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Behavioral Intervention

Intervention 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

Awards & highlights

BabyFeed Trial 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.Check my eligibility

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.See study design

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.

BabyFeed Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Diet Quality

Rate of weight gain

BabyFeed 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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Florida International UniversityLead Sponsor

100 Previous Clinical Trials

17,395 Total Patients Enrolled

Academy of Nutrition and DieteticsOTHER

24 Previous Clinical Trials

5,405 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical study accept individuals older than 40 years?

"For this particular study, eligible participants must be between 1 and 3 months of age to be enrolled."

Answered by AI

Is it possible for me to participate in this research endeavor?

"The research study seeks 160 candidates aged between 1 month and 3 months who are experiencing childhood obesity. Eligible participants should meet the subsequent requirements: infants must be between 1-3 months old at enrollment, born full-term with good health status, any weight range accepted, primary caretaker being a parent or family member, access to internet facilities, consent for receiving text message updates and reminders, readiness to engage for the entire duration of the investigation, and proficiency in English or Spanish language."

Answered by AI

Are new patients currently being accepted for enrollment in this medical study?

"Affirmative. Data from clinicaltrials.gov indicates that this research study is actively seeking volunteers. The trial was first posted on April 1, 2024 and last revised on April 9, 2024. Enrollment of approximately 160 subjects will take place at a single site."

Answered by AI

What is the current number of individuals enrolled in this clinical study?

"Indeed, information from clinicaltrials.gov confirms the ongoing recruitment for this trial. Originally shared on April 1st, 2024, and most recently revised on April 9th, 2024, the study aims to enroll 160 participants at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Baby-Feed Web Application for Infant Caregivers to Improve Diets and Weight Gain

2024. "Baby-Feed Web Application for Infant Caregivers to Improve Diets and Weight Gain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05990439.

All > Weight Gain