NCT06534541

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for not_applicable

Timeline
39mo left

Started Jul 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Jul 2024Aug 2029

Study Start

First participant enrolled

July 18, 2024

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

4 years

First QC Date

July 30, 2024

Last Update Submit

March 21, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Coercive Parental Food Practices

    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

    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.

    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

    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.

Study Arms (2)

Food Cues

ACTIVE COMPARATOR

Attentional bias to Food cues experimental measurement

Behavioral: Attentional bias to food cues

Control Cues

ACTIVE COMPARATOR

Attentional bias to food cues control measurement

Behavioral: Attentional bias to food cues

Interventions

Measurement of the amount of attention given to food cues

Control CuesFood Cues

Eligibility Criteria

Age27 Months - 72 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmotuh College

Hanover, New Hampshire, 03765, United States

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jennifer Emond, PhD

    Dartmouth College

    PRINCIPAL INVESTIGATOR
  • Diane Gilbert-Diamond, ScD

    Dartmouth College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Principal Investigator

Study Record Dates

First Submitted

July 30, 2024

First Posted

August 2, 2024

Study Start

July 18, 2024

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2029

Last Updated

March 26, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations