ObesityNCT05062824

Pilot Testing of Baby Feed: A Web Application for Health Professionals and Parents to Improve Infant Diets

A study testing Baby Feed in people with Obesity, run by Florida International University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 4 to 12 monthsHealthy volunteers can take part
Conditions the study is for: Obesity
What is being tested?: Baby Feed
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 20 Sep 2021to 1 Apr 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 to 12 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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;

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Borinquen Medical Center
Miami, Florida, 33174

Other trials in United States

About this study

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.

Read the 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.

Conditions: Obesity
Being tested: Baby Feed
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Baby FeedBehavioural
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].

Study groups in NCT05062824
Study group	Role	What they receive
Intervention	Experimental	Participants in the intervention will have access to Baby Feed Receives: Behavioral: Baby Feed
Standard Care	No intervention	Participants in the standard care group will NOT have access to Baby Feed

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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).
Measured: 3 months

Secondary outcomes (2)

Rate of weight gain
The investigators will calculate the weight z score and weight-for-length z score using the WHO Anthro Survey Analyzer. The rate of weight gain will be calculated as the change in weight z score between visits and categorized as: (1) Adequate weight gain (change of -0.67 to 0.67 standard deviations; (2) Rapid weight gain in (change > 0.67 standard deviations); (3) Slow weight gain (change of < -0.67 standard deviations).
Measured: 3 months
Parenting Self-Efficacy
This will be assessed using a validated questionnaire, as mediator of behavioral change. The investigators will evaluate changes in the level of confidence that parents feel about feeding their baby between baseline and follow up visits.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Sep 20211 Apr 2022

First posted30 Sep 2021
Study start20 Sep 2021
Primary completion1 Apr 2022
Study completion1 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05062824
Sponsor's protocol ID: IRB-20-0498
Status last verified: Apr 2023
First submitted: 21 Sep 2021
Last updated: 14 Apr 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 36948062
Bolton J, Wang W, Coccia C, Narayanan V, Varella M, Hannan J, Palacios C. Baby-Feed Pilot Trial for Improving Diet and Weight Gain in Infants and Toddlers. Matern Child Health J. 2026 Jun 18. doi: 10.1007/s10995-026-04282-z. Online ahead of print.
PubMed 42310262

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Testing of Baby Feed: A Web Application for Health Professionals and Parents to Improve Infant Diets
ClinicalTrials.gov ID: NCT05062824
Acronym / sponsor ID: IRB-20-0498
Conditions: Obesity
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Florida International UniversityUniversity, hospital or other
Study start: 20 Sep 2021 (actual)
Primary completion: 1 Apr 2022 (actual)
Study completion: 1 Apr 2022 (actual)
First posted: 30 Sep 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Behavioral: Baby FeedParticipants in the intervention will have access to Baby Feed
Standard Care	No intervention	–Participants in the standard care group will NOT have access to Baby Feed

Who may qualify

Ages: 4 to 12 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

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;

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Baby FeedBaby 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].	Behavioural	Intervention

Primary outcome

Infant's diet
Time frame: 3 months
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
Diet quality using the Diet Quality Index Score (DQIS)
Time frame: 3 months
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).

2 secondary outcomes

Rate of weight gain
Time frame: 3 months
Parenting Self-Efficacy
Time frame: 3 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
Background: PubMed 36948062Palacios 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.
Derived from this study: PubMed 42310262Bolton J, Wang W, Coccia C, Narayanan V, Varella M, Hannan J, Palacios C. Baby-Feed Pilot Trial for Improving Diet and Weight Gain in Infants and Toddlers. Matern Child Health J. 2026 Jun 18. doi: 10.1007/s10995-026-04282-z. Online ahead of print.
Individual participant dataSharing planned: Undecided

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
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Recruiting
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Active, not recruiting
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Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Baby Feed in people with Obesity, run by Florida International University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infant's diet (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05062824, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.