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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-12
SponsorTufts University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Web-based customizable comic and newsletters

    Behavioral

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

  • Didactic health information

    Behavioral

    Web-based newsletters child only

  • Web-based comic and newsletters

    Behavioral

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

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Enhanced ComicExperimental treatment 1 intervention
Group B: Non-enhanced ComicActive comparator 1 intervention
Group C: ComparisonActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.
2

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.
3

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.
4

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.

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tufts University

Lead sponsor

POPCOM HEALTH INC

Collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: