Pediatric Obesity Clinical Trial
Official title:
Neural Mechanisms Underlying Children's Responses to Food Portion Size and Energy Density
| NCT number | NCT02759523 |
| Other study ID # | FoodBehavior01 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 2013 |
| Est. completion date | December 2015 |
| Verified date | December 2020 |
| Source | Penn State University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Increased portion sizes of foods high in energy density (calories per gram of food) have been implicated in the obesity epidemic. Numerous studies show that children and adults eat more from larger portions of food than they do from smaller portions, a response known as the portion size effect. Despite the robust and consistent nature of these findings, the mechanisms underlying the portion size effect are not known. The long-term goal of this research is to identify the neural mechanisms involved in the portion size effect so that this information can be used to develop effective weight-management strategies. Differences in neural response to food cues, as demonstrated by functional magnetic resonance imaging (fMRI), can help clarify the factors that determine susceptibility to large portions. The goal of this study is to identify brain regions activated in response to portion size and energy density and relate these neural responses to laboratory eating behaviors in children. The investigators hypothesize that high relative to low energy density food images will be associated with increased activation in regions of the brain involved in reward- and sensory- processing and that large relative to small portion size food images will be associated with increased activation in regions of the brain involved in cognitive control. In addition, the investigators hypothesize that these brain responses will influence the relationship between portion size served and energy intake at laboratory meals.
| Status | Completed |
| Enrollment | 108 |
| Est. completion date | December 2015 |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 7 Years to 10 Years |
| Eligibility | Inclusion Criteria: - Right-handedness - English as native language - Reading at /above grade level - Not claustrophobic - Generally healthy Exclusion Criteria: - Left-handedness - Metal in or on the body that cannot be removed - Claustrophobic - Medication usage that could alter brain activity - Medical disorder that may impact comfort in scanner - Food allergies |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Penn State University | Social Science Research Institute |
English L, Lasschuijt M, Keller KL. Mechanisms of the portion size effect. What is known and where do we go from here? Appetite. 2015 May;88:39-49. doi: 10.1016/j.appet.2014.11.004. Epub 2014 Nov 11. Review. — View Citation
Fearnbach SN, English LK, Lasschuijt M, Wilson SJ, Savage JS, Fisher JO, Rolls BJ, Keller KL. Brain response to images of food varying in energy density is associated with body composition in 7- to 10-year-old children: Results of an exploratory study. Ph — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Appetitive traits | Parent-reported questionnaire of habitual eating styles in children | Collected at week 1 (Baseline) | |
| Other | Body composition a/o weight status | Height, weight and body fat percentage were measured. Body mass index (BMI), BMI z score, fat-mass index and fat-free-mass index will be calculated. | Collected at week 1 (Baseline) | |
| Other | Liking of foods | Ratings of how much child likes food presented on a computerized visual analog scale | Collected at week 5 | |
| Other | Wanting of foods | Ratings of how much child wants food presented on a computerized visual analog scale | Collected at week 5 | |
| Other | Loss of control eating | Loss of control when eating is frequently reported in middle childhood. Loss of control when eating was assessed via interview-style questionnaire to determine pre-clinical binge-like eating behaviors that may influence the primary outcome of energy intake at the 4 conditions of test-meals. | Collected at week 1 (Baseline) | |
| Other | Parental feeding strategies | Parent-reported measures of feeding practices | Collected at week 1 (Baseline) | |
| Primary | fMRI blood oxygen level dependent (BOLD) response to food portion size and energy density | Whole-brain response to food images that varied at 2 levels of portion size and 2 levels of energy density | Collected at fMRI scan (1 of 1) at week 5 | |
| Primary | Energy intake | Energy intake (kcal and grams) of foods consumed ad libitum at each laboratory test-meal in response to 4 conditions of portion sizes (100% reference, 133%, 167%, 200%). | Collected at week 1, 2, 3, and 4 | |
| Secondary | Region of Interest (ROI)-response to food portion size and energy density | Response in selected brain regions of interest to food images varied at 2 levels of portion size and 2 levels of energy density | Collected at fMRI scan (1 of 1) at week 5 |
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