Parental Feeding Practices and Children's Healthy DietSF4KNCT04591496
The SmartFeeding4Kids: Study of a New Web-based Food Parenting Intervention
A study testing Behavioral change intervention; and Health Education in people with Parental Feeding Practices and Children's Healthy Diet, run by University of Lisbon at 1 site in Portugal.
Trial summary
This research aims to develop and study the efficacy of a web-based brief intervention, Smart Feeding4Kids, to promote healthy dietary patterns in young children (2 to 6 years old) through changes in parents' feeding practices. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parental Feeding Practices and Children's Healthy Diet
- What is being tested?
- Behavioral change intervention; and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 sitePortugal
- Study dates
- 13 Jul 2021to 31 Dec 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parent/caregiver of a 2 to 6 years old child, at baseline (if the parent has two children in the same age interval, the parent must choose the child that raises more concerns about their health habits, as reference)
- Have access to a mobile phone or computer/tablet with internet
- Be fluent in Portuguese
- Agree to participate in the study to accomplish the intervention in which they are allocated, the evaluation protocols, and the tasks required in each condition
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Faculdade de Psicologia, Universidade de Lisboa
Lisbon, 1649-013
About this study
Official title: The SmartFeeding4Kids, a Web-based Food Parenting Intervention to Promote Positive Feeding Practices and Healthy Diet in Preschool Children, Through Self-regulation and Behavior Change Techniques: a Randomized Control Trial
This research aims to develop and study the efficacy of a web-based brief intervention, Smart Feeding4Kids, to promote healthy dietary patterns in young children (2 to 6 years old) through changes in parents' feeding practices. The intervention is grounded on self-regulation and habit-formation models and combines the use of several effective behavioral methodologies. The multidisciplinary team integrates experienced researchers on parenting interventions, child nutrition, and the development of online applications to support personalized nutritional assessment and psychological interventions. The monitoring of the use of the platform and the knowledge about the predictors of efficacy, adherence, and involvement obtained in this project will offer professionals essential information to the development of future online interventions. The project will also contribute with knowledge concerning the most effective methodologies for changing parental feeding practices and collects unique information about the eating habits and practices of parents of Portuguese children.
The main hypotheses of the study:
- parents who enrolled in behavior change and social support interventions will report significantly higher use of effective feeding practices (child's self-regulation intake practices, food availability, and accessibility practices) and significantly lower use of ineffective feeding practices (food control, restriction, and permissiveness feeding practices);
- children whose parents enrolled in behavior change and social support interventions will have a significantly more frequent intake of vegetables and fruits intake, and significantly less frequent intake of sugar-sweetened foods and beverages;
- positive changes in parental feeding practices will mediate children's food intake, with increased vegetables and fruits and decreased sugar-sweetened foods and beverages intake.
Read the detailed description
A Randomized Control Trial with two groups (SmartFeeding4Kids, SmartFeeding4Kids Health) x 4 times (pre, post, 3-months, 6-month follow-up) repeated measures design will be used. Invitations to participate in the program will be made through flyers and social media messages. The invitation will show a link where parents can access detailed information about the program (study objectives, procedures, random allocation to one of the three conditions, data collected during the study). As this is a Randomized Control Trial study with repeated measurements, participants' identification must be recorded. The data relating to the parent's answers to evaluation protocols and self-monitoring, and time or interaction with the application/program, are associated with a personal account created by the participants at the beginning of the process. Consent protocol includes a paragraph that explains which data will be recorded and how it will be saved; parents must consent to researchers accessing this information. Only relevant information is collected. Data will be stored in a secure server. The team chose the server Amazon Web Services because is one of the most used services for hosting a website securely. Amazon Web Services delivers a mature set of services specifically designed for the unique security, compliance, privacy, and governance requirements of large organizations.
Once registered, parents are directed to the baseline assessment protocol. After the completion of the questionnaires and 24h food recalls, parents will be randomized and allocated to one of the two conditions through an automated web-based randomization program. For both conditions, parents will be invited to participate in five sessions plus two brief booster sessions. A new session is only accessible once parents have visualized the contents of the last session and performed the tasks proposed between sessions (for experimental conditions). Although the intervention is self-guided, each session is expected to be accomplished within an average of one week. At the end of the program, parents are redirected to fill the post-intervention assessment protocol; a similar procedure is performed after 3 and 6 months.
