OverweightPAWSNCT04573426
Pain and Acetaminophen in Women Study
An observational study of Overweight and Obesity, run by Ohio State University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the influence of acetaminophen on pain response and inflammation. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity, Healthy Adults
- What is being tested?
- Acetaminophen and Weight stigma vignette
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2019to 2 May 2021
- Phase
- Observational
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- At least 18 years old and biologically female
Who cannot join
- 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:
- 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.
- Stopping schooling prior to completing ninth grade.
- A history of liver disorder and/or alcohol abuse.
- A current prescription of a drug that contains acetaminophen.
Show all 9Show fewer
- Allergy to acetaminophen
- A score on the Patient Health Questionnaire - 9 depressive symptom scale of 15 or greater.
- For normal weight participants, a history of overweight or obesity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Acetaminophen on Pain Response Among Overweight or Obese Women Exposed to Weight Stigmatization
The purpose of this study is to evaluate the influence of acetaminophen on pain response and inflammation.
Read the 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.
- Conditions
- Overweight, Obesity, Healthy Adults
- Being tested
- Acetaminophen, Placebo, Weight stigma vignette, Control vignette
- Keywords
- Weight stigma, Stigma, Overweight, Obesity, Acetaminophen, Inflammation, Analgesics, Anti-inflammatory
- Medical subject headings
- Overweight, Obesity, Weight Prejudice, Social Stigma, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
1,000mg liquid acetaminophen
PlaceboDrug
Liquid placebo solution
Weight stigma vignetteBehavioural
Short vignette meant to induce weight stigma by describing one's rejection for a promotion due to their weight
Control vignetteBehavioural
Short vignette meant to have no effect on emotion describing a generic promotion process
| Study group | Role | What they receive |
|---|---|---|
| Overweight/Obese+Drug+Stigma | 40 participants with overweight or obesity will consume 1,000mg of acetaminophen in a liquid vehicle briefly following the start of the appointment. After one hour, they will read a short vignette meant to induce weight stigma. Receives: Drug: Acetaminophen; Behavioral: Weight stigma vignette | |
| Overweight/Obese+Drug+Control | 40 participants with overweight or obesity will consume 1,000mg of acetaminophen in a liquid vehicle briefly following the start of the appointment. After one hour, they will read a short control vignette meant to have no impact on their emotional state. Receives: Drug: Acetaminophen; Behavioral: Control vignette | |
| Overweight/Obese+Placebo+Stigma | 40 participants with overweight or obesity will consume a placebo solution briefly following the start of the appointment. After one hour, they will read a short vignette meant to induce weight stigma. Receives: Drug: Placebo; Behavioral: Weight stigma vignette | |
| Overweight/Obese+Placebo+Control | 40 participants with overweight or obesity will consume a placebo solution briefly following the start of the appointment. After one hour, they will read a short control vignette meant to have no impact on their emotional state. Receives: Drug: Placebo; Behavioral: Control vignette | |
| Normal Weight+Placebo+Stigma | 40 participants with normal weight will consume a placebo solution briefly following the start of the appointment. After one hour, they will read a short vignette meant to induce weight stigma. Receives: Drug: Placebo; Behavioral: Weight stigma vignette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Prostaglandin level
Prostaglandin level (measured via PGE2) will be assessed via saliva and will be utilized as an objective marker of baseline inflammation Baseline prostaglandin level will be determined by analyzing saliva collected within the first ten minutes of the single, two-hour session.
Measured: Within the first 10 minutes of the two-hour session
Change in Prostaglandin level
Change in prostaglandin level (measured via PGE2) will be assessed via difference in two saliva samples and will be utilized as an objective marker of change in inflammation over the course of the two-hour session. Change in prostaglandin level will be determined by calculating the difference between PGE2 level within the first 10 minutes of the two-hour session, and level of prostaglandins via saliva collection approximately ten minutes prior to ending the two-hour session.
Measured: Within the first 10 minutes of the two-hour session and approximately ten minutes prior to the end of the two-hour session.
Baseline C-Reactive Protein
C-Reactive Protein (CRP) will be determined via dried blood spot analysis. The dried blood spots are collected within the first 10 minutes of the single, two-hour session. This CRP will be used an as objective measure of baseline inflammation.
Measured: Within the first 10 minutes of the two-hour session.
McGill Pain Questionnaire (baseline)
The McGill Pain Questionnaire (MPQ) will be used to assess baseline pain severity across sensory, affective, evaluative, and miscellaneous qualities of pain. Pain severity scores may range from 0-78 with high scores reflecting greater pain severity. The MPQ also consists of an overall pain intensity scale ranging from 0-5, with higher scores reflecting greater present pain intensity. Baseline pain will be measured via an MPQ administered with a set of questionnaires in the first hour of the two-hour session.
Measured: In the first hour of the two-hour session.
McGill Pain Questionnaire (change)
The McGill Pain Questionnaire (MPQ) will also be used to assess change in pain severity across sensory, affective, evaluative, and miscellaneous qualities of pain. Pain severity scores may range from 0-78 with high scores reflecting greater pain severity. The MPQ also consists of an overall pain intensity scale ranging from 0-5, with higher scores reflecting greater present pain intensity. Change in pain will be measured by calculating the difference in MPQ score at baseline and the score from the second MPQ administration, which is administered within the final 30 minutes of the two-hour session.
Measured: Within the first hour and again within the final 30 minutes of the two-hour session.
Visual Analog Scale for Pain (baseline)
The Visual Analog Scale for Pain (VAS-Pain) will also be used to measure pain. This is a unidimensional measure of physical pain intensity consisting of a line measuring 100 millimeters anchored by two descriptors representing the extremes of pain: "no pain" versus "my pain is as bad as it could possibly be." Participants mark on the line to indicate their current level of pain. Scores range from 0-100 with higher scores, or greater pain intensity, represented by mark's made farther from the "no pain" anchor. Baseline pain will be measured via a VAS-Pain administered with a set of questionnaires in the first hour of the two-hour session.
Measured: In the first hour of the two-hour session.
Visual Analog Scale for Pain (change)
The Visual Analog Scale for Pain (VAS-Pain) will also be used to measure pain. This is a unidimensional measure of physical pain intensity consisting of a line measuring 100 millimeters anchored by two descriptors representing the extremes of pain: "no pain" versus "my pain is as bad as it could possibly be." Participants mark on the line to indicate their current level of pain. Scores range from 0-100 with higher scores, or greater pain intensity, represented by mark's made farther from the "no pain" anchor. Change in pain will be measured by calculating the difference in VAS-Pain score at baseline and the score from the second VAS-Pain administration, which is administered within the final 30 minutes of the two-hour session.
Measured: Within the first hour and again within the final 30 minutes of the two-hour session.
Stigma Situations Inventory
The Stigma Situations Inventory (SSI) is a 50-item questionnaire of lifetime frequency of obesity-related experiences rated on a 0 (never) to 9 (daily) scale. A higher mean score across all items suggesting greater experience of weight stigma. SSI is administered with a series of questionnaires in the first hour of the two-hour session and will provide a baseline measure of weight stigma experience.
Measured: In the first hour of the two-hour session.
Weight Bias Internalization Scale
The Weight Bias Internalization Scale (WBIS) is an 11-item scale measuring individuals' belief that anti-fat attitudes are relevant to the self. Items are answered on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree), with total scores ranging from 11 to 77. WBIS is administered with a series of questionnaires in the first hour of the two-hour session and will provide a baseline measure of belief that anti-fat attitudes are relevant to the self.
Measured: In the first hour of the two-hour session.
Stigma Impact Scale
The Stigma Impact Scale (SIS) is a 24-item measure used to evaluate the impact of perceived stigma among those with chronic illnesses. The term 'illness' has been changed to 'condition' to enhance applicability to participants in this study. Each item is rated on a 5-point Likert scale ranging from 0 (not applicable) to 4 (strongly agree). Total scores range from 0-96, with higher scores reflecting greater perceived impact of stigma. SIS is administered with a series of questionnaires in the first hour of the two-hour session and will provide a baseline measure of perceived impact of condition, in this case obesity, on the respondent.
Measured: In the first hour of the two-hour session.
Impact of Weight on Quality of Life
The Impact of Weight on Quality of Life-Lite (IWQOL-Lite) is a 31-item measure of obesity-related quality of life. Each item is rated on a 5-point Likert scale. Total scores range from 31 to 155 with higher scores reflecting greater impact of weight on quality of life. IWQOL-Lite is administered with a series of questionnaires in the first hour of the two-hour session and will provide a baseline measure of impact of weight on quality of life.
Measured: In the first hour of the two-hour session.
Medical Outcomes Survey, Short-Form-36
The Medical Outcomes Survey, Short Form-36 (SF-36) is a 36-item measure of health-related quality of life. Mental and physical quality of life scores are calculated into a 0-100 scale, with higher scores reflecting better health-related quality of life. SF-36 is administered with a series of questionnaires in the first hour of the two-hour session and will provide a baseline measure of health-related quality of life.
Measured: In the first hour of the two-hour session
Positive and Negative Affect Schedule (baseline)
The Positive and Negative Affect Schedule (PANAS) is a 20-item measure of positive and negative affect. A 5-point Likert scale is used to indicate the degree to which one is experiencing an emotion during the present moment. Total scores for the negative and positive affect subscales range from 10-50. PANAS is administered with a series of questionnaires in the first hour of the two-hour session and will provide a baseline measure of present moment emotional experience.
Measured: In the first hour of the two-hour session
Positive and Negative Affect Schedule (change)
The Positive and Negative Affect Schedule (PANAS) is a 20-item measure of positive and negative affect. A 5-point Likert scale is used to indicate the degree to which one is experiencing an emotion during the present moment. Total scores for the negative and positive affect subscales range from 10-50. Change in PANAS will be calculated and represent a change in present moment emotional experience during the course of the session. This will be calculated by determining the difference between PANAS scores at baseline and the second PANAS administration, which is administered within the final 30 minutes of the two-hour session.
Measured: Within the first hour and again within the final 30 minutes of the two-hour session.
Visual Analog Scale for Distress (baseline)
The Visual Analog Scale for Distress (VAS-Distress) is a unidimensional measure of distress intensity consisting of a line measuring 100 millimeters anchored by two descriptors representing the extremes of distress: "no distress" versus "as distressed as I could possibly be." Participants mark on the line to indicate their current level of distress. Scores range from 0-100 with higher scores, or greater distress intensity, represented by mark's made farther from the "no distress" anchor. Baseline distress will be measured via a VAS-Distress administered with a set of questionnaires in the first hour of the two-hour session.
Measured: In the first hour of the two-hour session
Visual Analog Scale for Distress (change)
The Visual Analog Scale for Distress (VAS-Distress) is a unidimensional measure of distress intensity consisting of a line measuring 100 millimeters anchored by two descriptors representing the extremes of distress: "no distress" versus "as distressed as I could possibly be." Participants mark on the line to indicate their current level of distress. Scores range from 0-100 with higher scores, or greater distress intensity, represented by mark's made farther from the "no distress" anchor. Change in distress will be measured by calculating the difference in VAS-Distress score at baseline and the score from the second VAS-Distress administration, which is administered within the final 30 minutes of the two-hour session.
Measured: Within the first hour and again within the final 30 minutes of the two-hour session.
Secondary outcomes (9)
International Physical Activity Questionnaire - Short Form
The International Physical Activity Questionnaire - Short Form (IPAQ-SF) measures physical activity and inactivity performed during the previous seven days. Respondents report the number of days, hours per day, and minutes per day in the last seven days they engaged in vigorous exercise, moderate exercise, walking, and sitting. The IPAQ-SF will be administered with a set of questionnaires in the first hour of the two-hour session.
Measured: In the first hour of the two-hour session
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is used to assess sleep behavioral (quality and disturbances) over a one-month interval. The PSQI yields a total score (ranging 0-21) as well as the following seven subscales (ranging 0-3): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction. Higher scores reflect worse sleep quality. The PSQI will be administered with a set of questionnaires in the first hour of the two-hour session.
Measured: In the first hour of the two-hour session
Rosenberg Self-Esteem Scale
The Rosenberg Self-Esteem Scale (RSES) is a 10-item measure used to assess overall self-esteem. Both positive and negative feelings about the self are measured. Items are answered on a Likert scale ranging from 0 (strongly agree) to 3 (strongly disagree), with higher scores indicating higher self-esteem. The RSES will be administered with a set of questionnaires in the first hour of the two-hour session.
Measured: In the first hour of the two-hour session
Need Threat Scale
The Need Threat Scale is a 12-item measure designed to assess one's need for belonging, self-esteem, control, and meaningful existence, each of which represent a subscale of the measure. Respondents indicate how they are feeling right now using a five-point Likert scale ranging from "not at all" to "very much so." In addition to four subscale scores, a composite score is calculated by averaging responses across the 12 items, with lower scores reflecting less needs satisfaction (i.e., more need threat). The Need Threat Scale will be administered with a set of questionnaires in the first hour of the two-hour session.
Measured: In the first hour of the two-hour session
Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (HADS) is a 14-item measure developed to assess depression and anxiety among non-psychiatric medical patients. Respondents are asked to rate each item on a scale ranging from 0 (not at all) to 3 (most of the time). The HADS consists of a total distress score ranging from 0-42, and two subscales consisting of seven items each: anxiety (range 0-21) and depression (range 0-21). Higher scores reflect greater distress. The HADS will be administered with a set of questionnaires in the first hour of the two-hour session.
Measured: In the first hour of the two-hour session
Buckley Scale (baseline)
The Buckley Scale is a 12-item measure designed to assess feelings of happiness, anxiety, anger, sadness, and hurt feelings in the present moment. The scale is composed of five subscales for these five domains of emotion. Respondents indicate the degree to which they endorse a particular feeling using a seven-point Likert scale ranging from "not at all" to "extremely," with higher scores reflecting more intensity of each of the aforementioned emotions. The Buckley Scale will be administered with a set of questionnaires in the first hour of the two-hour session.
Measured: In the first hour of the two-hour session
Buckley Scale (change)
The Buckley Scale is a 12-item measure designed to assess feelings of happiness, anxiety, anger, sadness, and hurt feelings in the present moment. The scale is composed of five subscales for these five domains of emotion. Respondents indicate the degree to which they endorse a particular feeling using a seven-point Likert scale ranging from "not at all" to "extremely," with higher scores reflecting more intensity of each of the aforementioned emotions. Change in Buckley Scale will be calculated by determining the difference between Buckley Scale score at baseline and score from when it is administered again within the final 30 minutes of the two-hour session.
Measured: Within the first hour and again within the final 30 minutes of the two-hour session.
Binge Eating Scale
The Binge Eating Scale (BES) is a 16-item questionnaire designed to assess the behavioral (e.g., large amount of food consumed), as well as the cognitive and emotional (e.g., feeling out of control while eating), features of binge eating. Respondents select one of three or four response options coded 0 to 2 or 3, respectively. Scores are summed and range from 0 to 46, with higher scores reflecting more severe binge eating problems. The BES will be administered with a set of questionnaires in the first hour of the two-hour session.
Measured: In the first hour of the two-hour session
Vividness of Recall
A single-item measure will be administered to assess vividness of participants' recall of the instance when they themselves experienced weight stigmatization that they write about in the weight stigma induction.
Measured: Immediately following weight stigma vignette in the final 30 minutes of the two-hour session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start15 Nov 2019
- Primary completion2 May 2021
- Study completion2 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Emery PhD, Ohio State University
- Investigators
- Charles F Emery, Ph.D., Principal investigator, Professor and Psychology Department Chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573426
- Sponsor's protocol ID
- 2019H0381
- Acronym
- PAWS
- Status last verified
- Sep 2021
- First submitted
- 14 Sep 2020
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acetaminophen on Pain Response Among Overweight or Obese Women Exposed to Weight Stigmatization
- ClinicalTrials.gov ID
- NCT04573426
- Acronym / sponsor ID
- PAWS / 2019H0381
- Conditions
- Overweight, Obesity, Healthy Adults
- Keywords
- Weight stigma, Stigma, Overweight, Obesity, Acetaminophen, Inflammation, Analgesics, Anti-inflammatory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 2 May 2021 (actual)
- Study completion
- 2 May 2021 (actual)
- First posted
- 5 Oct 2020 (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 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Overweight/Obese+Drug+Stigma | – | Drug: Acetaminophen, Behavioral: Weight stigma vignette40 participants with overweight or obesity will consume 1,000mg of acetaminophen in a liquid vehicle briefly following the start of the appointment. After one hour, they will read a short vignette meant to induce weight stigma. |
| Overweight/Obese+Drug+Control | – | Drug: Acetaminophen, Behavioral: Control vignette40 participants with overweight or obesity will consume 1,000mg of acetaminophen in a liquid vehicle briefly following the start of the appointment. After one hour, they will read a short control vignette meant to have no impact on their emotional state. |
| Overweight/Obese+Placebo+Stigma | – | Drug: Placebo, Behavioral: Weight stigma vignette40 participants with overweight or obesity will consume a placebo solution briefly following the start of the appointment. After one hour, they will read a short vignette meant to induce weight stigma. |
| Overweight/Obese+Placebo+Control | – | Drug: Placebo, Behavioral: Control vignette40 participants with overweight or obesity will consume a placebo solution briefly following the start of the appointment. After one hour, they will read a short control vignette meant to have no impact on their emotional state. |
| Normal Weight+Placebo+Stigma | – | Drug: Placebo, Behavioral: Weight stigma vignette40 participants with normal weight will consume a placebo solution briefly following the start of the appointment. After one hour, they will read a short vignette meant to induce weight stigma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- At least 18 years old and biologically female
Key exclusion criteria (9 listed)
- 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.
- 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.
- Stopping schooling prior to completing ninth grade.
- A history of liver disorder and/or alcohol abuse.
- A current prescription of a drug that contains acetaminophen.
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 |
|---|---|---|
| Acetaminophen1,000mg liquid acetaminophen | Drug | Overweight/Obese+Drug+Control, Overweight/Obese+Drug+Stigma |
| PlaceboLiquid placebo solution | Drug | Normal Weight+Placebo+Stigma, Overweight/Obese+Placebo+Control, Overweight/Obese+Placebo+Stigma |
| Weight stigma vignetteShort vignette meant to induce weight stigma by describing one's rejection for a promotion due to their weight | Behavioural | Normal Weight+Placebo+Stigma, Overweight/Obese+Drug+Stigma, Overweight/Obese+Placebo+Stigma |
| Control vignetteShort vignette meant to have no effect on emotion describing a generic promotion process | Behavioural | Overweight/Obese+Drug+Control, Overweight/Obese+Placebo+Control |
Primary outcome
Baseline Prostaglandin level
Time frame: Within the first 10 minutes of the two-hour session
Prostaglandin level (measured via PGE2) will be assessed via saliva and will be utilized as an objective marker of baseline inflammation Baseline prostaglandin level will be determined by analyzing saliva collected within the first ten minutes of the single, two-hour session.
Change in Prostaglandin level
Time frame: Within the first 10 minutes of the two-hour session and approximately ten minutes prior to the end of the two-hour session.
Change in prostaglandin level (measured via PGE2) will be assessed via difference in two saliva samples and will be utilized as an objective marker of change in inflammation over the course of the two-hour session. Change in prostaglandin level will be determined by calculating the difference between PGE2 level within the first 10 minutes of the two-hour session, and level of prostaglandins via saliva collection approximately ten minutes prior to ending the two-hour session.
Baseline C-Reactive Protein
Time frame: Within the first 10 minutes of the two-hour session.
C-Reactive Protein (CRP) will be determined via dried blood spot analysis. The dried blood spots are collected within the first 10 minutes of the single, two-hour session. This CRP will be used an as objective measure of baseline inflammation.
McGill Pain Questionnaire (baseline)
Time frame: In the first hour of the two-hour session.
The McGill Pain Questionnaire (MPQ) will be used to assess baseline pain severity across sensory, affective, evaluative, and miscellaneous qualities of pain. Pain severity scores may range from 0-78 with high scores reflecting greater pain severity. The MPQ also consists of an overall pain intensity scale ranging from 0-5, with higher scores reflecting greater present pain intensity. Baseline pain will be measured via an MPQ administered with a set of questionnaires in the first hour of the two-hour session.
McGill Pain Questionnaire (change)
Time frame: Within the first hour and again within the final 30 minutes of the two-hour session.
The McGill Pain Questionnaire (MPQ) will also be used to assess change in pain severity across sensory, affective, evaluative, and miscellaneous qualities of pain. Pain severity scores may range from 0-78 with high scores reflecting greater pain severity. The MPQ also consists of an overall pain intensity scale ranging from 0-5, with higher scores reflecting greater present pain intensity. Change in pain will be measured by calculating the difference in MPQ score at baseline and the score from the second MPQ administration, which is administered within the final 30 minutes of the two-hour session.
Visual Analog Scale for Pain (baseline)
Time frame: In the first hour of the two-hour session.
The Visual Analog Scale for Pain (VAS-Pain) will also be used to measure pain. This is a unidimensional measure of physical pain intensity consisting of a line measuring 100 millimeters anchored by two descriptors representing the extremes of pain: "no pain" versus "my pain is as bad as it could possibly be." Participants mark on the line to indicate their current level of pain. Scores range from 0-100 with higher scores, or greater pain intensity, represented by mark's made farther from the "no pain" anchor. Baseline pain will be measured via a VAS-Pain administered with a set of questionnaires in the first hour of the two-hour session.
Visual Analog Scale for Pain (change)
Time frame: Within the first hour and again within the final 30 minutes of the two-hour session.
The Visual Analog Scale for Pain (VAS-Pain) will also be used to measure pain. This is a unidimensional measure of physical pain intensity consisting of a line measuring 100 millimeters anchored by two descriptors representing the extremes of pain: "no pain" versus "my pain is as bad as it could possibly be." Participants mark on the line to indicate their current level of pain. Scores range from 0-100 with higher scores, or greater pain intensity, represented by mark's made farther from the "no pain" anchor. Change in pain will be measured by calculating the difference in VAS-Pain score at baseline and the score from the second VAS-Pain administration, which is administered within the final 30 minutes of the two-hour session.
Stigma Situations Inventory
Time frame: In the first hour of the two-hour session.
The Stigma Situations Inventory (SSI) is a 50-item questionnaire of lifetime frequency of obesity-related experiences rated on a 0 (never) to 9 (daily) scale. A higher mean score across all items suggesting greater experience of weight stigma. SSI is administered with a series of questionnaires in the first hour of the two-hour session and will provide a baseline measure of weight stigma experience.
Weight Bias Internalization Scale
Time frame: In the first hour of the two-hour session.
The Weight Bias Internalization Scale (WBIS) is an 11-item scale measuring individuals' belief that anti-fat attitudes are relevant to the self. Items are answered on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree), with total scores ranging from 11 to 77. WBIS is administered with a series of questionnaires in the first hour of the two-hour session and will provide a baseline measure of belief that anti-fat attitudes are relevant to the self.
Stigma Impact Scale
Time frame: In the first hour of the two-hour session.
The Stigma Impact Scale (SIS) is a 24-item measure used to evaluate the impact of perceived stigma among those with chronic illnesses. The term 'illness' has been changed to 'condition' to enhance applicability to participants in this study. Each item is rated on a 5-point Likert scale ranging from 0 (not applicable) to 4 (strongly agree). Total scores range from 0-96, with higher scores reflecting greater perceived impact of stigma. SIS is administered with a series of questionnaires in the first hour of the two-hour session and will provide a baseline measure of perceived impact of condition, in this case obesity, on the respondent.
Impact of Weight on Quality of Life
Time frame: In the first hour of the two-hour session.
The Impact of Weight on Quality of Life-Lite (IWQOL-Lite) is a 31-item measure of obesity-related quality of life. Each item is rated on a 5-point Likert scale. Total scores range from 31 to 155 with higher scores reflecting greater impact of weight on quality of life. IWQOL-Lite is administered with a series of questionnaires in the first hour of the two-hour session and will provide a baseline measure of impact of weight on quality of life.
Medical Outcomes Survey, Short-Form-36
Time frame: In the first hour of the two-hour session
The Medical Outcomes Survey, Short Form-36 (SF-36) is a 36-item measure of health-related quality of life. Mental and physical quality of life scores are calculated into a 0-100 scale, with higher scores reflecting better health-related quality of life. SF-36 is administered with a series of questionnaires in the first hour of the two-hour session and will provide a baseline measure of health-related quality of life.
Positive and Negative Affect Schedule (baseline)
Time frame: In the first hour of the two-hour session
The Positive and Negative Affect Schedule (PANAS) is a 20-item measure of positive and negative affect. A 5-point Likert scale is used to indicate the degree to which one is experiencing an emotion during the present moment. Total scores for the negative and positive affect subscales range from 10-50. PANAS is administered with a series of questionnaires in the first hour of the two-hour session and will provide a baseline measure of present moment emotional experience.
Positive and Negative Affect Schedule (change)
Time frame: Within the first hour and again within the final 30 minutes of the two-hour session.
The Positive and Negative Affect Schedule (PANAS) is a 20-item measure of positive and negative affect. A 5-point Likert scale is used to indicate the degree to which one is experiencing an emotion during the present moment. Total scores for the negative and positive affect subscales range from 10-50. Change in PANAS will be calculated and represent a change in present moment emotional experience during the course of the session. This will be calculated by determining the difference between PANAS scores at baseline and the second PANAS administration, which is administered within the final 30 minutes of the two-hour session.
Visual Analog Scale for Distress (baseline)
Time frame: In the first hour of the two-hour session
The Visual Analog Scale for Distress (VAS-Distress) is a unidimensional measure of distress intensity consisting of a line measuring 100 millimeters anchored by two descriptors representing the extremes of distress: "no distress" versus "as distressed as I could possibly be." Participants mark on the line to indicate their current level of distress. Scores range from 0-100 with higher scores, or greater distress intensity, represented by mark's made farther from the "no distress" anchor. Baseline distress will be measured via a VAS-Distress administered with a set of questionnaires in the first hour of the two-hour session.
Visual Analog Scale for Distress (change)
Time frame: Within the first hour and again within the final 30 minutes of the two-hour session.
The Visual Analog Scale for Distress (VAS-Distress) is a unidimensional measure of distress intensity consisting of a line measuring 100 millimeters anchored by two descriptors representing the extremes of distress: "no distress" versus "as distressed as I could possibly be." Participants mark on the line to indicate their current level of distress. Scores range from 0-100 with higher scores, or greater distress intensity, represented by mark's made farther from the "no distress" anchor. Change in distress will be measured by calculating the difference in VAS-Distress score at baseline and the score from the second VAS-Distress administration, which is administered within the final 30 minutes of the two-hour session.
9 secondary outcomes
International Physical Activity Questionnaire - Short Form
Time frame: In the first hour of the two-hour session
Pittsburgh Sleep Quality Index
Time frame: In the first hour of the two-hour session
Rosenberg Self-Esteem Scale
Time frame: In the first hour of the two-hour session
Need Threat Scale
Time frame: In the first hour of the two-hour session
Hospital Anxiety and Depression Scale
Time frame: In the first hour of the two-hour session
Buckley Scale (baseline)
Time frame: In the first hour of the two-hour session
Buckley Scale (change)
Time frame: Within the first hour and again within the final 30 minutes of the two-hour session.
Binge Eating Scale
Time frame: In the first hour of the two-hour session
Vividness of Recall
Time frame: Immediately following weight stigma vignette in the final 30 minutes of the two-hour session.
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 8 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
Charles F Emery, Ph.D. principal investigator
Professor and Psychology Department Chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity, run by Ohio State University 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 1 inclusion and 9 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 8 Sep 2021. 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?
Baseline Prostaglandin level (time frame: Within the first 10 minutes of the two-hour session). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2021; AzTrials last refreshed its copy on 6 Nov 2026.