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

Sponsor
University of Delaware (Other)
Overall Status
Recruiting
CT.gov ID
NCT06145009
Collaborator
(none)
36
1
1
13.7
2.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Time restricted eating
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Time Restricted Eating, Eating Behaviors, and Cardiometabolic Risk in Emerging Adult Women
Actual Study Start Date :
Oct 30, 2023
Anticipated Primary Completion Date :
Dec 20, 2024
Anticipated Study Completion Date :
Dec 20, 2024

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Emotional Eating [3 time points: baseline, end of 4-week intervention, end of 4-week follow up]

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

    2. External Eating [3 time points: baseline, end of 4-week intervention, end of 4-week follow up]

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

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

    Secondary Outcome Measures

    1. Diet Quality [3 time points: baseline, end of 4-week intervention, end of 4-week follow up]

      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) [Baseline and end of 4-week intervention]

      Percent body fat measured by DXA

    3. Body composition (visceral fat) [Baseline and end of 4-week intervention]

      Visceral fat measured by DXA

    4. Body weight [3 time points: baseline, end of 4-week intervention, end of 4-week follow up]

      Total body weight

    Other Outcome Measures

    1. Participant experience [End of 9-week study (following 1-week baseline, 4-week intervention, and 4-week follow up)]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 29 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Delaware Newark Delaware United States 19711

    Sponsors and Collaborators

    • University of Delaware

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Carly R Pacanowski, Associate Professor, University of Delaware
    ClinicalTrials.gov Identifier:
    NCT06145009
    Other Study ID Numbers:
    • 2089190-1
    First Posted:
    Nov 22, 2023
    Last Update Posted:
    Nov 22, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 22, 2023