Project GAME ON! A Digital Comic Tool to Promote Healthy Behaviors

Project GAME ON!: Empowering Urban Children to Engage in Healthy Behaviors to Reduce Obesity Risk Through an Interactive Digital Comic Tool

This clinical trial aims to evaluate an interactive, culturally relevant digital health promotion comic designed to support healthy dietary and physical activity behaviors among Black/African American and Latino children ages 8 to 12 years. The comic allows children's choices to affect the storyline and health content, with the goal of increasing engagement, empowering children, and improving attitudes, beliefs, and self-efficacy related to healthy behaviors. Caregivers will also receive newsletters reinforcing healthy dietary and physical activity behaviors at home.

The main questions it aims to answer are:

1. Does an interactive, customizable "choose-your-own-adventure" style comic lead to greater engagement and acceptability compared to standard digital comic formats?
2. Is greater engagement with the comic associated with improved self-efficacy related to dietary and physical activity behaviors? Researchers will compare three study groups to evaluate differences in engagement, acceptability, and self-efficacy outcomes related to dietary and physical activity behaviors.

Participants will:

• Use a 6-week digital comic and health promotion website remotely
• Complete surveys about engagement, attitudes, beliefs, and self-efficacy related to healthy behaviors
• Receive periodic reminders and support messages during the intervention period
• For caregivers in the enhanced and non-enhanced comic groups: receive newsletters promoting healthy dietary and physical activity behaviors at home

Study Overview

• Status: Not yet recruiting
• Conditions: Physical Activity; Childhood; Obesity & Overweight; Diet Habits; Engagement; Digital Health Intervention
• Intervention / Treatment: Behavioral: Web-based customizable comic and newsletters; Behavioral: Web-based comic and newsletters; Behavioral: Didactic health information

Detailed Description

The proposed study aims to develop and evaluate the usability, acceptability, engagement, and preliminary effectiveness of a customizable, 6-week interactive digital health promotion comic tool for Black/African American and Latino children ages 8 to 12 years. The intervention is designed to promote self-efficacy related to healthy dietary and physical activity behaviors through an interactive, culturally relevant, family-centered web-based platform.

A previous version of the tool was developed through an R21 grant from the Agency for Healthcare Research and Quality (AHRQ). Building on this prior work, the current study will develop a new six-chapter intervention comic available in both a standard and enhanced interactivity format, in which children's choices influence the storyline and health-related content.

In the first phase of the study (Aim 1), usability testing will be conducted with children from the intended audience to evaluate the enhanced interactive comic format and identify strengths, weaknesses, and areas for refinement related to navigation, comprehension, engagement, and overall user experience.

In the second phase of the study (Aim 2), a three-group pilot randomized controlled trial (30 parent-child dyads per arm) with a 6-week intervention period and 3-month follow-up will be conducted to assess engagement and acceptability of the enhanced comic structure and explore the association between engagement and self-efficacy related to dietary and physical activity behaviors. Participants will be randomized to one of three conditions: an enhanced interactive comic intervention with caregiver newsletters, a standard comic intervention with caregiver newsletters, or a comparison condition consisting of child newsletters only. Caregiver newsletters provided in the intervention groups will reinforce healthy dietary and physical activity behaviors at home.

This study evaluates an innovative digital health communication approach designed to increase accessibility and engagement among an underserved and diverse pediatric population. Findings from this study may help inform future digital health interventions aimed at promoting healthy behaviors and reducing long-term chronic disease risk among children.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: May May Leung, PhD, RDN; Phone Number: 617-636-3676; Email: maymay.leung@tufts.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria (child):

• Self-identifies as Black/AA and/or Latino
• Between the ages of 8 and 12 (preadolescents) at the time enrollment
• Reads and speaks in English
• Has regular internet access via a tablet device, smartphone, or computer/laptoP
• Has regular access to a phone with texting capability
• Is comfortable reading/viewing material on electronic devices
• Is comfortable speaking with study staff about thoughts/experiences while participating in the study
• Is part of a household with low income
• Resides in New York City
• At least one of their current diet and PA-related behaviors do not meet the current recommendations for a healthy lifestyle
• Has a legal parent/guardian willing to participate in the study

Inclusion Criteria (parent)

• Legal parent/guardian of child willing to participate in the study
• Reads and speaks in English or Spanish
• Primarily responsible for preparing/purchasing food for child
• Has regular internet access via a tablet device, smartphone, or computer/laptop
• Has regular access to a phone with texting capability
• Comfortable reading/viewing material on electronic devices
• Able to complete online questionnaires with their child over the full duration of the study
• Is part of a household with low income
• Resides in New York City.

Exclusion Criteria (child):

• has allergies, food aversions, food disorders, or medications with side-effects that may impact participation in study
• has a pacemaker or heart condition
• in foster care

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced Comic; Children in the Enhanced Comic Group (E) will receive access to a theory-guided, family-centered, web-based tool promoting healthy diet behaviors that includes a 6-chapter comic with customizable features, including main character customization and user-selected options to determine the main character's actions and storyline. Parents of children in this group will receive a digital newsletter.	Behavioral: Web-based customizable comic and newsletters; Web-based customizable comic and health messages (child component) and health newsletters (parent component)
Active Comparator: Non-enhanced Comic; The children in the Non-enhanced Comic Group will receive the same comic as children in the E group, but with a default main character and storyline (no user-selected options). Parents of children in this group will receive the same digital newsletter as parents of children in the E group	Behavioral: Web-based comic and newsletters; Web-based standard (non-customizable) comic and health messages (child component) and health newsletters (parent component)
Active Comparator: Comparison; Children in the Comparison group will receive the web-based newsletters focused on promoting healthy diet behaviors.	Behavioral: Didactic health information; Web-based newsletters child only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Engagement - Number of Weeks With at Least One Session	Child engagement will be assessed based on the number of intervention weeks during which the child has at least one session on the intervention website. Children with at least one session during 4-6 of the 6 intervention weeks will be categorized as having high engagement, and children with at least one session during 0-3 weeks will be categorized as having low engagement.	Tool usage will be tracked for the 6-week intervention period.
Child Engagement - Average Session Length	Child engagement will be assessed based on the average length of sessions on intervention website. An average session length of 20 minutes or more will be categorized as high engagement, and an average session length of less than 20 minutes will be categorized as low engagement.	Tool usage will be tracked for the 6-week intervention period.
Child Engagement - Interactive Features	Child engagement will be assessed based on the number of intervention weeks during which the child completes at least 5 interactive features. Interactive features include clickable health-message pop-ups, goal selection, and goal self-assessment. Children who complete at least 5 interactive features during 4-6 of the 6 intervention weeks will be categorized as having high engagement, and children who meet this threshold during 0-3 weeks will be categorized as having low engagement.	Tool usage will be tracked for the 6-week intervention period.
Parent Engagement - Number of Weeks With at Least One Session	Parent engagement will be assessed based on the number of intervention weeks during which the parent has at least one session on the intervention website. Parents with at least one session during 4-6 of the 6 intervention weeks will be categorized as having high engagement, and parents with at least one session during 0-3 weeks will be categorized as having low engagement.	Tool usage will be tracked for the 6-week intervention period.
