Genetic Risk, Parental Feeding Practices, and Appetitive Traits in Early Life

March 21, 2025 updated by: Jennifer Emond, Trustees of Dartmouth College

Characterizing the Relationships of Genetic Risk and Parental Coercive Feeding Practices With Appetitive Traits and Adiposity Gain Across Early Life.

The preschool years (2-5 years of age) is a critical timeframe to shape the lifetime risk of obesity. While the causes of obesity are complex, appetitive traits related to overeating, such as high food approach and low food avoidance, are robustly associated with a greater BMI among children. Some children are genetically pre-disposed to expressing obesogenic appetitive traits, and those traits may mediate a genetic risk for obesity. Separately, parental feeding practices are emerging as an important, yet modifiable, influence on children's obesity risk. Coercive control feeding practices, such as strictly limiting a child's intake of highly palatable foods (restriction) and using food to control children's negative emotions (emotional feeding), are believed to be detrimental for young children because they impede self-regulatory skills around eating and may increase the saliency of highly palatable foods. The goal for this project is to disentangle the inter-relationships between coercive control feeding practices, children's obesogenic appetitive traits, and children's dietary intake across the preschool years to understand how coercive control feeding practices ultimately impact children's adiposity gain over time. Importantly, the investigators aim to understand how those effects differ based on children's underlying genetic risk for obesity. The investigators hypothesize that parents will respond to children's obesogenic appetitive traits by exhibiting more coercive control feeding practices (restriction, emotional feeding), which in turn, will promote future increase in obesogenic appetitive traits and overconsumption, leading to excess adiposity gain among children. Importantly, the investigators hypothesize children with a high genetic risk for obesity will be most susceptible to the negative effects of coercive control feeding practices because food is highly salient for them. The investigators will test the hypotheses among a cohort of children aged 2.5 years old using a longitudinal study design with repeated assessments every 6 months until children are 5 years old. If successful, study findings may be leveraged to develop tailored strategies to help parents support healthy eating behaviors among their young children that consider the heterogeneity in obesogenic appetitive traits among young children due to genetic risk factors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The goal for this project is to disentangle the inter-relationships between coercive control feeding practices, children's obesogenic appetitive traits, and children's dietary intake across the preschool years to understand how coercive control feeding practices ultimately impact children's adiposity gain over time.

The investigators will assess children's genetic risk for obesity via candidate single-nucleotide polymorphisms (SNPs) and a polygenic risk score. Importantly, this novel approach expands upon previous research by including the investigator's lab's proven, objective paradigm to measure children's food approach and overconsumption. Specifically, the investigators will use eye-tracking to measure children's attentional bias to food, an objective metric of food approach. The investigators also include an eating in the absence of hunger paradigm to objectively measure children's overconsumption.

The investigators will test this hypotheses among a cohort of children aged 2.5 years old using a longitudinal study design with repeated assessments every 6 months until children are 5 years old.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
330

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • parent must be ≥18 years old, have primary custody of their child for ≥75% of the month, comprehend verbal and written English and not plan to move out of Vermont or New Hampshire during the study timeframe.
  • Children must be ≥2.25 and ≤2.99 years old at first visit and have normal or corrected-to-normal vision to enable eye tracking.

Exclusion Criteria:

  • Children with any relevant food allergies or dietary restrictions, taking medication or with a medical condition that affects appetite or attention, or with a relative enrolled in the study will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Food Cues
Attentional bias to Food cues experimental measurement
Behavioral: Attentional bias to food cues
Measurement of the amount of attention given to food cues
Active Comparator: Control Cues
Attentional bias to food cues control measurement
Behavioral: Attentional bias to food cues
Measurement of the amount of attention given to food cues

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Coercive Parental Food Practices
Time Frame: Measured every 6 months from baseline until 2.5 years after baseline.
Coercive Parental Food Practices will be assessed using the Child Feeding Questionnaire (CFQ) and Parental Feeding Style Questionnaire (PFSQ). The CFQ restriction subscale, with scores for each of 8 items ranging from 1 to 5 (never to always practice the behavior), will be averaged for a single final Restriction score. The 3 items of the emotional feeding domain from the PFSQ, ranging from 1 to 5 (never to always practice the behavior) will be averaged for a single final Emotional Feeding score.
Measured every 6 months from baseline until 2.5 years after baseline.
Appetitive Traits
Time Frame: Measured every 6 months from baseline until 2.5 years after baseline.
Child appetitive traits will be assessed via parent report using the validated Children's Eating Behavior Questionnaire (CEBQ). The CEBQ includes subscales to measure food approach and food avoidance traits. Final scores for each subscale is computed as the average across subscale items and range from 1 to 5 (never to always express that trait).
Measured every 6 months from baseline until 2.5 years after baseline.
Eating in the Absence of Hunger.
Time Frame: Measured every 6 months from baseline until 2.5 years after baseline.
Eating in the Absence of Hunger. Eating in the absence of hunger will be calculated using established methods (Gilbert-Diamond et al., IJO 2017; Fisher & Birch., AM J of Clin Nutr 2002). The pre- and post-weights of each snack items will be used to calculate the number of kCals a child consumed. Increased kCal consumption is evidence of increased eating in the absence of hunger.
Measured every 6 months from baseline until 2.5 years after baseline.
Adiposity
Time Frame: Measured every 6 months from baseline until 2.5 years after baseline.
Adiposity in children will be operationalized as the age- and sex-adjusted BMI z-score. Child height and weight at each assessment will be measured in-person and be used to calculate age and sex-specific BMI z-scores based on WHO child growth charts. If the child is lost to follow up and we cannot obtain in-person measures, we will abstract height and weight from the child's medical records if they consented to that data collection during the baseline visit.
Measured every 6 months from baseline until 2.5 years after baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Trustees of Dartmouth College

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Dartmouth-Hitchcock Medical Center
Dartmouth College

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Diane Gilbert-Diamond, ScD, Dartmouth College
  • Principal Investigator: Jennifer Emond, PHD, Dartmouth College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 18, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AWD00012907
  • 1R01DK136698-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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