200 Participants Needed

mHealth Tool for Childhood Obesity

Recruiting at 1 trial location
MM
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)

Trial Summary

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 data supports the effectiveness of the treatment Didactic health information, Web-based comic and newsletters for childhood obesity?

Research shows that using comics for health education can improve understanding and recall of health information, as seen in studies where parents better remembered child development milestones after reading educational comics. Additionally, tailored text messages have been effective in supporting healthy lifestyle changes in adolescents, suggesting that similar digital tools could help in managing childhood obesity.12345

Is the mHealth Tool for Childhood Obesity, using comics and web-based information, safe for humans?

The research on using comics and web-based information for health education, including for conditions like diabetes and liver disease, suggests that these tools are generally safe for humans. They are primarily used to improve understanding and awareness of health issues, with no reported safety concerns.36789

How is the mHealth Tool for Childhood Obesity treatment different from other treatments for childhood obesity?

This treatment is unique because it combines didactic health information with engaging web-based comics and newsletters, making it more interactive and appealing to children. Unlike traditional methods, it leverages digital tools to provide education and support, potentially increasing adherence and engagement in a fun and relatable way.24101112

What is the purpose of this trial?

Using a two-group randomized study design, this study aims to evaluate the effectiveness of the adapted family-centered mHealth tool on child BMI z-score (primary outcome), child dietary behaviors, and parental feeding practices, from baseline to 12-month follow-up, among 200 child-parent dyads. It is hypothesized that children in the experimental group will demonstrate larger BMI-z score improvements between baseline and 12-month follow-up compared to children in the comparison group.

Eligibility Criteria

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

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)

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental GroupExperimental Treatment1 Intervention
The experimental group will receive access to Intervention INC, a theory-guided interactive, family-centered web-based tool promoting healthy dietary behaviors.
Group II: Comparison GroupActive Control1 Intervention
The comparison group will receive access to web-based newsletters focused on promoting healthy dietary behaviors.

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+

Findings from Research

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]
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]

References

A Novel tool for Health Literacy: Using Comic Books to Combat Childhood Obesity. [2020]
Tailored mobile phone text messages as an adjunct to obesity treatment for adolescents. [2021]
Comics as a Medium for Parent Health Education: Improving Understanding of Normal 9-Month-Old Developmental Milestones. [2020]
Text Messaging Based Obesity Prevention Program for Parents of Pre-Adolescent African American Girls. [2022]
Development of a Health Information Technology Tool for Behavior Change to Address Obesity and Prevent Chronic Disease Among Adolescents: Designing for Dissemination and Sustainment Using the ORBIT Model. [2023]
Humanising illness: presenting health information in educational comics. [2014]
Communicating information to patients: the use of cartoon illustrations to improve comprehension of instructions. [2019]
A Healthy Liver Will Always Deliver: Impact Study of a Non-Alcoholic Fatty Liver Disease (NAFLD) Awareness Comic. [2023]
The use of comics to promote health awareness: A template using nonalcoholic fatty liver disease. [2022]
mHealth approaches to child obesity prevention: successes, unique challenges, and next directions. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Blood Sugar, Your Pancreas, and Unicorns: The Development of Health Education Materials for Youth With Prediabetes. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Lifestyle intervention using an internet-based curriculum with cell phone reminders for obese Chinese teens: a randomized controlled study. [2022]
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