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| ID | Type | Description | Link |
|---|---|---|---|
| 15-CH-0096 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All pediatric participants | All pediatric participants in the study will be evaluated as one group | ||
| Parents of participants | Parents provide information about their children and supply DNA / blood samples for future analyses |
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| Measure | Description | Time Frame |
|---|---|---|
| Differences in eating behavior of pediatric participants | Multiple outcome measures | up to 6 years of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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INCLUSION CRITERIA:
Parents/Guardians will qualify if they meet the following criteria.
EXCLUSION CRITERIA:
Parents/Guardians will be excluded for the following reasons:
If their child is not eligible to participate in the study (see below)
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.
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community sample
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bobby K Cheon | Contact | (301) 827-1857 | bobby.cheon@nih.gov |
| Name | Affiliation | Role |
|---|---|---|
| Bobby K Cheon | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Recruiting | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14756614 | Background | Tanofsky-Kraff M, Yanovski SZ, Wilfley DE, Marmarosh C, Morgan CM, Yanovski JA. Eating-disordered behaviors, body fat, and psychopathology in overweight and normal-weight children. J Consult Clin Psychol. 2004 Feb;72(1):53-61. doi: 10.1037/0022-006X.72.1.53. | |
| 21114355 | Background | Tanofsky-Kraff M, Shomaker LB, Olsen C, Roza CA, Wolkoff LE, Columbo KM, Raciti G, Zocca JM, Wilfley DE, Yanovski SZ, Yanovski JA. A prospective study of pediatric loss of control eating and psychological outcomes. J Abnorm Psychol. 2011 Feb;120(1):108-18. doi: 10.1037/a0021406. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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All individual participant data sets that underlie results in a publication are to be shared.
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.
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.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D005247 | Feeding Behavior |
| D015775 | Fractures, Stress |
| D002032 | Bulimia |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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 | Immediately following completion of the computer task and movie. |
| 16585316 | Background | Tanofsky-Kraff M, Cohen ML, Yanovski SZ, Cox C, Theim KR, Keil M, Reynolds JC, Yanovski JA. A prospective study of psychological predictors of body fat gain among children at high risk for adult obesity. Pediatrics. 2006 Apr;117(4):1203-9. doi: 10.1542/peds.2005-1329. |
| 40878932 | Derived | Parker MN, Tanofsky-Kraff M, Bloomer BF, Te-Vazquez J, Adekola PE, Nwosu EE, Lazareva J, Jones JL, Moore A, Schvey NA, Brady SM, Yang SB, Turner SA, Yanovski JA, Kelly NR. The Effect of Experimentally Induced Cognitive Fatigue on Energy Intake Among Youth With and Without Recent Reported Dietary Restraint. Int J Eat Disord. 2025 Oct;58(10):2003-2008. doi: 10.1002/eat.24508. Epub 2025 Jul 16. |
| 40489009 | Derived | Parker MN, Kelly NR, Moore A, Loch LK, Vazquez JT, Bloomer BF, Nwosu EE, Lazareva J, Yang SB, Courville AB, Moursi NA, Brady SM, Olsen CH, Shank LM, Tanofsky-Kraff M, Yanovski JA. Cognitive fatigue did not significantly influence youth's total energy intake or snack food consumption during a randomized trial. J Behav Med. 2025 Aug;48(4):683-693. doi: 10.1007/s10865-025-00577-8. Epub 2025 Jun 9. |
| 37943608 | Derived | Smith MR, Bittner JMP, Loch LK, Haynes HE, Bloomer BF, Te-Vazquez J, Bowling AI, Brady SM, Tanofsky-Kraff M, Chen KY, Yanovski JA, Cheon BK. Independent and Interactive Associations of Subjective and Objective Socioeconomic Status With Body Composition and Parent-Reported Hyperphagia Among Children. Child Obes. 2024 Sep;20(6):394-402. doi: 10.1089/chi.2023.0086. Epub 2023 Nov 9. |
| 33831812 | Derived | Rubin AG, Schvey NA, Shank LM, Altman DR, Swanson TN, Ramirez E, Moore NA, Jaramillo M, Ramirez S, Davis EK, Broadney MM, LeMay-Russell S, Byrne ME, Parker MK, Brady SM, Kelly NR, Tanofsky-Kraff M, Yanovski JA. Associations between weight-based teasing and disordered eating behaviors among youth. Eat Behav. 2021 Apr;41:101504. doi: 10.1016/j.eatbeh.2021.101504. Epub 2021 Mar 29. |
| 33059389 | Derived | Schvey NA, Shank LM, Tanofsky-Kraff M, Ramirez S, Altman DR, Swanson T, Rubin AG, Kelly NR, LeMay-Russell S, Byrne ME, Parker MN, Broadney MM, Brady SM, Yanovski SZ, Yanovski JA. Weight-based teasing in youth: Associations with metabolic and inflammatory markers. Pediatr Obes. 2021 Mar;16(3):e12729. doi: 10.1111/ijpo.12729. Epub 2020 Oct 15. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001522 | Behavior, Animal |
| D001519 | Behavior |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |