Baby-Feed Web Application for Childhood Obesity
(BabyFeed Trial)
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Florida International University
Disqualifiers: Special diets, Preterm birth, others
Trial Summary
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).
Will I have to stop taking my current medications?
The trial information does not specify whether participants must stop taking their 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.
12345How 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.
13678Eligibility 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
+4 more
Exclusion Criteria
Infants with special diets
Preterm birth (<37 weeks)
Caregiver inability to consent to participate
+2 more
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 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 groupPlacebo Group1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Florida International UniversityMiami, FL
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Who Is Running the Clinical Trial?
Florida International UniversityLead Sponsor
Academy of Nutrition and DieteticsCollaborator
References
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]Childhood obesity is a serious public health problem worldwide. The ENDORSE platform is an innovative software ecosystem based on Artificial Intelligence which consists of mobile applications for parents and health professionals, activity trackers, and mobile games for children. This study explores the impact of the ENDORSE platform on metabolic parameters associated with pediatric obesity and on the food parenting practices of the participating mothers. Therefore, the metabolic parameters of the 45 children (mean age: 10.42 years, 53% girls, 58% pubertal, mean baseline BMI z-score 2.83) who completed the ENDORSE study were evaluated. The Comprehensive Feeding Practices Questionnaire was used for the assessment of food parenting practices. Furthermore, regression analysis was used to investigate possible associations between BMI z-score changes and changes in metabolic parameters and food parenting practices. Overall, there was a statistically significant reduction in glycated hemoglobin (mean change = -0.10, p = 0.013), SGOT (mean change = -1.84, p = 0.011), and SGPT (mean change = -2.95, p = 0.022). Emotional feeding/food as reward decreased (mean change -0.21, p = 0.007) and healthy eating guidance increased (mean change = 0.11, p = 0.051). Linear regression analysis revealed that BMI z-score change had a robust and significant correlation with important metabolic parameters: HOMA-IR change (beta coefficient = 3.60, p-value = 0.046), SGPT change (beta coefficient = 11.90, p-value = 0.037), and cortisol change (beta coefficient = 9.96, p-value = 0.008). Furthermore, healthy eating guidance change had a robust negative relationship with BMI z-score change (beta coefficient = -0.29, p-value = 0.007). Conclusions: The Endorse digital weight management program improved several metabolic parameters and food parenting practices.
Systematic review of interventions in the management of overweight and obese children which include a dietary component. [2011]Background The prevalence of overweight and obesity in children and adolescents is increasing at an alarming rate around the world and prevention has become a key public health objective. Treatment and management of those already overweight and obese must be aligned with the best available evidence on effectiveness, if the risk of obesity-related morbidity and mortality is yet be reduced. Diet plays a pivotal role in successful treatment of obesity but to date, there is limited evidence on which to base practice. Objectives To identify and present the best available evidence on the optimal dietetic treatment and management of children and adolescent who are overweight or obese. Search strategy Published English language literature was searched using the electronic databases CINAHL, MEDLINE, PRE-MEDLINE, DARE, COCHRANE, EMBASE, AUSTROM, Current Concepts and Dissertation Abstracts. The databases were limited to English Language from 1975 until 2003. Government reports from the UK, USA and Australian were also searched and a hand search performed for the Journal of the Dietitians Association of Australia, International Journal of Obesity and the Journal of Human Nutrition and Dietetics and the bibliographies of retrieved articles. Selection criteria (i) Interventions that evaluated the effectiveness of nutrition or dietary interventions to treat or manage overweight and obesity; (ii) Children aged less than 18 years; and (iii) Participants were defined as overweight or obese by relative weight or a measure of body weight status, studies that reported body weight per se were excluded. Data collection and analysis An experienced professional librarian searched the databases, and two trained research assistants independently identified studies for retrieval and assessed each article for inclusion. The included studies were critically appraised for methodological quality by two people independently. Data were extracted from the appropriate articles and when a discrepancy arose, a third party would arbitrate. Main results There were 116 articles that met the inclusion criteria. While 49 articles described randomised controlled trials, they arose from 37 separate studies. There were 67 non-randomised trials. Meta-analyses were performed on eight studies that included both a dietary intervention component and an adequate control group and on four studies that had follow-up data. There was a high degree of heterogeneity between studies and this made comparisons between studies problematic. Interventions that include diet therapy generally result in significant weight loss, at least in the short term. Many studies were poorly designed and had no or only minimal follow up. The details of the dietary intervention were often inadequately described and dietary outcomes rarely reported, making repetition of the studies difficult. Reviewers' conclusions There is an urgent need for high quality studies investigating the optimal dietary approach to management of paediatric overweight and obesity. These studies require adequate follow up to ascertain if weight loss can be sustained in the long term. Details of the dietary prescription, adherence to the dietary intervention and diet-specific outcomes need to be reported in order to inform best practice.
Time2bHealthy - An online childhood obesity prevention program for preschool-aged children: A randomised controlled trial protocol. [2018]The use of parent-focused internet-based programs for the prevention and treatment of childhood obesity has shown promise but there is an acknowledged gap in parent-focused interventions which target the early childhood stage.
The ENDORSE Feasibility Study: Exploring the Use of M-Health, Artificial Intelligence and Serious Games for the Management of Childhood Obesity. [2023]Childhood obesity constitutes a major risk factor for future adverse health conditions. Multicomponent parent-child interventions are considered effective in controlling weight. Τhe ENDORSE platform utilizes m-health technologies, Artificial Intelligence (AI), and serious games (SG) toward the creation of an innovative software ecosystem connecting healthcare professionals, children, and their parents in order to deliver coordinated services to combat childhood obesity. It consists of activity trackers, a mobile SG for children, and mobile apps for parents and healthcare professionals. The heterogeneous dataset gathered through the interaction of the end-users with the platform composes the unique user profile. Part of it feeds an AI-based model that enables personalized messages. A feasibility pilot trial was conducted involving 50 overweight and obese children (mean age 10.5 years, 52% girls, 58% pubertal, median baseline BMI z-score 2.85) in a 3-month intervention. Adherence was measured by means of frequency of usage based on the data records. Overall, a clinically and statistically significant BMI z-score reduction was achieved (mean BMI z-score reduction -0.21 ± 0.26, p-value < 0.001). A statistically significant correlation was revealed between the level of activity tracker usage and the improvement of BMI z-score (-0.355, p = 0.017), highlighting the potential of the ENDORSE platform.
[PRIMARY CARE INTERVENTIONS FOR PEDIATRIC OVERWEIGHT OR OBESITY]. [2018]Obesity is a slow progressive chronic disease, for the complications as well as efficacy of the care. A long-term success requires a comprehensive educational diagno- sis that explores the various dimensions of the child and his family, thus allowing to define the care project. Both the motivational Interviewing that is based on the technics of therapeutic patient education and the parents' implication are the key factors for the success of the care. They allow, from the assessment of competencies of parents and child to propose, according to child's situation, the best targeted management. The follow up will be step by step, in long-term concerted interdisciplinarity, with in each visit the possibility of choosing a new objective or reinforcing some objectives suitable for the child, in combination with strategies that frequently involve the parents. Negotiation between caregiver(s), the child and his family are suitable. The greatest flexibility on both sides will allow to go forward together to reach the chosen aim.
Usability and Engagement Testing of mHealth Apps in Paediatric Obesity: A Narrative Review of Current Literature. [2022]Mobile health (mHealth) platforms have become increasingly popular for delivering health interventions in recent years and particularly in light of the COVID-19 pandemic. Childhood obesity treatment is an area where mHealth interventions may be useful due to the multidisciplinary nature of interventions and the need for long-term care. Many mHealth apps targeting youth exist but the evidence base underpinning the methods for assessing technical usability, user engagement and user satisfaction of such apps with target end-users or among clinical populations is unclear, including for those aimed at paediatric overweight and obesity management. This review aims to examine the current literature and provide an overview of the scientific methods employed to test usability and engagement with mHealth apps in children and adolescents with obesity. A narrative literature review was undertaken following a systematic search. Four academic databases were searched. Inclusion criteria were studies describing the usability of mHealth interventions for childhood obesity treatment. Following the application of inclusion and exclusion criteria, fifty-nine articles were included for full-text review, and seven studies met the criteria for usability and engagement in a clinical paediatric population with obesity. Six apps were tested for usability and one for engagement in childhood obesity treatment. Sample sizes ranged from 6-1120 participants. The included studies reported several heterogenous measurement instruments, data collection approaches, and outcomes. Recommendations for future research include the standardization and validation of instruments to measure usability and engagement within mHealth studies in this population.
Application Design for Child Obesity Management Based on Users' Preferences and Needs. [2021]This study aimed to investigate the constructive preferences and needs of children and guardians in a child obesity management application, and to suggest and visualize the key features of its design. To reflect users' preferences and needs, the questionnaires used in this study were developed in four stages: draft, validity test, review, and final version. The survey was conducted with fifth and sixth grade children who are overweight or obese and their guardians. Differences were observed by gender and between children and guardians with respect to children's perceived body shape, technology experience and preferences, preferred obesity management method, application design, exercise and diet-related features, preferred partner for obesity management, and preferred reward after mission completion. Our study suggests and visualizes the key features of a child obesity management application for both children and guardians based on their preferences and needs, which can be utilized by both application developers and researchers.
BabyByte: Qualitative Research to Inform the Development of an App to Improve Responsive Feeding Practices in Parents of Infants and Toddlers. [2023]Responsive feeding is associated with a reduced risk of childhood obesity. The objective of this qualitative study was to determine parental preferences for mobile health (mHealth) app content and features designed to improve responsive feeding practices. Parents of 0-2-year-old children were interviewed individually. Interview questions were informed by the Technology Acceptance Model, and parents provided feedback on sample app content and features. Interviews were audio-recorded, transcribed verbatim, and coded by two researchers using thematic analysis; responses were compared by parent gender and income. Parents (n = 20 fathers, n = 20 mothers) were, on average, 33 years old, low-income (50%), identified as non-white (52.5%), and had a bachelor's degree or higher (62%). Overall, parents were most interested in feeding tips and recipe content, and app features that allowed tracking child growth and setting feeding goals. Fathers were most interested in content about first foods, choking hazards, and nutrition information, while mothers preferred content on breastfeeding, picky eating, and portion sizes. Parents with lower incomes were interested in nutrition guidelines, breastfeeding, and introducing solids. Non-low-income parents preferred information related to food allergies, portion sizes, and picky eating. The findings of this study provide considerations when developing mHealth apps to improve responsive feeding practices in parents.