The Impact of the COVID-19 Pandemic on Eating Behavior and Weight Change

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
Overall Status
Not yet recruiting
CT.gov ID
NCT04896060
Collaborator
(none)
5,000
Enrollment
1
Location
20.8
Anticipated Duration (Months)
240.4
Patients Per Site Per Month

Study Details

Study Description

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....

Condition or DiseaseIntervention/TreatmentPhase

    Detailed 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 cohort of these participants will may also enroll in a 1-week daily assessment study that 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Prospective
    Official Title:
    The Impact of the Food Environment and Psychosocial Stress From the COVID-19 Pandemic on Eating Behavior and Weight Change
    Anticipated Study Start Date :
    Oct 20, 2021
    Anticipated Primary Completion Date :
    Jul 15, 2023
    Anticipated Study Completion Date :
    Jul 15, 2023

    Arms and Interventions

    ArmIntervention/Treatment
    Ecological Momentary Assessment (EMA) volunteers

    Volunteers with access to mobile device with Wi-Fi and data recruited for an additional 1-week daily assessment study utilizing EMA to examine COVID-19 related stress and eating behavior in real-time

    General global population volunteers

    Newly recruited volunteers 18 and above from the general global population that agree to participate in the COVID study

    NIDDK-Phoenix study volunteers

    Previous research participants, who signed consents that allow data sharing that agree to participate in the COVID study

    Outcome Measures

    Primary Outcome Measures

    1. Nighttime Eating Behavior [Baseline and 12 months]

      2 questions taken from the Night Eating Diagnostic Questionnaire (NEDQ), a self-report questionnaire containing 14 questions about eating after the evening meal and waking up in the night to eat. Symptoms are rated on a 5-point Likert-type scale, which are then summed to obtain a NEQ Global Score.

    2. The Intuitive Eating Scale-2 (IES-2) [Baseline and 12 months]

      The IES-2 consists of 23-items measuring individuals tendency to follow their physical hunger and satiety cues when determining when, what, and how much to eat. Scores are rated on a 5-point Likert scale ranging from strongly disagree to strongly agree. Items are summed and an average score is computed for the entire scale and its four subscales.

    3. Three Factor Eating Questionnaire (TFEQ) [Baseline and 12 months]

      TFEQ consists of 18 items on a 4-point response scale (definitely true/mostly true/mostly false/definitely false) (scores recorded on a 0-100 scale). Higher scores in the respective scales are indicative of greater cognitive restraint, uncontrolled, or emotional eating.

    4. Loss of Control Eating [Baseline and 12 months]

      2 questions to assess eating a large amount of food and sense of loss of control over one s eating behavior

    5. Food Frequency Questionnaire (FFQ) [Baseline and 12 months]

      Semiquantitative self-administered questionnaire that estimates average daily intake of foods, drinks, energy, and major nutrients out of about 124 different foods.

    6. Changes in self-reported weight [Baseline and 12 months]

      Changes in self-reported weight from baseline to 12 months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    • 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

    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1NIDDK, PhoenixPhoenixArizonaUnited States85014

    Sponsors and Collaborators

    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    Investigators

    • Principal Investigator: Marci Gluck, Ph.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    ClinicalTrials.gov Identifier:
    NCT04896060
    Other Study ID Numbers:
    • 10000172
    • 000172-DK
    First Posted:
    May 21, 2021
    Last Update Posted:
    Oct 15, 2021
    Last Verified:
    May 18, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 15, 2021