NCT04161638

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

2.1 years

First QC Date

November 6, 2019

Last Update Submit

May 18, 2022

Conditions

Stigma, SocialObesityCardiovascular Disease Risk FactorBlood Pressure

Outcome Measures

Primary Outcomes (1)

  • Ambulatory systolic BP (SABP) reactivity

    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 Outcomes (7)

  • 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).

  • Ambulatory diastolic BP (DABP) reactivity

    19 hours (10 hours awake, 9 hours sleep)

  • 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).

  • 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).

  • Ambulatory heart rate (HR) reactivity

    19 hours (10 hours awake, 9 hours sleep)

  • +2 more secondary outcomes

Study Arms (2)

High Blood Pressure

EXPERIMENTAL

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 ExposureBehavioral: Neutral video exposure

Normal Blood Pressure

EXPERIMENTAL

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 ExposureBehavioral: Neutral video exposure

Interventions

Stigma Video ExposureBEHAVIORAL

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.

Also known as: STIGMA
High Blood PressureNormal Blood Pressure
Neutral video exposureBEHAVIORAL

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.

Also known as: NEUTRAL
High Blood PressureNormal Blood Pressure

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Panza GA, Puhl RM, Taylor BA, Cilhoroz B, Himmelstein MS, Fernandez AB, Pescatello LS. The effects of an acute weight stigma exposure on cardiovascular reactivity among women with obesity and hypertension: A randomized trial. J Psychosom Res. 2023 Feb;165:111124. doi: 10.1016/j.jpsychores.2022.111124. Epub 2022 Dec 21.

    PMID: 36571973DERIVED

MeSH Terms

Conditions

Social StigmaObesity

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Beth A Taylor, PhD

    University of Connecticut

    PRINCIPAL INVESTIGATOR

  • Linda S Pescatello, PhD

    University of Connecticut

    PRINCIPAL INVESTIGATOR

  • Rebecca Puhl, PhD

    University of Connecticut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Participants were randomized using www.randomization.com to either STIGMA at Visit 2 and NEUTRAL at Visit 3, or NEUTRAL at Visit 2 and STIGMA at Visit 3.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 6, 2019

First Posted

November 13, 2019

Study Start

November 22, 2016

Primary Completion

January 11, 2019

Study Completion

January 11, 2019

Last Updated

May 25, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share