Clinical trial NCT05714696: Weight Discrimination and Poor Cardiovascular Health
Official title: Mechanisms Explaining the Link Between Weight Discrimination and Poor Cardiovascular Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-02-06
Enrollment: 333
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Detailed description: Discrimination is a critical social determinant of health that underlies poor health outcomes. One common but understudied form of discrimination is weight discrimination. Weight discrimination is the behavioral manifestation of weight stigma-the social devaluation of people with excess body weight. Findings suggest that the stress produced by weight discrimination prompts weight gain, creating a vicious cycle between weight discrimination and obesity. Further, there is now well-documented evidence that experiencing weight discrimination is associated with increased risk for cardiovascular disease. Little is known, however, about mechanisms explaining the link between weight discrimination and poor cardiovascular health. Using a rigorous experimental approach, this project will identify mechanisms through which weight discrimination harms health. Findings will facilitate the long-term goal of this research: interventions to decrease the negative health consequences of weight discrimination.

As a step toward this goal, this project proposes to conduct an experiment in which a diverse sample of adults with obesity will be randomly assigned to experience (vs. not experience) weight discrimination in a controlled experimental setting. Drawing on previous research and the investigators' pilot data, the interpersonal context chosen for the study simulates situations in which people with obesity commonly experience weight discrimination in their daily lives (e.g., employment settings).

The study will involve two parts: a pre-session baseline survey and an experimental session that will take place in the lab. The baseline survey will be completed online and will assess individual difference variables/psychological variables and demographic characteristics. The in-person lab visit will take place on campus about one week after completion of the baseline survey. The study manipulation (i.e., intervention) will be delivered during the lab visit. Primary outcome variables will be assessed during the lab visit, after delivery of the intervention.

The following aims will be tested: (1) Identify early-stage cognitive, affective, behavioral, and physiological mechanisms activated by experimentally manipulated weight discrimination; (2) Identify psychological variables (e.g., internalized weight bias) that moderate effects of weight discrimination; and (3) Identify demographic characteristics (e.g., gender, race) that moderate effects of weight discrimination. Exposure to weight discrimination (vs. control) is hypothesized to result in elevated responses on early-stage mechanisms that culminate in poor cardiovascular health (e.g., impaired self-regulation, higher negative emotion, more social withdrawal and comfort eating, increased cortisol secretion). This research will identify novel and highly modifiable targets for interventions designed to reduce the negative health effects of weight discrimination. In testing moderator variables, this work will identify individuals who display vulnerability vs. resilience to the harmful effects of discrimination. Information about moderators will thus help future intervention efforts target those individuals most likely to benefit from intervention. Given the high prevalence of obesity and the millions of Americans affected by weight discrimination, this research will address a crucial public health issue.

Eligibility criteria: Inclusion Criteria:

* (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

Exclusion Criteria:

* (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).

Primary outcomes:
measure: Negative Affect
timeFrame: 2 minutes after delivery of the intervention
measure: Positive Affect
timeFrame: 2 minutes after delivery of the intervention
measure: Self-efficacy for Weight Control Behavior
timeFrame: 6 minutes after delivery of the intervention
measure: Intentions for Weight Control Behavior
timeFrame: 10 minutes after delivery of the intervention
measure: Executive control_accuracy
timeFrame: 15 minutes after delivery of the intervention
measure: Executive control_speed
timeFrame: 15 minutes after delivery of the intervention
measure: Delay Discounting
timeFrame: 20 minutes after delivery of the intervention
measure: Change in Cortisol From Baseline to First Follow-up Assessment
timeFrame: 25 minutes after delivery of the intervention
measure: Comfort Eating
timeFrame: 30 minutes after delivery of the intervention
measure: Social Withdrawal
timeFrame: 45 minutes after delivery of the intervention
measure: Change in Cortisol From Baseline to Second Follow-up Assessment
timeFrame: 60 minutes after delivery of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
affiliation: Florida State University, College of Medicine
name: Mary A Gerend, PhD
role: PRINCIPAL_INVESTIGATOR
References: