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Completed

NCT Number: NCT05402137

Daily Habits & Consumer Preferences Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles

Los Angeles, California, 90034, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weight stigma intervention

Behavioral

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.

Primary outcomes

  1. Hyperpalatable Food Intake

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

    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.

  2. 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.

    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.

  3. 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.

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

  4. 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.

    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.

  5. 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.

    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.

  6. 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).

  7. 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.

    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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Miami University
  • University of California, San Francisco

Registry information

Official study title

Obesity Stigma and Health Behavior: An Experimental Approach

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 2, 2022
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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