[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06534541":3,"trial-entities:NCT06534541":92,"trial-summary:NCT06534541":95},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":36,"secondary_outcomes":50,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":54,"eligibility_criteria":55,"std_ages":62,"locations":64,"central_contacts":79,"overall_officials":84,"references":90,"see_also_links":91},"NCT06534541","AWD00012907","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.","RECRUITING","2029-08","2025-03","2025-03-26","2024-07-18","Trustees of Dartmouth College","OTHER",null,"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.","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.\n\nThe 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.\n\nThe 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.",[19],"Childhood Obesity",[],"INTERVENTIONAL","BASIC_SCIENCE",[24],"NA",{"count":26,"type":27},330,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","Attentional bias to food cues","Measurement of the amount of attention given to food cues",[34,35],"Control Cues","Food Cues",[37,41,44,47],{"measure":38,"description":39,"timeFrame":40},"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.",{"measure":42,"description":43,"timeFrame":40},"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).",{"measure":45,"description":46,"timeFrame":40},"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.",{"measure":48,"description":49,"timeFrame":40},"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.",[],"ALL","27 Months","72 Months",true,{"inclusion":56,"exclusion":59,"raw_text":61},[57,58],"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.",[60],"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.","Inclusion Criteria:\n\n* 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.\n* 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.\n\nExclusion Criteria:\n\n* 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.",[63],"CHILD",[65],{"facility":66,"status":8,"city":67,"state":68,"zip":69,"country":70,"contacts":71,"geoPoint":76},"Dartmotuh College","Hanover","New Hampshire","03765","United States",[72],{"name":73,"role":74,"email":75},"John Brand, PhD","CONTACT","john.brand@dartmouth.edu",{"lat":77,"lon":78},43.70229,-72.28954,[80],{"name":81,"role":74,"phone":82,"email":83},"Jennifer Emond, PhD","1-603-646-5709","jennifer.emond@dartmouth.edu",[85,88],{"name":81,"affiliation":86,"role":87},"Dartmouth College","PRINCIPAL_INVESTIGATOR",{"name":89,"affiliation":86,"role":87},"Diane Gilbert-Diamond, ScD",[],[],{"nct_id":4,"conditions":93,"biomarkers":94},[19],[],{"nct_id":4,"found":54,"summary":96,"prompt_version":106},{"design":97,"status":98,"heading":99,"summary":100,"follow_up":101,"word_count":102,"commitments":103,"compensation":104,"drugs_mentioned":105},"This interventional study plans to enroll 330 participants. It will follow children from 2.5 years old until they are 5 years old.","completed","Genetic Risk, Parental Feeding, and Appetitive Traits in Early Life","This study is looking at how genetics, parental feeding styles, and a child's natural eating habits (appetitive traits) are connected to childhood obesity. Researchers want to understand how parental feeding practices, like strictly limiting certain foods or using food to soothe emotions, might affect a child's weight gain over time. They will measure how much attention children pay to food cues and how much they eat even when not hungry. This study is for children aged 27 months to 72 months. The goal is to see if these factors influence a child's weight gain from age 2.5 to 5 years old. The study is currently unclear on its recruitment status.","Participants will be followed for 2.5 years after baseline, with measurements taken every 6 months.",110,"Participants will have assessments every 6 months from baseline until 2.5 years after baseline. This includes measurements of attentional bias to food cues and eating in the absence of hunger.","Not stated in the trial record.",[],"v2"]