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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04161638
Other study ID # H16-292HHC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 22, 2016
Est. completion date January 11, 2019

Study information

Verified date May 2022
Source University of Connecticut
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date January 11, 2019
Est. primary completion date January 11, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 50 Years
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Connecticut Hartford Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Laboratory systolic blood pressure (SBP) reactivity 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).
Secondary Ambulatory diastolic BP (DABP) reactivity 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)
Secondary Laboratory diastolic blood pressure (DBP) reactivity 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).
Secondary Laboratory heart rate (HR) reactivity 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).
Secondary Ambulatory heart rate (HR) reactivity 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)
Secondary Ambulatory rate pressure product (RPP) reactivity 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)
Secondary Laboratory rate pressure product (RPP) reactivity 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).
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