search
Back to results

Daily Habits & Consumer Preferences Study

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight stigma intervention
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Weight Prejudice, Sleep, Eating, Exercise, Ecological Momentary Assessment, Actigraphy, Diet Records

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California, Los AngelesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental (Weight Stigma) Arm

Control Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 25, 2022
Last Updated
July 18, 2023
Sponsor
University of California, Los Angeles
Collaborators
University of California, San Francisco, Miami University
search

1. Study Identification

Unique Protocol Identification Number
NCT05402137
Brief Title
Daily Habits & Consumer Preferences Study
Official Title
Obesity Stigma and Health Behavior: An Experimental Approach
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
University of California, San Francisco, Miami University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Weight Prejudice, Sleep, Eating, Exercise, Ecological Momentary Assessment, Actigraphy, Diet Records

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental (Weight Stigma) Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Weight stigma intervention
Intervention Description
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 Outcome Measure Information:
Title
Hyperpalatable food intake
Description
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.
Time Frame
Hyperpalatable food intake will be measured directly after the intervention.
Title
Change in self-reported dietary intake
Description
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.
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.
Title
Change in physical activity
Description
Physical activity, quantified as Metabolic Equivalent of Task (MET) units, will be assessed using ActivPAL4 actigraphs.
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.
Title
Change in sleep duration
Description
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.
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.
Title
Change in self-reported sleep quality
Description
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.
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.
Title
Change in sleep onset latency
Description
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).
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.
Title
Change in sleep efficiency
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alejandra Lopez, B.A.
Phone
310-825-9092
Email
alopez@psych.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel F Ramirez, B.A.
Phone
310-825-9092
Email
mramirez@psych.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A. Janet Tomiyama, Ph.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandra Lopez, B.A.
Phone
310-825-9092
Email
alopez@psych.ucla.edu
First Name & Middle Initial & Last Name & Degree
Manuel F Ramirez, B.A.
Phone
310-825-9092
Email
mramirez@psych.ucla.edu
First Name & Middle Initial & Last Name & Degree
A. Janet Tomiyama, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Daily Habits & Consumer Preferences Study

We'll reach out to this number within 24 hrs