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NCT04105712 · ClinicalTrials.gov registry record · NA

The Biobehavioral Impact of Diet Quality on Affect and Craving

A NA study, sponsored by University of Michigan.

Completed
Registry status
NA
Development phase
68
Enrollment target

NCT04105712: Completed NA study, sponsored by University of Michigan.

NCT04105712 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 68 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04105712, a NA study, has completed, sponsored by University of Michigan.

COMPLETED
Registry status
NA
Development phase
68 participants
Enrollment target

Study 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 (e.g. headaches), cognitive (e.g. difficulty concentrating), and affective (e.g., irritability) withdrawal symptoms). 2. To test the hypothesis that reducing highly processed food intake will result in increased negative affect (e.g., 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

Primary Outcome

The PRoWS is a validated self-report measure of indicators of withdrawal. Affective withdrawal symptoms are measured by asking participants to complete the Highly Processed Food Withdrawal Scale (PRoWS), which is a validated self-report measure of withdrawal. PRoWS questions ask about current feelings / emotions. Response options are "strongly disagree" "disagree" "feel neutral" "agree" and "strongly agree". Participants are asked to complete these measures every day of the pre and post dietary

Interventions

  • BEHAVIORAL Dietary Change (low in highly processed foods)

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2019-06-18
Est. Completion 2021-10-21
Phase NA
University of Michigan

1,327 total trials

What the finished NCT04105712 record still lists

NCT04105712 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which Dietary Change (low in highly processed foods) is the first listed.

NCT04105712 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04105712 about?

NCT04105712 is a clinical study titled "The Biobehavioral Impact of Diet Quality on Affect and Craving". 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 ...

What is the current status of trial NCT04105712?

This trial is currently completed. It is a NA study. The enrollment target is 68 participants. The study started on 2019-06-18. Estimated completion is 2021-10-21.

What interventions are being tested in trial NCT04105712?

The interventions under investigation include: Dietary Change (low in highly processed foods) (BEHAVIORAL).

Who is sponsoring clinical trial NCT04105712?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04105712's enrollment target sits among peer trials

68 1133rd of 2000 higher than 862 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04105712, the US trial registry maintained by the National Library of Medicine. NCT04105712 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.