NCT05062824

Brief Summary

This project will pilot test "Baby Feed" online web portals among clinicians and parents to learn about their experience with the portals. Baby Feed evaluates infant diets online using a validated Infant Food Frequency Questionnaire, provides immediate results online to health care providers on nutrients and foods/beverages consumed above or below the recommended levels, provides current diet recommendations by infant's age online, and helps track progress at home. The investigators will recruit 2 clinicians from Borinquen Health Care Center in Miami and 50 of their patients (parents with infants) scheduled for a routine Well-Child Visit when infants are 4-12 months old. Participants will be equally randomized to the intervention group or the control group. If randomized to Baby Feed, parents will discuss the results with the healthcare professional and track their infants' diets at home. Parents in the Control group will only complete the infant FFQ online but will not have access to the other features of Baby Feed. After 3 months, the investigators will evaluate the infant diet and weight gain during this period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 21, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 30, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

6 months

First QC Date

September 21, 2021

Last Update Submit

April 12, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Infant's diet

    Results from the infant FFQ will be analyzed to calculate if percentage change of the foods and beverages consumed above or below the recommended levels changed during this study period

    3 months

  • Diet quality using the Diet Quality Index Score (DQIS)

    Using the results from the infant FFQ, the investigators will calculate the DQIS score, which is composed of 9 food groups: breastfeeding and milk, grains, proteins, vegetables, fruits, 100% juices, sugar-sweetened beverages, sweets, and salty snacks. A total of 5 points are assigned if the intake is within the recommended amounts, 2.5 points if the intake is slightly over or under recommended amount, and 0 points if the intake is excessive or not consumed. The points are summed, and diet quality is categorized as Excellent (score: 45-55), Good (score: 35-44), Needs Improvement (score: 25-34), and Poor (score: 0-24).

    3 months

Secondary Outcomes (2)

  • Rate of weight gain

    3 months

  • Parenting Self-Efficacy

    3 months

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in the intervention will have access to Baby Feed

Behavioral: Baby Feed

Standard Care

NO INTERVENTION

Participants in the standard care group will NOT have access to Baby Feed

Interventions

Baby FeedBEHAVIORAL

Baby Feed web portals can (1) Quickly and easily evaluate infant diet using a validated Infant Food Frequency Questionnaire (infant FFQ) developed by our group14. \[Parental FFQ portal\]; (2) Provide automatic results to healthcare professionals on nutrients and foods/beverages consumed above or below the recommended levels to discuss with parents for improving the infant's diet. Also, to provide recommendations for amounts of foods/beverages that the infant should be consuming by age \[Clinician Portal\]; (3) Give online access to parents to these diet recommendations to implement at home, with an easy tracking component \[Parent's Portal\].

Intervention

Eligibility Criteria

Age4 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • parent/guardian responsible for infant's care;
  • parent of an infant age 4 to 12 months, who is healthy and with any weight status;
  • have internet access;
  • willing to participate for the full study duration of 2 weeks;

You may not qualify if:

  • parents of infants with special diets, limited mobility, preterm birth of \< 37 weeks, birthweight \< 10th or \> 90th percentile;
  • parent/guardian unable to consent to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Borinquen Medical Center

Miami, Florida, 33174, United States

Location

Related Publications (1)

  • Palacios C, Bolton J, Wang W, Gatto A, Concepcion L, Sadjadi M, Varella M, Hannan J. Development and pilot testing of the Baby-Feed web application for healthcare professionals and parents to improve infant diets. Int J Med Inform. 2023 Jun;174:105047. doi: 10.1016/j.ijmedinf.2023.105047. Epub 2023 Mar 17.

    PMID: 36948062BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Weight and length are being collected by the nurse in Borinquen Health Center, they are blinded to the study groups.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 21, 2021

First Posted

September 30, 2021

Study Start

September 20, 2021

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

April 14, 2023

Record last verified: 2023-04

Locations