Clinical trial NCT04896060: The Impact of the COVID-19 Pandemic on Eating Behavior and Weight Change
Official title: The Impact of the Food Environment and Psychosocial Stress From the COVID-19 Pandemic on Eating Behavior and Weight Change
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Obesity
Keywords: Obesity
Food Intake
Food Insecurity
Resilience
Unpredictability
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2021-05-21
Enrollment: 5056
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers of any health status, sex, or gender who are at least 18 years old. English-speaking. Previously consented NIDDK Phoenix study volunteers and new participants from the general population. Conducted online so physical location is unrestricted.

Brief summary: Background:

The indirect effects of the COVID-19 pandemic on mental health are of increasing concern. Perceived stress can lead to binge eating and weight gain. Researchers want to learn more about the relationship between eating behavior and the pandemic.

Objective:

To study how the stress of the COVID-19 pandemic is affecting eating behaviors and weight.

Eligibility:

English-speaking adults ages 18 and older who have access to a computer or smartphone connected to the internet.

Design:

This is an online study. Participants will answer surveys through the study website.

Participants will complete a one-time survey. It will ask about their experiences throughout the COVID-19 pandemic, their socioeconomic standing, their mental and physical health, and their eating habits. They will have the option to repeat the survey once a month for the next 12 months. This will show changes in their thoughts and behaviors over time. They will provide their email address to get survey links.

Participants will also have the option to complete a 2-minute survey on their smartphone. They will complete the survey daily for 7 days in a row. It will ask about their stress and eating behavior in real time, in their home environment. They will provide their phone number to get survey links via text message.

If a participant has taken part in a previous NIH study on the Phoenix AZ campus, they will be asked to share their first and last name, date of birth, and email address. This information will be used to connect data from this study to their past data.

Participation is typically 25 minutes but may last up to 1 year.

\*\*\*To participate in this study go to the REDCap study link: https://redcap.link/nihcovidstudy.\*\*\*...

Detailed description: Study Description:

We will recruit previous NIDDK study participants as well as newly recruited individuals from the general population to examine how the COVID-19 pandemic has exacerbated the impact of psychosocial stressors that impact eating behavior and weight. The study will describe the relationship between specific COVID-19 related stressors (e.g. fear of becoming sick) and self-rated measures of food insecurity, unpredictability, perceived stress, behavioral health dysfunction, eating behaviors and weight change among a range of participants including previous NIDDK-Phoenix study volunteers and various newly recruited volunteers from the general global population. Participants will be invited to enroll in a follow- up study which will involve completing additional surveys on a monthly basis for 12 months. A smaller U.S. only cohort of these participants may also enroll in a 2 minute daily at-home survey study for 1-weekthat will utilize Ecological Momentary Assessment (EMA) to examine stress and eating behavior in real-time, in the home environment. Participants will complete an online consent form and online survey through a secure weblink (REDCap). Because the situation with the COVID-19 pandemic is rapidly changing, survey data collection is an effective way to measure outcomes at multiple time points with relatively low subject burden.

Objectives:

Primary Objective: to examine the food environment and psychosocial stressors related to COVID-19 with self-reported measures of behavioral health symptoms, eating behaviors and weight.

Secondary Objective: to determine whether sociodemographic, existing behavioral health dysfunction, or environmental condition moderates this relationship and to identify risk and resilience factors among study participants regarding the impact of the COVID-19 pandemic on eating behavior and weight.

Endpoints:

Primary Endpoints: measures of eating behavior and body weight. These endpoints will be measured repeatedly using an online platform (REDCap) at baseline and then monthly for up to 12 months. We also plan to examine these COVID-19 related measures with previously collected phenotypic data (e.g. biological samples and behavioral data) from former NIDDK-Phoenix participants.

Secondary Endpoints: in addition to those outlined as primary endpoints, we will examine data gathered from demographic forms and additional questionnaires measuring environmental conditions and psychosocial stress.

Eligibility criteria: * INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all the following criteria:

1. 18 years of age or older
2. Able to read and write English
3. Consistent access to computer or mobile devices connected to the internet
4. Able to provide informed consent online and/or in-person

In order to be eligible to participate in the EMA arm of the study, an individual must meet all the following criteria:

1. Access to a mobile device with WI-FI and data

EXCLUSION CRITERIA:

1. Non-English-speaking individuals.

Non-English-speaking subjects as a population will be excluded from participation in this protocol. The primary aim of the protocol relates to the questionnaires administered to the participants online. There are currently no validated, translated forms of these questionnaires available; therefore, we will restrict enrollment to English speaking subjects only.

Primary outcomes:
measure: Nighttime Eating Behavior
timeFrame: Baseline and 12 months
measure: The Intuitive Eating Scale-2 (IES-2)
timeFrame: Baseline and 12 months
measure: Three Factor Eating Questionnaire (TFEQ)
timeFrame: Baseline and 12 months
measure: Loss of Control Eating
timeFrame: Baseline and 12 months
measure: Food Frequency Questionnaire (FFQ)
timeFrame: Baseline and 12 months
measure: Changes in self-reported weight
timeFrame: Baseline and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: NIDDK, Phoenix
state: Arizona
Study officials:
affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Marci E Gluck, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: