Project GAME ON!: Empowering Urban Children to Engage in Healthy Behaviors to Reduce Obesity Risk Through an Interactive Digital Comic Tool
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 主要终点
- Child Engagement - Number of Weeks With at Least One Session
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Web-based customizable comic and newsletters (Behavioral)
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
干预措施: Web-based comic and newsletters (Behavioral)
Comparison
Children in the Comparison group will receive the web-based newsletters focused on promoting healthy diet behaviors.
干预措施: Didactic health information (Behavioral)
结局指标
主要结局
Child Engagement - Number of Weeks With at Least One Session
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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))
- Child Dietary Intake(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(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: 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(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(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(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(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(T2 (intervention mid-point, 3-weeks post-baseline) and T3 (intervention endpoint, 6-weeks post-baseline))
- Child - Narrative Transportation(T2 (intervention mid-point, 3-weeks post-baseline) and T3 (intervention endpoint, 6-weeks post-baseline))
- Parent Feeding Practices(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(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(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(T1 (baseline), T2 (intervention mid-point, 3-weeks post-baseline), T3 (intervention endpoint, 6-weeks post-baseline), T4 (follow-up, 3-months post intervention))
研究者
Maymay Leung
Associate Professor and Chair, Division of Nutrition Interventions, Communication, and Entrepreneurship
Tufts University