Clinical trial NCT04161638: Weight Stigma in Women Who Are Obese: Assessing How an Acute Exposure to Stigma Negatively Impacts Cardiovascular Health
Official title: Weight Stigma in Women Who Are Obese: Assessing How an Acute Exposure to Stigma Negatively Impacts Cardiovascular Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stigma, Social
Obesity
Cardiovascular Disease Risk Factor
Blood Pressure
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: Hartford Hospital
First posted: 2019-11-13
Enrollment: 49
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ambulatory systolic BP (SABP) reactivity
timeFrame: 19 hours (10 hours awake, 9 hours sleep)
Secondary outcomes:
measure: Laboratory systolic blood pressure (SBP) reactivity
timeFrame: 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).
measure: Ambulatory diastolic BP (DABP) reactivity
timeFrame: 19 hours (10 hours awake, 9 hours sleep)
measure: Laboratory diastolic blood pressure (DBP) reactivity
timeFrame: 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).
measure: Laboratory heart rate (HR) reactivity
timeFrame: 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).
measure: Ambulatory heart rate (HR) reactivity
timeFrame: 19 hours (10 hours awake, 9 hours sleep)
measure: Ambulatory rate pressure product (RPP) reactivity
timeFrame: 19 hours (10 hours awake, 9 hours sleep)
measure: Laboratory rate pressure product (RPP) reactivity
timeFrame: 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).
Other outcomes:
Locations:
Study officials:
affiliation: University of Connecticut
name: Beth A Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Connecticut
name: Linda S Pescatello, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Connecticut
name: Rebecca Puhl, PhD
role: PRINCIPAL_INVESTIGATOR
References: