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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two mobile health interventions aimed at Latino parents to improve their children's health and learning. The Beverage Intervention focuses on reducing sugary drink consumption to address childhood obesity and related health issues. The Reading Intervention encourages parents to read aloud to their children to enhance early literacy skills, crucial for future academic success. To participate, parents should identify their child as Latino, have a child aged 1 to 5, and own a cell phone capable of receiving texts. As an unphased trial, this study offers parents a unique opportunity to contribute to research that could enhance their children's health and learning.

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 prior data suggests that these mobile health interventions are safe for children?

Research has shown that efforts to reduce sugary drink consumption in children are safe. Studies have found that these efforts can lower sugary drink intake without causing harm. For example, one study found that when healthier drinks were provided at home, children drank fewer sugary drinks and lost weight. This suggests the approach is both safe and effective.

Research also supports the safety of the reading program. Encouraging reading to children improves their language and literacy skills without negative effects. In fact, reading programs have been linked to positive outcomes in children's development and education.

Overall, both the drink and reading programs appear safe and beneficial for children, according to previous studies. No reports of negative side effects have emerged, making these programs a promising choice for families. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for childhood obesity because they focus on early behavioral changes using innovative delivery methods. The Beverage Intervention promotes healthy drink choices through engaging videos and supportive text messages, targeting families directly to influence young children's habits. The Reading Intervention, on the other hand, encourages parents to read to their children, using videos and texts to reinforce this habit, aiming to improve cognitive and emotional development. Unlike traditional methods that might involve medication or dietary supplements, these interventions capitalize on technology and parental involvement to create sustainable lifestyle changes.

What evidence suggests that this trial's interventions could be effective for reducing sugar-sweetened beverage consumption and promoting reading aloud to children?

Research has shown that reducing sugary drink consumption can help lower obesity rates in children. In this trial, one group of participants will receive the Beverage Intervention. Parents will watch a video promoting optimal beverage practices for young children and receive reinforcing messages. One study found that a digital program helped adults drink fewer sugary drinks, suggesting similar methods might work for children. Another study discovered that a program, which included providing bottled water, helped Latina mothers reduce their sugar intake.

For the Reading Intervention group in this trial, studies have shown that improving health knowledge can help lower the risk of childhood obesity. Encouraging parents to read to their children can boost early reading skills, which are important for long-term success in school. Reading aloud to children is linked to better preparation for school, supporting better academic results. ^{1 2 6 7 8}

Who Is on the Research Team?

Amy L Beck, MD, MPH

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04754269

A Mobile Health Intervention to Reduce Sweet Beverage ...

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.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4309175/

A systematic review investigating interventions that can ...

The aim of this systematic review was to identify interventions that can help to reduce the consumption of SSBs in children resulting in changes in body ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39909707/

Efficacy of a 24-month behavioral intervention focused on ...

Conclusions: This intervention, combined with home delivery of bottled water, was effective in reducing sugar consumption from beverages for Latina mothers by ...

4.

cdc.gov

cdc.gov/pcd/issues/2025/24_0520.htm

Maintenance of Sugar-Sweetened Beverage Behaviors ...

Behavior-change interventions to reduce intake of sugar-sweetened beverages (SSBs) have shown promising short-term outcomes, but little is ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0002916525003326?dgcid=rss_sd_all

A digital behavioral intervention to reduce sugar ...

Conclusions. A digital behavioral intervention was efficacious in reducing SSB consumption among Appalachian adults and yielded high engagement and retention ...

6.

clinicaltrials.ucsf.edu

clinicaltrials.ucsf.edu/trial/NCT04754269

Mobile Health Intervention to Reduce Sweet Beverage ...

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.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10181264/

A Technology-Driven, Healthcare-Based Intervention to ...

The goal of the intervention was to reduce sugar-sweetened beverage (SSB) and fruit juice (FJ) consumption in 60 parent–child dyads, in which ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S0002916524008803

Efficacy of a 24-month behavioral intervention focused on ...

Mothers receiving Intervention + Water Delivery demonstrated significantly greater reductions in consumption of free sugars from beverages from baseline to 12 ...