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

Diet, Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06145009
• Other study ID #: 2089190-1
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2023
• Est. completion date: December 20, 2024

Study information

• Verified date: November 2023
• Source: University of Delaware
• Contact: Diane Vizthum, MS
• Phone: 302-831-1109
• Email: dvizthum[@]udel.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 20, 2024
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet, Healthy
• Eating Behavior
• Time Restricted Eating

Intervention

Behavioral:
• Time restricted eating
Limit food intake to 10 hours per day as described in the experimental arm section.

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	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
Primary	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
Primary	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	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
Secondary	Body composition (total percent body fat)	Percent body fat measured by DXA	Baseline and end of 4-week intervention
Secondary	Body composition (visceral fat)	Visceral fat measured by DXA	Baseline and end of 4-week intervention
Secondary	Body weight	Total body weight	3 time points: baseline, end of 4-week intervention, end of 4-week follow up