REPORTING  
All serious adverse events must be reported to the IRB according to regulatory requirements. The 
Principal Investigator will immediately report to the sponsor any serious adverse event, whether or not 
considered study intervention related, including those listed in the protocol or package insert and must 
include an assessment of whether there is a reasonable possibility that the study intervention caused 
the event. Study endpoints that are serious adverse events (e.g., all-cause mortality) must be reported 
in accordance with the protocol unless there is evidence suggesting a causal relationship between the 
study intervention and the event (e.g., death from anaphylaxis). In that case, the investigator must 
immediately report the event to the sponsor. 
 
All serious adverse events (SAEs) will be followed until satisfactory resolution or until the Principal 
Investigator deems the event to be chronic or the subject is stable. Other supporting documentation of 
the event may be requested and should be provided as soon as possible. 
 
7.3 
UNANTICIPATED PROBLEMS 
 
7.3.1 DEFINITION OF UNANTICIPATED PROBLEMS (UP) 
The Office for Human Research Protections (OHRP) considers unanticipated problems involving risks to 
subjects or others to include, in general, any incident, experience, or outcome that meets all of the 
following criteria: 
 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-

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approved research protocol and informed consent document; and (b) the characteristics of the 
subject population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 
• 
Suggests that the research places subjects or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized. 
 
7.3.2  UNANTICIPATED PROBLEM REPORTING  
The investigator will report unanticipated problems (UPs) to the reviewing Institutional Review Board 
(IRB). The UP report will include the following information: 
• 
Protocol identifying information: protocol title and number, PI’s name, and the IRB project 
number; 
• 
A detailed description of the event, incident, experience, or outcome;  
• 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP;  
• 
A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP. 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline:   
• 
UPs that are serious adverse events (SAEs) will be reported to the IRB within 10 working days of 
the investigator becoming aware of the event.  
• 
Any other UP will be reported to the IRB within 10 working days of the investigator becoming 
aware of the problem.  
 
8 
STATISTICAL CONSIDERATIONS  
 
8.1 
STATISTICAL HYPOTHESES 
• 
Primary Endpoint(s):  The primary aim of this study is to compare the effects of treatment on 
children’s and mothers’ weight outcomes at 6- and 12-months. Hypothesis 1a: Mothers 
receiving HABITS will have a lower weight than mothers receiving standard services. Hypothesis 
1b: Children receiving HABITS will have slower weight gain than children receiving standard 
services. 
• 
Secondary Endpoint(s): The secondary aim of this study is to compare the effects of treatment 
on maternal feeding practices, habit strength of targeted behaviors, and features of the 
household environment relevant to targeted behaviors at 6- and 12-months. Hypothesis 2: 
Compared to standard services, HABITS will result in heathier maternal feeding practices (less 
fried foods and SSB; more vegetables/fruits), greater habit strength of targeted behaviors, and 
greater home availability of cues that support targeted behaviors 
 
8.2 
SAMPLE SIZE DETERMINATION 
The power analysis is prepared for comparing means of weight change from baseline to 12-months 
between the control and HABITS study arms. A sample size of 59 dyads per group, total of 118 dyads, 
will have 80% power to detect that mean of weight change in the control is 0.53 standard deviation 

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apart from that in HABITS by performing two-sided t-test of equal means at α=0.05. Since participants 
will be nested in 18 home visitors, the unadjusted calculated sample size must be further increased by 
an inflation factor to account for clustering due to home visitors. The inflation factor is given by the 
following equation: IF = [1 + (m – 1) p], where m represents the number of participants per home visitor, 
and p represents the intraclass correlation coefficient (ICC), the ratio of between-home visitors and total 
variability. In this study, we assume ICC is 0.01 consistent with typical values of ICC in community-based 
studies.86 By considering a 15% attrition rate between baseline and 12-month follow-up, the required 
total sample size is 140 (70 dyads per group). If ICC is weaker or attrition rate is smaller than we 
expected, we will have stronger power to detect the same difference of means. 
 
8.3 
STATISTICAL ANALYSES 
At each time of measurement, descriptive statistics and measures of association will be used to summarize 
demographic characteristics and outcome measures. The analysis will also include graphical and statistical 
analysis of outlying observations and distributional characteristics of variables. Differences in outcomes 
of interest between the control and HABITS will be assessed by t-test of equal means and Chi-square test 
of equal proportions for continuous, ordinal, and categorical values, respectively.  
 
For hypothesis 1 (primary outcomes), weight of mother or child between baseline and the 6-month and 
12-month timepoints will be calculated and summarized by tabulating and plotting descriptive statistics 
by the study arms. Linear association of HABITS with weight changes will be estimated and adjusted for 
demographic information and other measured covariates by performing mixed regression models with 
home visitors as a random effect.  
 
For hypothesis 2 (secondary outcomes), the analyses approach planned for Aim 1 will be used for 
determining if HABITS is associated with changes in maternal feeding practices, habit strength of targeted 
behaviors, or the household environments between baseline and 6- or 12-month follow-up.  
 
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. All statistical analyses will be performed using the most current version of SAS 9.4. 
Final results will be determined to be statistically significant when the accompanying statistical test yields 
a two-tailed probability of 0.05 or less. 
 
8.3.1 GENERAL APPROACH 
At each time of measurement, descriptive statistics and measures of association will be used to summarize 
demographic characteristics and outcome measures. The analysis will also include graphical and statistical 
analysis of outlying observations and distributional characteristics of variables. Differences in outcomes 
of interest between the control and HABITS will be assessed by t-test of equal means and Chi-square test 
of equal proportions for continuous, ordinal, and categorical values, respectively. Primary and secondary 
outcomes will be assessed using mixed regression models with home visitors as a random effect with 
adjustment for relevant demographic information and other measured covariates. 
 
8.3.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
For the primary endpoints, weight of mother or child between baseline and the 6-month and 12-month 
timepoints will be calculated and summarized by tabulating and plotting descriptive statistics by the study 
arms. Linear association of HABITS with weight changes will be estimated and adjusted for demographic 

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information and other measured covariates by performing mixed regression models with home visitors as 
a random effect.  
 
8.3.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
For the secondary endpoints, the analyses approach planned for primary endpoints will be used for 
determining if HABITS is associated with changes in maternal feeding practices, habit strength of targeted 
behaviors, or the household environments between baseline and 6- or 12-month follow-up.  
 
8.3.4 SAFETY ANALYSES 
Rates and severity of adverse events will be summarized using descriptive statistics and compared 
between study arms by Chi-square test of equal proportions. 
 
8.3.5 BASELINE DESCRIPTIVE STATISTICS 
At baseline, descriptive statistics will be used to summarize demographic characteristics and outcome 
measures by study arm and for the entire sample. The analysis will also include graphical and statistical 
analysis of outlying observations and distributional characteristics of baseline descriptive variables. 
Differences in baseline characteristics of interest between the control and HABITS will be assessed by t-
test of equal means and Chi-square test of equal proportions for continuous, ordinal, and categorical 
values, respectively.  
 
9 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
9.1 
REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
9.1.1 INFORMED CONSENT PROCESS 
 
9.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO SUBJECTS 
Consent forms describing in detail the study intervention, study procedures, and risks are given to the 
subject and written documentation of informed consent is required prior to conducting study screening 
procedures. A separate screening consent form will not be used. 
 
9.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the 
study and continues throughout the individual’s study participation. Consent forms will be Institutional 
Review Board (IRB)-approved and the subject will be asked to read and review the document. The 
investigator will explain the research study to the subject and answer any questions that may arise. A 
verbal explanation will be provided in terms suited to the subject’s comprehension of the purposes, 
procedures, and potential risks of the study and of their rights as research subjects.  Subjects will have 
the opportunity to carefully review the written consent form and ask questions prior to signing. The 
subjects should have the opportunity to discuss the study with their family or surrogates or think about 
it prior to agreeing to participate. The subject will sign the informed consent document prior to any 
procedures being done specifically for the study. Subjects must be informed that participation is 
voluntary and that they may withdraw from the study at any time, without prejudice. A copy of the 

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informed consent document will be given to the subjects for their records. The informed consent 
process will be conducted and documented in the source document (including the date), and the form 
signed, before the subject undergoes any study-specific procedures. The rights and welfare of the 
subjects will be protected by emphasizing to them that the quality of their medical care will not be 
adversely affected if they decline to participate in this study. 
9.1.2 STUDY DISCONTINUATION AND CLOSURE 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause.  Written notification, documenting the reason for study suspension or termination, will be 
provided by the suspending or terminating party to regulatory authorities.  If the study is prematurely 
terminated or suspended, the Principal Investigator (PI) will promptly inform study subjects and the 
Institutional Review Board (IRB), will provide the reason(s) for the termination or suspension.  Study 
subjects will be contacted, as applicable, and be informed of changes to study visit schedule. 
  
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to subjects 
• 
Demonstration of efficacy that would warrant stopping    
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination that the primary endpoint has been met 
• 
Determination of futility 
 
Study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the IRB. 
 
9.1.3 CONFIDENTIALITY AND PRIVACY  
Subject confidentiality and privacy is strictly held in trust by the participating investigators and their 
staff. Therefore, the study protocol, documentation, data, and all other information generated will be 
held in strict confidence. No information concerning the study or the data will be released to any 
unauthorized third party without prior written approval of the Principal Investigator.  
 
All research activities will be conducted in as private a setting as possible. 
 
Representatives of the Institutional Review Board (IRB) may inspect all documents and records required 
to be maintained by the investigator, including but not limited to, medical records (office, clinic, or 
hospital) and pharmacy records for the subjects in this study. The clinical study site will permit access to 
such records. 
 
The study subject’s contact information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as 
long a period as dictated by the reviewing IRB and/or Institutional policies. 
 
Study subject research data, which is for purposes of statistical analysis and scientific reporting, will be 
stored at the UAB Department of Medicine, Division of Preventive Medicine research office. This will not 
include the subject’s contact or identifying information. Rather, individual subjects and their research 

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data will be identified by a unique study identification number. The study data entry and study 
management systems used by research staff will be secured and password protected.  
 
9.1.4 QUALITY ASSURANCE AND QUALITY CONTROL 
The site will perform internal quality management of study conduct, data collection, documentation and 
completion.  Quality control (QC) procedures will be completed by the Data Manager during data entry 
into REDCap. Any missing data or data anomalies will be communicated to the Study Coordinator for 
clarification/resolution. 
 
Following written Standard Operating Procedures (SOPs), the MPIs and research team will verify that the 
trial is conducted and data generated are collected, documented (recorded), and reported in 
compliance with the protocol, International Conference on Harmonisation Good Clinical Practice (ICH 
GCP), and applicable regulatory requirements.  
 
The site will provide direct access to all trial related sites, source data/documents, and reports for the 
purpose of monitoring and inspection by local and regulatory authorities. 
 
9.1.5 DATA HANDLING AND RECORD KEEPING  
 
9.1.5.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
Data collection is the responsibility of the trial staff at the site under the supervision of the Principal 
Investigator. The Principal Investigator is responsible for ensuring the accuracy, completeness, legibility, 
and timeliness of the data reported. 
 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation 
of data.   
 
Hard copies of source document worksheets will be used for recording data for each subject enrolled in 
the study.  
 
9.1.5.2 STUDY RECORDS RETENTION  
Study documents should be retained for a minimum of 3 years after the completion of the study. These 
documents should be retained for a longer period, however, if required by local regulations.  
 
9.1.6 PROTOCOL DEVIATIONS  
A protocol deviation is any noncompliance with the clinical trial protocol requirements. The 
noncompliance may be either on the part of the subject, the investigator, or the study site staff. As a 
result of deviations, corrective actions are to be developed by the site and implemented promptly.  
 
These practices are consistent with ICH GCP:  
• 
4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3  
• 
5.1 Quality Assurance and Quality Control, section 5.1.1  
• 
5.20 Noncompliance, sections 5.20.1, and 5.20.2.  
 

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It is the responsibility of the Principal Investigator to use continuous vigilance to identify and report 
deviations within 10 working days of identification of the protocol deviation.  Protocol deviations must 
be sent to the reviewing Institutional Review Board (IRB) per their policies. The Principal Investigator is 
responsible for knowing and adhering to the reviewing IRB requirements.  
 
9.1.7 CONFLICT OF INTEREST POLICY 
The independence of this study from any actual or perceived influence is critical.  Therefore, any actual 
conflict of interest of persons who have a role in the design, conduct, analysis, publication, or any aspect 
of this trial will be disclosed and managed. Furthermore, persons who have a perceived conflict of 
interest will be required to have such conflicts managed in a way that is appropriate to their 
participation in the design and conduct of this trial.   
 
 
 

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9.2 
ABBREVIATIONS 
 
AE 
Adverse Event 
ANCOVA 
Analysis of Covariance 
CFR 
Code of Federal Regulations 
CONSORT Consolidated Standards of Reporting Trials 
DHHS 
Department of Health and Human Services 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act  
ICH 
International Conference on Harmonisation  
ICMJE 
International Committee of Medical Journal Editors 
IRB 
Institutional Review Board 
LSMEANS 
Least-squares Means 
NCT 
National Clinical Trial 
NIH  
National Institutes of Health 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SOA 
Schedule of Activities 
SOP 
Standard Operating Procedure 
SSB 
Sugar-Sweetened Beverage 
UP 
Unanticipated Problem 
US 
United States 
 
 
 

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Page 1 of 8 
Version Date: 11-16-21 
CONSENT FORM TO BE PART OF A RESEARCH STUDY 
 
 
Title of Research: 
Healthy Homes, Healthy Habits: A Home Visitation Program 
to Improve Health for Families  
 
UAB IRB Protocol #: 
IRB-300001353 
 
Principal Investigator: 
Gareth Dutton, PhD 
 
Sponsor:  
National Institute on Minority Health and Health Disparities   
 
General Information 
You and your child are being asked to take part in a research study. 
This research study is voluntary, meaning you and your child do not 
have to take part in it. The procedures, risks, and benefits are fully 
described further in the consent form. 
Purpose 
The purpose of the study is test if a program we call “Healthy Homes, 
Healthy Habits” helps families like yours start habits for healthy 
eating and physical activity. 
Duration & Visits 
You and your child will be in this study for 12 months. 
Overview of 
Procedures 
This study will include your and your child’s normal home visits as 
part of the home visit program you and your child are in, as well as 3 
assessment visits to collect information related to healthy habits at 
the start of the study, after 6 months, and after 12 months. 
Risks 
The most common risks may include minor and temporary injury, 
such as spraining your ankle from exercise.  This is not common, and 
you will only be asked to make changes that are comfortable for you. 
Benefits 
You may or may not benefit from being in this study.  
Alternatives 
If you do not want to take part in the study, you and your child will 
still be seen for your regular home visiting program visits. 
 
Purpose of the Research Study 
We are asking you to take part in a research study with your child because you are receiving 
home visiting services and your child is no more than 5 years old and eligible to remain in the 
First Teacher Program for up to a year.  Please take as much time as you need to read this form. 
You may want to talk about the study with your family, friends, or with the Family Guidance 
Center staff. If you do not understand parts of this form, please ask questions. The study team 
wants to know if a program called “Healthy Homes, Healthy Habits” (“Habits” for short) helps 
families like yours develop healthy habits. About 300 families will be enrolled in this study. 
 
Study Participation & Procedures 
 
If you agree to be in the study, we will ask you questions about your and your child’s eating and 
physical activity habits. We will also collect information about the foods and activity equipment 
you have in your home. All families in the study will continue to receive home visits and they will 
continue to work with a parent educator to meet the goals of the program.  
UAB IRB
Approved
10-Mar-2022
until
09-Mar-2023

Page 2 of 8 
Version Date: 11-16-21 
 
If you decide to be in our study with your child, you and your child will be randomly assigned by a 
computer to one of two groups. This means that you and your child have an equal chance of 
being in either study group, and which group you and your child are in is based on chance, like 
flipping a coin. The two possible study groups are: (1) the standard home visiting program only, 
or (2) the standard home visiting program + Habits. 
 
If you and your child are in the group that gets the “standard home visiting program only”, you 
and your child will keep getting the same home visit services without changes. If you and your 
child are in the “standard home visiting program + Habits” group, you and your child will get the 
home visit program AND the healthy habits program. The Habits program is a 10-20 minute 
program delivered by your parent educator during your regular home visits.  Those assigned to 
the Habits program will learn about how their family can eat more fruits and vegetables, eat less 
fried foods, drink less sugary drinks, cook tasty budget-friendly food with healthy ingredients, 
and find fun and easy ways to be more active with their families. If you are assigned to the 
“standard home visiting program + Habits” group, your parent educator will also collect your 
weight every week as part of the study. 
 
Assessments: 
All families in the study will complete three (3) assessments: 1) at the start of the study, 2) after 
6 months, and 3) after 12 months. Home visiting staff, called assessment workers, will work with 
you to complete these assessments. Assessments may be done completely in-person at your 
home, a combination of over the phone and in-person, or all remotely with no in-person, physical 
contact. The visits will include surveys and other measures described below. 
 
Intake and Demographics Survey (Visit 1 only, 10-15 minutes): Asks questions about your age, 
education, income level, race, medical history.   
 
PAR-Q Survey (Visits 1 and 2, 5 minutes): Assesses your health and ability to do physical activities. 
If there are any concerns about your ability to participate in the walking and movement section 
of the Habits program, you may be asked to see a doctor about your health before you take part 
in this section of the program. You will still be able to participate in other parts of the program. 
 
BRIEF Survey (All 3 visits, 15-25 minutes): You will complete a questionnaire that asks about your 
attention and how you react to different situations. 
 
Medical Changes Survey: (Visits 2 and 3, 5-15 minutes): Assesses medical or health changes that 
might have happened since you first started the study.   
 
Self-Reported Habit Index Surveys (All 3 visits, 15-25 minutes): Assesses eating and activity habits. 
  
Height and weight measurements (All 3 visits, 10-20 minutes): We will measure your and your 
child’s weight and height/length. When a height measurement is not possible, we may ask you to 
estimate your height.  
 
PHQ-8 Survey: (All 3 visits, 5 minutes): Assesses your thoughts and feelings over the last two 
weeks.  
 

Page 3 of 8 
Version Date: 11-16-21 
Food and Activity Frequency Survey (All 3 visits, 10-15 minutes): Assesses how often you and your 
child eat certain types of foods and are physically active.  
 
 
 
Trust in Parent Educator Survey (Visits 2 and 3, 3-5 minutes): You will complete a questionnaire 
that asks about how long you have known your parent educator and the level of trust you have 
with your parent educator. 
 
We will also monitor your and your child’s progress in the First Teacher Home Visiting Program to 
ensure the study does not affect your services. For this, First Teacher Home Visiting Program will 
provide us with their assessments that are done as part of the standard First Teacher Home Visiting 
Program yearly evaluations. These questionnaires are not part of our study assessments. 
 
If you are participating in the group that receives the “standard home visiting program + Habits”, 
we will also ask you to record your healthy habits and daily weight as a way to help you keep 
track of your progress. We will collect this information to help us learn how people create habits. 
 
Your de-identified private information (private information with all identifiers removed) may be 
used for future research studies or distributed to another researcher for future research studies 
without additional informed consent. This is only when there are no identifiers associated 
with the data. 
 
Risks and Discomforts 
 
The risks to you and your child for participating in this study are judged to be low but include 
minor and temporary injury, such as spraining your ankle from exercise.  This is not common, 
and you will only be asked to make changes that are comfortable for you.  If this type of injury 
happens or you have an injury not related to being in the study, you can stop participating in the 
study at any time, or only participate in parts of the program until you recover.  
 
Some questions on the surveys ask about personal information, such as income and information 
about your health.  There is a small risk that you will feel uncomfortable or not want to answer 
these questions.  If this happens, you can choose to skip any questions at any time. If our staff 
feels that you may be under distress or might need additional help, they will work with your 
parent educator to connect you to additional services and/or offer referrals to someone who can 
help you and/or your child. 
 
Information for Women of Childbearing Potential, Nursing Mothers, and/or Men 
Capable of Fathering a Child 
 
If you become pregnant during the study or are nursing, you will continue to be allowed to 
participate in the program.  The information on diet and healthy activity does not cause any extra 
risk to you or your baby and does not affect mother’s milk supply.  
 
 

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Benefits 
 
You may not benefit directly from taking part in this study. However, if you are assigned to the 
“standard home visiting program + Habits” group it is possible that you may learn skills that help 
your family to have healthy habits. These healthy habits may help you improve what you and 
your child eat and how active you and your child are.  You may also feel good about helping to 
develop a health program for families like yours. Your parent educator will be randomly 
assigned (like the flip of a coin) by a computer to either provide the nutrition and physical 
activity material (Habits) and the First Teacher Home Visiting Program material, or to provide 
just the usual First Teacher Home Visiting Program material. You will be assigned to receive the 
First Teacher Home Visiting Program or the First Teacher Home Visiting Program + Habits by 
chance. We do not know if one intervention program will help you more than the other, and we 
do not know which program will be more effective for reaching the First Teacher Home Visiting 
Program educational goals or the Habits health goals. Because your parent educator will be 
assigned to provide these programs by chance, it is possible that your group may have more or 
less benefits than the other study group. 
 
Alternatives 
 
Your alternative is to not participate in this study.  If you decide not to be in this study, you 
would still be seen for your regular home visiting program visits. 
 
