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Completed

NCT Number: NCT06145009

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 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.

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Key information

Conditions

Time Restricted Eating Behavior Behavior, Animal Diet, Healthy Eating Behavior Fasting Feeding Behavior Intermittent Fasting Nutrition, Healthy

Age range

20 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware

Newark, Delaware, 19711, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

Time restricted eating

Behavioral

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

Other names: Time restricted feeding, Intermittent fasting, Meal timing

Primary outcomes

  1. Emotional Eating

    Time frame: 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

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

  2. External Eating

    Time frame: 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

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

  3. Eating in the Absence of Hunger

    Time frame: 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

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

Secondary outcomes

  1. Diet Quality

    Time frame: 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

    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.

  2. Body composition (total percent body fat)

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

    Percent body fat measured by DXA

  3. Body composition (visceral fat)

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

    Visceral fat measured by DXA

  4. Body weight

    Time frame: 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

    Total body weight

  5. Continuous Glucose Monitoring

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

    Participants will wear a Dexcom continuous glucose monitor

Other outcomes

  1. Participant experience

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

    Qualitative interview to glean information on participants' subjective experience of the intervention

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 22, 2023
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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