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 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

1.1 years

First QC Date

October 17, 2023

Last Update Submit

July 29, 2024

Conditions

Time Restricted EatingEating BehaviorDiet, HealthyNutrition, Healthy

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.

    3 time points: baseline, end of 4-week intervention, end of 4-week follow up

  • External Eating

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

    3 time points: baseline, end of 4-week intervention, end of 4-week follow up

  • Eating in the Absence of Hunger

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

    Baseline week, weeks 1 and 4 of intervention, weeks 1 and 4 of follow up

Secondary Outcomes (4)

  • Diet Quality

    3 time points: baseline, end of 4-week intervention, end of 4-week follow up

  • Body composition (total percent body fat)

    Baseline and end of 4-week intervention

  • Body composition (visceral fat)

    Baseline and end of 4-week intervention

  • Body weight

    3 time points: baseline, end of 4-week intervention, end of 4-week follow up

Other Outcomes (1)

  • Participant experience

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

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

Time restricted eatingBEHAVIORAL

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

RECRUITING

MeSH Terms

Conditions

Intermittent FastingFeeding Behavior

Condition Hierarchy (Ancestors)

FastingBehaviorBehavior, Animal

Study Officials

  • Carly Pacanowski, PhD

    University of Delaware

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diane Vizthum, MS

CONTACT

302-831-1109dvizthum@udel.edu

Carly Pacanowski, PhD

CONTACT

302-831-1109cpacanow@udel.edu

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

December 20, 2024

Study Completion

December 20, 2024

Last Updated

July 30, 2024

Record last verified: 2024-07

Locations

US(1)