An observational study in Obesity, Eating Behaviors and Healthy Volunteers, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Recruiting at 1 site in United States. Open to participants aged 8 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Observational
Background:
- Studies show that many factors affect children's eating behavior and health. These include sleep, mood, thinking skills, and genetics. Studying children over time may identify children at higher risk for eating-related health concerns.
Objective:
- To understand how genes and environment influence eating behavior and health over time.
Eligibility:
- Children ages 8-17 in good general health.
Design:
Participants will be compensated for the time and inconvenience involved with completing study procedures.
This study aims to disentangle the varying disinhibited eating patterns, or eating behavior endophenotypes, that lead to excessive weight gain and obesity-related comorbidities in youth. Extensive baseline evaluations, including three separate experimental paradigms, and annual follow-up assessments will assist with identifying biopsychosocial mechanisms that appear to increase risk for, and maintain, these eating behaviors and lead to weight gain. Illumination of early risk factors for specific eating behavior endophenotypes and their associated health outcomes will inform the development of targeted interventions for pediatric obesity. Participants for the current study will include 500 healthy obese and non-obese boys and girls (8 to 17yo at baseline) and their parents/caregivers. Youth will first complete two visits in order to ensure study eligibility and to evaluate self-regulatory, motivational, and neurocognitive factors that appear to be salient to the development and maintenance of disinhibited eating behavior, including: psychological distress, sleep behavior, food reinforcement, reward sensitivity, executive functioning, attention bias, and a range of related genetic and physiological factors. Eating behavior will be observed in the laboratory using several validated paradigms. For two weeks, participants will monitor their sleep using wrist actigraphy, as well as record their mood, eating behavior, and eating cognitions using smart phones (via ecological momentary assessment methods). Youth will then be invited to complete up to three separate experimental paradigms designed to further elucidate cognitive, emotional, and physiological processes associated with disinhibited eating behavior. All participants will then complete annual evaluations of weight and adiposity for a total of six years, with more extensive evaluations of self-regulatory, motivational and neurocognitive functioning every three years. Studying children and adolescents longitudinally will allow for examination of the independent and shared risk factors for pediatric disinhibited eating and excess weight. Data from these evaluations will not only be used to test specific hypotheses, but will also be hypothesis-generating in that they will inform the development of additional empirical questions and subsequent experiments. Thus, the current protocol will offer the flexibility to examine potentially critical contributions to weight gain in children as they continue their biopsychosocial development.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 114 across 2,154 observational studies indexed under Obesity.
Browse Obesity studies →Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is the lead sponsor of 422 studies on the registry; 24 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 11 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
community sample
INCLUSION CRITERIA:
Parents/Guardians will qualify if they meet the following criteria.
EXCLUSION CRITERIA:
Parents/Guardians will be excluded for the following reasons:
If they are believed by the medical study team to have a medical or psychiatric problem that will not allow them to complete study procedures safely (these will be determined on a case-by-case basis)
Eligibility Criteria for Child Participants:
INCLUSION CRITERIA:
Volunteers will qualify if they meet the following criteria.
EXCLUSION CRITERIA:
Individuals will be excluded (and provided treatment referrals as needed) for the following reasons:
Additional exclusions for (optional) stool sample collection include:
Stool Sample only:
In addition, Experiments 1 and 2 have specific additional exclusions:
Experiment 1 only:
Experiment 2 only:
All participants will receive a written explanation of the purposes, procedures, and potential hazards of the study. Communication of this information and of the participant's assent as well as the consent of the parent or guardian will be documented in the medical record and copies of all signed documents given to each family. All participants will be informed of their right to withdraw from the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All pediatric participants in the study will be evaluated as one group
Parents provide information about their children and supply DNA / blood samples for future analyses
Differences in eating behavior of pediatric participants
Multiple outcome measures
Time frame: up to 6 years of follow-up
Experiment 2 (Hormone and Brain Development Study): oscillatory power activity in hypothesized brain regions-of-interest and food intake in the laboratory
Explore whether gonadal hormone concentrations moderate the association between activation in ROIs and LOC-eating in the laboratory. Hyp 3a: The associations among activation in ROIs and LOC-eating severity will be stronger among girls with higher concentrations of estradiol. Hyp 3a: The associations among activation in ROIs and total energy intake will be stronger among girls with higher concentrations of estradiol. Hyp 3c: The associations among activation in ROIs and LOC-eating severity will be stronger among boys with lower concentrations of testosterone. Hyp 3d: The associations among activation in ROIs and total energy intake will be stronger among boys with lower concentrations of testosterone.
Time frame: During palatable (vs non-palatable) food cues attention bias paradigm
Experiment 2 (Hormone and Brain Development Study): oscillatory power activity in hypothesized brain regions-of-interest and food intake in the laboratory
Investigate if model-based decision making mediates the link between activation in ROIs while attending to images of food and LOC-eating in the laboratory. Hyp 2a: Model-based decision making (DM) will mediate the association between activation in all ROIs and severity of LOC-eating. Hyp 2a: Model-based DM will mediate the association between activation in all ROIs and total energy intake.
Time frame: During palatable (vs non-palatable) food cues attention bias paradigm
Experiment 2 (Hormone and Brain Development Study): oscillatory power activity in hypothesized brain regions-of-interest
Examine if activation in neural regions of interest (ROIs; striatum, prefrontal cortex, and hippocampus) while attending to food images is linked to decision making (DM) during a decision-making task. Hyp 1a: Striatum activation will be related to model-free learning. Hyp 1b: Activation in all ROIs will be linked to model-based learning.
Time frame: During palatable (vs non-palatable) food cues attention bias paradigm
Experiment 2 (Hormone and Brain Development Study): oscillatory power activity in hypothesized brain regions-of-interest
Differences in neural activity in youth with- and without Loss of Control Eating. In the model examining the initial attention capture period of the palatable food attention bias paradigm, condition will be coded as high-palatable food, low-palatable food, and neutral non-food trials. In the model examining the sustained attention deployment period of the palatable food attention bias paradigm, the conditions will be coded as high palatable-congruent and -incongruent trials, as well as low palatable-congruent and -incongruent trials.
Time frame: During palatable (vs non-palatable) food cues attention bias paradigm
Experiment 2 (Hormone and Brain Development Study): oscillatory power activity in hypothesized brain regions-of-interest
Differences in neural activity in youth with- and without Loss of Control Eating. In the model examining the initial attention capture period, condition will be coded as angry, happy, and neutral trials. In the model examining the sustained attention deployment period, the conditions will be coded as angry-congruent and -incongruent trials, as well as happy-congruent and -incongruent trials.
Time frame: During social threat attention bias paradigm
Experiment 3 (Sleep/fatigue): fatigue and task resistance
Difference in self-report of fatigue and resistance during the computer task and movie. According to a prior power calculations, the sample size (40 participants) was expected to have 80% power to detect a significant difference between the cognitive fatigue and non-fatigue conditions based on effect sizes from previous studies of adults (Cohen s d=0.8-2.5) \[Faber, Maurits, \& Lorist, 2012; Van der Linden \& Eling, 2006\].Faber LG, Maurits NM, Lorist MM. Mental fatigue affects visual selective attention. PLoS One 2012;7:e48073. doi: 10.1371/journal.pone.0048073Van der Linden D, Eling P. Mental fatigue disturbs local processing more than global processing. Psychol Res 2006;70:395-402.
Time frame: Immediately before and after completion of the computer task and movie (approximately 2hours)
Experiment 3 (Sleep/fatigue): behavioral performance
Reaction time and proportion of correct responses during the fatigue task.
Time frame: During the computer task (approximately 2hours).
Experiment 3 (Sleep/fatigue): energy intake.
Difference in total energy intake (kcals) during the laboratory meals following the computer task and movie.A priori power computations were based on the effect size from a previous laboratory study evaluating energy intake differences between adults randomized to a high or low cognitive reduction condition \[Ward and Mann, 2000\]. To detect a difference in energy intake, using a randomized crossover design with power of 0.9 and a 2-sided significance level of =.05, 88 participants were required.Ward A, Mann T. Don't mind if i do: Disinhibited eating under cognitive load. J Pers Soc Psychol 2000;78:753-63. doi: 10.1037//0022-3514.78.4.753
Time frame: Immediately following completion of the computer task and movie.
Plan to share: Yes — All individual participant data sets that underlie results in a publication are to be shared.
Supporting information: Study protocol, Informed consent form, Clinical study report
Time frame: NIH subject data will become available starting 6 months after publication of a results paper and will be available from the NIH site for 2 years.
Access criteria: NIH data with personal identifiers removed will be shared upon reasonable request to the PI, who will review requests. A data sharing agreement will be required to be negotiated with NICHD before sharing takes place.
Started Apr 2015 (actual). Primary completion is estimated for Dec 2030, 187 months after the start.
Of 791 non-industry observational studies under Obesity, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 106. This study's planned 187 months is above that.
Counting every sponsor, half of 836 studies reached it within 39 months; a quarter within 17 and three quarters within 96.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) →