Cohen's f criteria will be used, with a small effect size of 0.15, an alpha equal to 0.05, and power of 0.80 for a two-group with four repeated measures design (with a moderate correlation pattern between time measurements of 0.35). The sample size needed is approximately 130 participants (i.e., 65 parents in each of the two-arm groups), but the total sample size was adjusted to account for a dropout rate of 50%. Therefore, the sample will be collected until 130 participants in each group (N = 260) finish the program. The proposed sample size will also be adequate for multilevel modeling with level-1 repeated measures nested within level-2 individuals, by assuring a minimum of 50 individuals required for level-2.
As mentioned before, the application does not allow participants to proceed to the sessions without completing all items of the baseline evaluation protocol, nor the participants have access to a new session if they do not complete the requested between-sessions records. As such, missing data will only be due to participant's dropout, during the intervention, or during the follow-up assessments completion. The researchers will use intention-to-treat principles: participants will be analyzed in the group in which they were allocated in the randomization process, independently of whether they had completed all measurement time points and/or the intervention. An evaluation of missing data mechanisms will be performed to inform which imputation strategy should be applied between multiple imputations (MI) and maximum likelihood estimation (FIML). Assuming the data are missing at random, a sensitivity analysis will be included, considering the whole samples vs. samples with complete data separately.
- Being tested
- Behavioral change intervention;, Health Education
- Keywords
- Preschool child, Internet-based intervention, Parenting, Feeding behavior, Eating habits, Health education, Behavior change techniques, Random allocation
- Medical subject headings
- Feeding Behavior, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral change intervention;Behavioural
Behavioral change intervention: goal setting, regarding child's diet and parental feeding practices; self-monitoring, with observation and recording of the child's food intake and parental feeding practices; individualized feedback, based on preceding week monitoring and according to the defined objectives, regarding child's and parent's behaviors; modeling and direct suggestions by tailored parent figures; positive reinforcement associated to parents' accomplishment of the objectives; prompts, to remember the defined objectives and the main messages of the intervention.
Health EducationBehavioural
Health education: provision of information about preschool children's nutrition guidelines, effective parental feeding practices, strategies to overcome food and feeding-related barriers, and steps to form healthy habits.
| Study group | Role | What they receive |
|---|---|---|
| SmartFeeding4Kids | Experimental | SmartFeeding4Kids: information about children's healthy diet and effective parental feeding practices, with a behavioral intervention (5 sessions plus 2 brief booster sessions online intervention) Receives: Behavioral: Behavioral change intervention;; Behavioral: Health Education |
| SmartFeeding4Kids Health | Active comparator | Psychoeducational condition: information about children's healthy diet and effective parental feeding practices (5 sessions plus 2 brief booster sessions online intervention) Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in the child's dietary intake reported by parents
Child's dietary intake reported by parents: Child's dietary intake is evaluated through a 24h food recall, completed during 3 days (two weekdays and one weekend day). Data regarding the mean number of portions of vegetables, fruit, and sugar-sweetened foods and beverages registered on three days will be extracted from the database and analyzed separately as primary outcomes.
Measured: Baseline, immediately after the intervention, 3 months after the intervention, 6 months after the intervention
Changes from baseline in parental feeding practices
Parental feeding practices: Parental feeding practices are evaluated through a self-reported questionnaire, Food Parenting Practices Questionnaire, with three subscales (Child's Intake Self-regulation Practices, Food Availability and Accessibility Practices, and Ineffective Control Practices) developed and adapted to the Portuguese population within this study. Parents answer to 40 items on a 5-point Likert scale (from Totally false to Totally true). Higher values on each subscale indicate a more frequent use of this type of parental feeding practices. The total mean score of each subscale ranged from 1 to 5.
Measured: Baseline, immediately after the intervention, 3 months after the intervention, 6 months after the intervention
Secondary outcomes (3)
Changes from baseline in parental perceived barriers related to food and feeding
Parental barriers are evaluated through a self-reported instrument, Parental Perception on Children's Healthy Feeding Barriers Questionnaire, developed and adapted to the Portuguese population within this study. The instrument has 30 items divided by 5 subscales (Child-related barriers, Parent-related barriers: vegetables \& fruit, Parent-related barriers: added sugars, Context-related barriers, Cost-related barriers), answered on a 5-point Likert scale (from Totally false to Totally true). Higher values on each subscale indicate that a specific kind of parental barriers is more present. The total mean score of each subscale ranged from 1 to 5.
