NCT06145009

Brief Summary

The purpose of this study is to assess how time restricted eating interventions impact eating behaviors, diet quality, and body composition in women ages 20-29 years. Participants will be asked to limit all food and drinks (except water and some non-caloric beverages) to a 10-hour period during the day for four weeks. Participants 1-36 will follow their usual eating and activity patterns for one week before starting, and follow whatever eating pattern they want for 4 weeks after finishing. Participants 37-51 will follow their usual eating and activity patterns for one week before starting, and will not complete a follow up period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

October 30, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2025

Completed
Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

1.9 years

First QC Date

October 17, 2023

Last Update Submit

June 25, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Emotional Eating

    Dutch Eating Behavior Questionnaire: Emotional Eating Subscale. This subscale is scored from 1-5, with higher scores indicating higher emotional eating.

    Participants 1-36: 3 time points: baseline, end of 4-week intervention, end of 4-week follow up Participants 37-51: 2 time points: baseline, end of 4-week intervention

  • External Eating

    Dutch Eating Behavior Questionnaire: External Eating Subscale. This subscale is scored from 1-5, with higher scores indicating higher external eating.

    Participants 1-36: 3 time points: baseline, end of 4-week intervention, end of 4-week follow up Participants 37-51: 2 time points: baseline, end of 4-week intervention

  • Eating in the Absence of Hunger

    Assessed through surveys sent 5x/day asking about if food was eaten and why.

    Participants 1-36: Baseline week, weeks 1 and 4 of intervention, weeks 1 and 4 of follow up Participants 37-51: Baseline week, weeks 1 and 4 of intervention

Secondary Outcomes (5)

  • Diet Quality

    Participants 1-36: 3 time points: baseline, end of 4-week intervention, end of 4-week follow up Participants 37-51: 2 time points: baseline, end of 4-week intervention

  • Body composition (total percent body fat)

    Baseline and end of 4-week intervention (participants 1-36 only)

  • Body composition (visceral fat)

    Baseline and end of 4-week intervention (participants 1-36 only)

  • Body weight

    Participants 1-36: 3 time points: baseline, end of 4-week intervention, end of 4-week follow up Participants 37-51: 2 time points: baseline, end of 4-week intervention

  • Continuous Glucose Monitoring

    First 10 days of study, last 7 days of intervention period (added for participants 37-51, optional for participants 29-36)

Other Outcomes (1)

  • Participant experience

    End of 9-week study (following 1-week baseline, 4-week intervention, and 4-week follow up, participants 1-36 only)

Study Arms (1)

Time Restricted Eating

EXPERIMENTAL

Participants will limit their eating (all food and caloric beverages) to an eating window of 10 hours per day for 4 weeks. The eating window must end by 8pm. Water and non-caloric beverages are allowed outside of the eating window. No other changes are required to the types or total amount of food eaten.

Behavioral: Time restricted eating

Interventions

Limit food intake to 10 hours per day as described in the experimental arm section.

Also known as: Time restricted feeding, Intermittent fasting, Meal timing
Time Restricted Eating

Eligibility Criteria

Age20 Years - 29 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsPeople who identify as a woman are eligible.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Able to speak and read English
  • Own a smartphone
  • BMI ≥ 20 kg/m2
  • Usual eating window ≥ 12 hours with the last eating occasion after 8pm on the majority of days
  • Have at least a moderate baseline level of dietary restraint

You may not qualify if:

  • Shift workers
  • Being pregnant, nursing, or planning to become pregnant in the next 6 months
  • Having a past or current eating disorder diagnosis
  • Having a chronic medical condition (including diabetes, heart, kidney, or thyroid disease) or a condition that requires therapeutic diet or specified meal timing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Delaware

Newark, Delaware, 19711, United States

Location

Related Publications (1)

  • Vizthum D, Earthman CP, Patterson F, Melough MM, Allison KC, Pacanowski CR. Four-week time restricted eating intervention is associated with improvements in cardiometabolic risk factors and dysregulated eating among emerging adult women: a single-armed trial. Eat Weight Disord. 2026 May 8. doi: 10.1007/s40519-026-01814-y. Online ahead of print.

MeSH Terms

Conditions

Intermittent FastingFeeding Behavior

Condition Hierarchy (Ancestors)

FastingBehaviorBehavior, Animal

Study Officials

  • Carly Pacanowski, PhD

    University of Delaware

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 17, 2023

First Posted

November 22, 2023

Study Start

October 30, 2023

Primary Completion

October 10, 2025

Study Completion

October 10, 2025

Last Updated

June 30, 2026

Record last verified: 2026-06

Locations