Parent Engagement - Average Session Length	Parent engagement will be assessed based on the average length of intervention sessions during the 6-week intervention period. An average session length of 15 minutes or more will be categorized as high engagement, and an average session length of less than 15 minutes will be categorized as low engagement.	Tool usage will be tracked for the 6-week intervention period.
Parent Engagement -Interactive Features	Parent engagement will be assessed based on the number of intervention weeks during which the parent completes both available interactive features: goal setting and goal self-assessment. Parents who complete both interactive features during 4-6 of the 6 intervention weeks will be categorized as having high engagement, and parents who complete both features during 0-3 weeks will be categorized as having low engagement.	Tool usage will be tracked for the 6-week intervention period.
Child Website Usability	Child website usability will be measured using 10 items adapted from the SUS Questionnaire. The items assess perceived website usability and ease of use. Response options are on a 5-point scale (1=Strongly Disagree to 5=Strongly Agree). Item responses will be averaged to produce a mean score ranging from 1 to 5, with higher scores indicating greater perceived website usability.	T2 (intervention mid-point, 3-weeks post-baseline) and T3 (intervention endpoint, 6-weeks post-baseline)
Child Website Acceptance and Satisfaction	Child website acceptance and satisfaction will be assessed using 2 items adapted from the USE Questionnaire measuring enjoyment of the website and willingness to recommend the website to a friend. Response options are on a 5-point scale (1 = Strongly Disagree to 5 = Strongly Agree). Higher scores indicate greater website acceptance and satisfaction.	T2 (intervention mid-point, 3-weeks post-baseline) and T3 (intervention endpoint, 6-weeks post-baseline)
Parent Website Usability	Parent website usability will be measured using 9 items, including items adapted from the SUS, USE, and PSSUQ Questionnaires. The items assess website usability, usefulness, and ease of use. Response options are on a 5-point scale (1=Strongly Disagree to 5=Strongly Agree). Item responses will be averaged to produce a mean score ranging from 1 to 5, with higher scores indicating greater perceived website usability.	T2 (intervention mid-point, 3-weeks post-baseline) and T3 (intervention endpoint, 6-weeks post-baseline)
Parent Website Acceptance and Satisfaction	Parent website acceptance and satisfaction will be assessed using 2 items adapted from the USE Questionnaire measuring satisfaction with the website and willingness to recommend the website to a friend. Response options are on a 5-point scale (1 = Strongly Disagree to 5 = Strongly Agree). Higher scores indicate greater website acceptance and satisfaction.	T2 (intervention mid-point, 3-weeks post-baseline) and T3 (intervention endpoint, 6-weeks post-baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Dietary Self-Efficacy	Child participants will complete a 10-item questionnaire informed by and modified from the validated ProChildren and Reynolds questionnaires on self-efficacy related to behaviors associated with fruits, vegetables, water, junk food, and sugary drinks. Response options are on a 5-point scale (1=Strongly Disagree to 5=Strongly Agree). Higher scores indicate better outcomes.	T1 (baseline), T2 (intervention mid-point, 3-weeks post-baseline), T3 (intervention endpoint, 6-weeks post-baseline), T4 (follow-up, 3-months post intervention)
Child Dietary Knowledge	Child dietary knowledge will be assessed using 6 items, including 4 items from the ProChildren and Reynolds questionnaires and 2 internally developed items. Items assess knowledge related to fruit, vegetable, and water intake. Response options are on a 5-point scale (1 = Strongly Disagree to 5 = Strongly Agree). Higher scores indicate better outcomes.	T1 (baseline), T2 (intervention mid-point, 3-weeks post-baseline), T3 (intervention endpoint, 6-weeks post-baseline), T4 (follow-up, 3-months post intervention)
Child Dietary Outcome Expectations	Child dietary outcome expectations will be assessed using 15 items from or adapted from the ProChildren and Reynolds questionnaires assessing outcome expectations related to fruit, vegetable, water, junk food, and and sugary drink intake. Response options are on a 5-point scale (1 = Strongly Disagree to 5 = Strongly Agree). Higher scores indicate better outcomes.	T1 (baseline), T2 (intervention mid-point, 3-weeks post-baseline), T3 (intervention endpoint, 6-weeks post-baseline), T4 (follow-up, 3-months post intervention)
Child Dietary Behavioral Intentions	Child dietary behavioral intentions will be assessed using 8 items adapted from the ProChildren Questionnaire. Items assess intentions related to fruit, vegetable, water, junk food, and sugary drink intake. Response options are on a 5-point scale (1 = Strongly Disagree to 5 = Strongly Agree). Higher scores indicate better outcomes.	T1 (baseline), T2 (intervention mid-point, 3 weeks post-baseline), T3 (intervention endpoint, 6 weeks post-baseline), T4 (follow-up, 3 months post-intervention)
Child Dietary Attitudes and Beliefs	Child dietary attitudes and beliefs will be assessed using 10 items adapted from the ProChildren Questionnaire. Items assess attitudes and beliefs related to fruit, vegetable, water, junk food, and sugary drinks. Response options are on a 5-point scale (1 = Strongly Disagree to 5 = Strongly Agree). Higher scores indicate better outcomes.	T1 (baseline), T2 (intervention mid-point, 3 weeks post-baseline), T3 (intervention endpoint, 6 weeks post-baseline), T4 (follow-up, 3 months post-intervention)
Child Dietary Intake	Child dietary intake will be assessed using 10 items adapted from the YRBSS Questionnaire and the Beverage and Snack Questionnaire. Items assess intake of fruit, vegetables, junk food, sugary drinks, and water.	T1 (baseline), T2 (intervention mid-point, 3-weeks post-baseline), T3 (intervention endpoint, 6-weeks post-baseline), T4 (follow-up, 3-months post intervention)
Child Physical Activity Self-Efficacy	Child participants will complete a 4-item questionnaire informed by the PASE Questionnaire on self-efficacy related to behaviors associated with physical activity. Response options are on a 5-point scale (1=Strongly Disagree to 5=Strongly Agree). Higher scores indicate better outcomes.	T1 (baseline), T2 (intervention mid-point, 3-weeks post-baseline), T3 (intervention endpoint, 6-weeks post-baseline), T4 (follow-up, 3-months post intervention)
Child Physical Activity Knowledge	Child physical activity knowledge will be assessed using 2 internally developed items. Response options are on a 5-point scale (1 = Strongly Disagree to 5 = Strongly Agree). Higher scores indicate better outcomes.	[Time Frame: T1 (baseline), T2 (intervention mid-point, 3-weeks post-baseline), T3 (intervention endpoint, 6-weeks post-baseline), T4 (follow-up, 3-months post intervention)]
Child Physical Activity Outcome Expectations	Child physical activity outcome expectations will be assessed using 3 items from or adapted from the Social-Cognitive Measures for Physical Activity Questionnaire. Items assess outcome expectations related to physical activity. Response options are on a 5-point scale (1 = Strongly Disagree to 5 = Strongly Agree). Higher scores indicate better outcomes.	T1 (baseline), T2 (intervention mid-point, 3-weeks post-baseline), T3 (intervention endpoint, 6-weeks post-baseline), T4 (follow-up, 3-months post intervention)
Child Physical Activity Behavioral Intentions	Child physical activity behavioral intentions will be assessed using 10 items adapted from the ProChildren Questionnaire. Response options are on a 5-point scale (1 = Strongly Disagree to 5 = Strongly Agree). Higher scores indicate better outcomes.	T1 (baseline), T2 (intervention mid-point, 3 weeks post-baseline), T3 (intervention endpoint, 6 weeks post-baseline), T4 (follow-up, 3 months post-intervention)
Child Physical Activity Attitudes and Beliefs	Child physical activity attitudes and beliefs will be assessed using 2 items adapted from the ProChildren Questionnaire. Response options are on a 5-point scale (1 = Strongly Disagree to 5 = Strongly Agree). Higher scores indicate better outcomes.	T1 (baseline), T2 (intervention mid-point, 3 weeks post-baseline), T3 (intervention endpoint, 6 weeks post-baseline), T4 (follow-up, 3 months post-intervention)
Child Physical Activity	Child physical activity and sedentary behavior will be assessed using 5 items, including 3 items from the YRBSS and 2 internally developed items. Items assess the number of days children are physically active for at least 60 minutes, frequency of physical activity on school and weekend days, and screen time on school and weekend days.	T1 (baseline), T2 (intervention mid-point, 3 weeks post-baseline), T3 (intervention endpoint, 6 weeks post-baseline), T4 (follow-up, 3 months post-intervention)
Child - Identification	Identification will be assessed using a 2-item scale adapted from Cohen et al.'s Identification Scale. Items assess the extent to which participants identify with and relate to the main character in the story. Response options are on a 5-point scale (1 = Strongly Disagree to 5 = Strongly Agree), with higher scores indicating greater identification.	T2 (intervention mid-point, 3-weeks post-baseline) and T3 (intervention endpoint, 6-weeks post-baseline)
Child - Narrative Transportation	5-item scale adapted from the Transportation Scale -Short Form. Items assess the extent to which participants become mentally and emotionally absorbed and immersed in the story. Response options are on a 5-point scale (1 = Strongly Disagree to 5= Strongly Agree), with higher scores indicating greater narrative transportation.	T2 (intervention mid-point, 3-weeks post-baseline) and T3 (intervention endpoint, 6-weeks post-baseline)
Parent Feeding Practices	Parent feeding practices will be assessed using 25 items informed by the the Comprehensive Feeding Practices Questionnaire questionnaire. Items assess parent practices that support healthy dietary intake, including discussing healthy behaviors with the child, providing opportunities and resources for healthy behaviors, encouraging healthy choices, involving the child in food-related activities, modeling healthy behaviors, and confidence in discussing healthy behaviors with the child. Response options are on a 5-point scale (1=Strongly Disagree to 5=Strongly Agree). Higher scores indicate better outcomes.	T1 (baseline), T2 (intervention mid-point, 3-weeks post-baseline), T3 (intervention endpoint, 6-weeks post-baseline), T4 (follow-up, 3-months post intervention)
Parent Physical Activity Practices	Parent physical activity practices will be assessed using 8 items informed by the ACTS-MG questionnaire. Items assess parent practices that support physical activity, including discussing physical activity with the child, providing opportunities and resources for physical activity, encouraging physical activity, modeling physical activity and confidence in discussing physical activity with the child. Response options are on a 5-point scale (1=Strongly Disagree to 5=Strongly Agree). Higher scores indicate better outcomes.	T1 (baseline), T2 (intervention mid-point, 3-weeks post-baseline), T3 (intervention endpoint, 6-weeks post-baseline), T4 (follow-up, 3-months post intervention)
Parent Perspective - Home Food Environment	Parent-reported home food environment will be assessed using 10 items from or adapted from the ProChildren Questionnaire and the Home Environment Survey. Items assess the availability and accessibility of fruits, vegetables, water, junk food, and sugary drinks in the home. Higher scores indicate better outcomes.	T1 (baseline), T2 (intervention mid-point, 3-weeks post-baseline), T3 (intervention endpoint, 6-weeks post-baseline), T4 (follow-up, 3-months post intervention)
Child Perspective - Home Food Environment	Child-reported home food environment will be assessed using 5 items from or adapted from the ProChildren Questionnaire. Items assess the availability fruits, vegetables, water, junk food, and sugary drinks in the home. Higher scores indicate better outcomes.	T1 (baseline), T2 (intervention mid-point, 3-weeks post-baseline), T3 (intervention endpoint, 6-weeks post-baseline), T4 (follow-up, 3-months post intervention)

Collaborators and Investigators

• Sponsor: Tufts University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); POPCOM HEALTH INC

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: August 24, 2026
• First Submitted That Met QC Criteria: September 10, 2026
• First Posted (Actual): September 15, 2026

Study Record Updates

• Last Update Posted (Actual): September 15, 2026
• Last Update Submitted That Met QC Criteria: September 10, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Behavior, Animal; Overweight; Obesity; Motor Activity; Feeding Behavior
• Other Study ID Numbers: STUDY00006271; R41MD020611 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No