Daily Habits & Consumer Preferences Study
Obesity Stigma and Health Behavior: An Experimental Approach
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Manuel F Ramirez, B.A.
- Phone Number: 310-825-9092
- Email: mramirez@psych.ucla.edu
Study Contact Backup
- Name: Alejandra Lopez, B.A.
- Phone Number: 310-825-9092
- Email: alopez@psych.ucla.edu
Study Locations
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California
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Los Angeles, California, United States, 90034
- University of California, Los Angeles
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18+
- English-speaking
- BMI greater than or equal to 28
Exclusion Criteria:
- Major mental disorder including eating disorder, mood disorder, schizophrenia, PTSD
- Recent (<1 year) diagnosis of major physical conditions that limit physical movement
- Recent (<1 year) diagnosis of sleep disorder
- Allergy to any of the foods in the food buffet
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: Experimental (Weight Stigma) Arm
Participants undergoing the experimental (Weight Stigma) arm are exposed to an interaction partner (a trained confederate) who endorses anti-fat attitudes.
Prior to their interaction, participants exchange a "Getting to Know You Questionnaire" with the confederate, where the confederate endorses anti-fat attitudes.
During their interaction with the confederate, participants are told they will be completing consumer rating tasks with another participant in the study.
During the ostensible consumer rating task, participants in the experimental condition rate items such as a diet magazine, body sunscreen, running shoes, and a size small T-shirt labeled as size large to bolster the weight stigma manipulation.
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Those undergoing the weight stigma manipulation will be exposed to an interaction partner (a trained confederate) who will endorse anti-fat attitudes.
The purpose of this interaction is to examine the causal effects of weight stigma on eating behaviors, physical activity, and sleep.
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No Intervention: Control Arm
Participants undergoing the control arm are also exposed to an interaction partner (a trained confederate) who does not endorse anti-fat attitudes.
Prior to their interaction, participants exchange a "Getting to Know You Questionnaire" with the confederate; however, the confederate does not endorse anti-fat attitudes.
During their interaction with the confederate, participants are told they will be completing consumer rating tasks with another participant in the study.
During the ostensible consumer rating task, participants in the control condition rate items such as an interior design magazine, face sunscreen, regular (non-running) shoes, and a size large T-shirt correctly labeled as size large to avoid weight stigma.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Hyperpalatable Food Intake
Time Frame: Hyperpalatable food intake will be measured directly after the intervention, on average 10 minutes later.
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Hyperpalatable food intake will initially be measured in grams and then converted into kilocalories.
The food will consist of the following items: chocolate chip cookies, M&Ms, potato chips, and Sprite.
These foods were chosen because processed foods, added sugars, refined grains, starchy vegetables, and sugar sweetened beverages are foods to avoid according to the 2019 American Diabetes Association Nutrition Consensus Report and are high in carbohydrates and glycemic index.
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Hyperpalatable food intake will be measured directly after the intervention, on average 10 minutes later.
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Change in Self-reported Dietary Intake
Time Frame: Change in self-reported dietary intake will be assessed by measuring self-reported dietary intake 72 hours before the intervention as part of the baseline, and 72 hours after the intervention.
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Dietary intake data for food recalls will be collected and analyzed using the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool developed by the National Cancer Institute, Bethesda, MD.
The primary eating outcome for the food diaries will be kilocalories.
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Change in self-reported dietary intake will be assessed by measuring self-reported dietary intake 72 hours before the intervention as part of the baseline, and 72 hours after the intervention.
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Change in Physical Activity
Time Frame: Change in physical activity will be assessed by measuring physical activity for 72 hours before the intervention as part of the baseline, and 72 hours after the intervention.
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Physical activity, quantified as Metabolic Equivalent of Task (MET) units, will be assessed using ActivPAL4 actigraphs.
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Change in physical activity will be assessed by measuring physical activity for 72 hours before the intervention as part of the baseline, and 72 hours after the intervention.
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Change in Sleep Duration
Time Frame: Change in sleep duration will be assessed by measuring sleep duration for three days before the intervention as part of the baseline, and three days after the intervention.
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Change in sleep duration will be assessed using an Actiwatch-2 (Philips Respironics).
Data will be captured in 30-second epochs and validated.
Actiware 6.0.9 software algorithms will be used to estimate sleep parameters with the following sleep/wake algorithm: D = A-2*(1/25) + A1*(1/5) + A*(1) + A + 1*(1/5) + A + 2*(1/25), where AX = accelerometer activity for that minute.
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Change in sleep duration will be assessed by measuring sleep duration for three days before the intervention as part of the baseline, and three days after the intervention.
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Change in Self-reported Sleep Quality
Time Frame: Change in self-reported sleep quality will be assessed by measuring self-reported sleep quality during the mornings of the first 72 hour baseline period before the intervention, and in the mornings of the 72 hour period after the intervention.
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Participants will respond to a single item assessing past night's sleep quality, with response options ranging from 1 (very bad) to 4 (very good).
Change in subjective sleep quality will be calculated by taking the difference of the item score pre- and post-intervention.
The possible minimum for change in self-reported sleep quality is -3 and the possible maximum is 3.
In this difference score, higher scores indicate improvements in sleep quality from baseline to post.
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Change in self-reported sleep quality will be assessed by measuring self-reported sleep quality during the mornings of the first 72 hour baseline period before the intervention, and in the mornings of the 72 hour period after the intervention.
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Change in Sleep Onset Latency
Time Frame: Change in sleep onset latency will be assessed by measuring sleep onset latency for three days before the intervention as part of the baseline, and three days after the intervention.
|
Change in sleep onset latency will be assessed using an Actiwatch-2 (Philips Respironics).
Data will be captured in 30-second epochs and validated.
Actiware 6.0.9 software algorithms will be used to estimate sleep parameters with the following sleep/wake algorithm: D = A-2*(1/25) + A1*(1/5) + A*(1) + A + 1*(1/5) + A + 2*(1/25), where AX = accelerometer activity for that minute.
Sleep onset is operationalized as after 10 consecutive minutes of D ≤ 40 (as D > 40 indicates participants are awake).
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Change in sleep onset latency will be assessed by measuring sleep onset latency for three days before the intervention as part of the baseline, and three days after the intervention.
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Change in Sleep Efficiency
Time Frame: Change in sleep efficiency will be assessed by measuring sleep efficiency for three days before the intervention as part of the baseline, and three days after the intervention.
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Change in sleep efficiency will be assessed using an Actiwatch-2 (Philips Respironics).
Data will be captured in 30-second epochs and validated.
Actiware 6.0.9 software algorithms will be used to estimate sleep parameters with the following sleep/wake algorithm: D = A-2*(1/25) + A1*(1/5) + A*(1) + A + 1*(1/5) + A + 2*(1/25), where AX = accelerometer activity for that minute.
The possible minimum value is -100 and the possible maximum value is 100.
Higher scores indicate better sleep efficiency.
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Change in sleep efficiency will be assessed by measuring sleep efficiency for three days before the intervention as part of the baseline, and three days after the intervention.
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: A. Janet Tomiyama, Ph.D., University of California, Los Angeles
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 21-000460
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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