Childhood ObesityONE PATHNCT03817021
ONE PATH: Optimizing Nutrition Education for Parents and Teachers for Healthy Growth
A study testing ECE Provider, Parent Intervention and Child intervention in people with Childhood Obesity and Self-regulation, run by Penn State University at 1 site in United States.
Trial summary
This proposal uses an innovative methodological framework, the multiphase optimization strategy (MOST), to design an effective and efficient responsive feeding (RF) intervention that promotes child appetite self-regulation among a high-risk sample: families with preschoolers living in rural poverty. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Self-regulation, Appetite Regulation
- What is being tested?
- ECE Provider, Parent Intervention and Child intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,461 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2022to 7 Jul 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 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children must be enrolled in a participating Head Start or Pre-K Counts center
- children must be between 2 and 6 years old
- parent or primary caregiver must be 18 years or older
- parent/child English speaking
- ECE providers must be employed in participating Head Start or Pre-K Counts center
Who cannot join
- Parents will not be eligible to participate if their child is not eligible and/or not enrolled in the study
- ECE providers will not be eligible if they do not teach in a participating preschool classroom
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
This proposal uses an innovative methodological framework, the multiphase optimization strategy (MOST), to design an effective and efficient responsive feeding (RF) intervention that promotes child appetite self-regulation among a high-risk sample: families with preschoolers living in rural poverty. The principles of MOST emphasize efficiency, allowing identification of the most efficacious intervention components (i.e., components that contribute to treatment effects) while minimizing participant burden and cost. ONE PATH will intervene on ~768 dyads recruited from 56 classrooms serving largely low-income, rural populations.
Read the detailed description
The ONE PATH: Optimizing Nutrition Education for Parents And Teachers for Healthy growth study will rigorously test the efficacy of responsive feeding (RF) and appetite regulation interventions. ONE PATH will intervene upon 3 unique targeted audiences, 1) Early Childhood Education providers (ECE), 2) preschool children, and 3) parents of the preschool children, to address childhood obesity in rural, under-served areas. ECE providers will receive online RF training and coaching. Preschool children will receive an experiential play-based curriculum delivered in the classroom focused on recognition of hunger and fullness cues and using attention control and mindfulness strategies to regulate food intake. Parents will receive RF and parenting guidance from ONE PATH educators through remote coaching. In addition to the three candidate interventions, all classrooms had the option to elect to participate in an existing evidence-based intervention (CORE intervention), the Nutrition and Physical Activity Self-Assessment of Child Care (Go NAP SACC) program. This component will not be tested as part of the optimized intervention.
Aim 1 is to identify which intervention components improve feeding practices and children's appetite regulation (primary), and BMI z-scores (secondary) over the 9-month school year. The 3 candidate intervention components include 1) RF interactive web-based training curriculum and coaching for ECE providers ("ECE provider intervention"), 2) classroom curriculum that teaches regulation strategies to preschool children ("child intervention"), and 3) responsive parenting (RP) curriculum and interactive activities for parents that provide opportunities to practice RF at home ("parent intervention"). The investigators will use the highly efficient multi-phase optimization (MOST) experimental strategy powered to detect main effects and all interactions.
Aim 2 is to improve understanding of the mechanisms by which the 3 candidate intervention components work, and determine if individuals respond differently to intervention components using the data from the experiment in Aim 1. The investigators will examine whether food security and child temperament explain the effects of the intervention on the outcomes (child appetite regulation, caregiver feeding practices, and child BMI z-score).
To investigate whether certain intervention components are more or less effective in certain subgroups, the investigators will explore moderation by child sex, race/ethnicity, and BMI categories.
- Conditions
- Childhood Obesity, Self-regulation, Appetite Regulation
- Being tested
- ECE Provider, Parent Intervention, Child intervention
- Keywords
- Responsive parenting, Early Childhood Education, Appetite Regulation
- Medical subject headings
- Pediatric Obesity, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECE ProviderBehavioural
Also called Responsive feeding for early childhood educators, ECE
Provide online training for Head Start educators
Parent InterventionBehavioural
Also called RF, Parent Responsive Feeding
Coach parents remotely to educate them on responsive feeding and parenting
Child interventionBehavioural
Also called Appetite regulation, Child regulation
Through classrooms lessons cover 3 topics: 1) self-regulation, 2) hunger and fullness, and 3) mindfulness in eating and attention control practices
| Study group | Role | What they receive |
|---|---|---|
| All Factors On | Experimental | ECE Provider intervention will be turned on Parent intervention will be turned on Child intervention will be turned on Receives: Behavioral: ECE Provider; Behavioral: Parent Intervention; Behavioral: Child intervention |
| ECE on/Parent on | Experimental | ECE Provider intervention will be turned on Parent intervention will be turned on Child intervention will be turned off Receives: Behavioral: ECE Provider; Behavioral: Parent Intervention |
| ECE on/Child on | Experimental | ECE Provider intervention will be turned on Parent intervention will be turned off Child intervention will be turned on Receives: Behavioral: ECE Provider; Behavioral: Child intervention |
| ECE on | Experimental | ECE Provider intervention will be turned on Parent intervention will be turned off Child intervention will be turned off Receives: Behavioral: ECE Provider |
| Parent on/Child on | Experimental | ECE Provider intervention turned off Parent intervention turned on Child intervention turned on Receives: Behavioral: Parent Intervention; Behavioral: Child intervention |
| Parent on | Experimental | ECE Provider intervention turned off Parent intervention turned on Child intervention turned off Receives: Behavioral: Parent Intervention |
| Child on | Experimental | ECE Provider intervention turned off Parent intervention turned off Child intervention turned on Receives: Behavioral: Child intervention |
| All Factors Off | No intervention | ECE Provider intervention turned off Parent intervention turned off Child intervention turned off |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Appetite Regulation
Difference in mean COMPX score at post-intervention between intervention and control conditions:
Child appetite regulation skills will be assessed using the gold standard caloric compensation score (COMPX). On 2 occasions, children will be served a smoothie ~20 minutes prior to lunch - on 1 occasion, they will receive a low-calorie smoothie, and on the other a high-calorie smoothie (order will be randomized by classroom). Children will then be served an ad-libitum lunch (same foods on both occasions), and intake will be determined by pre- and post-weighing of food. The difference in intake between the two conditions reflects the child's ability to compensate for the higher calorie preload, a measure of appetite regulation. Caloric compensation score (COMPX) will be calculated as a percentage score. A COMPX of 100% reflects perfect caloric compensation. A COMPX higher than 100% indicates overcompensation, whereas a COMPX lower than 100% indicates under-compensation.
Measured: Post intervention (~9 months)
Parent feeding practices
Differences in baseline-post change in parent feeding practice scores between intervention and control conditions
Parent feeding practices will be assessed using the Structure and Control in Parent Feeding (SCPF) questionnaire, a 34-item measure that assesses positive, structure based feeding practices (i.e., limit-setting, consistent routines) and controlling feeding practices (i.e., restriction, pressure to eat). Items are scored on a 5-point likert scale (0 = never- 4 = always), with higher scores indicating higher frequency of engagement in a specific feeding behavior.
Measured: Baseline and post intervention (~9 months)
Parent feeding practices
Differences in baseline-post change in parent feeding practice scores between intervention and control conditions. Parent feeding practices will be assessed using the Feeding to Manage Child Behavior questionnaire (FMCBQ), a 9-item measure that assesses parents' use of food to soothe and food as reward. Items are scored on a 5-point Likert scale (0 = never- 4 = always), with higher scores indicating higher frequency of engagement in food to soothe or as reward.
Measured: Baseline and post intervention (~9 months)
Early childhood educator (ECE) feeding practices
Difference in percentage of educators engaging in specific feeding practices between intervention and control conditions at post-study.
Early childhood educators feeding practices will be assessed using the Mealtime Observation in Childcare Checklist (MOCC). This measure will capture whether educators engage in specific feeding styles and practices during meal time. Some of the behaviors observed will include: whether educators pressured children to eat their food, praised children for trying a certain food or finishing their food, or if they provided food- or non-food related rewards to children for eating food. Additionally, we will observe how educators handled food refusal and if they supported children's self-regulation. For each item on the check list, observers indicate if they did or did not observe the behavior.
Measured: Post intervention (~9 months)
Parent feeding practices
Differences in baseline-post change in parent feeding practice scores between intervention and control conditions
Parent feeding practices will be assessed using the Caregiver's Feeding Styles Questionnaire (CFSQ), a 19-item measure which classifies caregivers into 1 of 4 feeding styles (authoritarian, authoritative, indulgent and uninvolved). Items are scored on a 5-point scale (1=never-5=always), with higher scores indicating higher frequency of engagement in a specific feeding style.