Measured: Baseline, immediately after the intervention, 3 months after the intervention, 6 months after the intervention
Changes from baseline in food parenting self-efficacy
Parental self-efficacy is measured with a self-reported questionnaire, Parental Self-efficacy for Children's Healthy Diet Scale, previously developed by the team, with 4 items answered in a 5-point Likert scale (from No sure to Absolutely sure). Higher values on the scale correspond to higher parental self-efficacy. Score ranged from 1 to 5.
Measured: Baseline, immediately after the intervention, 3 months after the intervention, 6 months after the intervention
Changes from baseline in parental motivation to change
Parental motivation to change is measured through a self-reported questionnaire with three items developed within this study. In each item, parents report their degree of importance, confidence and readiness to adhere and promote healthy changes in the child's diet and parental feeding practices, answering in a 10-point numerical scale (e.g., from Not important to Extremely important). Higher mean scores correspond to a higher degree of motivation to change (score ranged between 1 and 10).
Measured: Baseline, immediately after the intervention, 3 months after the intervention, 6 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start13 Jul 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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 Parental Feeding Practices and Children's Healthy DietStudies 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
- Participants are assigned to one of three groups in parallel for the duration of the study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lisbon
- Sponsor type
- University, hospital or other
- Collaborators
- Faculdade de Psicologia, Universidade de Lisboa, Centro de Investigação em Ciência Psicológica, Faculdade de Psicologia, Universidade de Lisboa, FCiências.ID, Faculdade de Ciências, Universidade de Lisboa, Fundação para a Ciência e a Tecnologia
- Responsible party
- Principal investigator, Luisa Barros, University of Lisbon
- Investigators
- Luisa Barros, Principal investigator, University of Lisbon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591496
- Sponsor's protocol ID
- PTDC/PSI-GER/30432/2017
- Acronym
- SF4K
- Status last verified
- May 2026
- First submitted
- 9 Oct 2020
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Charneca S, Gomes AI, Branco D, Guerreiro T, Barros L, Sousa J. Intake of added sugar, fruits, vegetables, and legumes of Portuguese preschool children: Baseline data from SmartFeeding4Kids randomized controlled trial participants. Front Nutr. 2023 Mar 29;10:1150627. doi: 10.3389/fnut.2023.1150627. eCollection 2023.
PubMed 37063316Gomes AI, Pereira AI, Guerreiro T, Branco D, Roberto MS, Pires A, Sousa J, Baranowski T, Barros L. SmartFeeding4Kids, an online self-guided parenting intervention to promote positive feeding practices and healthy diet in young children: study protocol for a randomized controlled trial. Trials. 2021 Dec 18;22(1):930. doi: 10.1186/s13063-021-05897-z.
PubMed 34922616
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SmartFeeding4Kids, a Web-based Food Parenting Intervention to Promote Positive Feeding Practices and Healthy Diet in Preschool Children, Through Self-regulation and Behavior Change Techniques: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04591496
- Acronym / sponsor ID
- SF4K / PTDC/PSI-GER/30432/2017
- Keywords
- Preschool child, Internet-based intervention, Parenting, Feeding behavior, Eating habits, Health education, Behavior change techniques, Random allocation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- University of LisbonUniversity, hospital or other
- Collaborators
- Faculdade de Psicologia, Universidade de Lisboa, Centro de Investigação em Ciência Psicológica, Faculdade de Psicologia, Universidade de Lisboa, FCiências.ID, Faculdade de Ciências, Universidade de Lisboa, Fundação para a Ciência e a Tecnologia
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Oct 2020 (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 research aims to develop and study the efficacy of a web-based brief intervention, Smart Feeding4Kids, to promote healthy dietary patterns in young children (2 to 6 years old) through changes in parents' feeding practices. The intervention is grounded on self-regulation and habit-formation models and combines the use of several effective behavioral methodologies. The multidisciplinary team integrates experienced researchers on parenting interventions, child nutrition, and the development of online applications to support personalized nutritional assessment and psychological interventions. The monitoring of the use of the platform and the knowledge about the predictors of efficacy, adherence, and involvement obtained in this project will offer professionals essential information to the development of future online interventions. The project will also contribute with knowledge concerning the most effective methodologies for changing parental feeding practices and collects unique information about the eating habits and practices of parents of Portuguese children.
The main hypotheses of the study:
- parents who enrolled in behavior change and social support interventions will report significantly higher use of effective feeding practices (child's self-regulation intake practices, food availability, and accessibility practices) and significantly lower use of ineffective feeding practices (food control, restriction, and permissiveness feeding practices);
- children whose parents enrolled in behavior change and social support interventions will have a significantly more frequent intake of vegetables and fruits intake, and significantly less frequent intake of sugar-sweetened foods and beverages;
- positive changes in parental feeding practices will mediate children's food intake, with increased vegetables and fruits and decreased sugar-sweetened foods and beverages intake.
Detailed description
A Randomized Control Trial with two groups (SmartFeeding4Kids, SmartFeeding4Kids Health) x 4 times (pre, post, 3-months, 6-month follow-up) repeated measures design will be used. Invitations to participate in the program will be made through flyers and social media messages. The invitation will show a link where parents can access detailed information about the program (study objectives, procedures, random allocation to one of the three conditions, data collected during the study). As this is a Randomized Control Trial study with repeated measurements, participants' identification must be recorded. The data relating to the parent's answers to evaluation protocols and self-monitoring, and time or interaction with the application/program, are associated with a personal account created by the participants at the beginning of the process. Consent protocol includes a paragraph that explains which data will be recorded and how it will be saved; parents must consent to researchers accessing this information. Only relevant information is collected. Data will be stored in a secure server. The team chose the server Amazon Web Services because is one of the most used services for hosting a website securely. Amazon Web Services delivers a mature set of services specifically designed for the unique security, compliance, privacy, and governance requirements of large organizations.
Once registered, parents are directed to the baseline assessment protocol. After the completion of the questionnaires and 24h food recalls, parents will be randomized and allocated to one of the two conditions through an automated web-based randomization program. For both conditions, parents will be invited to participate in five sessions plus two brief booster sessions. A new session is only accessible once parents have visualized the contents of the last session and performed the tasks proposed between sessions (for experimental conditions). Although the intervention is self-guided, each session is expected to be accomplished within an average of one week. At the end of the program, parents are redirected to fill the post-intervention assessment protocol; a similar procedure is performed after 3 and 6 months.
Cohen's f criteria will be used, with a small effect size of 0.15, an alpha equal to 0.05, and power of 0.80 for a two-group with four repeated measures design (with a moderate correlation pattern between time measurements of 0.35). The sample size needed is approximately 130 participants (i.e., 65 parents in each of the two-arm groups), but the total sample size was adjusted to account for a dropout rate of 50%. Therefore, the sample will be collected until 130 participants in each group (N = 260) finish the program. The proposed sample size will also be adequate for multilevel modeling with level-1 repeated measures nested within level-2 individuals, by assuring a minimum of 50 individuals required for level-2.
