An interventional study of Web-based customizable comic and newsletters and Didactic health information and newsletters in Obesity & Overweight, Childhood and Diet Habits, sponsored by Tufts University. Not yet recruiting. Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Tufts University · Not applicable, Interventional, and Prevention
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:
Participants will:
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 180 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Tufts University is the lead sponsor of 228 studies on the registry; 23 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
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The criteria were revised on the registry on Oct 22, 2026. See what changed
Inclusion Criteria (child):
Inclusion Criteria (parent)
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
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
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.
Behavioral: Didactic health information and newsletters
Web-based customizable comic and health messages (child component) and health newsletters (parent component)
Web-based health newsletters for child and parent
Web-based standard (non-customizable) comic and health messages (child component) and health newsletters (parent component)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: T2 (intervention mid-point, 3-weeks post-baseline) and T3 (intervention endpoint, 6-weeks post-baseline)
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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: [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.
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
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.
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
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.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
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
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.
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
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.
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
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.
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)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Mar 2027, 4 months later.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 4 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 22, 2026: start Sep 2026 → Nov 2026 and primary completion Apr 2027 → Mar 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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