NCT04896060

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.\*\*\*...

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,056

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2025

Completed
Last Updated

April 8, 2026

Status Verified

February 5, 2026

Enrollment Period

2.5 years

First QC Date

May 19, 2021

Last Update Submit

April 7, 2026

Conditions

Keywords

ObesityFood IntakeFood InsecurityResilienceUnpredictabilityNatural History

Outcome Measures

Primary Outcomes (6)

  • Nighttime Eating Behavior

    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.

    Baseline and 12 months

  • The Intuitive Eating Scale-2 (IES-2)

    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.

    Baseline and 12 months

  • Three Factor Eating Questionnaire (TFEQ)

    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.

    Baseline and 12 months

  • Loss of Control Eating

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

    Baseline and 12 months

  • Food Frequency Questionnaire (FFQ)

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

    Baseline and 12 months

  • Changes in self-reported weight

    Changes in self-reported weight from baseline to 12 months

    Baseline and 12 months

Study Arms (3)

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

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • In order to be eligible to participate in this study, an individual must meet all the following criteria:
  • years of age or older
  • Able to read and write English
  • Consistent access to computer or mobile devices connected to the internet
  • 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:
  • \. Access to a mobile device with WI-FI and data

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIDDK, Phoenix

Phoenix, Arizona, 85014, United States

Location

Related Publications (1)

  • Willig M, Cabeza de Baca T, J Stinson E, M Trevino-Alvarez A, Rodzevik T, B Votruba S, C Lameman C, Krakoff J, Gluck ME. The impact of COVID-19 fear during the later stages of the pandemic on maladaptive eating, psychological distress and body weight: a global cross-sectional study. BMC Public Health. 2025 Apr 11;25(1):1365. doi: 10.1186/s12889-025-22444-6.

Related Links

MeSH Terms

Conditions

COVID-19Obesity

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marci E Gluck, Ph.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2021

First Posted

May 21, 2021

Study Start

September 1, 2022

Primary Completion

February 13, 2025

Study Completion

February 13, 2025

Last Updated

April 8, 2026

Record last verified: 2026-02-05

Data Sharing

IPD Sharing
Will not share

Locations