Time Restricted Eating, Eating Behaviors, and Cardiometabolic Risk in Emerging Adult Women

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.

Study Overview

• Status: Recruiting
• Conditions: Diet, Healthy; Eating Behavior; Nutrition, Healthy; Time Restricted Eating
• Intervention / Treatment: Behavioral: Time restricted eating

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diane Vizthum, MS; Phone Number: 302-831-1109; Email: dvizthum@udel.edu
• Study Contact Backup: Name: Carly Pacanowski, PhD; Phone Number: 302-831-1109; Email: cpacanow@udel.edu

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19711
      • Recruiting
      • University of Delaware
      • Principal Investigator: Carly Pacanowski, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Able to speak and read English
• Own a smartphone
• BMI ≥ 23 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Time Restricted Eating; 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; Limit food intake to 10 hours per day as described in the experimental arm section.; Other Names: Time restricted feeding; Intermittent fasting; Meal timing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diet Quality	Healthy Eating Index, calculated from 3-day food records. The Healthy Eating Index is scored from 0-100, with higher scores indicating higher diet quality.	3 time points: baseline, end of 4-week intervention, end of 4-week follow up
Body composition (total percent body fat)	Percent body fat measured by DXA	Baseline and end of 4-week intervention
Body composition (visceral fat)	Visceral fat measured by DXA	Baseline and end of 4-week intervention
Body weight	Total body weight	3 time points: baseline, end of 4-week intervention, end of 4-week follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant experience	Qualitative interview to glean information on participants' subjective experience of the intervention	End of 9-week study (following 1-week baseline, 4-week intervention, and 4-week follow up)

Collaborators and Investigators

• Sponsor: University of Delaware
• Investigators: Principal Investigator: Carly Pacanowski, PhD, University of Delaware

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2023
• Primary Completion (Estimated): December 20, 2024
• Study Completion (Estimated): December 20, 2024

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: November 17, 2023
• First Posted (Estimated): November 22, 2023

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2089190-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No