ParentingNCT06111040
Nurturing Needs Study: Parenting Food Motivated Children
A study testing Measurement in people with Parenting and Eating Behavior, run by Temple University at 2 sites in United States.
Trial summary
High food motivation among children is trait-like and increases risks of unhealthy dietary intake and obesity. Scientific knowledge of how parenting can best support healthy eating habits and growth among children who are predisposed to overeating is surprisingly limited. Read more about this study
- Who is it for?
- Ages 4 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Parenting, Eating Behavior, Diet, Healthy
- What is being tested?
- Measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Sep 2023to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child ages 4 or 5 years at baseline;
- Parent/ primary caregiver with legal representation (having 50% or more custody of child);
- Parent/primary caregiver reporting primary responsibility for child feeding outside of childcare (being with child when they are eating at least two times daily);
- Caregiver with a cell phone that can be used to send and receive text messages. If there is more than one age-eligible child in the family, we will ask the caregiver to pick the index child.
Who cannot join
- Parent/primary caregiver <18 years of age;
- Child history of major food allergies (e.g., peanuts);
- Child medication use (e.g., insulin), developmental disability (e.g., autism) or medical condition(s) (e.g., diabetes) known to affect food intake and growth;
- Foster child.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
USDA/ARS Children's Nutrition Research Center
Houston, Texas, 77030
Nilda Micheli, BS, 713-798-6737, nildam@bcm.edu
- Recruiting
Temple University - Center for Obesity Research and Education
Philadelphia, Pennsylvania, 19140
Christina Croce, MS, 267-428-7893, nurturingneeds@temple.edu
About this study
Official title: Deconstructing Food Parenting Approaches to Obesity Prevention for the Highly Food Motivated Child
High food motivation among children is trait-like and increases risks of unhealthy dietary intake and obesity. Scientific knowledge of how parenting can best support healthy eating habits and growth among children who are predisposed to overeating is surprisingly limited. This investigation will identify supportive food parenting approaches for obesity prevention that address the needs of highly food motivated children.
Read the detailed description
High levels of food motivation among young children are heritable, track over time, and associated with elevated risks of unhealthy eating and obesity. Despite significant growth of family-based obesity prevention efforts, the evidence base is remarkably scant on parenting highly food motivated children to prevent obesity and poor dietary outcomes. The goal of this investigation is to generate a robust basic science evidence for parenting highly food motivated children to prevent excessive dietary intakes and body mass index (BMI) gains during the preschool years. Using a prospective cohort design, this investigation follow 205 caregiver/child dyads over 18 months as children transition from preschool to elementary school, when significant numbers of children begin to experience problems of poor diet quality and obesity. Children with varying food motivation will be recruited to understand whether highly food motivated children have different needs than other children. A multi-method approach will use state-of-the-art measures, including ecological momentary assessment, to comprehensively investigate the amount, types, and consistency of food parenting practices (i.e., specific, goal-oriented behaviors) needed to prevent food motivated behaviors, excessive dietary intake, and BMI gains in children. Specifically, the role of structure (i.e., theoretically supportive) and its differentiation from more coercive types of food parenting control will be comprehensively characterized.
- Conditions
- Parenting, Eating Behavior, Diet, Healthy, Pediatric Obesity
- Being tested
- Measurement
- Medical subject headings
- Feeding Behavior, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeasurementOther
Also called Eating in the absence of hunger, Relative reinforcing value of food
The only interventions are at the measurement level and consist of two behavioral protocols designed to assess children's eating behavior, where food stimuli are provided and children's behavioral responses are recorded.
| Study group | Role | What they receive |
|---|---|---|
| Caregiver-child dyads | Other | A cohort of 205 caregivers and 205 children aged 4-5 years at baseline will be recruited and followed longitudinally for 18 months. Receives: Other: Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excessive dietary intakes
Indicators: SFAS intakes and meal/snack sizes estimated from 24-hour dietary recalls
Measured: Baseline, 18 months
BMI change
% of the 50th percentile per age- and sex-specific CDC reference values for BMI on a log scale
Measured: Baseline, 18 months
Secondary outcomes (1)
Observed food motivated behaviors
Indicators: Eating in the absence of hunger and relative reinforcing value of food
Measured: Baseline, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start7 Sep 2023
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
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 ParentingStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Family-based, prospective observational study with interventions at the measurement level
- Masking
- None (open label)
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine, University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Jennifer O Fisher, PhD, Principal investigator, Temple UniversitySheryl O Hughes, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111040
- Sponsor's protocol ID
- R01DK132642
- Other IDs
- 30291
- Status last verified
- Nov 2025
- First submitted
- 26 Oct 2023
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Research data generated by the project will be supported by TUScholarShare (https://scholarshare.temple.edu/), the institutional repository for Temple University. This is a repository service that is managed by the Temple University Libraries and uses Open Repository, an enhanced DSpace platform that is hosted by Atmire. TUScholarShare has been developed with the intent of helping researchers comply with grant-funding agency requirements. It enables dissemination and long-term preservation and curation (management, use, and re-use) of data.
Publications
Fisher JO, Hughes SO, Miller AL, Horodynski MA, Brophy-Herb HE, Contreras DA, Kaciroti N, Peterson KE, Rosenblum KL, Appugliese D, Lumeng JC. Characteristics of eating behavior profiles among preschoolers with low-income backgrounds: a person-centered analysis. Int J Behav Nutr Phys Act. 2022 Jul 23;19(1):91. doi: 10.1186/s12966-022-01323-y.
PubMed 35870976
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deconstructing Food Parenting Approaches to Obesity Prevention for the Highly Food Motivated Child
- ClinicalTrials.gov ID
- NCT06111040
- Acronym / sponsor ID
- R01DK132642
- Conditions
- Parenting, Eating Behavior, Diet, Healthy, Pediatric Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- Baylor College of Medicine, University of Minnesota
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 1 Nov 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.
High food motivation among children is trait-like and increases risks of unhealthy dietary intake and obesity. Scientific knowledge of how parenting can best support healthy eating habits and growth among children who are predisposed to overeating is surprisingly limited. This investigation will identify supportive food parenting approaches for obesity prevention that address the needs of highly food motivated children.
Detailed description
High levels of food motivation among young children are heritable, track over time, and associated with elevated risks of unhealthy eating and obesity. Despite significant growth of family-based obesity prevention efforts, the evidence base is remarkably scant on parenting highly food motivated children to prevent obesity and poor dietary outcomes. The goal of this investigation is to generate a robust basic science evidence for parenting highly food motivated children to prevent excessive dietary intakes and body mass index (BMI) gains during the preschool years. Using a prospective cohort design, this investigation follow 205 caregiver/child dyads over 18 months as children transition from preschool to elementary school, when significant numbers of children begin to experience problems of poor diet quality and obesity. Children with varying food motivation will be recruited to understand whether highly food motivated children have different needs than other children. A multi-method approach will use state-of-the-art measures, including ecological momentary assessment, to comprehensively investigate the amount, types, and consistency of food parenting practices (i.e., specific, goal-oriented behaviors) needed to prevent food motivated behaviors, excessive dietary intake, and BMI gains in children. Specifically, the role of structure (i.e., theoretically supportive) and its differentiation from more coercive types of food parenting control will be comprehensively characterized.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Family-based, prospective observational study with interventions at the measurement level
| Arm | Type | Receives |
|---|---|---|
| Caregiver-child dyads | Other | Other: MeasurementA cohort of 205 caregivers and 205 children aged 4-5 years at baseline will be recruited and followed longitudinally for 18 months. |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Child ages 4 or 5 years at baseline;
- Parent/ primary caregiver with legal representation (having 50% or more custody of child);
- Parent/primary caregiver reporting primary responsibility for child feeding outside of childcare (being with child when they are eating at least two times daily);
- Caregiver with a cell phone that can be used to send and receive text messages. If there is more than one age-eligible child in the family, we will ask the caregiver to pick the index child.
Key exclusion criteria (4 listed)
- Parent/primary caregiver <18 years of age;
- Child history of major food allergies (e.g., peanuts);
- Child medication use (e.g., insulin), developmental disability (e.g., autism) or medical condition(s) (e.g., diabetes) known to affect food intake and growth;
- Foster child.
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 |
|---|---|---|
| MeasurementAlso: Eating in the absence of hunger, Relative reinforcing value of foodThe only interventions are at the measurement level and consist of two behavioral protocols designed to assess children's eating behavior, where food stimuli are provided and children's behavioral responses are recorded. | Other | Caregiver-child dyads |
Primary outcome
Excessive dietary intakes
Time frame: Baseline, 18 months
Indicators: SFAS intakes and meal/snack sizes estimated from 24-hour dietary recalls
BMI change
Time frame: Baseline, 18 months
% of the 50th percentile per age- and sex-specific CDC reference values for BMI on a log scale
1 secondary outcome
Observed food motivated behaviors
Time frame: Baseline, 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Background: PubMed 35870976Fisher JO, Hughes SO, Miller AL, Horodynski MA, Brophy-Herb HE, Contreras DA, Kaciroti N, Peterson KE, Rosenblum KL, Appugliese D, Lumeng JC. Characteristics of eating behavior profiles among preschoolers with low-income backgrounds: a person-centered analysis. Int J Behav Nutr Phys Act. 2022 Jul 23;19(1):91. doi: 10.1186/s12966-022-01323-y.
- Individual participant dataSharing planned: Yes. Research data generated by the project will be supported by TUScholarShare (https://scholarshare.temple.edu/), the institutional repository for Temple University. This is a repository service that is managed by the Temple University Libraries and uses Open Repository, an enhanced DSpace platform that is hosted by Atmire. TUScholarShare has been developed with the intent of helping researchers comply with grant-funding agency requirements. It enables dissemination and long-term preservation and curation (management, use, and re-use) of data.
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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.
Jennifer O Fisher, PhD principal investigator
Temple University
Sheryl O Hughes, PhD principal investigator
Baylor College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement in people with Parenting and Eating Behavior, run by Temple University at 2 sites 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 4 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: looking for participants now, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Croce, MS (215-707-8672, christina.croce@temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excessive dietary intakes (time frame: Baseline, 18 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 NCT06111040, 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 5 Nov 2025.