Clinical trial NCT05062824: Pilot Testing of Baby Feed: A Web Application for Health Professionals and Parents to Improve Infant Diets
Official title: Pilot Testing of Baby Feed: A Web Application for Health Professionals and Parents to Improve Infant Diets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Florida International University
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: This project will pilot test "Baby Feed" online web portals among clinicians and parents to learn about their experience with the portals. Baby Feed can (1) Quickly and easily evaluate infant diets online using a validated Infant Food Frequency Questionnaire (FFQ) developed by the Principal Investigator \[Parental Portal\]; (2) Provide immediate results online to health care providers on nutrients and foods/beverages consumed above or below the recommended levels \[Clinician Portal\]; (3) Provide current diet recommendations by infant's age online to health care providers to discuss with parents, with the goal of improving their infant's diet \[Clinician Portal\]; (4) Give online access of the infant diet recommendations to parents for home implementation, with an online short tracking component \[Parental Portal\].

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. All parents will first complete the Infant FFQ online. Those randomized to Baby Feed will discuss the results as a part of the Well-Child Visit with the healthcare professional, who will also have access to the results from the Clinician Portal. They will discuss the most relevant results and the dietary recommendations to follow at home. Parents will also be able to see the recommendations online in the Parental Portal in a friendly and graphic way to follow easily at home. Parents will be prompted to complete the online short tracking questions once per week to evaluate how well they are following the dietary recommendations during the duration of the study: 3 months. 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 by reviewing the results from the infant FFQ at baseline and 3 months later in both groups. The investigators will also evaluate weight gain during this period and compare between groups. For this, the investigators will ask all parents to complete online a short form with the weight and length of the baby as recorded by the nurse in each Well-Child Visit at baseline and follow-up visits.

RISKS/BENEFITS: The main risk or discomfort from this research is the disclosure of personal information. The main benefit to those randomized to the intervention group is that clinicians will be receiving automatic results and dietary recommendations in "Baby Feed" online to discuss with parents, and for parents is receiving dietary recommendations from "Baby Feed" online to improve their infant's diet.

IMPORTANCE OF THE KNOWLEDGE: Baby Feed could be an important tool to help promote adherence to diet recommendations which could translate into healthy weight gain during the first year and thus prevent long-term obesity.

Eligibility criteria: Inclusion Criteria:

* 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;

Exclusion criteria:

* 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.

Primary outcomes:
measure: Infant's diet
timeFrame: 3 months
measure: Diet quality using the Diet Quality Index Score (DQIS)
timeFrame: 3 months
Secondary outcomes:
measure: Rate of weight gain
timeFrame: 3 months
measure: Parenting Self-Efficacy
timeFrame: 3 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Borinquen Medical Center
state: Florida
Study officials:
References:
citation: 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.