NCT05740254

Brief Summary

Determine the effectiveness of how limiting the time you eat within an early or late eating window and fasting for remainder of the day will impact weight loss and body mass index (BMI).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Mar 2023

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Mar 2023Jan 2027

First Submitted

Initial submission to the registry

February 8, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 27, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

October 22, 2024

Status Verified

October 1, 2024

Enrollment Period

2.8 years

First QC Date

February 8, 2023

Last Update Submit

October 19, 2024

Conditions

Pediatric ObesityTime Restricted FeedingTime Restricted Eating

Keywords

ObesityIntermitted-fastingTime Limited Eating

Outcome Measures

Primary Outcomes (1)

  • Mean change in weight in excess of the 95th percentile at week 24 compared to baseline

    Change in weight in excess of the 95th percentile

    week 24

Secondary Outcomes (5)

  • Mean change in total body fat mass as measured on DEXA scan at week 24 compared to baseline

    week 24

  • Mean change in percent time in range as captured on contiguous glucose monitor at week 24 compared to baseline

    week 24

  • Mean change in hemoglobin A1c at week 24 compared to baseline

    week 24

  • Mean change in ALT at week 24 compared to baseline

    week 24

  • Mean change in systolic and diastolic blood pressure at week 24 compared to baseline

    week 24

Study Arms (2)

Early Time Restricted Eating

EXPERIMENTAL

early-day TRE (7:00 to 15:00 h)

Behavioral: Early Time Restricted Eating

Late Time Restricted Eating

EXPERIMENTAL

late TRE (12:00 to 20:00 h)

Behavioral: Late Time Restricted Eating

Interventions

Early Time Restricted EatingBEHAVIORAL

Early Time Restricted Eating 7 AM to 3 PM

Early Time Restricted Eating
Late Time Restricted EatingBEHAVIORAL

Late Time Restricted Eating 12 PM to 8 PM

Late Time Restricted Eating

Eligibility Criteria

Age12 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years with obesity (BMI\>95th percentile)
  • participant must be willing and able to adhere to the assessments, visit schedules, and eating/fasting periods
  • baseline eating window greater than 12 hours.

You may not qualify if:

  • diagnosis of Prader-Willi Syndrome, brain tumor, or diabetes serious intellectual disability
  • previous diagnosis or subthreshold symptoms of an eating disorder (anorexia nervosa, bulimia nervosa, binge-eating disorder)
  • parent/guardian-reported physical, mental of other inability to participate in the assessments
  • previous bariatric surgery
  • current participation in other interventional weight loss studies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

MeSH Terms

Conditions

Pediatric ObesityIntermittent FastingObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFastingFeeding BehaviorBehavior

Study Officials

  • Alaina Vidmar, MD

    Children's Hospital Los Angeles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaina Vidmar, MD

CONTACT

323-361-4606avidmar@chla.usc.edu

Harvey Peralta

CONTACT

hperalta@chla.usc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 8, 2023

First Posted

February 22, 2023

Study Start

March 27, 2023

Primary Completion

January 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

October 22, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Clinical characteristics data will be available in CSV format, and will not require the use of specialized tools to be accessed. To facilitate interpretation of the data, study protocol and clinical data dictionary will be shared and associated with the relevant datasets. Information about our research process, including the details of biochemical assays be maintained contemporaneously. This information will be accessible to all members of the research team and will be shared alongside our data. Data to be shared will be made available at the time of associated publication or by the close of the reward. Data will be made available, at minimum, for length of the grant + 5 years. Restrictions on subsequent access, distribution, or reuse of scientific data from this project include confidentiality protections. All data shard will be de-identified and not include any sensitive information or potentially identifying variables.

Locations

US(1)