Ignite Creation Date:
2024-05-06 @ 1:43 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04105712
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2019-09-23
Brief Title:
The Biobehavioral Impact of Diet Quality on Affect and Craving
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
The Biobehavioral Impact of Diet Quality on Affect and Craving
Status:
COMPLETED
Status Verified Date:
2021-10
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:
The current study experimentally investigates whether reducing highly processed HP foods defined in this study as foods high in added sugars leads to psychological and or behavioral indicators of withdrawal The following hypotheses are tested
1 To test the hypothesis that reducing highly processed food intake will result in higher daily reports of physical eg headaches cognitive eg difficulty concentrating and affective eg irritability withdrawal symptoms
2 To test the hypothesis that reducing highly processed food intake will result in increased negative affect eg irritability depression as indicated by and psychological self - reported distress ratings daily emotion mood reports measures
3 To test the hypothesis that reducing highly processed food intake will result in increased food craving as indicated by psychological self - report craving ratings daily craving report measures
All activities are completed remotely Participants complete 4 phone appointments with a trained member of the research team Daily questionnaires and ecological momentary assessments are completed at home between phone appointments The initial call signs electronic consent and gets baseline measurements questionnaires After the initial call participants start an active assessment period pre post dietary change assessments Pre-dietary change includes at home questionnaires and ecological momentary assessments while eating a typical diet It also includes the second phone appointment Post-dietary change includes at home questionnaires and ecological momentary assessments while consuming 3 days of food portions lower in highly processed foods Participants will complete a food journal on the remaining 2 days of post - dietary change assessment to report what food they ate Post - dietary change also includes the third phone appointment The second and third phone appointments each include computer tasks and questionnaires The final phone appointment is a debriefing interview Participants planning to continue eating a healthier diet may also be invited to complete a follow-up period which involves answering a short questionnaire at home every other day for two weeks 7 individuals had in-person data collected prior to the pandemic requiring a shift to virtual data collection
1 To test the hypothesis that reducing highly processed food intake will result in higher daily reports of physical eg headaches cognitive eg difficulty concentrating and affective eg irritability withdrawal symptoms
2 To test the hypothesis that reducing highly processed food intake will result in increased negative affect eg irritability depression as indicated by and psychological self - reported distress ratings daily emotion mood reports measures
3 To test the hypothesis that reducing highly processed food intake will result in increased food craving as indicated by psychological self - report craving ratings daily craving report measures
All activities are completed remotely Participants complete 4 phone appointments with a trained member of the research team Daily questionnaires and ecological momentary assessments are completed at home between phone appointments The initial call signs electronic consent and gets baseline measurements questionnaires After the initial call participants start an active assessment period pre post dietary change assessments Pre-dietary change includes at home questionnaires and ecological momentary assessments while eating a typical diet It also includes the second phone appointment Post-dietary change includes at home questionnaires and ecological momentary assessments while consuming 3 days of food portions lower in highly processed foods Participants will complete a food journal on the remaining 2 days of post - dietary change assessment to report what food they ate Post - dietary change also includes the third phone appointment The second and third phone appointments each include computer tasks and questionnaires The final phone appointment is a debriefing interview Participants planning to continue eating a healthier diet may also be invited to complete a follow-up period which involves answering a short questionnaire at home every other day for two weeks 7 individuals had in-person data collected prior to the pandemic requiring a shift to virtual data collection
Detailed Description:
None
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