Measured: Baseline and post intervention (~9 months)
Secondary outcomes (6)
BMI z-scores
Difference in change in BMI z-scores from baseline to post between intervention and control conditions
Children's weights and heights will be obtained at baseline and the end of the study using standard procedures. BMI will be calculated and values will be standardized to z-scores and percentiles according to Centers for Disease Control (CDC) standards and adjusted for child's sex and age.
Measured: Baseline and post intervention (~9 months)
Child Appetite Regulation and Satiety Responsiveness
Differences in change from baseline-post intervention in calories consumed in the Eating in the Absence of Hunger (EAH) task between intervention and control conditions.
The EAH procedure measures children's snack food consumption when not hungry. Children will be presented with a variety of snack foods shortly after being fed a full meal. The snacks will be weighed prior to and following the procedure to calculate intake. This will be evaluated at baseline and post intervention.
Measured: Baseline and post intervention (~9 months)
Child Appetite Regulation and Satiety Responsiveness
Differences in change in appetitive traits (parent-rated) from baseline-post, and mean appetitive traits at post-intervention (ECE provider-rated) between intervention and control conditions.
Child appetitive traits will be assessed using the Children's Eating Behavior Questionnaire, which will be completed by parents at baseline and post intervention and by ECE providers post intervention only. This measure assesses children's eating style using a 5-point scale (1 = never - 5 = always).
Measured: Baseline and post intervention (~9 months)
Classroom/school food environment
Differences in percent of classrooms exhibiting specified characteristics of food environment at post-intervention between intervention and control conditions.
The ECE environment, including food and beverages served, physical environment, teacher engagement, and feeding practices will be assessed observationally at baseline (subset) and the conclusion of the project (all classrooms) using the validated MOCC. We hope to observe more teacher engagement, positive environment, and feeding practices in the classrooms post-intervention.
Measured: Post intervention (~9 months)
Waist Circumference
Differences in mean waist circumference at post-intervention between intervention and control conditions. Waist circumference values will be standardized to z-scores and percentiles according to sex- and age-specific guidelines. Waist circumference will be obtained using standardized procedures at baseline and post-intervention.
Measured: Baseline and post intervention (~9 months)
Weight Status
Differences in percentage of overweight and obesity status (compared to not having overweight or obesity) at post-intervention between intervention and control conditions.
BMI percentiles according to Centers for Disease Control (CDC) standards and adjusted for child's sex and age will be calculated and use to determine prevalence of overweight (≥ 85th percentile) and obesity (< 95th percentile).
Measured: Post intervention (~9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start21 Jul 2022
- Primary completion7 Jul 2025
- Study completion7 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- 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
- Factorial
- Model description
- Using Multiphase Optimization (MOST) Strategy, we will examine 3 treatment factors and their interactions to determine a 'best' or optimum approach to education of the Early Childhood Environment (ECE), child and family.
- Masking
- None (open label)
- Enrolment
- 1,461 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Savage Williams, Penn State University
- Investigators
- Jennifer S Williams, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817021
- Sponsor's protocol ID
- 1R01DK120754-01
- Acronym
- ONE PATH
- Status last verified
- Jan 2025
- First submitted
- 18 Jan 2019
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data will be available to researchers on request after the conclusion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ONE PATH: Optimizing Nutrition Education for Parents and Teachers for Healthy Growth
- ClinicalTrials.gov ID
- NCT03817021
- Acronym / sponsor ID
- ONE PATH / 1R01DK120754-01
- Conditions
- Childhood Obesity, Self-regulation, Appetite Regulation
- Keywords
- Responsive parenting, Early Childhood Education, Appetite Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,461 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 7 Jul 2025 (actual)
- Study completion
- 7 Jul 2025 (actual)
- First posted
- 25 Jan 2019 (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 proposal uses an innovative methodological framework, the multiphase optimization strategy (MOST), to design an effective and efficient responsive feeding (RF) intervention that promotes child appetite self-regulation among a high-risk sample: families with preschoolers living in rural poverty. The principles of MOST emphasize efficiency, allowing identification of the most efficacious intervention components (i.e., components that contribute to treatment effects) while minimizing participant burden and cost. ONE PATH will intervene on ~768 dyads recruited from 56 classrooms serving largely low-income, rural populations.
Detailed description
The ONE PATH: Optimizing Nutrition Education for Parents And Teachers for Healthy growth study will rigorously test the efficacy of responsive feeding (RF) and appetite regulation interventions. ONE PATH will intervene upon 3 unique targeted audiences, 1) Early Childhood Education providers (ECE), 2) preschool children, and 3) parents of the preschool children, to address childhood obesity in rural, under-served areas. ECE providers will receive online RF training and coaching. Preschool children will receive an experiential play-based curriculum delivered in the classroom focused on recognition of hunger and fullness cues and using attention control and mindfulness strategies to regulate food intake. Parents will receive RF and parenting guidance from ONE PATH educators through remote coaching. In addition to the three candidate interventions, all classrooms had the option to elect to participate in an existing evidence-based intervention (CORE intervention), the Nutrition and Physical Activity Self-Assessment of Child Care (Go NAP SACC) program. This component will not be tested as part of the optimized intervention.
Aim 1 is to identify which intervention components improve feeding practices and children's appetite regulation (primary), and BMI z-scores (secondary) over the 9-month school year. The 3 candidate intervention components include 1) RF interactive web-based training curriculum and coaching for ECE providers ("ECE provider intervention"), 2) classroom curriculum that teaches regulation strategies to preschool children ("child intervention"), and 3) responsive parenting (RP) curriculum and interactive activities for parents that provide opportunities to practice RF at home ("parent intervention"). The investigators will use the highly efficient multi-phase optimization (MOST) experimental strategy powered to detect main effects and all interactions.
Aim 2 is to improve understanding of the mechanisms by which the 3 candidate intervention components work, and determine if individuals respond differently to intervention components using the data from the experiment in Aim 1. The investigators will examine whether food security and child temperament explain the effects of the intervention on the outcomes (child appetite regulation, caregiver feeding practices, and child BMI z-score).
To investigate whether certain intervention components are more or less effective in certain subgroups, the investigators will explore moderation by child sex, race/ethnicity, and BMI categories.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- Using Multiphase Optimization (MOST) Strategy, we will examine 3 treatment factors and their interactions to determine a 'best' or optimum approach to education of the Early Childhood Environment (ECE), child and family.
| Arm | Type | Receives |
|---|---|---|
| All Factors On | Experimental | Behavioral: ECE Provider, Behavioral: Parent Intervention, Behavioral: Child interventionECE Provider intervention will be turned on Parent intervention will be turned on Child intervention will be turned on |
| ECE on/Parent on | Experimental | Behavioral: ECE Provider, Behavioral: Parent InterventionECE Provider intervention will be turned on Parent intervention will be turned on Child intervention will be turned off |
| ECE on/Child on | Experimental | Behavioral: ECE Provider, Behavioral: Child interventionECE Provider intervention will be turned on Parent intervention will be turned off Child intervention will be turned on |
| ECE on | Experimental | Behavioral: ECE ProviderECE Provider intervention will be turned on Parent intervention will be turned off Child intervention will be turned off |
| Parent on/Child on | Experimental | Behavioral: Parent Intervention, Behavioral: Child interventionECE Provider intervention turned off Parent intervention turned on Child intervention turned on |
| Parent on | Experimental | Behavioral: Parent InterventionECE Provider intervention turned off Parent intervention turned on Child intervention turned off |
| Child on | Experimental | Behavioral: Child interventionECE Provider intervention turned off Parent intervention turned off Child intervention turned on |
| All Factors Off | No intervention | –ECE Provider intervention turned off Parent intervention turned off Child intervention turned off |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- children must be enrolled in a participating Head Start or Pre-K Counts center
- children must be between 2 and 6 years old
- parent or primary caregiver must be 18 years or older
- parent/child English speaking
- ECE providers must be employed in participating Head Start or Pre-K Counts center
Key exclusion criteria (2 listed)
- Parents will not be eligible to participate if their child is not eligible and/or not enrolled in the study
- ECE providers will not be eligible if they do not teach in a participating preschool classroom
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 |
|---|---|---|
| ECE ProviderAlso: Responsive feeding for early childhood educators, ECEProvide online training for Head Start educators | Behavioural | All Factors On, ECE on, ECE on/Child on, ECE on/Parent on |
| Parent InterventionAlso: RF, Parent Responsive FeedingCoach parents remotely to educate them on responsive feeding and parenting | Behavioural | All Factors On, ECE on/Parent on, Parent on, Parent on/Child on |
| Child interventionAlso: Appetite regulation, Child regulationThrough classrooms lessons cover 3 topics: 1) self-regulation, 2) hunger and fullness, and 3) mindfulness in eating and attention control practices | Behavioural | All Factors On, Child on, ECE on/Child on, Parent on/Child on |
Primary outcome
Child Appetite Regulation
Time frame: Post intervention (~9 months)
Difference in mean COMPX score at post-intervention between intervention and control conditions: Child appetite regulation skills will be assessed using the gold standard caloric compensation score (COMPX). On 2 occasions, children will be served a smoothie ~20 minutes prior to lunch - on 1 occasion, they will receive a low-calorie smoothie, and on the other a high-calorie smoothie (order will be randomized by classroom). Children will then be served an ad-libitum lunch (same foods on both occasions), and intake will be determined by pre- and post-weighing of food. The difference in intake between the two conditions reflects the child's ability to compensate for the higher calorie preload, a measure of appetite regulation. Caloric compensation score (COMPX) will be calculated as a percentage score. A COMPX of 100% reflects perfect caloric compensation. A COMPX higher than 100% indicates overcompensation, whereas a COMPX lower than 100% indicates under-compensation.
Parent feeding practices
Time frame: Baseline and post intervention (~9 months)
Differences in baseline-post change in parent feeding practice scores between intervention and control conditions Parent feeding practices will be assessed using the Structure and Control in Parent Feeding (SCPF) questionnaire, a 34-item measure that assesses positive, structure based feeding practices (i.e., limit-setting, consistent routines) and controlling feeding practices (i.e., restriction, pressure to eat). Items are scored on a 5-point likert scale (0 = never- 4 = always), with higher scores indicating higher frequency of engagement in a specific feeding behavior.
Parent feeding practices
Time frame: Baseline and post intervention (~9 months)
Differences in baseline-post change in parent feeding practice scores between intervention and control conditions. Parent feeding practices will be assessed using the Feeding to Manage Child Behavior questionnaire (FMCBQ), a 9-item measure that assesses parents' use of food to soothe and food as reward. Items are scored on a 5-point Likert scale (0 = never- 4 = always), with higher scores indicating higher frequency of engagement in food to soothe or as reward.
Early childhood educator (ECE) feeding practices
Time frame: Post intervention (~9 months)
Difference in percentage of educators engaging in specific feeding practices between intervention and control conditions at post-study. Early childhood educators feeding practices will be assessed using the Mealtime Observation in Childcare Checklist (MOCC). This measure will capture whether educators engage in specific feeding styles and practices during meal time. Some of the behaviors observed will include: whether educators pressured children to eat their food, praised children for trying a certain food or finishing their food, or if they provided food- or non-food related rewards to children for eating food. Additionally, we will observe how educators handled food refusal and if they supported children's self-regulation. For each item on the check list, observers indicate if they did or did not observe the behavior.
Parent feeding practices
Time frame: Baseline and post intervention (~9 months)
Differences in baseline-post change in parent feeding practice scores between intervention and control conditions Parent feeding practices will be assessed using the Caregiver's Feeding Styles Questionnaire (CFSQ), a 19-item measure which classifies caregivers into 1 of 4 feeding styles (authoritarian, authoritative, indulgent and uninvolved). Items are scored on a 5-point scale (1=never-5=always), with higher scores indicating higher frequency of engagement in a specific feeding style.
6 secondary outcomes
BMI z-scores
Time frame: Baseline and post intervention (~9 months)
Child Appetite Regulation and Satiety Responsiveness
Time frame: Baseline and post intervention (~9 months)
Child Appetite Regulation and Satiety Responsiveness
Time frame: Baseline and post intervention (~9 months)
Classroom/school food environment
Time frame: Post intervention (~9 months)
Waist Circumference
Time frame: Baseline and post intervention (~9 months)
Weight Status
Time frame: Post intervention (~9 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 15 Oct 2025.
- Individual participant dataSharing planned: Yes. Deidentified participant data will be available to researchers on request after the conclusion of the study.
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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.
Jennifer S Williams, PhD principal investigator
Penn State 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 ECE Provider, Parent Intervention and Child intervention in people with Childhood Obesity and Self-regulation, run by Penn State 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 5 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 15 Oct 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. 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?
Child Appetite Regulation (time frame: Post intervention (~9 months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2025.