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

Florida International University (FIU)

Status: Active, not recruiting

Conditions: Obesity, Childhood

Treatments: Behavioral: Baby-Feed; Behavioral: Limited access to the Baby-Feed web application

Study type: Interventional

Funder types: Other

Identifiers

NCT05990439

23-0409

Details and patient eligibility

About

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).

Full 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

Enrollment: 160 estimated patients

Sex: All

Ages: 1 to 3 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Baby-Feed

Control group

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Limited access to the Baby-Feed web application