COVID-19NCT04896060
The Impact of the COVID-19 Pandemic on Eating Behavior and Weight Change
An observational study of COVID-19 and Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- How many people
- 5,056 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 13 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all the following criteria:
- 18 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:
- 1. Access to a mobile device with WI-FI and data
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of the Food Environment and Psychosocial Stress From the COVID-19 Pandemic on Eating Behavior and Weight Change
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.
Read more
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.*...
Read the 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.
- Keywords
- Obesity, Food Intake, Food Insecurity, Resilience, Unpredictability, Natural History
- Medical subject headings
- COVID-19, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline and 12 months
Changes in self-reported weight
Changes in self-reported weight from baseline to 12 months
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start1 Sep 2022
- Primary completion13 Feb 2025
- Study completion13 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 5,056 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Marci E Gluck, Ph.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896060
- Sponsor's protocol ID
- 10000172
- Other IDs
- 000172-DK
- Status last verified
- 26 Aug 2026
- First submitted
- 19 May 2021
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40217216
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Food Environment and Psychosocial Stress From the COVID-19 Pandemic on Eating Behavior and Weight Change
- ClinicalTrials.gov ID
- NCT04896060
- Acronym / sponsor ID
- 10000172
- Keywords
- Obesity, Food Intake, Food Insecurity, Resilience, Unpredictability, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,056 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 13 Feb 2025 (actual)
- Study completion
- 13 Feb 2025 (actual)
- First posted
- 21 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- In order to be eligible to participate in this study, an individual must meet all the following criteria:
- 18 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nighttime Eating Behavior
Time frame: 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.
The Intuitive Eating Scale-2 (IES-2)
Time frame: 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.
Three Factor Eating Questionnaire (TFEQ)
Time frame: 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.
Loss of Control Eating
Time frame: 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
Food Frequency Questionnaire (FFQ)
Time frame: 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.
Changes in self-reported weight
Time frame: Baseline and 12 months
Changes in self-reported weight from baseline to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Derived from this study: PubMed 40217216Willig 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.
- https://redcap.link/nihcovidstudyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marci E Gluck, Ph.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nighttime Eating Behavior (time frame: Baseline and 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04896060, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.