Clinical trial NCT04573426: Pain and Acetaminophen in Women Study
Official title: Effects of Acetaminophen on Pain Response Among Overweight or Obese Women Exposed to Weight Stigmatization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight
Obesity
Healthy Adults
Keywords: Weight stigma
Stigma
Overweight
Obesity
Acetaminophen
Inflammation
Analgesics
Anti-inflammatory
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 160 women with overweight or obesity from the Columbus, Ohio and surrounding areas who also meet other study criteria will be recruited for the study. A smaller cohort of 40 women with normal weight who meet the same study criteria, and deny a history of overweight or obesity, will also be recruited. All participants will be 18 years of age or older

Brief summary: The purpose of this study is to evaluate the influence of acetaminophen on pain response and inflammation.

Detailed description: The purpose of this study is to evaluate the influence of weight stigma on emotional functioning and biomarkers of inflammation among overweight and obese women; and to determine the degree to which acetaminophen moderates the stigma-related effects. Participants will provide blood spot and saliva samples upon arrival, and then be randomly assigned to consume either 1,000mg of acetaminophen in liquid form, or a placebo solution. Participants then will complete a series of questionnaires assessing a variety of relevant psychological and behavioral constructs. After this participants will be randomly assigned to read one of two shorts stories and answer a series of questions about their reaction to the story. Finally, participants will answer another series of questionnaires and provide a second saliva sample. Participants will first be adult women in the Columbus, Ohio and surrounding areas with body mass indices considered overweight or obese. A smaller cohort of women with normal weight will be recruited at a later time for purposes of comparison.

Eligibility criteria: Inclusion Criteria:

* At least 18 years old and biologically female

Exclusion Criteria:

* Due to the use of acetaminophen in this study, women who report current pregnancy will be excluded from the study due to potential negative effects on pregnancy.

The following are additional exclusion criteria:

1. Visual impairment that would impair one's ability to read to the extent that they could not read items on paper or a computer screen.
2. Stopping schooling prior to completing ninth grade.
3. A history of liver disorder and/or alcohol abuse.
4. A current prescription of a drug that contains acetaminophen.
5. Allergy to acetaminophen
6. A score on the Patient Health Questionnaire - 9 depressive symptom scale of 15 or greater.
7. For normal weight participants, a history of overweight or obesity.

Primary outcomes:
measure: Baseline Prostaglandin level
timeFrame: Within the first 10 minutes of the two-hour session
measure: Change in Prostaglandin level
timeFrame: Within the first 10 minutes of the two-hour session and approximately ten minutes prior to the end of the two-hour session.
measure: Baseline C-Reactive Protein
timeFrame: Within the first 10 minutes of the two-hour session.
measure: McGill Pain Questionnaire (baseline)
timeFrame: In the first hour of the two-hour session.
measure: McGill Pain Questionnaire (change)
timeFrame: Within the first hour and again within the final 30 minutes of the two-hour session.
measure: Visual Analog Scale for Pain (baseline)
timeFrame: In the first hour of the two-hour session.
measure: Visual Analog Scale for Pain (change)
timeFrame: Within the first hour and again within the final 30 minutes of the two-hour session.
measure: Stigma Situations Inventory
timeFrame: In the first hour of the two-hour session.
measure: Weight Bias Internalization Scale
timeFrame: In the first hour of the two-hour session.
measure: Stigma Impact Scale
timeFrame: In the first hour of the two-hour session.
measure: Impact of Weight on Quality of Life
timeFrame: In the first hour of the two-hour session.
measure: Medical Outcomes Survey, Short-Form-36
timeFrame: In the first hour of the two-hour session
measure: Positive and Negative Affect Schedule (baseline)
timeFrame: In the first hour of the two-hour session
measure: Positive and Negative Affect Schedule (change)
timeFrame: Within the first hour and again within the final 30 minutes of the two-hour session.
measure: Visual Analog Scale for Distress (baseline)
timeFrame: In the first hour of the two-hour session
measure: Visual Analog Scale for Distress (change)
timeFrame: Within the first hour and again within the final 30 minutes of the two-hour session.
Secondary outcomes:
measure: International Physical Activity Questionnaire - Short Form
timeFrame: In the first hour of the two-hour session
measure: Pittsburgh Sleep Quality Index
timeFrame: In the first hour of the two-hour session
measure: Rosenberg Self-Esteem Scale
timeFrame: In the first hour of the two-hour session
measure: Need Threat Scale
timeFrame: In the first hour of the two-hour session
measure: Hospital Anxiety and Depression Scale
timeFrame: In the first hour of the two-hour session
measure: Buckley Scale (baseline)
timeFrame: In the first hour of the two-hour session
measure: Buckley Scale (change)
timeFrame: Within the first hour and again within the final 30 minutes of the two-hour session.
measure: Binge Eating Scale
timeFrame: In the first hour of the two-hour session
measure: Vividness of Recall
timeFrame: Immediately following weight stigma vignette in the final 30 minutes of the two-hour session.
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Professor and Psychology Department Chair
name: Charles F Emery, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: