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

Primary Purpose

Obesity, Childhood

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Baby-Feed
Limited access to the Baby-Feed web application
Sponsored by
Florida International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Childhood

Eligibility Criteria

1 Month - 3 Months (Child)All SexesAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Intervention

    Control group

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Diet Quality
    It will be analyzed from the responses to the infant FFQ using the Diet Quality Index Score (DQIS)
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 7, 2023
    Last Updated
    October 5, 2023
    Sponsor
    Florida International University
    Collaborators
    Academy of Nutrition and Dietetics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05990439
    Brief Title
    Baby-Feed Web Application for Infant Caregivers to Improve Diets and Weight Gain
    Acronym
    BabyFeed
    Official Title
    Baby-Feed Web Application for Infant Caregivers to Improve Diets and Weight Gain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2024 (Anticipated)
    Study Completion Date
    December 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Florida International University
    Collaborators
    Academy of Nutrition and Dietetics

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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).
    Detailed 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Childhood

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized Clinical Trial
    Masking
    ParticipantInvestigator
    Masking Description
    randomization, assignment of arms, assessments
    Allocation
    Randomized
    Enrollment
    160 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Control group
    Arm Type
    Placebo Comparator
    Arm 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Baby-Feed
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Limited access to the Baby-Feed web application
    Intervention Description
    Limited access to the Baby-Feed web application, with only the options of completing the FFQ and inputing their baby's weight and length.
    Primary Outcome Measure Information:
    Title
    Diet Quality
    Description
    It will be analyzed from the responses to the infant FFQ using the Diet Quality Index Score (DQIS)
    Time Frame
    9 months
    Title
    Rate of weight gain
    Description
    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.
    Time Frame
    9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Month
    Maximum Age & Unit of Time
    3 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cristina Palacios, PhD
    Phone
    3053483235
    Email
    crpalaci@fiu.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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