Buen Provecho!: A Virtual Family-Based Intervention to Promote Health
Phase: NA
Conditions: Health Behavior, Diet, Healthy, Childhood Obesity
Sponsor: Inova Health Care Services

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Protocol ID:  U21-12-4630 
 
Title of Research Protocol: Buen Provecho!: A Virtual Family-Based 
Intervention to Promote Health 
 
 
 
Principal Investigator(s) 
 
Inova Loudoun Hospital 
Elyssa Wood, PhD, MPH, RN 
 
HealthWorks Northern Virginia 
Medhine Anusha Wijetilleke, MD, MS, FAAP 
 
Sub-Investigator(s) 
Inova Health System 
Kate Garsson, MPH 
 
HealthWorks for Northern Virginia 
Stephanie Puloka, MD 
 
 
 
 
 
Sponsor 
National Center for Advancing Translational Sciences of the National Institutes of Health  
under Award Number UL1TR003015 
 
 
Site of Investigation 
HealthWorks for Northern Virginia 
 
 
Date of Protocol 
July 21, 2022 
 
 
 
 
 
 
 
 
 
 
 

 
 
Table of Contents 
 
Abstract 
3 
Aims & Hypothesis 
4 
Background 
4 
Study Design 
6 
Recruitment 
7 
Study Methods & Procedures 
8 
Data Analysis  
9 
Human Subjects Protection 
10 
List of Abbreviations 
15 
Appendix A: Study Flow Chart 
16 
Appendix B: Recruitment Flyer  
17 
Appendix C: Survey 
18 
 
 
 
 
 
 

 
 
 
ABSTRACT 
 
Title:   Buen Provecho!: A Virtual Family-Based Intervention to Promote Health 
 
Short Title:  Buen Provecho Virtual Intervention 
 
Rationale:  Obesity rates are significantly higher among Hispanic youth in the United States, disproportionately putting 
these children at an increased risk for obesity-related diseases such as hypertension, dyslipidemia, and impaired glucose 
tolerance. While virtual programming offers an innovative option for pediatric weight management, limited data exists 
on the efficacy of virtual interventions for this population and their guardians (parents / caregivers).  
 
Objectives:  The purpose of this pilot study is to compare the effectiveness of an expanded virtual educational program 
(expanded –Inova Healthy Plate Club, x-IHPC) at modifying knowledge, self-efficacy, and behaviors when compared to 
traditional in-office counseling for guardians of children who are obese or overweight.  
 
Study Design:  In order to test the effectiveness of the x-IHPC intervention, outcomes from participants in this pilot study 
will be compared with outcomes from a comparison group of similar participants who receive standard nutrition 
counseling during their regularly scheduled check-ups. The team will enroll 25 children in the x-IHPC intervention and 
the same number in the comparison group (n=50). Both groups will receive standard in-office counseling, but the 
intervention group will also receive the x-IHPC. 
 
Study Methodology:  The comparison group receives standard, in-office counseling at visits 1, 3-months and 6-
months. The intervention group receives standard in-office counseling at the same intervals, and also participates in a 
12-week x-IHPC developed by a dietician curriculum specialist. In addition, a key pillar of this study is identifying and 
training Community Health Workers (CHWs) to be Spanish-speaking facilitators of the x-IHPC and utilizing 
community engagement strategies. Training these CHWs and including them in designing the x-IHPC curriculum, will 
ensure that the programming is culturally appropriate; includes local features that relate directly to the community’s 
needs; and enables study facilitators to respond effectively to the questions and learning needs of the parents and 
children involved in the program.  
 
Statistical Methodology:  
To examine the research question, a longitudinal analysis using generalized estimating equations (GEE) will be 
conducted to assess if mean differences exist on dietary measures, screen time, physical activity and guardian self-
efficacy and confidence between the intervention and comparison groups while accounting for the correlation among 
the repeated measurements and controlling for covariates.   
 
 
 
 
 
                                                                                                                              

 
1. INTRODUCTION 
 
1.1. Specific Aims 
 
 
Obesity rates are significantly higher among Hispanic youth in the United States, disproportionately 
putting these children at an increased risk for obesity-related diseases such as hypertension, dyslipidemia, and 
impaired glucose tolerance. Despite this disparity, there is a lack of literature pertaining to culturally relevant 
and family-centered interventions for Hispanic youth and their families. While virtual programming offers an 
innovative option for pediatric weight management, limited data exists on the efficacy of telehealth /virtual 
interventions for this population and their guardians.  
 
The purpose of this community-engaged quasi-experimental study is to determine whether a family-
based, culturally tailored, virtual intervention enables guardians to shape the weight-related aspects of their 
home environments and the lifestyle behavioral practices (diet, exercise, screen behaviors) to be more 
supportive of their family’s optimal health and weight, compared to standard in-office counseling alone. 
Specifically, the study intends to compare the effectiveness of an expanded virtual educational program (x-
IHPC) at modifying knowledge, self-efficacy, and behaviors when compared to traditional in-office counseling 
for guardians of children who are obese or overweight.  
 
1.2. Hypothesis  
Research Question: Among guardians of children ages 6-12 years who are obese or overweight, does a 
family-based, culturally-tailored, virtual intervention change knowledge, self-efficacy, and behaviors 
about modifiable lifestyle practices to promote healthy eating when compared to standard in-office 
counseling? 
 
Ho: A family-based, culturally-tailored, virtual intervention does not significantly change knowledge, 
self-efficacy, and behaviors about modifiable lifestyle practices when compared to standard in-office 
counseling.  
 
Ha: A family-based, culturally-tailored, virtual intervention does significantly change knowledge, self-
efficacy, and behaviors about modifiable lifestyle practices when compared to standard in-office 
counseling. 
 
1.3. Background and Significance  
 
Childhood obesity has been an epidemic in the United States for a generation. The national childhood 
obesity rate has been rising for decades putting millions of children at greater risk for Type 2 diabetes, high 
blood pressure, asthma, and other serious conditions.1,2  Recent data show that 15.5% of youth ages 10 to 17 
have obesity. More importantly, the data exposes persistent racial and ethnic disparities with rates significantly 
higher among Hispanic youth than among White or Asian youth.3 The high prevalence of obesity among 
Hispanic children contributes to disparities in obesity-related disease risk factors including hypertension, 
dyslipidemia, and impaired glucose tolerance. It also puts them at risk for chronic comorbidities in adulthood. 
 
Centers for Disease Control and Prevention (CDC) Growth Charts are used to measure the size and 
growth patterns of children and teens in the United States, with BMI-for-age weight status categories and 
corresponding percentiles. In children, BMI percentile cutoffs for obesity are intended to reliably define a level 
above which a child is more likely to have or be at risk of developing obesity-associated adverse health 
outcomes or diseases. Children are considered overweight at the 85th to less than the 95th percentile. Children 
are considered obese at the 95th percentile or greater.4 
 
1 QuickStats: Prevalence of Obesity and Severe Obesity Among Persons Aged 2–19 Years — National Health and Nutrition 
Examination Survey, 1999–2000 through 2017–2018. MMWR Morb Mortal Wkly Rep 2020;69:390. 
DOI: http://dx.doi.org/10.15585/mmwr.mm6913a6 
 
2 Mohanan S, Tapp H, McWilliams A, Dulin M. Obesity and asthma: pathophysiology and implications for diagnosis and 
management in primary care. Exp Biol Med (Maywood). 2014;239(11):1531–40. 
 
3 HRSA. (2019). National Survey of Children’s Health (NSCH). Accessed August, 2021. https://mchb.hrsa.gov/data/national-surveys 
 
4 CDC. (2020). https://www.cdc.gov/obesity/childhood/defining.html.  
 

 
 
 
Recent research is exposing the connection between obesity and COVID-19.5 The CDC includes obesity 
as one of the underlying conditions that increases risk of severe illness from COVID-19.6 People with obesity 
tend to become sicker, are more likely to be hospitalized, and are even more likely to die with COVID-19 
infection.7 COVID-19 has also disproportionately impacted people of color and impoverished communities. 
Hispanic people have higher rates of infection and are more than three times as likely to die from COVID-19 
as are White people. Risks of severe illness are also worse for children; Black and Hispanic children are much 
more likely than their White peers to be hospitalized because of COVID-19.8 
 
Given this high prevalence of childhood obesity and persistent racial/ethnic and socioeconomic 
disparities, there is an urgent need to find solutions to provide intensive, family-based pediatric weight 
management. Without such interventions, the chronic pandemic of obesity will continue to be exacerbated, 
particularly among disproportionately burdened populations.9 Ensuring populations affected disproportionately 
by obesity benefit from preventive strategies remains one of the most pressing unmet challenges in community 
health policy and practice.10 
 
While obesity is a function of biology and genetics, the role of social, environmental, and economic 
factors in the epidemic are equally important. Experts suggest offering virtual obesity-prevention programming 
as a needed solution for the complex management of childhood obesity.11 Providing culturally-tailored, 
targeted virtual programming allows children and families to have access to high quality obesity-reduction 
programming in their homes in a convenient and an accessible way to increase health equity. However, there is 
a lack of literature pertaining to culturally relevant, family-centered interventions for Hispanic youth and their 
families.12 While evidence supports the use of telehealth or mobile health interventions as adjuncts to pediatric 
weight management as being feasible and cost-effective, limited data exists on the efficacy or effectiveness of 
exclusive telehealth for pediatric weight management.9, 11 Therefore, the purpose of this project is to test a 
virtual program targeting modifiable weight-related lifestyle factors for Hispanic children and their families in 
Loudoun County, Virginia through a community-engaged partnership between HealthWorks for Northern 
Virginia (HWNV) and Inova. 
 
This project builds on the success of an existing community-focused program called the Inova Healthy 
Plate Club (IHPC).  Within the Inova Division of Population Health, the IHPC, aims to reduce obesity among 
 
5 Lange SJ, Kompaniyets L, Freedman DS, et al. Longitudinal trends in body mass index before and during the covid-19 pandemic 
among persons aged 2-19 years—United States, 2018-2020. CDC Morbidity and Mortality Weekly Report. 17 September 2021. 
www.cdc.gov/mmwr/volumes/70/wr/mm7037a3.htm 
 
6 CDC. (2020). Obesity, Race/Ethnicity, and COVID-19. https://www.cdc.gov/obesity/data/obesity-and-covid-19.html 
 
7 Popkin, B. M., Du, S., Green, W. D., Beck, M. A., Algaith, T., Herbst, C. H., Alsukait, R. F., Alluhidan, M., Alazemi, N., & 
Shekar, M. (2020). Individuals with obesity and COVID‐19: A global perspective on the epidemiology and biological relationships. 
Obesity Reviews; Obes Rev, 21(11), e13128-n/a. https://doi.org/10.1111/obr.13128 
 
8 Kim, L., Whitaker, M., O'Halloran, A., Kambhampati, A., Chai, S. J., Reingold, A., Armistead, I., Kawasaki, B., Meek, J., Yousey-
Hindes, K., Anderson, E. J., Openo, K. P., Weigel, A., Ryan, P., Monroe, M. L., Fox, K., Kim, S., Lynfield, R., Bye, E., . . . Garg, S. 
(2020). Hospitalization Rates and Characteristics of Children Aged <18 Years Hospitalized with Laboratory-Confirmed COVID-19 - 
COVID-NET, 14 States, March 1-July 25, 2020. MMWR.Morbidity and Mortality Weekly Report; MMWR Morb Mortal Wkly Rep, 
69(32), 1081-1088. https://doi.org/10.15585/mmwr.mm6932e3 
 
9 Woo Baidal, J. A., Chang, J., Hulse, E., Turetsky, R., Parkinson, K., & Rausch, J. C. (2020). Zooming Toward a Telehealth 
Solution for Vulnerable Children with Obesity During Coronavirus Disease 2019. Obesity (Silver Spring, Md.), 28(7), 1184–1186. 
https://doi.org/10.1002/oby.22860 
 
10 Kumanyika, S. K. (2019). A Framework for Increasing Equity Impact in Obesity Prevention. American Journal of Public Health 
(1971); Am J Public Health, 109(10), 1350-1357. https://doi.org/10.2105/AJPH.2019.305221 
 
11  Taveras, E. M., Marshall, R., Sharifi, M., Avalon, E., Fiechtner, L., Horan, C., Gerber, M. W., Orav, E. J., Price, S. N., Sequist, T., 
& Slater, D. (2017). Comparative Effectiveness of Clinical-Community Childhood Obesity Interventions: A Randomized Clinical 
Trial. JAMA pediatrics, 171(8), e171325. https://doi.org/10.1001/jamapediatrics.2017.1325 
 
12 Tamayo MC, Dobbs PD, Pincu Y. Family-Centered Interventions for Treatment and Prevention of Childhood Obesity in Hispanic 
Families: A Systematic Review. J Community Health. 2021 Jun;46(3):635-643. doi: 10.1007/s10900-020-00897-7. PMID: 
32734580. 
 

 
 
low-income children and prevent the future occurrence of heart disease/stroke, Type 2 Diabetes, and other 
related diseases. To date, IHPC has engaged more than 1,200 children in Northern Virginia in healthy-eating 
interventions. Two decades of research shows that family-based interventions work better than individual 
interventions at reducing childhood obesity.13 14 Therefore, the proposed study will examine the effectiveness 
of an expanded IHPC (x-IHPC), which will be virtual, family-based, and specifically designed for low-income 
Hispanic families in our community; all of which are evidence-based strategies for enhancing healthy eating 
interventions.  
 
1.4. Preliminary Studies 
None 
 
2. STUDY DESIGN AND SUBJECT SELECTION  
 
2.1. Study Type 
Quasi Experimental: Behavioral Intervention with convenience sampling.  In order to test the effectiveness of 
the x-IHPC intervention, outcomes from participants in this pilot study will be compared with outcomes from a 
comparison group of similar families who receive standard nutrition counseling during their regularly 
scheduled check-ups at HWNV. The team will enroll 25 children in the x-IHPC intervention and the same 
number in the comparison group (n=50). Both groups of children and guardians will receive standard in-office 
counseling, but the intervention group will additionally receive the x-IHPC (See study flowchart, Appendix A).  
 
2.2. Setting/Location 
Standard health counseling will take place during regularly scheduled office visits at the HWNV offices. The 
x-IHPC intervention is virtual and participants will engage in the intervention from their homes via virtual 
sessions. 
 
2.3. Duration of Study 
Participants will be part of the study for 6 months. This includes study recruitment, consenting, initial and 
subsequent in-office counseling, and x-IHPC for families enrolled in the intervention.  
 
2.4. Number of Subjects  
                 The team will enroll 25 children in the x-IHPC intervention and the same number in the comparison group 
(n=50). 
 
2.5. Study Population 
 
2.5.1.Gender of Subjects 
There are no restrictions on the gender of the participants for this program.  
 
2.5.2.Age of Subjects 
The primary parent /guardian participating in the study is required to be over the age of 18 years.   
 
2.5.3.Racial and Ethnic Origin  
The x-HPC program is designed to address the cultural needs of self-identified Hispanic families in our 
community related to the family features that impact health. Any family is eligible to participate who identifies 
as Hispanic and Spanish is one of the primary languages spoken in the home.  
 
2.5.4.Vulnerable Populations 
 
13 Berge, J. M., & Everts, J. C. (2011). Family-Based Interventions Targeting Childhood Obesity: A Meta-Analysis. Childhood 
Obesity; Child Obes, 7(2), 11-121. https://doi.org/10.1089/chi.2011.07.02.1004.berge 
 
14 Yavuz, H. M., van Ijzendoorn, M.,H., Mesman, J., & van der Veek, S. (2015). Interventions aimed at reducing obesity in early 
childhood: a meta-analysis of programs that involve parents. Journal of Child Psychology and Psychiatry; J Child Psychol Psychiatr, 
56(6), 677-692. https://doi.org/10.1111/jcpp.12330 
 

 
 
 
This study intervention is designed for Hispanic families in our community. The primary guardian of 
children between 6-12 years who screen eligible to be part of the intervention will be the individuals giving 
consent for their family to be part of the intervention as well as the individual providing data for the study 
through surveys about family and child behaviors. It is possible that some of these guardians may be pregnant 
at the time of consent or become pregnant during the study. Because the focus of the study is healthy eating 
and modifying lifestyle behaviors to improve health, the study intervention (surveys, healthy eating activities, 
and counseling) pose no more than minimal risk to this vulnerable group. Although children are also 
considered a vulnerable group, the study activities pose minimal or no risk to the children involved in the 
intervention.  
 
2.6. Recruitment  
 
The study employs convenience sampling. Recruitment will take place through email to families who 
receive care at HWNV in English and Spanish as well as posters advertising the program placed in community 
spaces where children and families who are clients at HWNV spend time (updated recruitment flyer, Appendix 
B). If guardians are interested in being part of the program, there will be a contact person listed on the 
advertisement who will screen for eligibility. If a family is screened as eligible to be part of the x-IHPC 
intervention, a member of the study team will meet with the family virtually or in person and consent the 
guardian to be part of the study. This consent process will take place with a trained interpreter. The consent 
will be emailed to program participants prior to the consent conversation when possible. Whether consent 
occurs virtually or in person, a hard copy of the consent will be printed and stored by the Inova PI. A copy of 
the consent will be given to the guardian.  
 
Participants will also be screened for eligibility during their well-child clinic visit at HWNV by the 
physician study PI. If guardian meets the study inclusion criteria, the PI will introduce the study to the guardian 
and ask if they would like more information.  
 
Families will decide if they have the capacity to participate in the x-HPC intervention. They will be 
offered both groups, but can choose which group works for their family. We realize that this introduces 
selection bias into the study (families who self select to be part of the intervention are families who are 
interested in health and have the time and ability to attend). However, the intervention takes a lot of time and 
families need to choose the arm that works for their schedule. 

 
 
2.7. Inclusion Criteria 
                 Inclusion criteria include:  
1. Child and Parent are clients at HealthWorks for Northern Virginia  
2. Child between the ages 6-12 years 
3. Child has a BMI percentage greater than 85% 
4. Primary parent or guardian is > 18 years of age 
5. Family identifies as Hispanic and Spanish is one of the primary languages spoken in the home 
6. Children will be living with the primary guardian or parent for the duration of the program  
7. Access to the internet  
8. Parent or guardian is willing to commit to engaging in the 12 week program 
 
2.8. Exclusion Criteria 
Exclusion criteria include:  
1. Family plans to change location within the year 
2. During initial screening for the study, the study PI determines that the intervention may exacerbate 
existing medical conditions of the child or the family.  
 
 
3. STUDY METHODS AND PROCEDURES 
 
3.1. Study Treatment/Intervention 
 
The purpose of this community-engaged quasi-experimental study is to determine whether family-
based, culturally tailored, virtual intervention enables and motivates parents and children (experimental 
group) to shape the weight-related aspects of their home environments and lifestyle behavioral practices 
(diet, exercise, screen behaviors) to be more supportive of their family’s optimal health and weight, 
compared to standard in-office counseling (comparison group). 
 
Intervention: This project builds on the success of an existing community-focused program called the 
IHPC.  Within the Inova Division of Population Health the IHPC aims to reduce obesity among low-
income children and prevent the future occurrence of heart disease/stroke, Type 2 Diabetes, and other 
related diseases. To date, IHPC has engaged more than 1,200 children in Northern Virginia in healthy-
eating interventions. Currently, this popular program is delivered in English, for 5-8 weeks, to children 
grades K - 8 in an afterschool setting.  
 
The proposed study will examine the effectiveness of an expanded IHPC (x-IHPC), which will be 
virtual, family-based, and specifically designed for low income Hispanic families in our community; all of 
which are evidence-based strategies for enhancing healthy eating interventions. Family-based interventions 
are not a novel approach to obesity reduction. Two decades of research shows that family-based 
interventions work better than individual interventions at reducing childhood obesity.13,14 When the IHPC 
moved to a virtual format due to COVID-19 in 2020, facilitators required parental home involvement. The 
anecdotal success of that family involvement has fueled the desire of IHPC to expand their programming to 
include more education and activities for parents.  
 
The x-IHPC will include 4 extra modules, (= 4 additional weeks of programming) that will be 
developed by a dietician curriculum specialist. The expanded IHPC will also include programming just for 
parents to increase their involvement. A key pillar of this study is identifying and training CHWs from 
HWNV to be Spanish-language facilitators of x-IHPC. Training these CHWs and including them in 
designing the x-IHPC curriculum will ensure that the programming is culturally appropriate; includes local 
features that relate directly to the community’s needs; and enables facilitators to respond effectively to the 
questions and learning needs of the parents and children involved in the program.  
 
IHPC provides produce boxes, nutrition and meal-preparation, education, and supportive counseling 
to address barriers related to obtaining produce and food. The intervention provides participants with a bi-
weekly produce box for 12 weeks (6 boxes total) and helps families identify sustainable ways to obtain 
vegetables once the produce boxes end. Providing produce boxes exposes families to new, unfamiliar 
vegetables that are not common in their home countries, and allows families to experiment with new 
recipes on a limited income. The CHW will support families by coaching them on how to prepare these 
unfamiliar vegetables, give tips on finding sales at grocery stores, as well as by navigation to food 
assistance sites including food pantries, school meal sites and bus routes, and neighborhood food 
distributions. Parents will learn strategies to increase vegetable consumption by addressing perceived 

 
 
barriers – such as the child doesn’t like vegetables. Curriculum will also include topics such as how to 
increase physical activity and reduce screen time. Both the families in the x-HPC and families who receive 
the in-office counseling will be offered the 6 vegetable food boxes, delivered on a bi-weekly basis during 
their time in the study.  
 
Families will decide if they have the capacity to participate in the x-HPC intervention. They will be 
offered both groups, but can choose which group works for their family. We realize that this introduces 
selection bias into the study (families who self select to be part of the intervention are families who are 
interested in health and have the time and ability to attend). However, the intervention takes a lot of time 
and families need to choose the arm that works for their schedule.  
 
3.2. Comparison Group  
 
A comparison group of similar families who receive standard nutrition, exercise, and weight-related 
lifestyle counseling during their regularly scheduled check-ups at HWNV will serve as the comparison 
group for this program. Both groups of children and guardians will receive standard in-office counseling, 
but the intervention group will also receive the x-IHPC intervention. Standard in-office counseling includes 
standard counseling related to diet, exercise, and screen behaviors,. The comparison group will also get 
food boxes.  
 
3.3. Randomization  
None 
 
3.4. Endpoints/Outcomes Measurements 
 
3.4.1.Primary outcomes. 
3.4.2. 
Primary outcomes measured via a survey, which will include food frequency questionnaires, screen time 
estimates, physical activity questionnaires, estimated screen time reports, and guardian self-efficacy and 
confidence questions related to modifiable lifestyle behaviors.15 16 17 Survey data will be collected during 
phone calls from the PI or CHW at the outset of the study and then again at the conclusion of the study. An 
example survey has been included (Appendix C: Survey). The survey questions may be altered or deleted 
based on feedback from the study advisory board or the CHWs, as this study is based on community 
engagement and feedback. The final survey instrument will be submitted to this IRB for approval before 
the data collection begins.  
 
3.4.3. Secondary outcomes 
BMI percentile of children and guardians enrolled in the study. This will be measured at each office visit by 
a trained medical assistant or the physician.  
 
3.5.    Consent/Assent 
Once a guardian has been screened as eligible for inclusion in the study, they will be approached by the 
physician PI and asked if they are interested in being part of the study. If they are interested, the PI will discuss 
whether they are interested in joining the comparison group or the intervention group. A  member of the study 
team will meet with the family virtually or in person and consent the guardian to be part of the study 
(Appendix D: Consent). This consent process will take place with a trained interpreter. The consent will be 
provided in both English and Spanish. The consent will be emailed to program participants prior to the 
 
15 Bryant, M. J., Ward, D. S., Hales, D., Vaughn, A., Tabak, R. G., & Stevens, J. (2008). Reliability and validity of the Healthy Home Survey: a 
tool to measure factors within homes hypothesized to relate to overweight in children. The international journal of behavioral nutrition and 
physical activity, 5, 23. https://doi.org/10.1186/1479-5868-5-23 
 
16 Schrempft, S., van Jaarsveld, C. H., Fisher, A., & Wardle, J. (2015). The Obesogenic Quality of the Home Environment: Associations with 
Diet, Physical Activity, TV Viewing, and BMI in Preschool Children. PloS one, 10(8), e0134490. https://doi.org/10.1371/journal.pone.0134490 
 
17 Kininmonth, A. R., Schrempft, S., Smith, A., Dye, L., Lawton, C., Fisher, A., Llewellyn, C., & Fildes, A. (2021). The Home Environment 
Interview and associations with energy balance behaviours and body weight in school-aged children - a feasibility, reliability, and validity 
study. The international journal of behavioral nutrition and physical activity, 18(1), 167. https://doi.org/10.1186/s12966-021-01235-3 

 
 
consent conversation when possible. Whether consent occurs virtually or in person, a hard copy of the 
consent will be printed and stored by the Inova PI. A copy of the consent will be given to the guardian. 
 
3.6.   Monitoring Subjects and Criteria for Withdrawal of Subjects from the Study.    
Study participants may leave the study at any time, without penalty. In some cases, the participant may be 
withdrawn if the HWNV physician PI determines that the study intervention is too burdensome for the 
participant or is adversely affecting the study participant’s health. If any study participant leaves the study 
or is withdrawn from the study, their data will not be used in analysis.  
 
4. STATISTICAL CONSIDERATIONS/DATA ANALYSIS 
 
4.1.   Sample Size   
In order to test the effectiveness of the x-IHPC intervention, outcomes from participants in this pilot study will 
be compared with outcomes from a comparison group of similar families who receive standard nutrition 
counseling during their regularly scheduled check-ups at HWNV. The team will enroll 25 children in the x-
IHPC intervention and the same number in the comparison group (n=50). Both groups of children and 
guardians will receive standard in-office counseling, but the intervention group will receive the x-IHPC.  
 
 
4.2.   Method of Data Analysis 
Analyses will follow the intention-to-treat principle, which categorizes participants by their 
treatment assignments regardless of adherence to the intervention or incomplete follow-up, and includes 
them in all analyses. Descriptive statistics will be calculated and reported as mean, standard deviation and 
95% confidence intervals for continuous variables and frequency and percentage for categorical variables. 
Characteristics of study participants will be compared at baseline between the intervention and control 
groups and tested for significance using the two-sample t-test for continuous variables and the Chi-square 
test for categorical variables. Comparisons that are significant at the P<0.10 level will be considered for 
inclusion in multivariable models for primary and secondary analyses given that participants will not be 
randomized to their respective treatment groups.  
Primary analyses will examine diet quality, screen time, physical activity, and guardian self-
efficacy and confidence of those in the intervention and control groups while controlling for the correlated 
nature of the repeated measures within participants (i.e. baseline, post-intervention, and 6-month post-
intervention). Secondary analyses will compare the BMI of guardians and BMI percentile of children at the 
three time points between the intervention and control groups. A longitudinal data analysis strategy will be 
employed with generalized estimating equations with robust CIs for both primary and secondary outcomes 
(Albert, 1999; Ma et al., 2012). A 2-sided p-value <0.05 will be accepted to indicate statistical significance. 
Additional analyses will be conducted to determine if results were influenced by other covariates including 
demographics (age, gender, educational attainment of guardian, income, etc.). All analyses will be 
conducted in SAS version 9.2.   
 
 
4.3.   Data Storage 
 
4.3.1. Data Management 
Information about study subjects will be kept confidential and managed according to the requirements of the 
Health Insurance Portability and Accountability Act of 1996 (HIPAA).  Privacy and confidentiality of all 
enrolled participants will be maintained.   
 
The PI and co-PI at HWNV will have an electronic list of participants who are part of the study so they can 
provide the standard in-office counseling and data collection. The list will be accessed only by them on a 
password-protected document that is stored on password-protected computers at HWNV.  
 Survey data collected during the study will be uploaded directly into a secure online platform, RedCap, by the 
CHW collecting the data. Only the study PIs will have access to this platform to manage data.  
 
 

 
 
 
4.3.2.   Records Retention 
Data will be stored electronically for six years in the secure online platform RedCap and on the password-protected 
computer of the PI Dr. Elyssa Wood. After three years the files will be permanently deleted.  
 
5. HUMAN SUBJECTS PROTECTION (RISKS, BENEFITS, AND    
ALTERNATIVES) 
 
5.1. Risks 
This study poses minimal physical or psychological risk to the study participants. There is a risk that guardians 
will find the intervention time-consuming. If the burden of the intervention becomes too great, the participant can 
leave the study with no consequences.  
 
Any adverse events related to the research study will be reported immediately to the IRB. Reportable events 
include any physical or psychological harm to any human that is related to the study intervention. Protocol 
deviations will also be reported to the IRB, including anything related to the study participants’ safety, rights, or 
integrity of the study data.  
 
 
 
5.2. 
Benefits   
The benefits to participating in this study include improved knowledge about modifiable lifestyle behaviors that 
effect healthy eating and weight. A second benefit to participating in the study is that families will receive 
complimentary vegetable food boxes (6 boxes, delivered every other week) for the duration of their time in the 
study.  
 
5.3.  Alternatives 
The alternative to participating in this research study is not to participate in the research study. There is no 
penalty to the eligible participants if they refuse to be part of the study or leave the study at any time.  
 
5.4. Confidentiality 
Every effort will take place to maintain the confidentiality of the study participants. Participants will be 
known to the physician study PI who is providing care during in-office clinic visits. Beside the PI and the 
co-PI at HWNV, no other HWNV staff member will have knowledge that the participant is part of the 
study. The PI and co-PI at HWNV will have an electronic list of participants who are part of the study, so 
they can provide the standard in-office counseling and data collection. The list will be accessed only by 
them on a password-protected document that is stored on password-protected computers at HWNV.  
 
Survey data collected during the study will be uploaded directly into a secured online platform, 
RedCap, by the CHW collecting the data. Only the Inova and the HWNV PIs, will have access to this 
platform to manage data. Data will be de-identified before it is shared with the statistician for analysis. De-
identification will occur by giving each participant a unique study ID. The document with participant 
names and unique study IDs will be kept on a password protected document on the Inova PI’s password-
protected computer.  
 
6. SUBJECT COMPENSATION    
6.1. Costs 
There are no costs to being part of this study except for the usual and expected costs of attending a routine clinic 
visit.  
 
6.2. Payment  
There is no payment for taking part in this study. However, families will receive complimentary vegetable 
food boxes (6 boxes, delivered every other week) for the duration of their time in the study. 
 

 
 
 
 
7. ADVERSE EVENT REPORTING   
There is very low risk of adverse events in this study. Any adverse events (such as an abnormal physical 
exam finding that may be temporally related to the participant’s involvement in the research) will be 
reported to the IRB immediately. Any unusual symptoms, actions, behaviors, or safety related events that 
occur during the study intervention activities will be reported immediately to the IRB. Any protocol 
deviations will be reported to the IRB immediately.  
 
8. FUNDING 
This study is supported in part by the National Center for Advancing Translational Sciences of the National 
Institutes of Health under Award Number UL1TR003015.  
 
9. CONFLICTS OF INTEREST  
There are no conflicts of interest from the PI or Co-PIs.  
10.   FACILITIES AND EQUIPMENT                                                          
In-office counseling will take place at the HWNV clinic building. The clinical building also supplies the 
computer equipment for the HWNV PI. The virtual platform (Zoom) and computer equipment for the x-IHPC 
comes from the Office of Community Engagement from the Inova health system. Storage for the boxes of x-
IHPC supplies is also provided through this office. The office space and computer for PI Wood is provided 
through Inova Health System.  
 
11.   OUTSIDE CONSULTANTS/COLLABORATORS   
The study statistician performing the data analysis is a consultant on this study. The statistician has a contract 
with the Inova Health System to provide statistical services.  
 
12. CONTRACTURAL AGREEMENTS      
The PI and co-PI from HWNV have a subrecipient agreement with Inova to partner on this research study.    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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LIST OF ABBREVIATIONS 
 
BMI 
Body mass index  
CDC 
Centers for Disease Control and Prevention 
CHW 
Community Health Workers 
co-PI  
Co-Principal Investigator 
COVID-19 Coronavirus disease 
H0 
Null hypothesis 
HA 
Alternative hypothesis 
HIPAA 
Health Insurance Portability and Accountability Act of 1996  
HWNV 
HealthWorks for Northern Virginia 
IHPC 
Inova Healthy Plate Club 
IDPH 
Inova Division of Population Health 
Inova 
Inova Health Services 
IRB 
Institutional Review Board 
PI 
Principal Investigator 
PRN 
Pro Re Nata position  
SAB 
Study Advisory Board  
x-IHPC 
expanded –Inova Healthy Plate Club   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
APPENDICES 
 
 
Appendix A: Study Flow Chart 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Appendix B: Example Recruitment Flyer  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
Appendix C: Study Survey 
 
 
Script and procedures f or administration of the Buen Provecho! Study Survey 
 
Adapted with permission from: Bryant, M. J., Ward, D. S., Hales, D., Vaughn, A., Tabak, R. G., & 
Stevens, J. (2008). Reliability and validity of the Healthy Home Survey: a tool to measure factors within 
homes hypothesized to relate to overweight in children. The international journal of behavioral nutrition 
and physical activity, 5, 23. https://doi.org/10.1186/1479-5868-5-23 
 
The script 
Administered By: 
Date: 
Start Time: 
 
CALL PARTICIPANT 
Good morning/evening. This is <your name>from <institute name>. Could I please speak to 
<participant name>? 
 
Hello <participant name>. We have received the form that you mailed to us with consent to take 
part in our family home study. As we described in the consent form, the first part of the study 
involves a telephone interview which should take approximately 15 minutes.  Is now a good time 
to conduct that interview with you? 
 
If no ….. No problem. I will try again using another time that you suggested might be alright on 
your availability form. Thank you. Goodbye. 
 
If yes….. Okay. I’ll begin with a few general questions and then move on to more specific 
questions about your family home environment. Please feel free to stop me at any point or ask 
me to clarify any questions that you don’t understand. There are no right or wrong answers. 
Please answer honestly. You are not being judged on any of your responses.