Confidentiality and Authorization to Use and Disclose Information for Research 
Purposes 
 
Federal regulations give you certain rights related to your health information. These include the 
right to know who will be able to get the information and why they may be able to get it. The 
study researchers must get your authorization (permission) to use or give out any health 
information that might identify you. 
 
What protected health information may be used and/or given to others? 
 
All medical information, including but not limited to information and/or records of any diagnosis 
or treatment of disease or condition, which may include sexually transmitted diseases (e.g., HIV, 
etc.) or communicable diseases, drug/alcohol dependency, etc.; all personal identifiers, including 
but not limited to your name, social security number, medical record number, date of birth, dates 
of service, etc.; any past, present, and future history, examinations, laboratory results, imaging 
studies and reports and treatments of any kind, including but not limited to drug/alcohol 
treatment, psychiatric/psychological treatment; financial/billing information, including but not 
limited to copies of your medical bills; any other information related to or collected for use in the 
research study, regardless of whether the information was collected for research or non-
research (e.g., treatment) purposes; records about any study drug you received or about study 
devices used; and consent forms from past studies that might be in your medical record. 
 
A description of this study will be available on www.ClinicalTrials.gov, as required by U.S. Law. 
This website will not include information that can identify you. At most, the website will include 
a summary of the results. You can search this website at any time. 
 

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Who may use and give out information about you? 
 
Information about your health may be used and given to others by the study doctor and staff. 
They might see the research information during and after the study. 
 
Who might get this information? 
 
All Individuals/entities listed in the informed consent document(s), including but not limited to, 
the physicians, nurses and staff and others performing services related to the research (whether 
at the University of Alabama at Birmingham or elsewhere). Your information may also be given to 
the sponsor of this research. “Sponsor” includes any persons or companies that are working for 
or with the sponsor, or are owned by the sponsor, or are providing support to the sponsor (e.g., 
contract research organization). 
 
Information about you and your health which might identify you may be given to: 
• the Office for Human Research Protections (OHRP) 
• the U.S. Food and Drug Administration (FDA) 
• Department of Health and Human Services (DHHS) agencies 
• Governmental agencies in other countries 
• Governmental agencies to whom certain diseases (reportable diseases) must be reported 
• the University of Alabama at Birmingham (UAB) - the physicians, nurses and staff working 
on the research study (whether at UAB or elsewhere); other operating units of UAB, UAB 
Hospital, UAB Highlands Hospital, University of Alabama Health Services Foundation, 
Children’s of Alabama, Eye Foundation Hospital, and the Jefferson County Department of 
Health, as necessary for their operations; the UAB IRB and its staff 
• the billing offices of UAB and UAB Health Systems affiliates and/or Children’s of Alabama 
and its billing agents 
 
Why will this information be used and/or given to others? 
 
Information about you and your health that might identify you may be given to others to carry 
out the research study. The sponsor will analyze and evaluate the results of the study. In 
addition, people from the sponsor and its consultants will be visiting the research site. They will 
follow how the study is done, and they will be reviewing your information for this purpose. 
 
This research is covered by a Certificate of Confidentiality from the National Institutes of Health. 
The researchers with this Certificate may not disclose or use information, documents, or 
biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, 
legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a 
court subpoena, unless you have consented for this use. Information, documents, or 
biospecimens protected by this Certificate cannot be disclosed to anyone else who is not 
connected with the research except, if there is a federal, state, or local law that requires 
disclosure (such as to report child abuse or communicable diseases but not for federal, state, or 
local civil, criminal, administrative, legislative, or other proceedings, see below); if you have 
consented to the disclosure, including for your medical treatment; or if it is used for other 
scientific research, as allowed by federal regulations protecting research subjects. 
 

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The Certificate cannot be used to refuse a request for information from personnel of the United 
States federal or state government agency sponsoring the project that is needed for auditing or 
program evaluation by the National Institute on Minority Health and Health Disparities which is 
funding this project or for information that must be disclosed in order to meet the requirements 
of the federal Food and Drug Administration (FDA). You should understand that a Certificate of 
Confidentiality does not prevent you from voluntarily releasing information about yourself or 
your involvement in this research. If you want your research information released to an insurer, 
medical care provider, or any other person not connected with the research, you must provide 
consent to allow the researchers to release it. 
 
The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, 
state, or local law of child abuse and neglect, or harm to self or others. 
 
The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you have 
consented to in this informed consent document. 
 
