Mobile Health Program for Childhood Obesity

(HEALTHY BITES Trial)

Recruiting in Philadelphia (>99 mi)

Overseen By Jessica E Decker, PhD, RD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Must not be taking: Weight loss drugs

Disqualifiers: Eating disorders, Diabetes, Celiac's, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

210 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to compare the effectiveness of a mobile health intervention in adolescents (14-17 years) with overweight or obesity. The main question\[s\] it aims to answer are: 1) is a digital-based diet quality intervention for adolescents with overweight or obesity feasible and 2) is there preliminary effectiveness in improving diet quality? Participants will: 1. Complete three-day 24-hour dietary recalls 2. Collect urine samples 3. Wear a continuous glucose monitor, sleep tracker, and physical activity tracker Researchers will compare control and intervention groups to see if diet quality and meal timing traits improve as assessed by 24-hour dietary recalls, a novel urine biomarker, and continuous glucose monitoring (CGM).

Will I have to stop taking my current medications?

The trial excludes participants who are regularly taking medications that may affect weight, appetite, or fluid levels. If you are on such medications, you may not be eligible to participate.

What data supports the effectiveness of the treatment Healthy Bite-Sized Eating Strategies, Digital Diet Quality Intervention for childhood obesity?

Research shows that mobile health (mHealth) programs, which include digital interventions for diet and physical activity, have shown promise in helping manage childhood obesity. These digital approaches are practical for engaging children and adolescents, who are comfortable with technology, and can improve dietary behaviors and weight-related outcomes. ^{1 2 3 4 5}

Is the Mobile Health Program for Childhood Obesity safe for children?

The research on mobile health programs for childhood obesity, like the MINISTOP trial, suggests that these interventions are generally safe for children. However, there are concerns about increased screen time and its potential effects, so it's important to monitor and balance technology use. ^{6 7 8 9 10}

How is the Healthy Bite-Sized Eating Strategies treatment different from other treatments for childhood obesity?

The Healthy Bite-Sized Eating Strategies treatment is unique because it uses a mobile health (mHealth) approach, leveraging smartphone technology to provide real-time feedback and support for healthy eating and physical activity, making it more accessible and engaging for children and their families compared to traditional methods. ^{1 9 11 12 13}

Research Team

Jonathan A Mitchell, PhD

Principal Investigator

Children's Hospital of Philadelphia

Eligibility Criteria

This trial is for teens aged 14-17 with obesity, marked by a body mass index between the 85th and 99th percentile. They should have had this BMI on two occasions six months apart within the last five years, be at risk for poor diet quality, and must have access to a text message-capable phone.

Inclusion Criteria

I am between 14 and 17 years old.

Have access to a phone capable of receiving text messages

At risk for poor or needs improvement diet quality (HEI score < 80) based on baseline 24-hour diet recall data

Exclusion Criteria

History of an eating disorder diagnosis (e.g., anorexia nervosa, bulimia nervosa, binge eating disorder, avoidant restrictive food intake disorder)

Currently being followed by a registered dietitian

Pregnant or lactating females

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a digital-based diet quality intervention with personalized goals, meal timing, nutrition skills, and home food environment components delivered through text messaging

4 weeks

Remote monitoring and data collection

Follow-up

Participants are monitored for changes in diet quality and urinary biomarkers after the intervention

6 weeks

Treatment Details

Interventions

• Healthy Bite-Sized Eating Strategies

Trial Overview The study tests if a mobile health intervention can improve adolescents' diet quality. It involves dietary recalls, urine samples, glucose monitoring, sleep tracking, and physical activity tracking to compare improvements between control and intervention groups.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

The trial duration will be four weeks. The intervention arm includes five components: personalized goal, meal timing, nutrition skills, home food environment, and engagement strategies. The specific number, design and content of the text messages for each component will be prepared and vetted by the investigators and by adolescents and parents through CHOP's Family Partners Program prior to study launch. The text messages will be sent through the REDCap Twilio integration.

Group II: Control Active Control 1 Intervention

The control arm will not receive any intervention materials.

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

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]

A scoping review of 45 systematic reviews and meta-analyses found that e-health and m-health interventions are widely used to address childhood obesity, with a focus on weight, physical activity, and diet, but only a small percentage evaluated cost-effectiveness.

Most reviews (97%) had critically low or low methodological quality, highlighting the need for future studies to identify effective components of these interventions and to assess broader metrics beyond just efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

E-&mHealth interventions targeting nutrition, physical activity, sedentary behavior, and/or obesity among children: A scoping review of systematic reviews and meta-analyses. Kracht, CL., Hutchesson, M., Ahmed, M., et al.[2022]

Digital health interventions are promising for helping adolescents change their dietary behaviors to combat obesity, but engaging this age group effectively remains a challenge.

Key strategies for improving engagement include involving adolescents in the design process, personalizing the interventions to their needs, and using real-time data from wearable devices to adapt the interventions as needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies to Engage Adolescents in Digital Health Interventions for Obesity Prevention and Management. Partridge, SR., Redfern, J.[2023]

In a six-month feasibility trial involving 28 children aged 5-12, an mHealth support system combined with standard care led to a significant reduction in BMI SDS by 0.24 units compared to no change in the control group, indicating its effectiveness in pediatric obesity treatment.

The mHealth approach improved appointment attendance and was well-received by both parents and clinicians, suggesting it is a feasible and accessible option for enhancing traditional obesity treatment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel interactive mobile health support system for pediatric obesity treatment: a randomized controlled feasibility trial. Johansson, L., Hagman, E., Danielsson, P.[2021]

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 involves a six-month randomized controlled trial with 120 Iranian children aged 5 to 6 years, focusing on improving dietary habits and nutritional knowledge through the KidFood mobile game.

The project aims to evaluate the effectiveness of mobile health interventions in promoting healthy lifestyles among preschoolers, making it a potentially cost-effective and accessible method for behavior therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of nutrition education via a mobile-based game on nutritional knowledge, dietary habits and anthropometric indices in preschool children: A study protocol. Riasatian, M., Karimian, Z., Mohsenpour, MA., et al.[2023]

Only 2.58% of the 189,770 users actively used the mobile app 'The Eatery' for dietary self-monitoring, indicating low adherence to the intervention.

Users with strict dietary preferences were more likely to remain active on the app, suggesting that targeting individuals already motivated to eat healthily could enhance the app's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors related to sustained use of a free mobile app for dietary self-monitoring with photography and peer feedback: retrospective cohort study. Helander, E., Kaipainen, K., Korhonen, I., et al.[2022]

The intervention successfully reduced the weekly consumption of fast food among 361 Latino families, indicating a positive impact on children's dietary habits.

Increased contact with the community health worker (promotora) led to a significant rise in the variety of fruits and vegetables consumed by children, highlighting the importance of engagement in promoting healthy eating.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting children's dietary behaviors in a family intervention: 'Entre familia: reflejos de salud'. Horton, LA., Parada, H., Slymen, DJ., 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.

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 mobile health (mHealth) obesity prevention program did not significantly reduce body fat mass index (FMI) in preschool-aged children, but it did lead to improved dietary habits and physical activity levels, particularly in children with higher initial FMI.

Children in the intervention group had a 99% higher likelihood of improving their composite score for healthy behaviors compared to the control group, indicating that mHealth programs can positively influence lifestyle changes even if they don't immediately affect body fat.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile-based intervention intended to stop obesity in preschool-aged children: the MINISTOP randomized controlled trial. Nyström, CD., Sandin, S., Henriksson, P., et al.[2023]

The MINISTOP 2.0 app intervention, tested with 552 parents of young children over 6 months, led to significant reductions in children's intake of sweet and savory treats, sweet drinks, and screen time, indicating its effectiveness in promoting healthier lifestyle behaviors.

Parents using the app reported increased self-efficacy in promoting healthy habits for their children, although there was no significant change in children's BMI, suggesting that while behavior changes occurred, they may take longer to reflect in weight outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Smartphone App (MINISTOP 2.0) integrated in primary child health care to promote healthy diet and physical activity behaviors and prevent obesity in preschool-aged children: randomized controlled trial. Alexandrou, C., Henriksson, H., Henström, M., et al.[2023]

Digital health interventions using Computerized Decision Support (CDS) and Machine Learning (ML) have shown promise in the prevention and treatment of childhood obesity, with all identified studies reporting statistically significant outcomes.

CDS tools, particularly those utilizing Electronic Health Records and BMI alerts, can aid in self-management of obesity, while ML algorithms like decision trees and artificial neural networks are effective for predicting obesity risk, highlighting the potential for smart interventions in childhood obesity care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized decision support and machine learning applications for the prevention and treatment of childhood obesity: A systematic review of the literature. Triantafyllidis, A., Polychronidou, E., Alexiadis, A., et al.[2021]

Only two randomized controlled trials (RCTs) have evaluated the effectiveness of smartphone technology in managing overweight or obesity in children and adolescents, and these studies found that electronic contact did not lead to significant weight loss.

Despite the lack of weight loss effectiveness, smartphone usage improved participant engagement and reduced dropout rates during long-term interventions, suggesting that they can help maintain interest in weight management programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone Interventions for Weight Treatment and Behavioral Change in Pediatric Obesity: A Systematic Review. Chaplais, E., Naughton, G., Thivel, D., et al.[2018]

References

1. Canada pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

E-&mHealth interventions targeting nutrition, physical activity, sedentary behavior, and/or obesity among children: A scoping review of systematic reviews and meta-analyses. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Strategies to Engage Adolescents in Digital Health Interventions for Obesity Prevention and Management. [2023]

4. England pubmed.ncbi.nlm.nih.gov

A novel interactive mobile health support system for pediatric obesity treatment: a randomized controlled feasibility trial. [2021]

5. England pubmed.ncbi.nlm.nih.gov

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

6. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of nutrition education via a mobile-based game on nutritional knowledge, dietary habits and anthropometric indices in preschool children: A study protocol. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

Factors related to sustained use of a free mobile app for dietary self-monitoring with photography and peer feedback: retrospective cohort study. [2022]

8. Mexico pubmed.ncbi.nlm.nih.gov

Targeting children's dietary behaviors in a family intervention: 'Entre familia: reflejos de salud'. [2021]

9. England pubmed.ncbi.nlm.nih.gov

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

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

Mobile-based intervention intended to stop obesity in preschool-aged children: the MINISTOP randomized controlled trial. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a Smartphone App (MINISTOP 2.0) integrated in primary child health care to promote healthy diet and physical activity behaviors and prevent obesity in preschool-aged children: randomized controlled trial. [2023]

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

Computerized decision support and machine learning applications for the prevention and treatment of childhood obesity: A systematic review of the literature. [2021]

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

Smartphone Interventions for Weight Treatment and Behavioral Change in Pediatric Obesity: A Systematic Review. [2018]