Daily Habits & Consumer Preferences Study

Obesity Clinical Trial

Official title:

Obesity Stigma and Health Behavior: An Experimental Approach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05402137
• Other study ID #: 21-000460
• Status: Recruiting
• Phase: N/A
• Start date: April 28, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2023
• Source: University of California, Los Angeles
• Contact: Alejandra Lopez, B.A.
• Phone: 310-825-9092
• Email: alopez[@]psych.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Weight stigma intervention
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.

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Los Angeles	Miami University, University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	Change in self-reported sleep quality	Participants will complete a questionnaire assessing self-reported measures of the past night's sleep quality, bedtime, number of minutes it took to fall asleep, number of minutes awake during the night, and the present morning's wake time using the consensus sleep diary (Carney et al., 2012). Data from the sleep diary will not be scored numerically, but instead will be used to supplement scoring of the behavioral actigraphy data. Sleep and wake times will be used to set rest intervals, which are needed to capture accurate sleep intervals. Subjective sleep quality will be used as a fourth dependent sleep variable.	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.
Primary	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.
Primary	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.	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.