Weight Discrimination and Poor Cardiovascular Health

NCT05714696 | Completed Results

• 1 other identifier: R56HL159177
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 1

Brief Summary

People with obesity regularly experience discrimination on the basis of their body weight and such experiences are associated with increased risk for poor cardiovascular health. The goal of this clinical trial is to identify cognitive, affective, behavioral, and physiological factors that explain the relationship between weight discrimination and poor health outcomes. A diverse sample of adults with obesity will be randomly assigned to a social interaction encounter that simulates a typical weight discrimination experience (experimental manipulation) vs. a control manipulation that does not involve discrimination. The investigators will examine the immediate effects of the experimental manipulation on cognitive (e.g., self-regulation), affective (e.g., negative emotion), behavioral (e.g., comfort eating), and physiological (e.g., cortisol secretion) outcomes. Two additional aims of the study are to identify psychological traits that moderate responses to weight discrimination and to assess whether the negative health effects of weight discrimination differ by age, sex/gender, race, or ethnicity.

Conditions

Obesity

Outcome Measures

Primary Outcomes (11)

• Negative Affect

  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.

  2 minutes after delivery of the intervention

• Positive Affect

  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.

  2 minutes after delivery of the intervention

• Self-efficacy for Weight Control Behavior

  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.

  6 minutes after delivery of the intervention

• Intentions for Weight Control Behavior

  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.

  10 minutes after delivery of the intervention

• Executive control_accuracy

  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.

  15 minutes after delivery of the intervention

• Executive control_speed

  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.

  15 minutes after delivery of the intervention

• Delay Discounting

  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.

  20 minutes after delivery of the intervention

• Change in Cortisol From Baseline to First Follow-up Assessment

  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.

  25 minutes after delivery of the intervention

• Comfort Eating

  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.

  30 minutes after delivery of the intervention

• Social Withdrawal

  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.

  45 minutes after delivery of the intervention

• Change in Cortisol From Baseline to Second Follow-up Assessment

  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.

  60 minutes after delivery of the intervention

Study Arms (2)

Weight discrimination experience

EXPERIMENTAL

Participants in the experimental condition will: 1. Learn that their group mates are biased against overweight people (i.e., they have negative attitudes toward people with higher body weight), 2. Receive feedback about their personal attributes that is consistent with negative weight-based stereotypes (e.g., lacking self-discipline), and 3. Not be selected as a partner for the remaining lab tasks (i.e., this experience may prompt feelings of social exclusion).

Behavioral: Weight discrimination experience

Control experience

ACTIVE COMPARATOR

Participants in the control condition will: 1. Learn that their group mates are very accepting of overweight people (i.e., they have positive attitudes toward people with higher body weight), 2. Receive positive feedback about their personal attributes that is not consistent with negative weight-based stereotypes, and 3. Will be told that one of their group members had to leave early for an emergency so the pairs cannot be assembled as usual (i.e., this experience should not prompt feelings of social exclusion).

Behavioral: Control experience

Interventions

Weight discrimination experience BEHAVIORAL

In the experimental condition, participants will learn that their group members are biased against overweight people but not elderly or racial/ethnic minority individuals, as indicated by the "getting to know you" summary ratings handout. Participants will also receive negative feedback about their personal attributes by being labeled with negative weight-based stereotypes. Although some ratings will be positive (e.g., they will receive high ratings on being friendly and kind), participants will be rated poorly on attributes viewed as necessary to develop a strong marketing campaign (i.e., motivation to work hard, possessing self-discipline to persist at the task, and competence). After (ostensibly) assembling the group's preferences, the experimenter will inform participants that no one selected them to be their partner, thus they will perform the next few tasks alone. This manipulation has been shown to prompt feelings of social exclusion.

Weight discrimination experience

Control experience BEHAVIORAL

In the control condition, participants will learn that their group members have positive attitudes toward people with higher body weight, as well as elderly and racial/ethnic minority individuals, as indicated by the "getting to know you" summary ratings handout. Participants will also receive positive feedback about their personal attributes, as indicated by the summary ratings averaged across the three members. Finally, participants in the control condition will be told that one of their group members had to leave unexpectedly for a family emergency, so pairs cannot be assembled as usual, thus they will perform the next few tasks alone. This manipulation should not prompt feelings of social exclusion.

Control experience

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) body mass index (BMI) greater than or equal to 30 (units: weight in kilograms divided by height in meters squared; BMI criteria for obesity)
• (2) 18 years of age or older
• (3) able to read and understand English
• (4) have Internet access (to complete the baseline survey)
• (5) able to come to FSU's campus to take part in a lab-based study

You may not qualify if:

• (1) having participated in any of our pilot studies on weight stigma
• (2) diagnosed with a current major psychiatric disorder (e.g., major depressive disorder, eating disorder)
• (3) pregnant or nursing
• (4) diagnosed with Cushing syndrome or taking steroid-based medications
• (5) having allergies to ingredients in the foods being offered during the taste test (e.g., gluten, peanuts).

Sponsors & Collaborators

• Florida State University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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.

Results Point of Contact

• Title: Dr. Mary Gerend
• Organization: Florida State University College of Medicine

mary.gerend@med.fsu.edu

8506451541

Study Officials

• Mary A Gerend, PhD

  Florida State University, College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: February 6, 2023
• Study Start: February 5, 2023
• Primary Completion: April 26, 2024
• Study Completion: April 26, 2024
• Last Updated: May 15, 2025
• Results First Posted: May 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available 9 months after completion of the trial and will be made accessible up to 36 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial data can be requested by qualified researchers engaging in independent scientific research. Investigators will be asked to complete a standardized request form stating the specific aims of the analysis, the analytic plan, resources the requestors have to carry out the project, the proposed timeline, and distribution goals (manuscripts and/or grant application). The PI will review these requests to determine whether the proposed analyses constitute an innovative and significant exploration of the data, whether the proposed team has sufficient resources to undertake the request, how data will be protected/managed, and whether there are sufficient resources to honor the request. If any of these issues are problematic, the PI will attempt to negotiate a fair resolution with the interested parties and/or with NIH program staff. The PI will keep a record of all individuals/research teams who receive a copy of the data.

Locations

US (1)