Weight Stigma in Women Who Are Obese: Assessing How an Acute Exposure to Stigma Negatively Impacts Cardiovascular Health

May 18, 2022 updated by: Linda Pescatello, University of Connecticut
The current study examined the influence of an acute weight stigma exposure on cardiovascular reactivity among women with obesity and high blood pressure and women with obesity and normal blood pressure.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The current study examined the influence of two video exposures, one containing scenes of weight stigma (STIGMA) and the other non-stigmatizing neutral (NEUTRAL) scenes, on cardiovascular reactivity as assessed by resting BP and ambulatory blood pressure (ABP) and heart rate (HR), among women with obesity and high BP (HBP) or normal BP (NBP). The investigators hypothesized that as a result of STIGMA compared to NEUTRAL, cardiovascular reactivity would be significantly greater immediately upon watching the video and persist outside of the laboratory over ambulatory conditions in women with obesity and HBP compared to women with obesity and NBP.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Premenopausal
  • BMI > 30 kg/m2
  • No other known chronic cardiovascular or metabolic diseases besides hypertension

Exclusion Criteria:

  • Pregnant or planned on becoming pregnant
  • Took medications that may have affected the primary outcome of BP (e.g., stimulants for attention deficit hyperactivity disorder or steroids for asthma)
  • Currently using tobacco products
  • Diagnosed with an eating disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High Blood Pressure
Ambulatory BP measurement was used to confirm the laboratory BP group classification according to the European Society of Hypertension. Participants were placed in the high blood pressure (HBP) group if they met any of the following criteria: 1) 19-hour average systolic BP/diastolic BP (SBP/DBP) > 130/80 mmHg, 2) daytime (awake) average SBP/DBP > 135/85 mmHg, or 3) nighttime (sleep) average SBP/DBP > 120/70 mmHg.
Behavioral: Stigma Video Exposure
The participants watched a 10 minute video on a computer screen that consisted of brief clips from popular television shows that depicted women with overweight and obesity and evoked negative weight-based stereotypes (e.g., clumsy, loud, and lazy). Both the high blood pressure and normal blood pressure arms participated in this intervention.
Other Names:
  • STIGMA
Behavioral: Neutral video exposure
The participants watched a 10 minute video on a computer screen that consisted of a series of clips depicting neutral scenes (e.g., insurance commercials). Both the high blood pressure and normal blood pressure arms participated in this intervention.
Other Names:
  • NEUTRAL
Experimental: Normal Blood Pressure
Participants were placed in the normal BP (NBP) group if they met all of the following criteria: 1) 19-hour average SBP/DBP < 130/80 mmHg, 2) daytime (awake) average SBP/DBP < 135/85 mmHg, and 3) night-time (asleep) average SBP/DBP <120/70 mmHg.
Behavioral: Stigma Video Exposure
The participants watched a 10 minute video on a computer screen that consisted of brief clips from popular television shows that depicted women with overweight and obesity and evoked negative weight-based stereotypes (e.g., clumsy, loud, and lazy). Both the high blood pressure and normal blood pressure arms participated in this intervention.
Other Names:
  • STIGMA
Behavioral: Neutral video exposure
The participants watched a 10 minute video on a computer screen that consisted of a series of clips depicting neutral scenes (e.g., insurance commercials). Both the high blood pressure and normal blood pressure arms participated in this intervention.
Other Names:
  • NEUTRAL

