Baby-Feed Web Application for Childhood Obesity

(BabyFeed Trial)

Overseen By Cristina Palacios, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Florida International University

Disqualifiers: Special diets, Preterm birth, others

Compensation: Varies

Number of Visits: 6

160 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Baby-Feed Web Application treatment for childhood obesity?

The ENDORSE digital weight management program, which is similar to the Baby-Feed Web Application, showed improvements in metabolic health and food parenting practices in children with obesity. Additionally, interventions that include dietary components generally result in significant short-term weight loss in children. ^{1 2 3 4 5}

What data supports the effectiveness of the Baby-Feed Web Application treatment for childhood obesity?

The ENDORSE platform, which is similar to the Baby-Feed Web Application, showed a significant reduction in BMI z-score and improvements in metabolic health and food parenting practices in children with obesity. This suggests that digital platforms involving parents and children can be effective in managing childhood obesity. ^{1 2 3 4 5}

How does the Baby-Feed treatment differ from other treatments for childhood obesity?

The Baby-Feed Web Application is unique because it leverages mobile health technology to engage both children and their guardians in managing childhood obesity, focusing on user preferences and needs. Unlike traditional treatments, it offers a personalized approach by incorporating features like tracking child growth, setting feeding goals, and providing feeding tips, which are designed to improve responsive feeding practices and long-term care. ^{1 3 6 7 8}

How is the Baby-Feed Web Application treatment different from other treatments for childhood obesity?

The Baby-Feed Web Application is unique because it leverages mobile health technology to engage both children and their guardians in managing childhood obesity, focusing on user preferences and needs. Unlike traditional treatments, it offers a personalized and interactive approach, incorporating features like tracking child growth, setting feeding goals, and providing tailored feeding tips and recipes. ^{1 3 6 7 8}

What is the purpose of this trial?

This study will test the Baby-Feed web platform among 160 parents with infants aged 1-3 months at the time of enrollment and follow them through their 9-month well-child visit (about a total of 6 months) using a mixed-methods approach (randomized control trial with qualitative interviews).

Eligibility Criteria

This trial is for parents or primary caretakers of healthy infants aged 1-3 months, regardless of the baby's weight. Participants must have internet access, be willing to receive texts, and commit to the full study duration. They should also be able to understand English or Spanish.

Inclusion Criteria

I am between 1 to 3 months old.

Parent/family member must be primary caretakers

Willing to participate for full study duration

Exclusion Criteria

Infants with special diets

Preterm birth (<37 weeks)

Caregiver inability to consent to participate

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention arm have full access to the Baby-Feed web application, receive automated weekly text messages, and complete the online infant FFQ at required intervals.

6 months

3 visits (in-person) at 4, 6, and 9 months

Control

Participants in the control arm have limited access to the Baby-Feed web application and complete the online infant FFQ at the same intervals without feedback.

6 months

3 visits (in-person) at 4, 6, and 9 months

Follow-up

Participants are monitored for diet quality and rate of weight gain using the Diet Quality Index Score and weight-for-length z-score.

3 months

Treatment Details

Interventions

• Baby-Feed

Trial Overview The Baby-Feed web application is being tested with caregivers to see if it can improve infant diets and manage weight gain over a period of about six months. Caregivers will either use Baby-Feed regularly or have limited access as part of a randomized control trial.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

This arm will have full access to the Baby-Feed web application. It was based on the Social Cognitive Theory and the Health Self-Empowerment Theory. It provides automatic feedback based on the infant FFQ, showing the total amounts of each food group consumed (milk, protein foods, whole and refined grains, fruits, vegetables, juices, sugary beverages, sweets, and salty snacks) with automated feedback of which are consumed adequately or above/below the recommendations. * Recommendations: this section displays the amount recommended for each food group by age group. * Tracking: This is a short form that asks participants to evaluate if they gave the recommended amounts of each food group in the past week. * Weight gain tracker: parents are asked to input the weight and length of their baby and it shows graphically how the baby is progressing.

Group II: Control group Placebo Group 1 Intervention

Participants randomized to the control arm (n=80) will have limited access to certain components of the Baby-Feed web application, such as the online infant FFQ to complete it at the same intervals (before the 4-month, 6-month, and 9-month well-child visits) and infant's weight and length as recorded in the well-child visits, but without any automatic results or feedback. The control group will have a separate user access to the Baby-Feed web application that only allows them to complete the required information without being able to see results, feedback, tracking, recommendations, or resources.

Who Is Running the Clinical Trial?

Florida International University

Lead Sponsor

Trials

114

Recruited

19,400+

Academy of Nutrition and Dietetics

Collaborator

Trials

25

Recruited

5,600+

Findings from Research

The ENDORSE platform, an AI-based digital weight management program, led to significant improvements in metabolic parameters among 45 children, including reductions in glycated hemoglobin and liver enzymes, indicating better metabolic health.

The program also positively influenced food parenting practices, with a decrease in emotional feeding and an increase in healthy eating guidance, which correlated with reductions in BMI z-scores, suggesting effective behavioral changes in families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of the ENDORSE Digital Weight Management Program on the Metabolic Profile of Children and Adolescents with Overweight and Obesity and on Food Parenting Practices. Pervanidou, P., Chatzidaki, E., Nicolaides, NC., et al.[2023]

A systematic review of 116 articles found that dietary interventions generally lead to significant short-term weight loss in children and adolescents who are overweight or obese, but many studies lacked rigorous design and follow-up.

There is a critical need for high-quality research to determine the best dietary strategies for managing pediatric obesity, with a focus on long-term sustainability and detailed reporting of dietary interventions and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of interventions in the management of overweight and obese children which include a dietary component. Collins, CE., Warren, JM., Neve, M., et al.[2011]

The Time2bHealthy program is an innovative 11-week online intervention designed for parents of preschool-aged children, focusing on healthy lifestyle changes, and is being evaluated through a randomized controlled trial involving various health outcomes, including BMI.

This study is significant as it targets early childhood obesity prevention, filling a gap in existing literature, and if effective, could be widely implemented in primary health care services to promote healthier behaviors among families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time2bHealthy - An online childhood obesity prevention program for preschool-aged children: A randomised controlled trial protocol. Hammersley, ML., Jones, RA., Okely, AD.[2018]

The ENDORSE platform, which combines m-health technologies, AI, and serious games, effectively reduced BMI z-scores in a pilot study of 50 overweight and obese children over 3 months, achieving a significant average reduction of -0.21.

Higher usage of the activity tracker within the ENDORSE platform was correlated with greater improvements in BMI z-scores, suggesting that increased engagement with the platform enhances its effectiveness in combating childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ENDORSE Feasibility Study: Exploring the Use of M-Health, Artificial Intelligence and Serious Games for the Management of Childhood Obesity. Zarkogianni, K., Chatzidaki, E., Polychronaki, N., et al.[2023]

A comprehensive educational approach that involves both the child and their family is essential for effectively managing obesity in children, emphasizing the importance of motivational interviewing and parental involvement.

Long-term success in obesity care requires a flexible, step-by-step follow-up plan that allows for ongoing negotiation of goals between caregivers, the child, and their family, ensuring that management strategies are tailored to the child's specific situation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[PRIMARY CARE INTERVENTIONS FOR PEDIATRIC OVERWEIGHT OR OBESITY]. Jouret, B., Haupp, A.[2018]

This review analyzed 59 articles and identified 7 studies that specifically tested the usability and engagement of mobile health (mHealth) apps designed for treating childhood obesity, with participant numbers ranging from 6 to 1120.

The findings highlighted a lack of standardized methods for assessing usability and engagement in these mHealth interventions, suggesting a need for future research to develop and validate consistent measurement tools for better evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability and Engagement Testing of mHealth Apps in Paediatric Obesity: A Narrative Review of Current Literature. Arthurs, N., Tully, L., O'Malley, G., et al.[2022]

The study involved fifth and sixth grade children who are overweight or obese, along with their guardians, to identify their preferences and needs for a child obesity management application.

Key differences were found between genders and between children and guardians regarding body image perceptions, technology preferences, and desired features in the app, which can guide developers in creating a more effective obesity management tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application Design for Child Obesity Management Based on Users' Preferences and Needs. Lee, J., Jeongeun, K., Ahjung, B., et al.[2021]

A qualitative study involving 40 parents of young children revealed that both fathers and mothers prioritize different content in mHealth apps aimed at improving responsive feeding practices, with fathers focusing on first foods and choking hazards, while mothers prefer topics like breastfeeding and picky eating.

Parents expressed a strong interest in features that allow tracking child growth and setting feeding goals, indicating that personalized and practical tools in mHealth apps could enhance their effectiveness in promoting healthy feeding habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BabyByte: Qualitative Research to Inform the Development of an App to Improve Responsive Feeding Practices in Parents of Infants and Toddlers. Mobley, AR., Jake-Schoffman, DE., Fedele, DA., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

The Impact of the ENDORSE Digital Weight Management Program on the Metabolic Profile of Children and Adolescents with Overweight and Obesity and on Food Parenting Practices. [2023]

2. Australia pubmed.ncbi.nlm.nih.gov

Systematic review of interventions in the management of overweight and obese children which include a dietary component. [2011]

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

Time2bHealthy - An online childhood obesity prevention program for preschool-aged children: A randomised controlled trial protocol. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The ENDORSE Feasibility Study: Exploring the Use of M-Health, Artificial Intelligence and Serious Games for the Management of Childhood Obesity. [2023]

5. France pubmed.ncbi.nlm.nih.gov

[PRIMARY CARE INTERVENTIONS FOR PEDIATRIC OVERWEIGHT OR OBESITY]. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Usability and Engagement Testing of mHealth Apps in Paediatric Obesity: A Narrative Review of Current Literature. [2022]

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

Application Design for Child Obesity Management Based on Users' Preferences and Needs. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

BabyByte: Qualitative Research to Inform the Development of an App to Improve Responsive Feeding Practices in Parents of Infants and Toddlers. [2023]