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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK106265 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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While a substantial body of research suggests that RRV is related to obesity, there is very little research on factors that contribute to the RRV of food, particularly how patterns of eating can increase or decrease the motivation to eat specific foods. Previous work has demonstrated that a subset of individuals with obesity show increases in RRV of food after repeated consumption of large portions of high energy density (HED) snack foods, which has been conceptualized as sensitization. Preliminary data suggest that sensitization of the RRV of HED food is a predictor of weight gain over time. However, more work needs to be done to address this relationship using a planned, prospective study design, using adolescent research subjects, and examining potential moderators of this relationship.
The purpose of this study is to identify risk and protective factors to excess zBMI change in adolescents over time. Aim 1 was to measure the relative reinforcing value (RRV) of a preferred HED and low energy density (LED) snack food before and after 2-weeks of daily exposure. Aim 2 was to assess the RRV of exercise and sedentary activity. Hypotheses include 1) sensitization to HED food will be associated with greater zBMI at the time of testing as well as greater zBMI change over time 2) sensitization to LED food will be associated with lower zBMI at the time of testing in adolescents and less zBMI change over time. 3) Greater RRV of exercise will be protective against zBMI increases over time.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reinforcing value of HED and LED foods in response to snack food monotony | Other | Each child will be asked to eat two different snack foods over the course of two weeks each. The RRV of that food (vs alternative reinforcer) will be tested and baseline and post exposure. Increases in RRv for food after monotony will be considered sensitization to that food. All children will be followed to observe weight change over time for 2 years each. |
| Measure | Description | Time Frame |
|---|---|---|
| zBMI Change | BMI z-score change over time. zBMI is a standardized index of body mass index used in children that is standardized to age and sex specific measurements from a national sample. 0 represents the national average. A positive number reflects a body mass index that is higher than the national average and a negative number reflects a body mass index that is lower than the national average. | through study completion, an average of 24 months from baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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Adolescents living in the Western New York area, aged 12-14 years at the time of enrollment. Flyers were posted in the community within a 30 min drive of UB South Campus. Additionally, flyers were sent to list serves, posted on facebook, and distributed to both private and public schools within a 40 min drive of the university campus.
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37967392 | Derived | Balantekin KN, Andrade ALP, Ziegler AM, Temple JL. Restriction and Pressure to Eat Are Associated Cross-Sectionally, But Not Longitudinally, With BMI z-Score in a Longitudinal Cohort Study of Adolescents. Child Obes. 2024 Sep;20(6):386-393. doi: 10.1089/chi.2023.0108. Epub 2023 Nov 15. | |
| 34848836 | Derived | Temple JL, Ziegler AM, Crandall AK, Mansouri T, Hatzinger L, Barich R, Epstein LH. Sensitization of the reinforcing value of high energy density foods is associated with increased zBMI gain in adolescents. Int J Obes (Lond). 2022 Mar;46(3):581-587. doi: 10.1038/s41366-021-01007-w. Epub 2021 Nov 30. |
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Participants were 201 boys and girls aged 12 - 14 years without obesity recruited using flyers, e-mail and social media, personal referrals, and advertisements distributed in schools in the Buffalo, NY area.
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| ID | Title | Description |
|---|---|---|
| FG000 | Satiators | Participants who decreased responding for high energy density food after consuming it every day for 2 weeks. |
| FG001 | Sensitizers | Participants who increased responding for high energy density food after consuming it every day for 2 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants with complete baseline data were included in this analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Satiators | Participants who decreased responding for high energy density food after consuming it every day for 2 weeks. |
| BG001 | Sensitizers | Participants who increased responding for high energy density food after consuming it every day for 2 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | zBMI Change | BMI z-score change over time. zBMI is a standardized index of body mass index used in children that is standardized to age and sex specific measurements from a national sample. 0 represents the national average. A positive number reflects a body mass index that is higher than the national average and a negative number reflects a body mass index that is lower than the national average. | We began with 165 and 36, but we lost several participants in each group for various reasons which are outlined in an earlier section. | Posted | Mean | Standard Error | z-score | through study completion, an average of 24 months from baseline. |
|
Through study completion up to 24 months.
We used the standard definitions of adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Satiators | Participants who decreased responding for high energy density food after consuming it every day for 2 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Temple, Principle Investigator | University at Buffalo | 7168295593 | jltemple@buffalo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 2, 2020 | Jan 6, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 13, 2020 | Aug 2, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 3, 2020 | Aug 2, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D000294 | Adolescent Behavior |
| D009765 | Obesity |
| D009043 | Motor Activity |
| D001836 | Body Weight Changes |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Physician Decision |
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| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| zBMI | zBMI was calculated using national standards with '0' being the middle value. A positive zBMI reflects a BMI that is higher than the national average for each sex and age and a negative zBMI reflects a BMI that is lower than the national average for each sex and age. | Mean | Standard Deviation | z score |
|
| Sensitizers |
Participants who increased responding for high energy density food after consuming it every day for 2 weeks. |
|
|
| 0 |
| 165 |
| 0 |
| 165 |
| 0 |
| 165 |
| EG001 | Sensitizers | Participants who increased responding for high energy density food after consuming it every day for 2 weeks. | 0 | 36 | 0 | 36 | 0 | 36 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |