NCT05402137

Brief Summary

The study will use a between-subjects design in a sample of individuals with BMI greater than or equal to 28 from the Los Angeles community (N=330). Participants will be randomly assigned to a weight stigma vs. control manipulation. Changes to the following health behaviors will be subsequently measured in their everyday lives: 3-day diet as captured by ecological momentary assessment (EMA) food diaries, objectively measured eating of obesogenic foods, objectively measured physical activity captured by 24-hour actigraphy, and sleep, captured objectively by overnight actigraphy and subjectively self-reported sleep measures. The investigators hypothesize that weight stigma causes decrements in health behaviors (e.g., sleep, eating, and physical activity) in everyday life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 28, 2022

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2024

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 20, 2026

Completed
Last Updated

January 20, 2026

Status Verified

October 1, 2025

Enrollment Period

2.3 years

First QC Date

May 25, 2022

Results QC Date

October 27, 2025

Last Update Submit

December 29, 2025

Conditions

Keywords

Weight PrejudiceSleepEatingExerciseEcological Momentary AssessmentActigraphyDiet Records

Outcome Measures

Primary Outcomes (7)

  • Hyperpalatable Food Intake

    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.

    Hyperpalatable food intake will be measured directly after the intervention, on average 10 minutes later.

  • Change in Self-reported Dietary Intake

    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.

    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.

  • Change in Physical Activity

    Physical activity, quantified as Metabolic Equivalent of Task (MET) units, will be assessed using ActivPAL4 actigraphs.

    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.

  • Change in Sleep Duration

    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.

    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.

  • Change in Self-reported Sleep Quality

    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.

    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.

  • Change in Sleep Onset Latency

    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).

    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 Efficiency

    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.

    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.

Study Arms (2)

Experimental (Weight Stigma) Arm

EXPERIMENTAL

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.

Behavioral: Weight stigma intervention

Control Arm

NO INTERVENTION

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.

Interventions

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.

Experimental (Weight Stigma) Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18+
  • English-speaking
  • BMI greater than or equal to 28

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90034, United States

Location

MeSH Terms

Conditions

ObesityWeight PrejudiceMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPrejudiceSocial BehaviorBehavior

Results Point of Contact

Title
A. Janet Tomiyama
Organization
University of California, Los Angeles

Study Officials

  • A. Janet Tomiyama, Ph.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 25, 2022

First Posted

June 2, 2022

Study Start

April 28, 2022

Primary Completion

August 3, 2024

Study Completion

August 3, 2024

Last Updated

January 20, 2026

Results First Posted

January 20, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations