200 Participants Needed

Mobile Health Intervention for Childhood Obesity

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Overseen ByAmy Beck, MD, MPH
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Francisco
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 information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Mobile Health Intervention for Reducing Sweet Beverage Consumption in the clinical trial for childhood obesity?

Research shows that mobile health (mHealth) interventions, which use mobile phones to promote healthy behaviors, have been effective in improving eating habits and managing weight. These interventions can help reduce the consumption of unhealthy foods and drinks, like sweet beverages, by encouraging healthier choices and providing real-time feedback.12345

Is the Mobile Health Intervention for Childhood Obesity safe for humans?

The studies on mobile health interventions for reducing sugary beverage consumption and promoting healthy habits in children and families have shown high acceptability and no reported safety concerns, suggesting they are generally safe for human use.678910

How is the Mobile Health Intervention for Childhood Obesity treatment different from other treatments?

This treatment is unique because it uses mobile health (mHealth) technology to reduce sweet beverage consumption and improve literacy through a parent-child reading program, making it accessible and cost-effective for families, especially those in socioeconomically disadvantaged groups. Unlike traditional treatments, it leverages digital tools for real-time feedback and remote delivery, which can enhance engagement and support long-term behavior change.211121314

What is the purpose of this trial?

Sugar-sweetened beverage consumption is a major contributor to childhood obesity, caries, fatty liver disease, and Type 2 diabetes. Latino children are more likely to consume sugar-sweetened beverages (SSBs) and to suffer from all of the aforementioned conditions. Reading out loud to children from birth through age 5 is critical for the promotion of language and early literacy skills. Children whose parents read aloud to them are more likely to start school with the skills required for early reading success. This is important as reading proficiency in third grade is the best predictor of high school graduation and career success. Latino children are less likely to be read to than non-Hispanic white children and at higher risk of entering kindergarten without critical early literacy skills. Thus, there is a pressing need for interventions to reduce SSB consumption among Latino children as well as interventions that promote reading out loud. Primary care is an optimal setting for such interventions. However, multiple demands on providers' time make it difficult to rely on in-person interventions. For this reason, it is critical to test intervention designs that do not rely directly on health care providers and that can be delivered remotely if needed. The investigators have developed two m-health interventions for Latino parents, one that promotes optimal beverage consumption patterns and one that promotes reading out loud to children. The purpose of this study is to test the impact of these interventions on child beverage intake patterns and the frequency with which parents read to children.

Research Team

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Amy L Beck, MD, MPH

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for Latino parents with children aged 1 to 5 who have a cell phone capable of receiving texts. Parents must speak English or Spanish. It aims to address childhood obesity by changing beverage consumption and improving early literacy through reading.

Inclusion Criteria

Parent identifies child as Latino/a/x
Parent has a cell phone that can receive text messages
My child is between 1 and 5 years old.

Exclusion Criteria

My child does not eat or drink by mouth.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Parents receive m-health interventions promoting optimal beverage consumption and reading to children

3 months
Remote intervention with video and text messages

Follow-up

Participants are monitored for changes in beverage consumption and reading frequency

3 months

Treatment Details

Interventions

  • Beverage Intervention
  • Reading Intervention
Trial Overview The study tests two mobile health interventions: one designed to optimize children's beverage intake, reducing sugary drinks, and another encouraging parents to read aloud more often, which can aid in child development and literacy skills.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Reading InterventionExperimental Treatment1 Intervention
Parents will watch a video that promotes reading to children. Parents will receive text messages that reinforce and expand on the messages in the video.
Group II: Beverage InterventionExperimental Treatment1 Intervention
Parents will watch a video that promotes optimal beverage practices for young children. Parents will receive that reinforce and expand on the messages in the video.

Beverage Intervention is already approved in United States for the following indications:

🇺🇸
Approved in United States as Beverage Intervention for:
  • Childhood Obesity Prevention
  • Reduction of Sugar-Sweetened Beverage Consumption

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Findings from Research

Computer- and web-based interventions can effectively improve eating behaviors and diet-related physical outcomes in children and adolescents, as shown in a systematic review of 15 studies.
To enhance the success of these interventions, strategies such as conducting them in schools and providing individually tailored feedback are beneficial, although long-term maintenance of changes remains a challenge.
Computer- and web-based interventions to promote healthy eating among children and adolescents: a systematic review.Hamel, LM., Robbins, LB.[2018]
The study involved 20 children and adolescents with obesity, who were randomized to either an mHealth intervention group using the Mandolean app or a control group receiving usual care, but faced a high attrition rate of 63% in the intervention group compared to 25% in the control group.
Low engagement with the Mandolean app and perceived task burden were significant barriers to adherence, suggesting that while self-monitoring tools like the myBigO app and smartwatches were acceptable, further improvements in the usability and acceptability of the Mandolean intervention are needed.
Mobile Health Apps in Pediatric Obesity Treatment: Process Outcomes From a Feasibility Study of a Multicomponent Intervention.Browne, S., Kechadi, MT., O'Donnell, S., et al.[2021]
Between 2005 and 2009, about 75% of studies showed that e-health technologies effectively helped reduce fat intake and increase fruit and vegetable consumption in behavioral nutrition interventions.
By 2010, interventions began to focus more on body weight management and included personalized features like self-monitoring, but there has been limited progress in using objective dietary behavior measures instead of self-reports.
Behavioral Nutrition Interventions Using e- and m-Health Communication Technologies: A Narrative Review.Olson, CM.[2019]

References

Computer- and web-based interventions to promote healthy eating among children and adolescents: a systematic review. [2018]
Mobile Health Apps in Pediatric Obesity Treatment: Process Outcomes From a Feasibility Study of a Multicomponent Intervention. [2021]
Behavioral Nutrition Interventions Using e- and m-Health Communication Technologies: A Narrative Review. [2019]
Smartloss: A Personalized Mobile Health Intervention for Weight Management and Health Promotion. [2023]
Diabetes self-management care via cell phone: a systematic review. [2022]
iAmHealthy: Rationale, design and application of a family-based mHealth pediatric obesity intervention for rural children. [2020]
Use of Electronic Health Record Data to Study the Association of Sugary Drink Consumption With Child Weight Status. [2021]
Randomized Controlled Trial of a Clinic-Based Intervention to Promote Healthy Beverage Consumption Among Latino Children. [2021]
Text Messages to Curb Sugar-Sweetened Beverage Consumption among Pregnant Women and Mothers: A Mobile Health Randomized Controlled Trial. [2023]
A Technology-Driven, Healthcare-Based Intervention to Improve Family Beverage Choices: Results from a Pilot Randomized Trial in the United States. [2023]
Assessing User Engagement of an mHealth Intervention: Development and Implementation of the Growing Healthy App Engagement Index. [2019]
A Systematic Review and Meta-Analysis of Intervention for Pediatric Obesity Using Mobile Technology. [2018]
mHealth approaches to child obesity prevention: successes, unique challenges, and next directions. [2022]
Digital Tools to Support Family-Based Weight Management for Children: Mixed Methods Pilot and Feasibility Study. [2021]
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