Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04896060
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2021-05-19
Brief Title:
The Impact of the COVID-19 Pandemic on Eating Behavior and Weight Change
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Impact of the Food Environment and Psychosocial Stress From the COVID-19 Pandemic on Eating Behavior and Weight Change
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07-30
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 httpsredcaplinknihcovidstudy
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 httpsredcaplinknihcovidstudy
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 eg 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 US 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 eg 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
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 eg 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 US 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 000172-DK | None | None | None |