Project GAME ON! A Digital Comic Tool to Promote Healthy Behaviors
10 de septiembre de 2026 actualizado por: Maymay Leung, Tufts University
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:
- 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
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
180
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: May May Leung, PhD, RDN
- Número de teléfono: 617-636-3676
- Correo electrónico: maymay.leung@tufts.edu
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria (child):
- 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.
Exclusion Criteria (child):
- 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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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Web-based customizable comic and health messages (child component) and health newsletters (parent component)
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Comparador activo: 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
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Web-based standard (non-customizable) comic and health messages (child component) and health newsletters (parent component)
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Comparador activo: Comparison
Children in the Comparison group will receive the web-based newsletters focused on promoting healthy diet behaviors.
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Web-based newsletters child only
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Child Engagement - Number of Weeks With at Least One Session
Periodo de tiempo: Tool usage will be tracked for the 6-week intervention period.
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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.
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Tool usage will be tracked for the 6-week intervention period.
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Child Engagement - Average Session Length
Periodo de tiempo: 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.
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Tool usage will be tracked for the 6-week intervention period.
|
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Child Engagement - Interactive Features
Periodo de tiempo: 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.
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Tool usage will be tracked for the 6-week intervention period.
|
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Parent Engagement - Number of Weeks With at Least One Session
Periodo de tiempo: 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.
|
Tool usage will be tracked for the 6-week intervention period.
|
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Parent Engagement - Average Session Length
Periodo de tiempo: 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.
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Tool usage will be tracked for the 6-week intervention period.
|
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Parent Engagement -Interactive Features
Periodo de tiempo: 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.
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Tool usage will be tracked for the 6-week intervention period.
|
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Child Website Usability
Periodo de tiempo: 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.
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T2 (intervention mid-point, 3-weeks post-baseline) and T3 (intervention endpoint, 6-weeks post-baseline)
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Child Website Acceptance and Satisfaction
Periodo de tiempo: T2 (intervention mid-point, 3-weeks post-baseline) and T3 (intervention endpoint, 6-weeks post-baseline)
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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.
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T2 (intervention mid-point, 3-weeks post-baseline) and T3 (intervention endpoint, 6-weeks post-baseline)
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Parent Website Usability
Periodo de tiempo: T2 (intervention mid-point, 3-weeks post-baseline) and T3 (intervention endpoint, 6-weeks post-baseline)
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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.
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T2 (intervention mid-point, 3-weeks post-baseline) and T3 (intervention endpoint, 6-weeks post-baseline)
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Parent Website Acceptance and Satisfaction
Periodo de tiempo: 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.
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T2 (intervention mid-point, 3-weeks post-baseline) and T3 (intervention endpoint, 6-weeks post-baseline)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Child Dietary Self-Efficacy
Periodo de tiempo: 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 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.
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T1 (baseline), T2 (intervention mid-point, 3-weeks post-baseline), T3 (intervention endpoint, 6-weeks post-baseline), T4 (follow-up, 3-months post intervention)
|
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Child Dietary Knowledge
Periodo de tiempo: 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 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.
|
T1 (baseline), T2 (intervention mid-point, 3-weeks post-baseline), T3 (intervention endpoint, 6-weeks post-baseline), T4 (follow-up, 3-months post intervention)
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Child Dietary Outcome Expectations
Periodo de tiempo: 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 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.
|
T1 (baseline), T2 (intervention mid-point, 3-weeks post-baseline), T3 (intervention endpoint, 6-weeks post-baseline), T4 (follow-up, 3-months post intervention)
|
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Child Dietary Behavioral Intentions
Periodo de tiempo: 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 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.
|
T1 (baseline), T2 (intervention mid-point, 3 weeks post-baseline), T3 (intervention endpoint, 6 weeks post-baseline), T4 (follow-up, 3 months post-intervention)
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Child Dietary Attitudes and Beliefs
Periodo de tiempo: 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 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.
|
T1 (baseline), T2 (intervention mid-point, 3 weeks post-baseline), T3 (intervention endpoint, 6 weeks post-baseline), T4 (follow-up, 3 months post-intervention)
|
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Child Dietary Intake
Periodo de tiempo: 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 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.
