Weight Discrimination and Poor Cardiovascular Health
NCT05714696, Not applicable, Completed, Florida State University; results first posted 2025-05-15
Trial 12
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Weight Discrimination and Poor Cardiovascular Health | ClinicalTrials.gov |
| NCT number | NCT05714696 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 333 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Florida State University | ClinicalTrials.gov |
| Conditions | Obesity | ClinicalTrials.gov |
| Interventions | Weight discrimination experience, Control experience | ClinicalTrials.gov |
| First posted | 2023-02-06 | ClinicalTrials.gov |
| Last updated | 2025-05-15 | ClinicalTrials.gov |
| Results first posted | 2025-05-15 | ClinicalTrials.gov |
| Limitations and caveats | Because the of mechanism used to fund this project (R56), we received only one year of funding and thus we were not able to reach our desired sample size of 320 participants. | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Negative Affect | 2 minutes after delivery of the intervention | A modified version of the Positive and Negative Affect Scale-Expanded Form (PANAS-X) will be used to assess emotions in response to the experimental manipulation. The scale demonstrates good validity and reliability. Emotions will be assessed with 46 adjectives (e.g., angry, confident) by indicating the extent to each emotion is felt at that moment (1=very slightly or not at all to 5=extremely). A composite score for negative affect will be created by taking the average of the relevant adjectives. Scores will range from 1 to 5, with higher scores indicating more negative emotion. | ClinicalTrials.gov |
| Primary | Positive Affect | 2 minutes after delivery of the intervention | A modified version of the Positive and Negative Affect Scale-Expanded Form (PANAS-X) will be used to assess emotions in response to the experimental manipulation. The scale demonstrates good validity and reliability. Emotions will be assessed with 46 adjectives (e.g., angry, confident) by indicating the extent to each emotion is felt at that moment (1=very slightly or not at all to 5=extremely). A composite score for positive affect will be created by taking the average of the relevant adjectives. Scores will range from 1 to 5, with higher scores indicating more positive emotion. | ClinicalTrials.gov |
| Primary | Self-efficacy for Weight Control Behavior | 6 minutes after delivery of the intervention | Self-efficacy (perceived confidence) in one's ability to engage in weight control behaviors (e.g., dietary restraint, physical activity) over the next six months will be assessed. Self-efficacy for dietary restraint will be assessed with the short form of the Weight Efficacy Lifestyle Questionnaire (e.g., I can resist eating … when I am depressed or down; 8 items). Self-efficacy for physical activity will be assessed with the Exercise Self-efficacy Scale (e.g., I am confident I can participate in regular exercise when … I am tired; 5 items). Weight control items will be interspersed with items assessing self-efficacy for other health behaviors (e.g., flu vaccination, sleep). Each item will be rated on an 8-point scale (0=not at all confident to 7=very confident). Items will be averaged to create a composite score. Scores will range from 0 to 7, with higher scores indicating higher self-efficacy for weight control behavior. | ClinicalTrials.gov |
| Primary | Intentions for Weight Control Behavior | 10 minutes after delivery of the intervention | Using the same health behaviors assessed for self-efficacy, intentions for weight control behavior will be assessed (i.e., intentions to engage in each behavior over the next six months). Each item will be rated on an 8-point scale (0=strongly disagree to 7=strongly agree). Items will be averaged to create a composite score. Scores will range from 0 to 7, with higher scores indicating higher intentions to engage in weight control behavior. | ClinicalTrials.gov |
| Primary | Executive control_accuracy | 15 minutes after delivery of the intervention | The Stroop task provides a measure of executive control by assessing the ability to inhibit an automatic response (reading) in favor of performing a more controlled task (color naming). The task is a classic, widely used and well-validated measure of executive control. Eight blocks of 20 trials will be performed that will take approximately 5 minutes to complete. Executive control scores will be calculated for response accuracy and speed. Metric: accuracy (percentage of correct answers on mismatched trials). A lower percentage of correct answers on mismatched trials indicates worse executive control. | ClinicalTrials.gov |
| Primary | Executive control_speed | 15 minutes after delivery of the intervention | The Stroop task provides a measure of executive control by assessing the ability to inhibit an automatic response (reading) in favor of performing a more controlled task (color naming). The task is a classic, widely used and well-validated measure of executive control. Eight blocks of 20 trials will be performed that will take approximately 5 minutes to complete. Executive control scores will be calculated for accuracy and speed (reaction time). Metric: reaction time (average reaction time in milliseconds on mismatched trials). Longer reaction times on mismatched trials indicate worse executive control. | ClinicalTrials.gov |
| Primary | Delay Discounting | 20 minutes after delivery of the intervention | Delay discounting involves the subjective depreciation of an incentive based on its timing. The measure assesses the ability to delay gratification, that is, a tendency to prioritize larger long-term rewards over smaller short-term rewards. The task involves choosing short vs. long-term rewards from a set of five dichotomous choices (e.g., to receive $1 immediately or $10 in one month). The task takes about 1 minute to administer, is highly reliable, and correlates well with longer and more extensive measures of delay discounting (metric: discount rate (k)). Scores will range from 0.000110 to 24, with higher scores indicating more impulsivity/lower ability to delay gratification. | ClinicalTrials.gov |
| Primary | Change in Cortisol From Baseline to First Follow-up Assessment | 25 minutes after delivery of the intervention | The investigators will measure cortisol secretion via saliva (passive drool) 25 minutes after delivery of the intervention (first follow-up) and compare it to baseline cortisol levels. | ClinicalTrials.gov |
| Primary | Comfort Eating | 30 minutes after delivery of the intervention | Comfort eating will be assessed via an eating task to objectively measure hyper-palatable (high-fat, -sodium, -sugar, and -carbohydrate) food intake. To avoid floor effects, the eating task will take place under the guise of a faux taste test, which will ostensibly guide the development of the food marketing campaign later during the study. To avoid ceiling effects and to allow eating behavior without fear that the experimenter will negatively judge the amount eaten, large quantities of each food will be made available. The task will take 10 minutes to complete and will be conducted in a private room. Bowls will be weighed (unobtrusively) before and after the task to compute the difference in grams, which will then be converted to kilocalories based on published nutrition information from the food maker. Higher kilocalorie consumption indicates a tendency to engage in more comfort eating during times of stress. | ClinicalTrials.gov |
| Primary | Social Withdrawal | 45 minutes after delivery of the intervention | Social withdrawal will be assessed with a measure from previous research. The experimenter will present three options for working on the final task: alone, with a former group member, or with a new partner. Choosing to work alone reflects a desire to avoid social interaction. Each response will be assigned a numerical code (work alone = 0; work with a former group member = 1; work with a new partner = 2). Scores of zero indicate a greater tendency to withdraw socially during times of stress. | ClinicalTrials.gov |
| Primary | Change in Cortisol From Baseline to Second Follow-up Assessment | 60 minutes after delivery of the intervention | The investigators will measure cortisol secretion via saliva (passive drool) 60 minutes after delivery of the intervention (second follow-up) and compare it to baseline cortisol levels. | ClinicalTrials.gov |
Outcomes 11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Negative Affect | 2 minutes after delivery of the intervention | score on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Positive Affect | 2 minutes after delivery of the intervention | score on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Self-efficacy for Weight Control Behavior | 6 minutes after delivery of the intervention | score on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Intentions for Weight Control Behavior | 10 minutes after delivery of the intervention | score on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Executive control_accuracy | 15 minutes after delivery of the intervention | There are some missing data on this variable due to experimenter error. | percentage of correct responses | MEAN | ClinicalTrials.gov |
| PRIMARY | Executive control_speed | 15 minutes after delivery of the intervention | There are some missing data on this variable due to experimenter error. | milliseconds | MEAN | ClinicalTrials.gov |
| PRIMARY | Delay Discounting | 20 minutes after delivery of the intervention | There are some missing data on this variable due to experimenter error. | score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Change in Cortisol From Baseline to First Follow-up Assessment | 25 minutes after delivery of the intervention | There are some missing data on this variable due to poor quality saliva samples (too watery). | ug/dL | MEAN | ClinicalTrials.gov |
| PRIMARY | Comfort Eating | 30 minutes after delivery of the intervention | There are some missing data on this variable due to participant eating restrictions or allergies that prevented them completing the taste test as designed. | kcals | MEAN | ClinicalTrials.gov |
| PRIMARY | Social Withdrawal | 45 minutes after delivery of the intervention | One participant is missing data due to experimenter error. | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
| PRIMARY | Change in Cortisol From Baseline to Second Follow-up Assessment | 60 minutes after delivery of the intervention | There are some missing data on this variable due to poor quality saliva samples (too watery). Of note, we were not able to run the statistical analysis on this variable due to the lack of variability in both groups. | ug/dL | MEAN | ClinicalTrials.gov |
Results by group 26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Negative Affect | Weight Discrimination Experience | 1.43 | Standard Deviation 0.49 | score on a scale | ClinicalTrials.gov | |
| Negative Affect | Control Experience | 1.29 | Standard Deviation 0.33 | score on a scale | ClinicalTrials.gov | |
| Positive Affect | Weight Discrimination Experience | 2.83 | Standard Deviation 0.94 | score on a scale | ClinicalTrials.gov | |
| Positive Affect | Control Experience | 3.04 | Standard Deviation 0.82 | score on a scale | ClinicalTrials.gov | |
| Self-efficacy for Weight Control Behavior | Weight Discrimination Experience | 4.29 | Standard Deviation 1.42 | score on a scale | ClinicalTrials.gov | |
| Self-efficacy for Weight Control Behavior | Control Experience | 3.91 | Standard Deviation 1.42 | score on a scale | ClinicalTrials.gov | |
| Intentions for Weight Control Behavior | Weight Discrimination Experience | 4.91 | Standard Deviation 1.30 | score on a scale | ClinicalTrials.gov | |
| Intentions for Weight Control Behavior | Control Experience | 4.70 | Standard Deviation 1.28 | score on a scale | ClinicalTrials.gov | |
| Executive control_accuracy | Weight Discrimination Experience | 96 | Standard Deviation 5.0 | percentage of correct responses | ClinicalTrials.gov | |
| Executive control_accuracy | Control Experience | 96 | Standard Deviation 4.7 | percentage of correct responses | ClinicalTrials.gov | |
| Executive control_speed | Weight Discrimination Experience | 1191 | Standard Deviation 429 | milliseconds | ClinicalTrials.gov | |
| Executive control_speed | Control Experience | 1362 | Standard Deviation 492 | milliseconds | ClinicalTrials.gov | |
| Delay Discounting | Weight Discrimination Experience | 0.86 | Standard Deviation 3.87 | score on a scale | ClinicalTrials.gov | |
| Delay Discounting | Control Experience | 1.20 | Standard Deviation 4.78 | score on a scale | ClinicalTrials.gov | |
| Change in Cortisol From Baseline to First Follow-up Assessment | Weight Discrimination Experience | .0000 | Standard Deviation .0000 | ug/dL | ClinicalTrials.gov | |
| Change in Cortisol From Baseline to First Follow-up Assessment | Control Experience | .0076 | Standard Deviation .0874 | ug/dL | ClinicalTrials.gov | |
| Comfort Eating | Weight Discrimination Experience | 299.42 | Standard Deviation 194.72 | kcals | ClinicalTrials.gov | |
| Comfort Eating | Control Experience | 365.73 | Standard Deviation 173.83 | kcals | ClinicalTrials.gov | |
| Social Withdrawal | Weight Discrimination Experience | Work by self | 72 | Participants | ClinicalTrials.gov | |
| Social Withdrawal | Control Experience | Work by self | 55 | Participants | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Weight Discrimination Experience | 136 | ClinicalTrials.gov | |
| Overall Study | STARTED | Control Experience | 135 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Weight Discrimination Experience | 136 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Control Experience | 135 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Weight Discrimination Experience | 0 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Control Experience | 0 | ClinicalTrials.gov |
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Weight Discrimination Experience | 0 | 136 | ClinicalTrials.gov |
| Total, all-cause mortality | Control Experience | 0 | 135 | ClinicalTrials.gov |
| Total, other adverse events | Weight Discrimination Experience | 0 | 136 | ClinicalTrials.gov |
| Total, other adverse events | Control Experience | 0 | 135 | ClinicalTrials.gov |
| Total, serious adverse events | Weight Discrimination Experience | 0 | 136 | ClinicalTrials.gov |
| Total, serious adverse events | Control Experience | 0 | 135 | ClinicalTrials.gov |
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Trial comparisons 2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Weight Discrimination Experience vs Control Experience: deaths from any cause | Trial comparisons |
| Weight Discrimination Experience vs Control Experience: serious adverse events | Trial comparisons |
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Delay Discounting | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.