Stigma, SocialNCT04161638
Weight Stigma in Women Who Are Obese: Assessing How an Acute Exposure to Stigma Negatively Impacts Cardiovascular Health
A study testing Stigma Video Exposure and Neutral video exposure in people with Stigma, Social and Obesity, run by University of Connecticut.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stigma, Social, Obesity, Cardiovascular Disease Risk Factor
- What is being tested?
- Stigma Video Exposure and Neutral video exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- 22 Nov 2016to 11 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Premenopausal
- BMI > 30 kg/m2
- No other known chronic cardiovascular or metabolic diseases besides hypertension
Who cannot join
- 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
About this study
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.
Read the 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.
- Being tested
- Stigma Video Exposure, Neutral video exposure
- Medical subject headings
- Social Stigma, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stigma Video ExposureBehavioural
Also called STIGMA
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 exposureBehavioural
Also called NEUTRAL
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Stigma Video Exposure; Behavioral: 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. Receives: Behavioral: Stigma Video Exposure; Behavioral: Neutral video exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 19 hours (10 hours awake, 9 hours sleep)
Secondary outcomes (7)
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.
Measured: 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
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.
Measured: 19 hours (10 hours awake, 9 hours sleep)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 19 hours (10 hours awake, 9 hours sleep)
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).
Measured: 19 hours (10 hours awake, 9 hours sleep)
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).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start22 Nov 2016
- Primary completion11 Jan 2019
- Study completion11 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stigma, SocialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- Hartford Hospital
- Responsible party
- Principal investigator, Linda Pescatello, University of Connecticut
- Investigators
- Beth A Taylor, PhD, Principal investigator, University of ConnecticutLinda S Pescatello, PhD, Principal investigator, University of ConnecticutRebecca Puhl, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161638
- Sponsor's protocol ID
- H16-292HHC
- Status last verified
- May 2022
- First submitted
- 6 Nov 2019
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36571973
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Stigma in Women Who Are Obese: Assessing How an Acute Exposure to Stigma Negatively Impacts Cardiovascular Health
- ClinicalTrials.gov ID
- NCT04161638
- Acronym / sponsor ID
- H16-292HHC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- Hartford Hospital
- Study start
- 22 Nov 2016 (actual)
- Primary completion
- 11 Jan 2019 (actual)
- Study completion
- 11 Jan 2019 (actual)
- First posted
- 13 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| High Blood Pressure | Experimental | Behavioral: Stigma Video Exposure, Behavioral: Neutral video exposureAmbulatory 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. |
| Normal Blood Pressure | Experimental | Behavioral: Stigma Video Exposure, Behavioral: Neutral video exposureParticipants 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Premenopausal
- BMI > 30 kg/m2
- No other known chronic cardiovascular or metabolic diseases besides hypertension
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stigma Video ExposureAlso: STIGMAThe 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. | Behavioural | High Blood Pressure, Normal Blood Pressure |
| Neutral video exposureAlso: NEUTRALThe 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. | Behavioural | High Blood Pressure, Normal Blood Pressure |
Primary outcome
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.
7 secondary outcomes
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).
Ambulatory diastolic BP (DABP) reactivity
Time frame: 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 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).
Ambulatory heart rate (HR) reactivity
Time frame: 19 hours (10 hours awake, 9 hours sleep)
Ambulatory rate pressure product (RPP) reactivity
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Derived from this study: PubMed 36571973Panza 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth A Taylor, PhD principal investigator
University of Connecticut
Linda S Pescatello, PhD principal investigator
University of Connecticut
Rebecca Puhl, PhD principal investigator
University of Connecticut
Questions about this trial
What is this clinical trial studying?
A study testing Stigma Video Exposure and Neutral video exposure in people with Stigma, Social and Obesity, run by University of Connecticut.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ambulatory systolic BP (SABP) reactivity (time frame: 19 hours (10 hours awake, 9 hours sleep)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04161638, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.