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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK128575 | 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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This study used a within-subjects design in a sample of individuals with a range of food insecurity recruited from the Los Angeles community (N = 400; 44.5% men). These participants then, in counterbalanced order, were exposed to a gold-standard laboratory stressor and a control condition, one month apart. Moderation analyses will test whether cortisol reactivity to the stressor acts as a modulator of the relationship between high levels of food insecurity and increased hyperpalatable food intake.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental (High Stress) First, Then Control | Experimental | Participants first completed the high-stress condition in which they were exposed to a gold-standard laboratory stressor, the Trier Social Stress Test (Kirschbaum et al., 1993). Participants were given five minutes to prepare for a five-minute speech task followed by a five-minute mental arithmetic task in front of two panelists wearing white lab coats (i.e., a male and female research assistant). The speech task put the participant in a mock interview, with the panelists listening to the speech in an unresponsive, neutral manner and asking standardized probing questions. During the mental arithmetic task, participants were instructed to subtract odd numbers (i.e., 7 and 13) from a large number (i.e., 2935) as quickly as possible. If the participant made a mistake, the panelist interrupted them and instructed them to start the task again from the beginning. The panelists reminded the participant to "go faster" if they started to slow down with the task. |
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| Control First, Then Experimental (High Stress) | No Intervention | Participants first underwent the control condition during which they were presented with low-stress equivalents to the speech and mental arithmetic tasks from the experimental (high-stress) condition. For the speech task, participants were instructed to talk out loud to themselves for five minutes about a movie or book of their choice. Their speech was recorded using a small audio recorder device the research assistant prepared. For the mental arithmetic task, participants were instructed to count by increments of 15 starting from zero to the largest number they could reach. Participants were left in the room alone for the task for five minutes, after which the participant self-reported to the research assistant the number they reached. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Stress Intervention | Behavioral | Those undergoing the High-Stress will be exposed to a gold-standard laboratory stressor, the Trier Social Stress Test (Kirschbaum et al., 1993), which reliably induces cortisol reactivity in most individuals. |
| Measure | Description | Time Frame |
|---|---|---|
| Hyperpalatable Food Intake Measured in Kilocalories | The primary outcome was hyperpalatable food intake, initially measured in grams and converted into kilocalories. The food consisted of the following items: donuts, M&Ms, potato chips, crackers, and Sprite. These foods were chosen because processed foods, added sugars, refined grains, starchy vegetables, and sugar sweetened beverages are foods to avoid according to the 2019 American Diabetes Association Nutrition Consensus Report and are high in carbohydrates and glycemic index. | Hyperpalatable food intake was measured twice: 5 minutes following the experimental (high stress) or control condition during the first visit, and again 5 minutes following the alternate condition during the second visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| A. Janet Tomiyama, Ph.D. | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8255414 | Background | Kirschbaum C, Pirke KM, Hellhammer DH. The 'Trier Social Stress Test'--a tool for investigating psychobiological stress responses in a laboratory setting. Neuropsychobiology. 1993;28(1-2):76-81. doi: 10.1159/000119004. | |
| Background | American Diabetes Association. Diabetes care standards of medical care in Diabetes - 2019. J Clin Appl Res Educ 2019. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental (High Stress) First, Then Control | Participants first completed the high-stress condition in which they were exposed to a gold-standard laboratory stressor, the Trier Social Stress Test (Kirschbaum et al., 1993). Participants were given five minutes to prepare for a five-minute speech task followed by a five-minute mental arithmetic task in front of two panelists wearing white lab coats (i.e., a male and female research assistant). The speech task put the participant in a mock interview, with the panelists listening to the speech in an unresponsive, neutral manner and asking standardized probing questions. During the mental arithmetic task, participants were instructed to subtract odd numbers (i.e., 7 and 13) from a large number (i.e., 2935) as quickly as possible. If the participant made a mistake, the panelist interrupted them and instructed them to start the task again from the beginning. The panelists reminded the participant to "go faster" if they started to slow down with the task. 4 weeks later, participants completed the control condition in which they were presented with low-stress speech and mental arithmetic tasks. For the speech task, participants were instructed to talk out loud for five minutes about a movie or book of their choice; their speech was recorded using a small audio recorder. For the mental arithmetic task, participants were instructed to count by increments of 15 starting from 0 to the largest number they could reach. After five minutes, they self-reported the number they reached. |
| FG001 | Control First, Then Experimental (High Stress) | Participants first completed the control condition in which they were presented with low-stress speech and mental arithmetic tasks. For the speech task, participants were instructed to talk out loud for five minutes about a movie or book of their choice; their speech was recorded using a small audio recorder. For the mental arithmetic task, participants were instructed to count by increments of 15 starting from 0 to the largest number they could reach. After five minutes, they self-reported the number they reached. 4 weeks later, participants completed the high-stress condition in which they were exposed to a gold-standard laboratory stressor, the Trier Social Stress Test (Kirschbaum et al., 1993). Participants were given five minutes to prepare for a five-minute speech task followed by a five-minute mental arithmetic task in front of two panelists wearing white lab coats (i.e., a male and female research assistant). The speech task put the participant in a mock interview, with the panelists listening to the speech in an unresponsive, neutral manner and asking standardized probing questions. During the mental arithmetic task, participants were instructed to subtract odd numbers (i.e., 7 and 13) from a large number (i.e., 2935) as quickly as possible. If the participant made a mistake, the panelist interrupted them and instructed them to start the task again from the beginning. The panelists reminded the participant to "go faster" if they started to slow down with the task. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental (High Stress) First, Then Control | Participants first completed the high-stress condition in which they were exposed to a gold-standard laboratory stressor, the Trier Social Stress Test (Kirschbaum et al., 1993). Participants were given five minutes to prepare for a five-minute speech task followed by a five-minute mental arithmetic task in front of two panelists wearing white lab coats (i.e., a male and female research assistant). The speech task put the participant in a mock interview, with the panelists listening to the speech in an unresponsive, neutral manner and asking standardized probing questions. During the mental arithmetic task, participants were instructed to subtract odd numbers (i.e., 7 and 13) from a large number (i.e., 2935) as quickly as possible. If the participant made a mistake, the panelist interrupted them and instructed them to start the task again from the beginning. The panelists reminded the participant to "go faster" if they started to slow down with the task. 4 weeks later, participants completed the control condition in which they were presented with low-stress speech and mental arithmetic tasks. For the speech task, participants were instructed to talk out loud for five minutes about a movie or book of their choice; their speech was recorded using a small audio recorder. For the mental arithmetic task, participants were instructed to count by increments of 15 starting from 0 to the largest number they could reach. After five minutes, they self-reported the number they reached. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Hyperpalatable Food Intake Measured in Kilocalories | The primary outcome was hyperpalatable food intake, initially measured in grams and converted into kilocalories. The food consisted of the following items: donuts, M&Ms, potato chips, crackers, and Sprite. These foods were chosen because processed foods, added sugars, refined grains, starchy vegetables, and sugar sweetened beverages are foods to avoid according to the 2019 American Diabetes Association Nutrition Consensus Report and are high in carbohydrates and glycemic index. | One participant was removed from analysis due to staff entry error leading to ambiguity regarding condition assignment. | Posted | Mean | Standard Deviation | Kilocalories | Hyperpalatable food intake was measured twice: 5 minutes following the experimental (high stress) or control condition during the first visit, and again 5 minutes following the alternate condition during the second visit. |
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From enrollment until end of follow-up, up to 4 weeks.
Adverse events were defined as in ClinicalTrials.gov
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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 | Experimental (High Stress) | Participants who underwent the experimental (high-stress) arm were exposed to a gold-standard laboratory stressor, the Trier Social Stress Test (Kirschbaum et al., 1993). Participants were given five minutes to prepare for a five-minute speech task followed by a five-minute mental arithmetic task in front of two panelists wearing white lab coats (i.e., a male and female research assistant). The speech task posited the participant in a mock interview, with the two panelists listening to the speech in an unresponsive, neutral manner and asking standardized probing questions. Participants who underwent the mental arithmetic task were instructed to subtract odd numbers (i.e., 7 and 13) from a large number (i.e., 2935) as quickly as possible. If the participant made a mistake, the panelist interrupted them and instructed them to start the task again from the beginning. The panelists also constantly reminded the participant to "go faster" if they started to slow down with the task. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| A. Janet Tomiyama | University of California, Los Angeles | 310-206-6875 | tomiyama@psych.ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 11, 2026 | May 11, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 14, 2026 | Apr 14, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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The study is a within-subjects experiment. The order in which participants underwent the experimental or control conditions/arms was counterbalanced. 50% of participants underwent the experimental condition first and then the control condition, one month later. The rest of the sample underwent the control condition first then the experimental condition, one month later.
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| BG001 | Control First, Then Experimental (High Stress) | Participants first completed the control condition in which they were presented with low-stress speech and mental arithmetic tasks. For the speech task, participants were instructed to talk out loud for five minutes about a movie or book of their choice; their speech was recorded using a small audio recorder. For the mental arithmetic task, participants were instructed to count by increments of 15 starting from 0 to the largest number they could reach. After five minutes, they self-reported the number they reached. 4 weeks later, participants completed the high-stress condition in which they were exposed to a gold-standard laboratory stressor, the Trier Social Stress Test (Kirschbaum et al., 1993). Participants were given five minutes to prepare for a five-minute speech task followed by a five-minute mental arithmetic task in front of two panelists wearing white lab coats (i.e., a male and female research assistant). The speech task put the participant in a mock interview, with the panelists listening to the speech in an unresponsive, neutral manner and asking standardized probing questions. During the mental arithmetic task, participants were instructed to subtract odd numbers (i.e., 7 and 13) from a large number (i.e., 2935) as quickly as possible. If the participant made a mistake, the panelist interrupted them and instructed them to start the task again from the beginning. The panelists reminded the participant to "go faster" if they started to slow down with the task. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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Participants who underwent the experimental (high-stress) arm were exposed to a gold-standard laboratory stressor, the Trier Social Stress Test (Kirschbaum et al., 1993). Participants were given five minutes to prepare for a five-minute speech task followed by a five-minute mental arithmetic task in front of two panelists wearing white lab coats (i.e., a male and female research assistant). The speech task posited the participant in a mock interview, with the two panelists listening to the speech in an unresponsive, neutral manner and asking standardized probing questions. Participants who underwent the mental arithmetic task were instructed to subtract odd numbers (i.e., 7 and 13) from a large number (i.e., 2935) as quickly as possible. If the participant made a mistake, the panelist interrupted them and instructed them to start the task again from the beginning. The panelists also constantly reminded the participant to "go faster" if they started to slow down with the task. |
| OG001 | Control | Participants who underwent the control arm were presented with low-stress equivalents to the speech and mental arithmetic tasks from the experimental (high-stress) arm. For the speech task, participants were instructed to talk out loud to themselves for five minutes about a movie or book of their choice. Their speech was recorded using a small audio recorder device the research assistant prepared. For the mental arithmetic task, participants were instructed to count by increments of 15 starting from zero to the largest number they could reach. Participants were left in the room alone for the task for five minutes, after which the participant self-reported to the research assistant the number they reached. |
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| 0 |
| 400 |
| 0 |
| 400 |
| 0 |
| 400 |
| EG001 | Control | Participants who underwent the control arm were presented with low-stress equivalents to the speech and mental arithmetic tasks from the experimental (high-stress) arm. For the speech task, participants were instructed to talk out loud to themselves for five minutes about a movie or book of their choice. Their speech was recorded using a small audio recorder device the research assistant prepared. For the mental arithmetic task, participants were instructed to count by increments of 15 starting from zero to the largest number they could reach. Participants were left in the room alone for the task for five minutes, after which the participant self-reported to the research assistant the number they reached. | 0 | 400 | 0 | 400 | 0 | 400 |
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