Skip to main content
Clinical Trials/NCT04161638
NCT04161638CompletedNot Applicable

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

University of Connecticut0 sites49 target enrollmentStarted: November 22, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
49
Primary Endpoint
Ambulatory systolic BP (SABP) reactivity

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Single (Participant)

Masking Description

Due to the nature of the experimental manipulation in this study and to maintain validity, mild deception was necessary. Participants were told that the study was examining BP, HR, mood, and behavioral responses to various forms of media and were not informed specifically of the purpose until after they completed the study. In order to verify that the participants were unaware that their cardiovascular reactivity to a weight stigma exposure was being measured, a manipulation check was implemented wherein participants were asked to report what they believed the study purpose to be. No participants reported the true purpose of the study during the manipulation check. At the conclusion of the study, participants were debriefed about the true purpose of the study.

Eligibility Criteria

Ages
20 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Laboratory systolic blood pressure (SBP) reactivity(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 diastolic blood pressure (DBP) reactivity(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 rate pressure product (RPP) reactivity(19 hours (10 hours awake, 9 hours sleep))
  • Laboratory heart rate (HR) reactivity(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 rate pressure product (RPP) reactivity(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(19 hours (10 hours awake, 9 hours sleep))
  • Ambulatory heart rate (HR) reactivity(19 hours (10 hours awake, 9 hours sleep))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Linda Pescatello

Professor

University of Connecticut

Similar Trials