Information obtained during the course of the study which, in the opinion of the investigator(s), 
suggests that you may be at significant risk of harm to yourself or others will be reportable to a 
third party in the interest of protecting the rights and welfare of those at potential risk. 
 
What if I decide not to give permission to use and give out my health information? 
By signing this consent form, you are giving permission to use and give out the health 
information listed above for the purposes described above. If you refuse to give permission, you 
will not be able to be in this research. 
 
May I review or copy the information obtained from me or created about me? 
You have the right to review and copy your health information. However, if you decide to be in 
this study and sign this permission form, you will not be allowed to look at or copy your 
information until after the research is completed. 
 
May I withdraw or revoke (cancel) my permission? 
Yes, but this permission will not stop automatically. The use of your personal health information 
will continue until you cancel your permission. 
 
You may withdraw or take away your permission to use and disclose your health information at 
any time. You do this by sending written notice to the study doctor. If you withdraw your 
permission, you will not be able to continue being in this study. 
 
When you withdraw your permission, no new health information which might identify you will 
be gathered after that date. Information that has already been gathered may still be used and 
given to others. This would be done if it were necessary for the research to be reliable. 
 
Is my health information protected after it has been given to others? 
If you give permission to give your identifiable health information to a person or business, the 
information may no longer be protected. There is a risk that your information will be released to 
others. Including others outside of UAB, without your permission. 
 

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Voluntary Participation and Withdrawal 
 
Whether or not you and your child take part in this study is your choice. There will be no penalty 
if you decide not to be in it. If you decide not to be in the study, you will not lose any benefits you 
are otherwise owed.  If you decide to stop being in the study, you and your child will still receive 
home visiting services, but you and your child will not receive the Habits program and we will 
not collect study assessments.  
 
You and your child are free to withdraw from this research study at any time. Your choice to 
leave the study will not affect your or your child’s relationship with UAB or the home visiting 
program. Contact your parent educator if you want to withdraw from the study. 
 
You and your child may be removed from the study without your consent if the sponsor ends the 
study, if the researchers decide it is not in the best interest of your or your child’s health, or if 
you are not following the study rules. 
 
If you are a UAB student or employee, taking part in this research is not a part of your UAB class 
work or duties. You can refuse to enroll, or withdraw after enrolling at any time before the study 
is over, with no effect on your class standing, grades, or job at UAB. You will not be offered or 
receive any special consideration if you take part in this research. 
 
Cost of Participation 
 
There will be no cost to you or your child for taking part in this study.  
 
Payment for Participation in Research 
 
You will be paid $100 for completing each of the three assessments.  If you and your child 
complete all of these assessments, you will receive a total of $300. If you and your child 
withdraw from the study, you will be paid $100 for each data collection visit that you and your 
child completed. We will try to pay you immediately after each data collection visit, or we will 
mail your payment to you within a few weeks of completing these visits. The total payment you 
can receive is $300. If you or your child do not finish the entire study, you will be paid at the time 
you decide to stop taking part in the study. Ask the study staff about the method of payment that 
will be used for this study (e.g., check, cash, gift card, direct deposit). 
 
Payment for Research-Related Injuries 
 
UAB has not provided for any payment if you are harmed as a result of taking part in this study. If 
harm occurs, treatment will be provided. However, this treatment will not be provided free of 
charge. 
 
New Findings 
 
You will be told by study staff if new information becomes available that might affect your choice 
to stay in the study. 
 

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Questions 
 
If you have any questions, concerns, or complaints about the research, please call Dr. Gareth 
Dutton at (205) 934-6876. You can also contact the research program coordinator at (205)-975-
7274.  
 
If you have questions about your rights as a research participant, or concerns or complaints 
about the research, you can call the UAB Office of the IRB (OIRB) at (205) 934-3789 or toll free at 
1-855-860-3789. Regular hours for the OIRB are 8:00 a.m. to 5:00 p.m. CT, Monday through 
Friday. 
 
Legal Rights 
 
 
 
 
 
Your signature below indicates that you have read (or been read) the information provided 
above and agree for you and your child to participate in this study. You will receive a copy of this 
signed consent form. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Parent Participant 
 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Person Obtaining Consent 
 
 
 
 
 
Date 
 
 
Waiver of Assent 
 
 
The assent of ______________________________ (name of child/minor) was waived because of: 
 
Age _________ Maturity ________ 
 
Psychological state of the child ________