Baby-Feed Web Application for Childhood Obesity (BabyFeed Trial)

N/A

Recruiting

Research Sponsored by Florida International University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months

Summary

This trial will test a website called Baby-Feed with 160 parents of infants aged 1-3 months. The study will follow them for about 6 months until the baby's 9-month

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves using a web application for information and communication without medical interventions, there are no direct physical side effects expected from participating in this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Diet Quality

Rate of weight gain

Trial Design

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.

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