Mobile Health Intervention for Childhood Obesity

Overseen By Amy Beck, MD, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Child does not feed by mouth

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{2 11 12 13 14}

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

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

Group I: Reading Intervention Experimental Treatment 1 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 Intervention Experimental Treatment 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Nutrition Interventions Using e- and m-Health Communication Technologies: A Narrative Review. Olson, CM.[2019]

SmartLoss is a semiautomated mobile health platform designed for weight loss, utilizing a dynamic energy balance model to provide personalized caloric prescriptions and recommendations based on real-time data from users.

The platform includes a clinician dashboard and integrates with connected devices like scales and accelerometers, allowing for efficient remote monitoring and tailored interventions, which may enhance adherence and treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartloss: A Personalized Mobile Health Intervention for Weight Management and Health Promotion. Martin, CK., Gilmore, LA., Apolzan, JW., et al.[2023]

Cell phone interventions for individuals with diabetes or obesity have been shown to significantly improve health outcomes, particularly in reducing hemoglobin A1c levels, with 9 out of 10 studies reporting positive results.

These interventions also enhance communication between patients and healthcare providers, leading to greater satisfaction with care and increased self-management skills among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes self-management care via cell phone: a systematic review. Krishna, S., Boren, SA.[2022]

The iAmHealthy intervention is a unique, family-based program designed specifically for rural children, addressing pediatric obesity through mobile health applications over an 8-month period, involving 144 children across 18 schools.

This study is the first randomized controlled trial to implement a rural-focused, mHealth intervention for pediatric obesity, measuring outcomes like Body Mass Index z-score (BMIz) and physical activity, with data collected at multiple time points to assess effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

iAmHealthy: Rationale, design and application of a family-based mHealth pediatric obesity intervention for rural children. Davis, AM., Beaver, G., Dreyer Gillette, M., et al.[2020]

A study of 22,291 children aged 6 months to 17 years found that higher consumption of sugary drinks is linked to increased body mass index (BMIz), particularly in school-aged children (6-17 years), where those consuming three or more sugary drinks per day had a significantly higher BMIz compared to those consuming less than one per week.

The research suggests that early childhood (ages 2-5) is a critical time for addressing sugary beverage consumption, as even at high consumption levels, it was associated with a notable increase in BMIz, indicating a potential target for obesity prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Electronic Health Record Data to Study the Association of Sugary Drink Consumption With Child Weight Status. Lewis, KH., Skelton, J., Hsu, FC., et al.[2021]

An educational module for Latino parents significantly reduced their children's consumption of sugar-sweetened beverages and 100% fruit juice by an average of 16 ounces at the 2-week follow-up, compared to a 4-ounce increase in the control group (P = .01).

Both intervention and control groups showed reduced consumption of sweet beverages at 2-month and 3-month follow-ups, indicating that the act of participating in frequent surveys may also influence beverage intake behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of a Clinic-Based Intervention to Promote Healthy Beverage Consumption Among Latino Children. Beck, AL., Fernandez, A., Rojina, J., et al.[2021]

In a randomized controlled trial involving 262 pregnant women and mothers in predominantly Hispanic/Latino neighborhoods, maternal consumption of sugar-sweetened beverages (SSBs) decreased across all groups over one month, indicating a general trend away from SSBs.

While no significant overall intervention effect was found, graphic health warning labels showed a potential reduction in SSB consumption by about 28 kcal daily when accounting for outliers, suggesting that such messages may have some impact on reducing SSB intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text Messages to Curb Sugar-Sweetened Beverage Consumption among Pregnant Women and Mothers: A Mobile Health Randomized Controlled Trial. Woo Baidal, JA., Nichols, K., Charles, N., et al.[2023]

A pilot study involving 60 parent-child dyads showed that a technology-driven intervention to reduce sugary beverage intake was well-accepted and feasible, but did not lead to significant differences in consumption between the intervention and control groups after 6 months.

While parents in the intervention group initially reduced their children's sugary beverage intake more than those in the control group at 3 months, this effect was not maintained at 6 months, suggesting that simpler interventions like electronic health record-based screening may be sufficient for achieving similar outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Technology-Driven, Healthcare-Based Intervention to Improve Family Beverage Choices: Results from a Pilot Randomized Trial in the United States. Lewis, KH., Hsu, FC., Block, JP., et al.[2023]

The Growing Healthy program, which provided an app for 300 mother-infant dyads to receive evidence-based infant feeding information, developed an Engagement Index (EI) to monitor user interaction over 9 months, revealing an average engagement score of 30%.

Key factors influencing engagement included the type of system used (app only vs. both app and email), the method of recruitment, and the age of the baby at recruitment, highlighting the importance of these variables in designing effective mHealth interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing User Engagement of an mHealth Intervention: Development and Implementation of the Growing Healthy App Engagement Index. Taki, S., Lymer, S., Russell, CG., et al.[2019]

In a review of pediatric obesity interventions using mobile technology, including four studies, it was found that involving parents and using text messages can help achieve better obesity-related outcomes in elementary school students.

Despite the positive impact on dropout rates, the mobile interventions did not significantly improve weight control, exercise levels, or reduce sugar-sweetened beverage intake, indicating a need for more effective strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review and Meta-Analysis of Intervention for Pediatric Obesity Using Mobile Technology. Lee, J., Piao, M., Byun, A., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth approaches to child obesity prevention: successes, unique challenges, and next directions. Tate, EB., Spruijt-Metz, D., O'Reilly, G., et al.[2022]

The mHealth DRIVE program, a digital adaptation of a family-based weight management therapy, showed high satisfaction rates among parents (4.9/6.0) and children (3.8/5.0) after a 13-week pilot study, indicating its acceptability for families.

Children participating in the program experienced a significant decrease in BMI z-scores (mean -0.14), suggesting that the mHealth intervention is effective in promoting healthier weight management among at-risk youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Tools to Support Family-Based Weight Management for Children: Mixed Methods Pilot and Feasibility Study. Staiano, AE., Shanley, JR., Kihm, H., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Computer- and web-based interventions to promote healthy eating among children and adolescents: a systematic review. [2018]

2. Canada pubmed.ncbi.nlm.nih.gov

Mobile Health Apps in Pediatric Obesity Treatment: Process Outcomes From a Feasibility Study of a Multicomponent Intervention. [2021]

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Behavioral Nutrition Interventions Using e- and m-Health Communication Technologies: A Narrative Review. [2019]

4. Canada pubmed.ncbi.nlm.nih.gov

Smartloss: A Personalized Mobile Health Intervention for Weight Management and Health Promotion. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Diabetes self-management care via cell phone: a systematic review. [2022]

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iAmHealthy: Rationale, design and application of a family-based mHealth pediatric obesity intervention for rural children. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Use of Electronic Health Record Data to Study the Association of Sugary Drink Consumption With Child Weight Status. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of a Clinic-Based Intervention to Promote Healthy Beverage Consumption Among Latino Children. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Text Messages to Curb Sugar-Sweetened Beverage Consumption among Pregnant Women and Mothers: A Mobile Health Randomized Controlled Trial. [2023]

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A Technology-Driven, Healthcare-Based Intervention to Improve Family Beverage Choices: Results from a Pilot Randomized Trial in the United States. [2023]

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Assessing User Engagement of an mHealth Intervention: Development and Implementation of the Growing Healthy App Engagement Index. [2019]

12. Netherlands pubmed.ncbi.nlm.nih.gov

A Systematic Review and Meta-Analysis of Intervention for Pediatric Obesity Using Mobile Technology. [2018]

13. England pubmed.ncbi.nlm.nih.gov

mHealth approaches to child obesity prevention: successes, unique challenges, and next directions. [2022]

14. Canada pubmed.ncbi.nlm.nih.gov

Digital Tools to Support Family-Based Weight Management for Children: Mixed Methods Pilot and Feasibility Study. [2021]