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

NCT07820735 | Not Yet Recruiting

• 2 other identifiers: STUDY00006271R41MD020611
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

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:

• 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

Conditions

Childhood; Diet Habits; Engagement; Physical Activity; Digital Health Intervention; Obesity & Overweight

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (18)

• Child Dietary Self-Efficacy

  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

  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

  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

  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

  T1 (baseline), T2 (intervention mid-point, 3 weeks post-baseline), T3 (intervention endpoint, 6 weeks post-baseline), T4 (follow-up, 3 months post-intervention)

Study Arms (3)

Enhanced Comic

EXPERIMENTAL

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

Non-enhanced Comic

ACTIVE COMPARATOR

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

Comparison

ACTIVE COMPARATOR

Children in the Comparison group will receive the web-based newsletters focused on promoting healthy diet behaviors.

Behavioral: Didactic health information

Interventions

Web-based customizable comic and newsletters BEHAVIORAL

Web-based customizable comic and health messages (child component) and health newsletters (parent component)

Enhanced Comic

Didactic health information BEHAVIORAL

Web-based newsletters child only

Comparison

Web-based comic and newsletters BEHAVIORAL

Web-based standard (non-customizable) comic and health messages (child component) and health newsletters (parent component)

Non-enhanced Comic

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts University: lead
• POPCOM HEALTH INC: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

MeSH Terms

Conditions

Obesity; Overweight; Feeding Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Central Study Contacts

May May Leung, PhD, RDN

CONTACT

617-636-3676; maymay.leung@tufts.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Chair, Division of Nutrition Interventions, Communication, and Entrepreneurship

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 15, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share