xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05990439</url>
    </required_header>
    <id_info>
      <org_study_id>23-0409</org_study_id>
      <nct_id>NCT05990439</nct_id>
    </id_info>
    <brief_title>Baby-Feed Web Application</brief_title>
    <acronym>BabyFeed</acronym>
    <official_title>Baby-Feed Web Application for Infant Caregivers to Improve Diets and Weight Gain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Florida International University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Academy of Nutrition and Dietetics</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Florida International University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will test the Baby-Feed web platform among 160 parents with infants aged 1-3&#xD;
        months at the time of enrollment and follow them through their 9-month well-child visit&#xD;
        (about a total of 6 months) using a mixed-methods approach (randomized control trial with&#xD;
        qualitative interviews).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will test the Baby-Feed web platform among 160 parents with infants aged 1-3&#xD;
        months at the time of enrollment and follow them through their 9-month well-child visit&#xD;
        (about a total of 6 months) using a mixed-methods approach (randomized control trial with&#xD;
        qualitative interviews). We chose this age range as this is the period in which parents&#xD;
        initiate and continue complementary foods in their infants' diets. Procedures: Participants&#xD;
        randomized to the intervention arm (n=80) will have full access to the Baby-Feed web&#xD;
        application and receive automated weekly text messages to complement the information received&#xD;
        in Baby-Feed and to remind them to access the web application. Within the Baby-Feed platform,&#xD;
        the intervention arm will assess the online infant FFQ to complete it at the required&#xD;
        intervals (before the 4-month, 6-month, and 9-month well-child visits) and receive automatic&#xD;
        feedback for obtaining recommended intake of food groups as well as input bi-weekly tracking&#xD;
        goals. They will also record their infant's weight and length as provided from the well-child&#xD;
        visits, which will plot on the WHO CDC 0-24 months growth chart and provide feedback to their&#xD;
        infant's growth pattern. Caregivers will also have access to educational resources to aid&#xD;
        them in reading and viewing appropriate infant guidance. Participants randomized to the&#xD;
        control arm (n=80) will have access to certain components of the Baby-Feed web application,&#xD;
        such as the online infant FFQ to complete it at the same intervals (before the 4-month,&#xD;
        6-month, and 9-month well-child visits) and infant's weight and length as recorded in the&#xD;
        well-child visits, but without any automatic results or feedback. Risks and anticipated&#xD;
        benefits: We anticipate minimal risks as it is self-reported data only. Anticipated benefits&#xD;
        include caregivers receiving dietary and weight gain guidance during the study which may&#xD;
        assist with optimal nutritional and weight status. The importance of the knowledge that may&#xD;
        reasonably be expected to result: The importance of this knowledge could lead to public use&#xD;
        of the Baby-Feed web application leads to improvements in diet and weight gain during this&#xD;
        critical time of growth and by potentially becoming a routine and accessible tool for&#xD;
        clinicians to recommend their patients to support optimal growth and development for infants&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Randomized Clinical Trial</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>randomization, assignment of arms, assessments</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Diet Quality</measure>
      <time_frame>9 months</time_frame>
      <description>It will be analyzed from the responses to the infant FFQ using the Diet Quality Index Score (DQIS)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of weight gain</measure>
      <time_frame>9 months</time_frame>
      <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.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Obesity, Childhood</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.&#xD;
  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.&#xD;
  Recommendations: this section displays the amount recommended for each food group by age group.&#xD;
  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.&#xD;
  Weight gain tracker: parents are asked to input the weight and length of their baby and it shows graphically how the baby is progressing.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Baby-Feed</intervention_name>
      <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.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Limited access to the Baby-Feed web application</intervention_name>
      <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.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1-3 months old at time of enrollment, term healthy infant, any weight status,&#xD;
               parent/family member must be primary caretakers, have internet access, agree to&#xD;
               receive text messaging service for communication and reminders, willing to participate&#xD;
               for full study duration, and English or Spanish language literate.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Infants with special diets, preterm birth (&lt;37 weeks), caregiver inability to consent&#xD;
               to participate, unwillingness to be randomized, and unable to read in English or&#xD;
               Spanish.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Month</minimum_age>
      <maximum_age>3 Months</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Cristina Palacios, PhD</last_name>
      <phone>3053483235</phone>
      <email>crpalaci@fiu.edu</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pediatric Obesity</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05990439
  org study id: 23-0409
  nct id: NCT05990439
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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 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). We chose this age range 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: We anticipate 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
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized Clinical Trial
  primary purpose: Prevention
  masking: Double (Participant, Investigator)
  masking description: randomization, assignment of arms, assessments
  measure: Diet Quality
  time frame: 9 months
  description: It will be analyzed from the responses to the infant FFQ using the Diet Quality Index Score (DQIS)
  measure: Rate of weight gain
  time frame: 9 months
  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.
  arm group label: Intervention
  arm group type: Experimental
  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 group label: Control group
  arm group type: Placebo Comparator
  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: Baby-Feed
  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.
  arm group label: Intervention
  intervention type: Behavioral
  intervention name: Limited access to the Baby-Feed web application
  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.
  arm group label: Control group
  criteria: 
  gender: All
  minimum age: 1 Month
  maximum age: 3 Months
  healthy volunteers: Accepts Healthy Volunteers
  last name: Cristina Palacios, PhD
  phone: 3053483235
  email: crpalaci@fiu.edu
  responsible party type: Sponsor
  mesh term: Pediatric Obesity
  sharing ipd: Undecided