As mentioned before, the application does not allow participants to proceed to the sessions without completing all items of the baseline evaluation protocol, nor the participants have access to a new session if they do not complete the requested between-sessions records. As such, missing data will only be due to participant's dropout, during the intervention, or during the follow-up assessments completion. The researchers will use intention-to-treat principles: participants will be analyzed in the group in which they were allocated in the randomization process, independently of whether they had completed all measurement time points and/or the intervention. An evaluation of missing data mechanisms will be performed to inform which imputation strategy should be applied between multiple imputations (MI) and maximum likelihood estimation (FIML). Assuming the data are missing at random, a sensitivity analysis will be included, considering the whole samples vs. samples with complete data separately.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to one of three groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| SmartFeeding4Kids | Experimental | Behavioral: Behavioral change intervention;, Behavioral: Health EducationSmartFeeding4Kids: information about children's healthy diet and effective parental feeding practices, with a behavioral intervention (5 sessions plus 2 brief booster sessions online intervention) |
| SmartFeeding4Kids Health | Active comparator | Behavioral: Health EducationPsychoeducational condition: information about children's healthy diet and effective parental feeding practices (5 sessions plus 2 brief booster sessions online intervention) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Parent/caregiver of a 2 to 6 years old child, at baseline (if the parent has two children in the same age interval, the parent must choose the child that raises more concerns about their health habits, as reference)
- Have access to a mobile phone or computer/tablet with internet
- Be fluent in Portuguese
- Agree to participate in the study to accomplish the intervention in which they are allocated, the evaluation protocols, and the tasks required in each condition
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| Behavioral change intervention;Behavioral change intervention: goal setting, regarding child's diet and parental feeding practices; self-monitoring, with observation and recording of the child's food intake and parental feeding practices; individualized feedback, based on preceding week monitoring and according to the defined objectives, regarding child's and parent's behaviors; modeling and direct suggestions by tailored parent figures; positive reinforcement associated to parents' accomplishment of the objectives; prompts, to remember the defined objectives and the main messages of the intervention. | Behavioural | SmartFeeding4Kids |
| Health EducationHealth education: provision of information about preschool children's nutrition guidelines, effective parental feeding practices, strategies to overcome food and feeding-related barriers, and steps to form healthy habits. | Behavioural | SmartFeeding4Kids, SmartFeeding4Kids Health |
Primary outcome
Changes from baseline in the child's dietary intake reported by parents
Time frame: Baseline, immediately after the intervention, 3 months after the intervention, 6 months after the intervention
Child's dietary intake reported by parents: Child's dietary intake is evaluated through a 24h food recall, completed during 3 days (two weekdays and one weekend day). Data regarding the mean number of portions of vegetables, fruit, and sugar-sweetened foods and beverages registered on three days will be extracted from the database and analyzed separately as primary outcomes.
Changes from baseline in parental feeding practices
Time frame: Baseline, immediately after the intervention, 3 months after the intervention, 6 months after the intervention
Parental feeding practices: Parental feeding practices are evaluated through a self-reported questionnaire, Food Parenting Practices Questionnaire, with three subscales (Child's Intake Self-regulation Practices, Food Availability and Accessibility Practices, and Ineffective Control Practices) developed and adapted to the Portuguese population within this study. Parents answer to 40 items on a 5-point Likert scale (from Totally false to Totally true). Higher values on each subscale indicate a more frequent use of this type of parental feeding practices. The total mean score of each subscale ranged from 1 to 5.
3 secondary outcomes
Changes from baseline in parental perceived barriers related to food and feeding
Time frame: Baseline, immediately after the intervention, 3 months after the intervention, 6 months after the intervention
Changes from baseline in food parenting self-efficacy
Time frame: Baseline, immediately after the intervention, 3 months after the intervention, 6 months after the intervention
Changes from baseline in parental motivation to change
Time frame: Baseline, immediately after the intervention, 3 months after the intervention, 6 months after the intervention
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 11 May 2026.
- Derived from this study: PubMed 37063316Charneca S, Gomes AI, Branco D, Guerreiro T, Barros L, Sousa J. Intake of added sugar, fruits, vegetables, and legumes of Portuguese preschool children: Baseline data from SmartFeeding4Kids randomized controlled trial participants. Front Nutr. 2023 Mar 29;10:1150627. doi: 10.3389/fnut.2023.1150627. eCollection 2023.
- Derived from this study: PubMed 34922616Gomes AI, Pereira AI, Guerreiro T, Branco D, Roberto MS, Pires A, Sousa J, Baranowski T, Barros L. SmartFeeding4Kids, an online self-guided parenting intervention to promote positive feeding practices and healthy diet in young children: study protocol for a randomized controlled trial. Trials. 2021 Dec 18;22(1):930. doi: 10.1186/s13063-021-05897-z.
- Individual participant dataSharing planned: No
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.
Luisa Barros principal investigator
University of Lisbon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral change intervention; and Health Education in people with Parental Feeding Practices and Children's Healthy Diet, run by University of Lisbon at 1 site in Portugal.
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 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 11 May 2026. 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 Portugal. 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?
Changes from baseline in the child's dietary intake reported by parents (time frame: Baseline, immediately after the intervention, 3 months after the intervention, 6 months after the intervention). 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 NCT04591496, 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 11 May 2026.