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

Obesity, Childhood Clinical Trial

— BabyFeed  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05990439
• Other study ID #: 23-0409
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 1, 2026

Study information

• Verified date: April 2024
• Source: Florida International University
• Contact: Cristina Palacios, PhD
• Phone: 3053483235
• Email: crpalaci[@]fiu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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). This age range was chosen as this is the period in which parents initiate and continue complementary foods in their infants' diets. Procedures: Participants randomized to the intervention arm (n=80) will have full access to the Baby-Feed web application and receive automated weekly text messages to complement the information received in Baby-Feed and to remind them to access the web application. Within the Baby-Feed platform, the intervention arm will assess the online infant FFQ to complete it at the required intervals (before the 4-month, 6-month, and 9-month well-child visits) and receive automatic feedback for obtaining recommended intake of food groups as well as input bi-weekly tracking goals. They will also record their infant's weight and length as provided from the well-child visits, which will plot on the WHO CDC 0-24 months growth chart and provide feedback to their infant's growth pattern. Caregivers will also have access to educational resources to aid them in reading and viewing appropriate infant guidance. Participants randomized to the control arm (n=80) will have 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. Risks and anticipated benefits: It is anticipated that this trial will have minimal risks as it is self-reported data only. Anticipated benefits include caregivers receiving dietary and weight gain guidance during the study which may assist with optimal nutritional and weight status. The importance of the knowledge that may reasonably be expected to result: The importance of this knowledge could lead to public use of the Baby-Feed web application leads to improvements in diet and weight gain during this critical time of growth and by potentially becoming a routine and accessible tool for clinicians to recommend their patients to support optimal growth and development for infants

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 3 Months

Eligibility

Inclusion Criteria:

• 1-3 months old at time of enrollment, term healthy infant, any weight status, parent/family member must be primary caretakers, have internet access, agree to receive text messaging service for communication and reminders, willing to participate for full study duration, and English or Spanish language literate.

Exclusion Criteria:

• Infants with special diets, preterm birth (<37 weeks), caregiver inability to consent to participate, unwillingness to be randomized, and unable to read in English or Spanish.

Related Conditions & MeSH terms

• Obesity, Childhood
• Pediatric Obesity
• Weight Gain

Intervention

Behavioral:
• Baby-Feed
The Baby-Feed web application was developed by the researchers of this application at Florida International University. It was designed based on a validated infant food frequency questionnaire (FFQ) developed by our group. The Social Cognitive Theory (SCT) and the Health Self-Empowerment Theory (HSET) were used in the development of the different components. The main intervention component is showing automatic results on how well parents are feeding their infants, upon completion of the infant FFQ, showing results on which food groups are consumed at the recommended level, which are consumed above and which are consumed below. It also shows a growth chart showing how the baby is progressing when they add their baby's weight and length. The website also includes a tracking system with short questions asking about their weekly progress and the recommendations to review frequently, if needed.
• Limited access to the Baby-Feed web application
Limited access to the Baby-Feed web application, with only the options of completing the FFQ and inputing their baby's weight and length.

Locations

Country	Name	City	State
United States	Florida International University	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida International University	Academy of Nutrition and Dietetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diet Quality	It will be analyzed from the responses to the infant FFQ using the Diet Quality Index Score (DQIS)	9 months
Primary	Rate of weight gain	It will be analyzed from the plotted weight and length as recorded by caregivers in the WHO gender-specific growth chart table in Baby-Feed after each well-child visit (4, 6, and 9 months) to calculate weight-for-length z-score.	9 months