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ambulatory systolic BP (SABP) reactivity
Time Frame: 19 hours (10 hours awake, 9 hours sleep)
Ambulatory SABP reactivity was calculated as the change in hourly SABP values (mmHg) over the awake (10 hours), sleep (9 hours), and 19 hours minus average baseline SABP following STIGMA and NEUTRAL.
19 hours (10 hours awake, 9 hours sleep)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Laboratory systolic blood pressure (SBP) reactivity
Time Frame: 20 minutes (2 minute intervals) before the exposure video; 10 minutes during the exposure video (2 min intervals); and 20 minutes following the exposure video (2 min. intervals).
Laboratory SBP reactivity was calculated as the change in SBP in millimeters of mercury (mmHg) during the stigma video exposure (STIGMA) and the neutral video exposure (NEUTRAL) and 20-minute post-STIGMA and NEUTRAL minus baseline SBP.
20 minutes (2 minute intervals) before the exposure video; 10 minutes during the exposure video (2 min intervals); and 20 minutes following the exposure video (2 min. intervals).
Ambulatory diastolic BP (DABP) reactivity
Time Frame: 19 hours (10 hours awake, 9 hours sleep)
Ambulatory DABP reactivity was calculated as the change in hourly DABP values (mmHg) over the awake (10 hours), sleep (9 hours), and 19 hours minus average baseline DABP following STIGMA and NEUTRAL.
19 hours (10 hours awake, 9 hours sleep)
Laboratory diastolic blood pressure (DBP) reactivity
Time Frame: 20 minutes (2 minute intervals) before the exposure video; 10 minutes during the exposure video (2 min intervals); and 20 minutes following the exposure video (2 min. intervals).
Laboratory DBP reactivity was calculated as the change in DBP in millimeters of mercury (mmHg) during the stigma video exposure (STIGMA) and the neutral video exposure (NEUTRAL) and 20-minute post-STIGMA and NEUTRAL minus baseline DBP.
20 minutes (2 minute intervals) before the exposure video; 10 minutes during the exposure video (2 min intervals); and 20 minutes following the exposure video (2 min. intervals).
Laboratory heart rate (HR) reactivity
Time Frame: 20 minutes (2 minute intervals) before the exposure video; 10 minutes during the exposure video (2 min intervals); and 20 minutes following the exposure video (2 min. intervals).
Laboratory HR reactivity was calculated as the change in HR in beats per minute (bpm) during the stigma video exposure (STIGMA) and the neutral video exposure (NEUTRAL) and 20-minute post-STIGMA and NEUTRAL minus baseline BP.
20 minutes (2 minute intervals) before the exposure video; 10 minutes during the exposure video (2 min intervals); and 20 minutes following the exposure video (2 min. intervals).
Ambulatory heart rate (HR) reactivity
Time Frame: 19 hours (10 hours awake, 9 hours sleep)
Ambulatory heart rate (HR) reactivity was calculated as the change in hourly HR values (bpm) over the awake (10 hours), sleep (9 hours), and 19 hours minus average baseline HR following STIGMA and NEUTRAL.
19 hours (10 hours awake, 9 hours sleep)
Ambulatory rate pressure product (RPP) reactivity
Time Frame: 19 hours (10 hours awake, 9 hours sleep)
Ambulatory RPP reactivity in mmHg*bpm was calculated as ambulatory SBP cardiovascular reactivity (mmHg) multiplied by ambulatory HR reactivity (bpm) (i.e., SBP x HR).
19 hours (10 hours awake, 9 hours sleep)
Laboratory rate pressure product (RPP) reactivity
Time Frame: 20 minutes (2 minute intervals) before the exposure video; 10 minutes during the exposure video (2 min intervals); and 20 minutes following the exposure video (2 min. intervals).
Laboratory RPP reactivity in mmHg*bpm was calculated as laboratory SBP cardiovascular reactivity (mmHg) multiplied by laboratory HR reactivity (bpm) (i.e., SBP x HR).
20 minutes (2 minute intervals) before the exposure video; 10 minutes during the exposure video (2 min intervals); and 20 minutes following the exposure video (2 min. intervals).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Connecticut

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hartford Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Linda S Pescatello, PhD, University of Connecticut
  • Principal Investigator: Beth A Taylor, PhD, University of Connecticut
  • Principal Investigator: Rebecca Puhl, PhD, University of Connecticut

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 22, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 11, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 11, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H16-292HHC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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