Clinical trial NCT05402137: Daily Habits & Consumer Preferences Study
Official title: Obesity Stigma and Health Behavior: an Experimental Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Weight Prejudice
Sleep
Eating
Exercise
Ecological Momentary Assessment
Actigraphy
Diet Records
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: Miami University
First posted: 2022-06-02
Enrollment: 353
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

1. Age 18+
2. English-speaking
3. BMI greater than or equal to 28

Exclusion Criteria:

1. Major mental disorder including eating disorder, mood disorder, schizophrenia, PTSD
2. Recent (\<1 year) diagnosis of major physical conditions that limit physical movement
3. Recent (\<1 year) diagnosis of sleep disorder
4. Allergy to any of the foods in the food buffet

Primary outcomes:
measure: Hyperpalatable food intake
timeFrame: Hyperpalatable food intake will be measured directly after the intervention.
measure: Change in self-reported dietary intake
timeFrame: 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.
measure: Change in physical activity
timeFrame: 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.
measure: Change in sleep duration
timeFrame: 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.
measure: Change in self-reported sleep quality
timeFrame: 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.
measure: Change in sleep onset latency
timeFrame: 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.
measure: Change in sleep efficiency
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: A. Janet Tomiyama, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: