- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06534541
Genetic Risk, Parental Feeding Practices, and Appetitive Traits in Early Life
Characterizing the Relationships of Genetic Risk and Parental Coercive Feeding Practices With Appetitive Traits and Adiposity Gain Across Early Life.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jennifer Emond, PhD
- Phone Number: 1-603-646-5709
- Email: jennifer.emond@dartmouth.edu
Study Locations
-
-
New Hampshire
-
Hanover, New Hampshire, United States, 03765
- Recruiting
- Dartmotuh College
-
Contact:
- John Brand, PhD
- Email: john.brand@dartmouth.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
Active Comparator: Food Cues
Attentional bias to Food cues experimental measurement
|
Measurement of the amount of attention given to food cues
|
|
Active Comparator: Control Cues
Attentional bias to food cues control measurement
|
Measurement of the amount of attention given to food cues
|
What is the study measuring?
Primary Outcome Measures
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Diane Gilbert-Diamond, ScD, Dartmouth College
- Principal Investigator: Jennifer Emond, PHD, Dartmouth College
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AWD00012907
- 1R01DK136698-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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