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NCT05402137

Daily Habits & Consumer Preferences Study

Completed NA Results posted Last updated 20 January 2026
What this trial tests

NA trial testing Weight stigma intervention in Obesity in 330 participants. Completed in 3 August 2024.

Timeline
28 April 2022
Primary endpoint
3 August 2024
3 August 2024

Quick facts

Lead sponsorUniversity of California, Los Angeles
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposebasic science
Enrollment330
Start date28 April 2022
Primary completion3 August 2024
Estimated completion3 August 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, Los Angeles

Who can join

18 and older, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Hyperpalatable Food Intake Primary · 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.

GroupValue95% CI
Control Group325.95± 261.24
Experimental Group262.51± 224.09
Change in Self-reported Dietary Intake Primary · 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.

GroupValue95% CI
Control Group100.32± 911.66
Experimental Group65.20± 916.82
Change in Physical Activity Primary · 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.

GroupValue95% CI
Control Group-0.50± 6.24
Experimental Group-0.90± 5.84
Change in Sleep Duration Primary · 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.

GroupValue95% CI
Control Group0.13± 1.38
Experimental Group-0.28± 1.26
Change in Self-reported Sleep Quality Primary · 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.

GroupValue95% CI
Control Group-0.01± 0.52
Experimental Group-0.04± 0.57
Change in Sleep Onset Latency Primary · 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).

GroupValue95% CI
Control Group4.80± 35.15
Experimental Group10.09± 20.45
Change in Sleep Efficiency Primary · 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.

GroupValue95% CI
Control Group0.33± 14.96
Experimental Group-5.01± 8.09

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05402137.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing