- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04161638
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
Completed
Intervention / Treatment
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
Interventional
Enrollment (Actual)
49
Phase
- 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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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:
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:
|
|
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.
|
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:
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:
|
What is the study measuring?
Primary Outcome Measures
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
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
Collaborators
Investigators
- 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)
November 22, 2016
Primary Completion (Actual)
January 11, 2019
Study Completion (Actual)
January 11, 2019
Study Registration Dates
First Submitted
November 6, 2019
First Submitted That Met QC Criteria
November 12, 2019
First Posted (Actual)
November 13, 2019
Study Record Updates
Last Update Posted (Actual)
May 25, 2022
Last Update Submitted That Met QC Criteria
May 18, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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