200 Participants Needed

mHealth Tool for Childhood Obesity

Recruiting at 2 trial locations
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Overseen ByMay May Leung, PhD, RDN
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Tufts University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a web-based tool designed to help children improve their eating habits and manage their weight. The researchers aim to determine if children using this tool show greater improvements in body measurements and eating behaviors over a year compared to those receiving general health newsletters. The trial is open to Black/African-American and Latino children aged 8-12 who have at least a healthy weight and regular internet access. Parents must also participate and be involved in their child's food choices. This trial presents a valuable opportunity for families seeking to make healthier lifestyle changes together. As an unphased trial, it offers families a unique chance to participate in innovative research focused on enhancing children's health and well-being.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes children taking medications with side effects that might affect participation.

What prior data suggests that this mHealth tool is safe for children?

Research has shown that online tools, such as interactive comics and newsletters, effectively share health messages to help reduce childhood obesity risk. Past studies tested these tools with children and their parents, and reports indicate they are generally well-received without significant side effects.

Teaching straightforward health facts and tips, known as didactic health information, is common in educational settings. This method is usually safe and poses no risks, as it focuses on sharing knowledge rather than administering medication.

Therefore, both the online tools and the straightforward health information used in this study are considered safe based on past research. Participants typically handle these methods well without major issues.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to promote healthy dietary behaviors in children using technology. Unlike traditional methods, which often rely solely on educational materials, this trial introduces a web-based comic and interactive tool that engages families in a fun and interactive way. The experimental group uses Intervention INC, a family-centered platform that encourages healthy eating habits with a theory-guided approach. These digital tools aim to make learning about nutrition more engaging and accessible, potentially leading to better adoption and lasting lifestyle changes among children and their families.

What evidence suggests that this trial's treatments could be effective for childhood obesity?

Research shows that clear health information can boost knowledge and confidence in managing obesity. Previous studies found that educational sessions helped medical students and pediatricians better understand and address child obesity. In this trial, the experimental group will access Intervention INC, a theory-guided, interactive, family-centered web-based tool promoting healthy dietary behaviors. The comparison group will access web-based newsletters focused on promoting healthy dietary behaviors. Previous studies have shown that web-based comics and newsletters effectively engage children and parents. One study discovered that interactive comics helped lower obesity risk among preteens, especially in minority communities. These tools use engaging stories and characters to promote healthy eating habits. Together, these strategies aim to improve BMI (a measure of body fat based on height and weight) and encourage healthier eating choices in children.16789

Are You a Good Fit for This Trial?

This trial is for Black/African-American and/or Latino preadolescents aged 9-12 who are overweight or obese, can read and speak English, have regular internet access, and a parent/guardian willing to participate. They must be comfortable with digital content and discussions with study staff.

Inclusion Criteria

Child self-identifies as Black/African-American and/or Latino
Child has regular internet access via a tablet device, smartphone, or computer/laptop
Child has regular access to a phone with texting capability
See 12 more

Exclusion Criteria

Child has allergies, food aversions, food disorders, or medications with side-effects that may impact participation in study
Child has a pacemaker or heart condition
Child is in foster care

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline

Eligible participants are randomized to either the experimental group or comparison group

1 week
1 visit (in-person)

Intervention

Experimental group receives access to Intervention INC; comparison group receives web-based newsletters

12 weeks
1 visit (virtual)

Maintenance

Continued access to intervention tools for both groups

6 months
1 visit (virtual)

Follow-up

Participants are monitored for changes in BMI z-score and dietary behaviors

12 months
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Didactic health information
  • Web-based comic and newsletters
Trial Overview The study tests an mHealth tool featuring web-based comics and newsletters against standard health information to see if it better improves children's BMI-z scores, eating habits, and parental feeding practices over a year.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental GroupExperimental Treatment1 Intervention
Group II: Comparison GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Tufts University

Lead Sponsor

Trials
271
Recruited
595,000+

Washington University School of Medicine

Collaborator

Trials
2,027
Recruited
2,353,000+

Children's Aid, New York City

Collaborator

Trials
1
Recruited
200+

City University of New York, School of Public Health

Collaborator

Trials
27
Recruited
36,200+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials
415
Recruited
6,777,000+

University of Massachusetts, Amherst

Collaborator

Trials
83
Recruited
3,474,000+

Hunter College of City University of New York

Collaborator

Trials
43
Recruited
10,000+

Children's Aid

Collaborator

Trials
2
Recruited
380+

CUNY Graduate School of Public Health and Health Policy

Collaborator

Trials
1
Recruited
200+

Brown School at the Washington University of St. Louis

Collaborator

Trials
1
Recruited
200+

Published Research Related to This Trial

mHealth systems present innovative opportunities for addressing childhood obesity through cost-effective interventions and real-time data collection, but they also face challenges such as a lack of scientific evidence for effectiveness and concerns over data security and privacy.
To maximize the benefits of mHealth in combating childhood obesity, researchers, health practitioners, and policymakers need to collaborate, focusing on developing secure technologies, regulating app quality, and creating effective partnerships between academia and industry.
mHealth approaches to child obesity prevention: successes, unique challenges, and next directions.Tate, EB., Spruijt-Metz, D., O'Reilly, G., et al.[2022]
A feasibility study involving 20 obese adolescents showed that tailored SMS messages about weight-related behaviors can effectively enhance adherence to a weight-management program.
Participants found the messages, especially meal suggestions and recipes, personally relevant and enjoyable, indicating that computerized tailored messaging is a promising tool for supporting healthy lifestyle changes in adolescents.
Tailored mobile phone text messages as an adjunct to obesity treatment for adolescents.Woolford, SJ., Clark, SJ., Strecher, VJ., et al.[2021]

Citations

Effect of Child Overweight/Obesity Didactic Session on ...Objective. To evaluate the impact of an obesity didactic session for pediatric physicians on confidence in counseling and identified overweight/obesity and ...
A Didactic Curriculum and Program AnalysisResults: After both the didactic curriculum and coaching sessions, medical students demonstrated statistically significant improvement in knowledge and ...
Child Obesity Electronic Health Record Tool - PubMed CentralAmong children ages 2–19 years, 18.5% meet body mass index (BMI) criteria for obesity, including 5.6% with severe obesity; an additional 16.6% of 2–19-year-olds ...
The Influence of Parental Health Literacy Status on Reach ...This study explores how parent HL affects the reach, attendance, and retention of and outcomes in a 3-month multicomponent family-based program to treat ...
Prevention of Pediatric Overweight and Obesity: Position ...From 2017 to 2018, the rate of pediatric obesity in the United States was 19.3%. Rates were 13.4% among 2- to 5-year-olds, 20.3% among 6- to 11-year-olds, and ...
Childhood Obesity FactsThe prevalence of obesity among US children and adolescents was 19.7%1. This means that approximately 14.7 million US youths aged 2–19 years have obesity.
Childhood and Adolescent Obesity in the United StatesChildhood and adolescent obesity have reached epidemic levels in the United States. Currently, about 17% of US children are presenting with obesity.
Preventing Childhood Obesity: 6 Things Families Can DoCompared to children with healthy weight, children with obesity are at a higher risk for asthma, sleep apnea, bone and joint problems, type 2 ...
Noncommunicable diseases: Childhood overweight and ...Overweight and obese children are likely to stay obese into adulthood and more likely to develop noncommunicable diseases like diabetes and cardiovascular ...
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