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T1 (baseline), T2 (intervention mid-point, 3-weeks post-baseline), T3 (intervention endpoint, 6-weeks post-baseline), T4 (follow-up, 3-months post intervention)
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Child Physical Activity Self-Efficacy
Periodo de tiempo: 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 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.
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T1 (baseline), T2 (intervention mid-point, 3-weeks post-baseline), T3 (intervention endpoint, 6-weeks post-baseline), T4 (follow-up, 3-months post intervention)
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Child Physical Activity Knowledge
Periodo de tiempo: [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 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: T1 (baseline), T2 (intervention mid-point, 3-weeks post-baseline), T3 (intervention endpoint, 6-weeks post-baseline), T4 (follow-up, 3-months post intervention)]
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Child Physical Activity Outcome Expectations
Periodo de tiempo: 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 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.
|
T1 (baseline), T2 (intervention mid-point, 3-weeks post-baseline), T3 (intervention endpoint, 6-weeks post-baseline), T4 (follow-up, 3-months post intervention)
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Child Physical Activity Behavioral Intentions
Periodo de tiempo: 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 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.
|
T1 (baseline), T2 (intervention mid-point, 3 weeks post-baseline), T3 (intervention endpoint, 6 weeks post-baseline), T4 (follow-up, 3 months post-intervention)
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Child Physical Activity Attitudes and Beliefs
Periodo de tiempo: 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 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.
|
T1 (baseline), T2 (intervention mid-point, 3 weeks post-baseline), T3 (intervention endpoint, 6 weeks post-baseline), T4 (follow-up, 3 months post-intervention)
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Child Physical Activity
Periodo de tiempo: 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 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.
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T1 (baseline), T2 (intervention mid-point, 3 weeks post-baseline), T3 (intervention endpoint, 6 weeks post-baseline), T4 (follow-up, 3 months post-intervention)
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Child - Identification
Periodo de tiempo: T2 (intervention mid-point, 3-weeks post-baseline) and T3 (intervention endpoint, 6-weeks post-baseline)
|
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.
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T2 (intervention mid-point, 3-weeks post-baseline) and T3 (intervention endpoint, 6-weeks post-baseline)
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Child - Narrative Transportation
Periodo de tiempo: T2 (intervention mid-point, 3-weeks post-baseline) and T3 (intervention endpoint, 6-weeks post-baseline)
|
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.
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T2 (intervention mid-point, 3-weeks post-baseline) and T3 (intervention endpoint, 6-weeks post-baseline)
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Parent Feeding Practices
Periodo de tiempo: 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 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.
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T1 (baseline), T2 (intervention mid-point, 3-weeks post-baseline), T3 (intervention endpoint, 6-weeks post-baseline), T4 (follow-up, 3-months post intervention)
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Parent Physical Activity Practices
Periodo de tiempo: 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 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.
|
T1 (baseline), T2 (intervention mid-point, 3-weeks post-baseline), T3 (intervention endpoint, 6-weeks post-baseline), T4 (follow-up, 3-months post intervention)
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Parent Perspective - Home Food Environment
Periodo de tiempo: 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-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.
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T1 (baseline), T2 (intervention mid-point, 3-weeks post-baseline), T3 (intervention endpoint, 6-weeks post-baseline), T4 (follow-up, 3-months post intervention)
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Child Perspective - Home Food Environment
Periodo de tiempo: 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-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.
|
T1 (baseline), T2 (intervention mid-point, 3-weeks post-baseline), T3 (intervention endpoint, 6-weeks post-baseline), T4 (follow-up, 3-months post intervention)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de abril de 2027
Finalización del estudio (Estimado)
30 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
24 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
10 de septiembre de 2026
Publicado por primera vez (Actual)
15 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00006271
- R41MD020611 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .