Testing a Web-Based Interactive Comic Tool to Decrease Obesity Risk Among Minority Preadolescents: Protocol for a Pilot Randomized Control Trial

Background Childhood obesity is a public health crisis, particularly in low-income, minority populations in the United States. Innovative and technology-enhanced interventions may be an engaging approach to reach at-risk youth and their parents to improve dietary behaviors and feeding practices. However, such tools are limited, especially ones that are theory-based; co-developed with user-centered approaches; tailored to low-income, minority preadolescents; and include parent-focused content. Objective The objectives of this study include assessing the feasibility and acceptability and exploring the potential impact of the Intervention INC (Interactive Nutrition Comics for urban, minority preadolescents) Web-based tool, which is focused on decreasing childhood obesity risk in black/African American and Latino children aged 9 to 12 years. Methods Intervention INC is underpinned by the narrative transportation theory, social cognitive theory, and health belief model, and it was co-developed by children and parents from the intended population. The child component consists of a 6-chapter interactive nutrition comic optimized for use on tablet devices, a goal-setting and self-assessment feature, and weekly text/email messages and reminders. The parental component consists of 6 Web-based newsletters, access to the child comic, and weekly text/email messages and reminders. The tool was evaluated using a pilot, single-blind, 2-group randomized controlled study design. Child-parent dyads were randomized to either the experimental or comparison group and assigned to a targeted behavior (increase fruit/vegetable or water intake) based on initial screening questions. Data were collected at 4 time points: baseline (T1), intervention midpoint (T2), intervention endpoint (T3), and 3 months postintervention (T4). Primary measures comprise usage, usability, and feasibility of the Web-based tool. Secondary measures comprise dietary knowledge, preferences, and intake and anthropometric measures (for child) and feeding practices and home food environment (for parent). Results Study enrollment was completed in November 2017. A total of 89 child-parent dyads were randomized to either the experimental (n=44) or comparison (n=45) group. Data analysis is currently being conducted. Conclusions This study aims to implement and assess an innovative approach to deliver health messages and resources to at-risk minority preadolescents and their parents. If found to be acceptable, engaging, feasible, and a potential approach to improve dietary behaviors, a full-fledged randomized controlled trial will be conducted to assess its efficacy and potential impact. Trial Registration ClinicalTrials.gov NCT03165474; https://clinicaltrials.gov/ct2/show/NCT03165474 (Archived by WebCite at http://www.webcitation.org/73122IjgP) International Registered Report Identifier (IRRID) RR1-10.2196/10682

1 R21 HS024117-01A1 3 HITR LEUNG, M minority, inner-city children ages 10 to 12, a high risk population for childhood obesity. The proposed study will examine usability and usefulness of the newly designed intervention, with the aim of enhancing its adoption, engagement and use, and explore the intervention's impact on knowledge, attitudes and food preferences related to childhood obesity risk. Intervention INC has strong public health relevance as it aims to not only reduce childhood obesity risk, but has significant long-term implications for improved overall quality of life and reduction of adult morbidity and mortality risk for the vulnerable urban minority population.

CRITIQUE NOTE:
The sections that follow are the essentially unedited, verbatim comments of the individual committee members assigned to review this application. The attached commentaries may not necessarily reflect the position of the reviewers at the close of group discussion, nor the final majority opinion of the group. The above RESUME/SUMMARY OF DISCUSSION represents the evaluation of the application by the entire committee.

CRITIQUE 1
Significance: 2 Investigator(s): 2 Innovation: 2 Approach: 4 Environment: 1 Overall Impact: Strengths Childhood obesity is an important public health problem in the US especially among lowincome, minority populations and is associated with significant short and long-term economic, physical, and psychosocial consequences, as well as increased child's risk of adult morbidity and mortality. While electronic interventions focused on childhood obesity prevention have been developed, sustainable results are limited. The applicant plans to address knowledge gaps in the usability and usefulness of HIT in changing behavior, including its potential for adoption, engagement, and sustained use, as well as its effectiveness in reducing childhood obesity. The applicant has addressed many of the concerns reviewers highlighted in the previous application that improve the study impact. The application includes a well-organized theoretical framework including the Human Centered (HC) approach, narrative-based approach using narrative transportation theory (NTT), and social cognitive theory (SCT), to develop the INC intervention.

Weaknesses
One element of the INC intervention relies on the parents to send encouragement message to their children. This assumes underserved parent participants have optimal knowledge and selfefficacy about obesity risk management to help their children achieve optimal behavior change.
Often parents are the problem of the child obesity despite education provided without any active intervention that also involves them. The intervention on the parent is underdeveloped. The intervention development, implementation, follow-up with multiple surveys seems very complex for the study population (children 10-12) and time consuming and there are concerns about feasibility of the project within 2 years.

Significance: Strengths
Childhood obesity is an important public health problem in the US especially among lowincome, minority populations and is associated with significant short and long-term economic, 1 R21 HS024117-01A1 4 HITR LEUNG, M physical, and psychosocial consequences, as well as increased child's risk of adult morbidity and mortality. The intervention to be designed will use the opportunity presented by children who are living in a multi-media environment (e.g. video games, computers and television) to capture their attention. If successful, the proposal can lead to a new approach of technology-based health promotion interventions to engage children in self-management of obesity. The investigators have experience with the field of study and provided strong preliminary data, which demonstrates their ability to engage children in such study and to successfully carry out the project.

Weaknesses
The intervention development, implementation, follow-up with multiple surveys seems complex for the study population (children 10-12) and time consuming, and there are concerns about feasibility of completing this project within 2 years.

Investigators: Strengths
The applicant (Dr. Leung) is Assistant Professor, Nutrition Program, City University of New York School of Public Health and Hunter College. She is an early stage investigator and applied nutrition interventionist, who has experience developing and evaluating innovative health communication and community-based interventions, to reduce childhood obesity risk in vulnerable, minority youth populations. She also has experience using community-based participatory research methods and tailoring of interventions to the needs and preferences of the intended population. The applicant is supported by Dr. Joshi, an experience researcher in Biomedical informatics. Dr. Allison Gorman is an Assistant Professor of Pediatrics, will act as a consultant for the project and the primary contact of the project at Weill Cornell Medical College (WCMC). She will provide consultation related to the clinical perspective in development and implementation of the intervention, as well as logistical support and assistance in subject recruitment efforts at WCMC.

Weaknesses
No weaknesses noted.

Innovation: Strengths
Use of narrative-based approach with comics related to lifestyle choices to increase persuasion to low income minority youth of the story's health messages using an online application seems innovative. Use of both NTT and SCT in the development of the INC intervention to enhance acceptability and use of the program.

Weaknesses
Comic like approach with avatar has been used in obesity, although previous studies have not included NTT.

Approach: Strengths
The project will use well organized interdisciplinary theoretical framework including the Human Centered (HC) approach, narrative-based approach using narrative transportation theory (NTT), and social cognitive theory (SCT) to involve potential users, develop the INC intervention and increase the likelihood of the application use and acceptance by children.
Use of a randomized control trial to test the effectiveness of the application is strong. Weaknesses 1 R21 HS024117-01A1 5 HITR LEUNG, M One element of the INC intervention relies on the parents to send encouragement message to their children. This assumes underserved parent participants have optimal knowledge and selfefficacy about obesity risk management to help their children achieve optimal behavior change. Often parents are the problem of the child obesity despite education provided without any active intervention that also involves them. The intervention on the parent is underdeveloped. The intervention development, implementation, follow-up with multiple surveys seems very complex for the study population (children 10-12) and time consuming and there are concerns about feasibility of the project within 2 years.

Environment: Strengths
The research environment of Hunter College of the City University of New York (CUNY) and The CUNY School of Public Health as well as of The Children's Aid Society (which operates a network of community centers, community schools, teen centers, early childhood centers, and medical, dental and mental health clinics in geographic pockets of poverty) throughout New York City, is excellent. The applicant has letters from involved organizations supporting the project. Collaboration with Weill Cornell Medical College is strong.

Weaknesses
No weaknesses noted.

Privacy and Security Protections in the Development and Implementation of Health IT System:
Addressed.

Protection of Human Subjects from Research Risks:
Acceptable.

Inclusion of Women and Minority Subjects: Acceptable. Strengths
This study targets low-income (both males and females) minority children 10-12 years of age.

Weaknesses
No weaknesses noted.

Inclusion of AHRQ Priority Populations:
Acceptable.

Degree of Responsiveness:
The application is responsive.
Budget and Period of Support: Acceptable.

Resubmission Applications: Strengths
The applicant has addressed many of the concerns reviewers highlighted in the previous application, including: accessibility of computers and internets in low-income populations, accessibility and availability of healthy food choice for the study population, rationale for targeting children 10-12 years old, difference between their intervention comics and avatars (which are not narrative), description on how they will improve the existing print form to computer-based intervention, methods to engage children in the focus group, addition of parental education about the intervention, previous success recruiting children in a study, specifying that study population criteria including use of BMI, assessment of child and parent literacy, assessment of barriers and facilitators of the intervention use, sample size calculation which consider attrition etc.

Weaknesses
No weaknesses noted.