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Appetitive BehaviorNCT03934424

Weight Stigma Effect on Neural Control of Appetite

A study testing Weight stigma and Ethnic stigma in people with Appetitive Behavior, run by University of Missouri-Columbia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The limited data available suggest that exposure to weight-based stigmatization leads to overeating and increased desire for food. In the present study, overweight and obese individuals (BMI from 25-35 kg/m2) who are generally healthy will be randomized to read a weight-stigma article or control article and… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Appetitive Behavior
What is being tested?
Weight stigma and Ethnic stigma
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
10 Apr 2019to 25 Jul 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 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Generally healthy individuals aged from 18 to 55 years
  • BMI 25-35 kg/m2 will be recruited

Who cannot join

  • Being on a weight-loss or special diet
  • Taking any medications or drugs known to affect appetite
  • Have serious claustrophobia.
  • Individuals with mental disorders (self-report) will be excluded.
  • Due to MRI, any individuals with metallic objects in their body, including surgical staples left in the body following surgery, middle ear prosthesis, permanent eye liner, metal foreign objects lodged inside the eye, heart pacemakers, and/or pins inside the knee or other joints or who are pregnant or could be pregnant (assessed through a urine pregnancy test for women) will be excluded from this study because of the risk associated with the MRI scanner.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Missouri-Columbia

    Columbia, Missouri, 65212

Other trials in United States

About this study

Official title: Exposure to Weight Stigmatization Content: Neural Correlations With Appetite Control, Social Support, Mood and Weight Stigma Experiences

The limited data available suggest that exposure to weight-based stigmatization leads to overeating and increased desire for food. In the present study, overweight and obese individuals (BMI from 25-35 kg/m2) who are generally healthy will be randomized to read a weight-stigma article or control article and subsequently scanned to collect fMRI data. These procedures will be employed to accomplish two specific aims.

Specific Aim 1: Determine the neural mechanisms involved in exposure to weight stigma on central control of appetite in overweight and obese individuals. To accomplish this aim we will collect fMRI data in study participants when viewing food and scenery pictures after being exposed to either a weight-stigma or control article. In addition, participants will complete validated questionnaires to measure perceived weight-stigma experiences and social support for eating and physical activity. Hypothesis: After reading an article depicting weight stigmatization, when shown pictures of food in the fMRI scanner, overweight/obese individuals that perceive themselves as having experienced higher levels of weight stigma and lower levels of social support, will have higher activations of brain regions that control appetite and food reward (amygdala, orbitofrontal cortex, striatum, insula) and reduced activations in brain areas that regulate self-control and decision making (prefrontal cortex and cingulate cortex respectively) compared to a control group that reads a non-weight stigma article.

Specific Aim 2: To assess the relationship between activity in appetitive and self-control brain regions and self-reported, eating-related behavior. To accomplish this aim, participants will also complete questionnaires that measure self-reported food intake motivation (dietary restraint, disinhibition and hunger), appetitive responses, and mood. Hypothesis: Higher activations in appetite and reward regions and lower activations in self-control brain regions will be correlated with higher levels of dietary disinhibition, hunger/appetite, and dietary restraint.

Read the detailed description

Introduction Over two-thirds of Americans are either overweight or obese (Fryar et al., 2016) and thus the search for therapeutic strategies for the overweight/obesity epidemic is key. As much as 20% of overweight/obese individuals also report having weight stigma experiences (Levy and Pilfer, 2012) and may experience stigmatization repeatedly over the course of their lifetimes. Weight stigma, as defined by Araiza and Wellman (Araiza and Wellman, 2017), is the social depreciation and condemnation of individuals with higher body weight.

Emerging data from two recent review articles demonstrate that the negative impact of weight stigma experienced by overweight and obese individuals occurs on the physiological, psychological, and behavioral levels (Vartanian and Porter, 2016; Wu and Berry, 2018). Weight stigma could actually lead to overconsumption of food and eating disorders such as binge eating (Wott and Carels, 2010; Almeida et al., 2011) which can further exacerbate the obesity epidemic. For example, the more participants perceived themselves as experiencing weight stigma, the more calories they selected (Araiza and Wellman, 2017) or consumed (Major et al., 2014) and the more poorly they performed on cognitive tests (Araiza and Wellman, 2017) when they read an article depicting discrimination against individuals with higher body weight compared to a control group. In the Major et al. study, women who perceived themselves as being overweight consumed 80 calories more of a high-calorie snack which translated to a magnitude of effect of 47%. Perceived weight stigma has also been shown to be positively correlated with emotional and rigid restrained eating as well as predicting weight gain over a ten-week period (Wellman et al., 2017).

Importantly, individuals with higher body weights are more affected when put in situations that remind them more of weight stigmatization (Major et al., 2014; Hunger et al., 2015), though not everyone may respond in the same manner. While data exist to show the negative impacts of weight stigma of overweight/obese individuals on eating behavior, there is a paucity of data regarding the effect of exposure to weight-stigma content on the neural control of appetite and self-control in overweight/obese individuals. The so-called 'appetitive network' is centered around the following interconnected brain regions: the amygdala and hippocampus, the orbitofrontal cortex (OFC) and adjacent ventromedial prefrontal cortex (VMPFC), the striatum, and the insula. These areas of the brain are normally activated during functional magnetic resonance imaging (fMRI) studies where food cue reactivity is assessed, and the activity is regulated by peripheral signals of energy balance, current hunger, and personality traits (Dagher, 2012). Furthermore, how these neural control measures correlate with self-reports of weight stigma experiences, social support for eating behavior and physical activity, food intake motivation (dietary restraint, disinhibition and hunger), mood and appetite require further investigation.

Study Design This is a cross-sectional study of overweight/obese, generally healthy subjects. After having completed a telephone prescreening test to determine eligibility for the study, subjects will be invited to the Brain Imaging Center (BIC) at the University of Missouri for a one-time research visit lasting approximately three hours. The subject will report to the BIC in the fasted state. The sequence of events during this test visit is outlined in Figure 1 and is described in detail below.

Upon arrival at the BIC, the subject will be screened for eligibility for MRI research following the standard University of Missouri screening protocol. The subject will then be taken through the informed consent process and then testing will begin. Informed consent is performed in a quiet, closed office and the subject will be given ample time to discuss the study and ask questions. Anthropometric measurements (weight and height), as well as a finger prick glucose measurement, is preformed and subsequently, the subject is asked to fill out a series of questionnaires (appetite/ mood, social support, weight stigma experiences, Three-Factor Eating questionnaire). Research staff are present to answer any questions the subject may have about the surveys. Then, the subject will read their assigned weight-stigma or control article (randomization to either the control or weight stigma article condition will be done before data collection commence). One of the questionnaires (appetite/mood) is repeated after reading the article just prior to scanning, and also again after scanning is over. The subject then undergoes fMRI scanning followed by a final repeat of the appetite/mood survey and a finger stick for glucose measurement. Upon completion of all the test procedures, the subject is debriefed as to the purpose of the article and told that the article was fictional.

Being tested
Weight stigma, Ethnic stigma
Keywords
appetite, fMRI, overweight, obese, weight stigma
Medical subject headings
Appetitive Behavior, Overweight, Obesity, Weight Prejudice

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Weight stigmaBehavioural

    Subject will read an article depicting discrimination against individuals with higher body weights for 5-10 minutes on one day

  • Ethnic stigmaBehavioural

    Subject will read a control article for weight stigma depicting discrimination against individuals from a minority ethnic group for 5-10 minutes on one day

Study groups in NCT03934424
Study groupRoleWhat they receive
Weight StigmaExperimentalWeight stigma, read a weight stigma article for 5-10 minutes on one day
Receives: Behavioral: Weight stigma
Ethnic stigmaOtherEthnic stigma, read an ethnic stigma article for 5-10 minutes on one day
Receives: Behavioral: Ethnic stigma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in cerebral blood flow in appetite/reward regions

    BOLD contrast-Measures activity in the brain by detecting changes in cerebral blood flow

    Measured: ~1 hour

  2. Change in cerebral blood flow on self-control regions

    BOLD contrast-Measures activity in the brain by detecting changes in cerebral blood flow

    Measured: ~ 1 hour

  3. Score of perceived appetite

    Scale of 1 to 100 with higher scores indicating greater appetite

    Measured: Time 0, before and after fMRI scanning

Secondary outcomes (7)
  1. Score of Dietary Restraint

    Scale of 0-21, with higher score indicating higher restraint

    Measured: Baseline

  2. Score of Disinhibition

    Scale of 0 to 16, with higher score indicating greater disinhibition

    Measured: Baseline

  3. Score of perceived Hunger

    Scale of 0 to 14, with higher score indication higher hunger level

    Measured: Baseline

  4. Score of Weight stigma experience

    scale of 1 to 7 with higher scores indicating greater stigma experiences

    Measured: Baseline

  5. Score of Social support

    Scale of 1 to 5 for each question

    Measured: Baseline

  6. Glucose

    mg/dL

    Measured: Time 0 and at the end of fMRI scanning

  7. Frequency of weight stigma experience

    scale of 0 to 9 with higher scores indicating greater frequency of stigma experiences

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2019
  2. Study start10 Apr 2019
  3. Primary completion25 Jul 2019
  4. Study completion25 Jul 2019

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized to read a weight stigma article or control article and subsequently scanned for fMRI data
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03934424
Sponsor's protocol ID
2013871
Status last verified
Oct 2020
First submitted
12 Feb 2019
Last updated
27 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Levy BR, Pilver CE. Residual stigma: psychological distress among the formerly overweight. Soc Sci Med. 2012 Jul;75(2):297-9. doi: 10.1016/j.socscimed.2012.03.007. Epub 2012 Apr 3.

    PubMed 22560867
  • Araiza AM, Wellman JD. Weight stigma predicts inhibitory control and food selection in response to the salience of weight discrimination. Appetite. 2017 Jul 1;114:382-390. doi: 10.1016/j.appet.2017.04.009. Epub 2017 Apr 14.

    PubMed 28416329
  • Vartanian LR, Porter AM. Weight stigma and eating behavior: A review of the literature. Appetite. 2016 Jul 1;102:3-14. doi: 10.1016/j.appet.2016.01.034. Epub 2016 Jan 29.

    PubMed 26829371
  • Wu YK, Berry DC. Impact of weight stigma on physiological and psychological health outcomes for overweight and obese adults: A systematic review. J Adv Nurs. 2018 May;74(5):1030-1042. doi: 10.1111/jan.13511. Epub 2017 Dec 8.

    PubMed 29171076
  • Wott CB, Carels RA. Overt weight stigma, psychological distress and weight loss treatment outcomes. J Health Psychol. 2010 May;15(4):608-14. doi: 10.1177/1359105309355339.

    PubMed 20460417
  • Almeida L, Savoy S, Boxer P. The role of weight stigmatization in cumulative risk for binge eating. J Clin Psychol. 2011 Mar;67(3):278-92. doi: 10.1002/jclp.20749. Epub 2010 Dec 3.

    PubMed 21254056
  • Blodorn A, Major B, Hunger J, Miller C. Unpacking the psychological weight of weight stigma: A rejection-expectation pathway. J Exp Soc Psychol. 2016 Mar 1;63:69-76. doi: 10.1016/j.jesp.2015.12.003.

    PubMed 26752792
  • Wellman JD, Araiza AM, Newell EE, McCoy SK. Weight stigma facilitates unhealthy eating and weight gain via fear of fat. Stigma Health. 2018 Aug;3(3):186-194. doi: 10.1037/sah0000088. Epub 2017 Feb 9.

    PubMed 30221195
  • Hunger JM, Major B, Blodorn A, Miller CT. Weighed down by stigma: How weight-based social identity threat contributes to weight gain and poor health. Soc Personal Psychol Compass. 2015 Jun;9(6):255-268. doi: 10.1111/spc3.12172. Epub 2015 Jun 4.

    PubMed 29225670
  • Dagher A. Functional brain imaging of appetite. Trends Endocrinol Metab. 2012 May;23(5):250-60. doi: 10.1016/j.tem.2012.02.009. Epub 2012 Apr 5.

    PubMed 22483361

Questions about this trial

What is this clinical trial studying?

A study testing Weight stigma and Ethnic stigma in people with Appetitive Behavior, run by University of Missouri-Columbia at 1 site in United States.

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 2 inclusion and 5 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 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Change in cerebral blood flow in appetite/reward regions (time frame: ~1 hour). The study lists 3 primary outcomes in all. 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 NCT03934424, which also lists 10 linked publications.

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 27 Oct 2020.

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