Obesity, ChildhoodBabyFeedNCT05990439
Baby-Feed Web Application for Infant Caregivers to Improve Diets and Weight Gain
A study testing Baby-Feed and Limited access to the Baby-Feed web application in people with Obesity, Childhood, run by Florida International University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 month to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Baby-Feed and Limited access to the Baby-Feed web application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 1 Aug 2025
- 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 1 month to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University
Miami, Florida, 33199
About this study
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).
Read the 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
- Conditions
- Obesity, Childhood
- Being tested
- Baby-Feed, Limited access to the Baby-Feed web application
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby-FeedBehavioural
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.
Limited access to the Baby-Feed web applicationBehavioural
Limited access to the Baby-Feed web application, with only the options of completing the FFQ and inputing their baby's weight and length.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Baby-Feed |
| Control group | Placebo comparator | 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. Receives: Behavioral: Limited access to the Baby-Feed web application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet Quality
It will be analyzed from the responses to the infant FFQ using the Diet Quality Index Score (DQIS)
Measured: 9 months
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Apr 2024
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies 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
- Model description
- Randomized Clinical Trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- Academy of Nutrition and Dietetics
- Responsible party
- Sponsor
- Investigators
- Cristina Palacios, PhD, Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990439
- Sponsor's protocol ID
- 23-0409
- Acronym
- BabyFeed
- Status last verified
- Sep 2025
- First submitted
- 7 Aug 2023
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gatto A, Paes-Leme M, Acosta S, Leon M, Reingevurts G, Coccia C, Palacios C. The effect of the Baby-Feed website intervention on diet quality in healthy infants: a randomized controlled trial. Int J Behav Nutr Phys Act. 2026 May 30. doi: 10.1186/s12966-026-01934-9. Online ahead of print.
PubMed 42216037
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baby-Feed Web Application for Infant Caregivers to Improve Diets and Weight Gain
- ClinicalTrials.gov ID
- NCT05990439
- Acronym / sponsor ID
- BabyFeed / 23-0409
- Conditions
- Obesity, Childhood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Collaborators
- Academy of Nutrition and Dietetics
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 14 Aug 2023 (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.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Baby-FeedThis 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. |
| Control group | Placebo comparator | Behavioral: Limited access to the Baby-Feed web applicationParticipants 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. |
Who may qualify
- Ages
- 1 month to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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-FeedThe 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. | Behavioural | Intervention |
| Limited access to the Baby-Feed web applicationLimited access to the Baby-Feed web application, with only the options of completing the FFQ and inputing their baby's weight and length. | Behavioural | Control group |
Primary outcome
Diet Quality
Time frame: 9 months
It will be analyzed from the responses to the infant FFQ using the Diet Quality Index Score (DQIS)
Rate of weight gain
Time frame: 9 months
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.
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 12 Sep 2025.
- Derived from this study: PubMed 42216037Gatto A, Paes-Leme M, Acosta S, Leon M, Reingevurts G, Coccia C, Palacios C. The effect of the Baby-Feed website intervention on diet quality in healthy infants: a randomized controlled trial. Int J Behav Nutr Phys Act. 2026 May 30. doi: 10.1186/s12966-026-01934-9. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
Cristina Palacios, PhD principal investigator
Florida International University
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 and Limited access to the Baby-Feed web application in people with Obesity, Childhood, 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 1 inclusion and 1 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 12 Sep 2025. 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. Some participants in this study may receive a placebo. 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?
Diet Quality (time frame: 9 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 NCT05990439, which also lists 1 linked publication.
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 12 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.