Obesity & OverweightNCT07820735
Project GAME ON! A Digital Comic Tool to Promote Healthy Behaviors
A study testing Web-based customizable comic and newsletters, Didactic health information and newsletters and Web-based comic and newsletters in people with Obesity & Overweight and Childhood, run by Tufts University.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity & Overweight, Childhood, Diet Habits
- What is being tested?
- Web-based customizable comic and newsletters, Didactic health information and newsletters and Web-based comic and newsletters
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 17Show fewer
- Is comfortable speaking with study staff about thoughts/experiences while participating in the study
- Resides in a under-resourced US urban neighborhood
- 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
- 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
- Resides in a under-resourced US urban neighborhood
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
Read more
- Does an interactive, customizable "choose-your-own-adventure" style comic lead to greater engagement and acceptability compared to standard digital comic formats?
- 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
Read the 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.
- Conditions
- Obesity & Overweight, Childhood, Diet Habits, Engagement, Physical Activity, Digital Health Intervention
- Being tested
- Web-based customizable comic and newsletters, Didactic health information and newsletters, Web-based comic and newsletters
- Medical subject headings
- Obesity, Overweight, Feeding Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based customizable comic and newslettersBehavioural
Web-based customizable comic and health messages (child component) and health newsletters (parent component)
Didactic health information and newslettersBehavioural
Web-based health newsletters for child and parent
Web-based comic and newslettersBehavioural
Web-based standard (non-customizable) comic and health messages (child component) and health newsletters (parent component)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Parents of children in this group will receive the same digital newsletter as parents of children in the other two groups. Receives: Behavioral: Didactic health information and newsletters |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: T2 (intervention mid-point, 3-weeks post-baseline) and T3 (intervention endpoint, 6-weeks post-baseline)
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: [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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: T1 (baseline), T2 (intervention mid-point, 3-weeks post-baseline), T3 (intervention endpoint, 6-weeks post-baseline), T4 (follow-up, 3-months post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- POPCOM HEALTH INC, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Maymay Leung, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820735
- Sponsor's protocol ID
- STUDY00006271
- Other IDs
- R41MD020611
- Status last verified
- Oct 2026
- First submitted
- 24 Aug 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project GAME ON!: Empowering Urban Children to Engage in Healthy Behaviors to Reduce Obesity Risk Through an Interactive Digital Comic Tool
- ClinicalTrials.gov ID
- NCT07820735
- Acronym / sponsor ID
- STUDY00006271
- Conditions
- Obesity & Overweight, Childhood, Diet Habits, Engagement, Physical Activity, Digital Health Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- POPCOM HEALTH INC, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does an interactive, customizable "choose-your-own-adventure" style comic lead to greater engagement and acceptability compared to standard digital comic formats?
- 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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enhanced Comic | Experimental | Behavioral: Web-based customizable comic and newslettersChildren 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. |
| Non-enhanced Comic | Active comparator | Behavioral: Web-based comic and newslettersThe 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 |
| Comparison | Active comparator | Behavioral: Didactic health information and newslettersChildren in the Comparison group will receive the web-based newsletters focused on promoting healthy diet behaviors. Parents of children in this group will receive the same digital newsletter as parents of children in the other two groups. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based customizable comic and newslettersWeb-based customizable comic and health messages (child component) and health newsletters (parent component) | Behavioural | Enhanced Comic |
| Didactic health information and newslettersWeb-based health newsletters for child and parent | Behavioural | Comparison |
| Web-based comic and newslettersWeb-based standard (non-customizable) comic and health messages (child component) and health newsletters (parent component) | Behavioural | Non-enhanced Comic |
Primary outcome
Child Engagement - Number of Weeks With at Least One Session
Time frame: Tool usage will be tracked for the 6-week intervention period.
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.
Child Engagement - Average Session Length
Time frame: Tool usage will be tracked for the 6-week intervention period.
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.
Child Engagement - Interactive Features
Time frame: Tool usage will be tracked for the 6-week intervention period.
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.
Parent Engagement - Number of Weeks With at Least One Session
Time frame: Tool usage will be tracked for the 6-week intervention period.
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.
Parent Engagement - Average Session Length
Time frame: Tool usage will be tracked for the 6-week intervention period.
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.
Parent Engagement -Interactive Features
Time frame: Tool usage will be tracked for the 6-week intervention period.
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.
Child Website Usability
Time frame: T2 (intervention mid-point, 3-weeks post-baseline) and T3 (intervention endpoint, 6-weeks post-baseline)
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.
Child Website Acceptance and Satisfaction
Time frame: T2 (intervention mid-point, 3-weeks post-baseline) and T3 (intervention endpoint, 6-weeks post-baseline)
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.
Parent Website Usability
Time frame: T2 (intervention mid-point, 3-weeks post-baseline) and T3 (intervention endpoint, 6-weeks post-baseline)
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.
Parent Website Acceptance and Satisfaction
Time frame: T2 (intervention mid-point, 3-weeks post-baseline) and T3 (intervention endpoint, 6-weeks post-baseline)
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.
18 secondary outcomes
Child Dietary Self-Efficacy
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 Dietary Knowledge
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 Dietary Outcome Expectations
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 Dietary Behavioral Intentions
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 Dietary Attitudes and Beliefs
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 Dietary Intake
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 Self-Efficacy
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 Knowledge
Time frame: [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
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 Behavioral Intentions
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 Attitudes and Beliefs
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
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 - Identification
Time frame: T2 (intervention mid-point, 3-weeks post-baseline) and T3 (intervention endpoint, 6-weeks post-baseline)
Child - Narrative Transportation
Time frame: T2 (intervention mid-point, 3-weeks post-baseline) and T3 (intervention endpoint, 6-weeks post-baseline)
Parent Feeding Practices
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)
Parent Physical Activity Practices
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)
Parent Perspective - Home Food Environment
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 Perspective - Home Food Environment
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based customizable comic and newsletters, Didactic health information and newsletters and Web-based comic and newsletters in people with Obesity & Overweight and Childhood, run by Tufts University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact May May Leung, PhD, RDN (617-636-3676, maymay.leung@tufts.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Engagement - Number of Weeks With at Least One Session (time frame: Tool usage will be tracked for the 6-week intervention period.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.