NCT03954223

Brief Summary

The investigators propose a randomized controlled trial in 90 children (age 13-21y) with obesity recruited from clinical programs at the Children's Hospital Los Angeles (CHLA). Patients will be randomized to one of three treatment groups for a 12-week intervention: Group 1) Low sugar and carbohydrate diet (LSC, \<90 gm carbohydrate (CHO)/day, \<25 gm added sugar/day) + blinded CGM (used to monitor adherence and glycemic outcomes without real time feedback). Group 2) LSC+TLE (16-hour fast/8-hour feed for 3 days per week) + blinded CGM, Group 3) LSC+TLE+ real time feedback via CGM (to evaluate effect of providing CGM data on intervention efficacy).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 6, 2023

Completed
Last Updated

March 4, 2024

Status Verified

February 1, 2024

Enrollment Period

1.9 years

First QC Date

May 15, 2019

Results QC Date

February 6, 2023

Last Update Submit

February 14, 2024

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (1)

  • Percent Change in BMI in Excess of the 95th Percentile (%BMIp95)

    Percent Change in BMI in excess of the 95th percentile (%BMIp95) as calculated by the CDC extended SAS equations at week 12 minus %BMIp95 at baseline. For example If the BMI is greater than the 95th percentile: BMI percentile equals 90 plus 10 times the cumulative distribution function (CDF) of the standard normal distribution. Sigma is the value from the data table corresponding to the sex of the child and the age in months. and are the cumulative distribution function (CDF) of the standard normal distribution and its inverse function. Standard normal distribution tables can be found in statistics textbooks, online sources, and statistical computer programs. Example: A boy aged 4 years and 2 months (50.5 months) with BMI = 22.6. For this boy, P95 (95th percentile) is 17.8219 so his BMI is above the 95th percentile and sigma = 2.3983.

    %BMIp95 at Week 12 minus %BMIp95 at baseline

Secondary Outcomes (1)

  • Average Glucose

    Change in average glucose at week 12 minus average glucose at baseline

Study Arms (3)

LSC + blinded CGM

EXPERIMENTAL

Group 1) Low sugar and carbohydrate diet (LSC, \<90 gm carbohydrate (CHO)/day, \<25 gm added sugar/day) + blinded CGM (used to monitor adherence and glycemic outcomes without real time feedback)

Behavioral: Low sugar and carbohydrate dietDevice: Continuous Glucose Monitor

LSC+TLE + blinded CGM

EXPERIMENTAL

Group 2) LSC+Time limited eating (TLE) (16-hour fast/8-hour feed for 3 days per week) + blinded CGM

Behavioral: Low sugar and carbohydrate dietBehavioral: Time Limited EatingDevice: Continuous Glucose Monitor

LSC+TLE+ real time feedback via CGM

EXPERIMENTAL

Group 3) LSC+TLE+ real time feedback via CGM (to evaluate effect of providing CGM data on intervention efficacy).

Behavioral: Low sugar and carbohydrate dietBehavioral: Time Limited EatingDevice: Continuous Glucose Monitor

Interventions

Low sugar and carbohydrate dietBEHAVIORAL

Low sugar and carbohydrate diet (LSC, \<90 gm carbohydrate (CHO)/day, \<25 gm added sugar/day)

Also known as: LSC
LSC + blinded CGMLSC+TLE + blinded CGMLSC+TLE+ real time feedback via CGM
Time Limited EatingBEHAVIORAL

16-hour fast/8-hour feed for 3 days per week

Also known as: TLE
LSC+TLE + blinded CGMLSC+TLE+ real time feedback via CGM
Continuous Glucose MonitorDEVICE

CGM (used to monitor adherence and glycemic outcomes without real time feedback)

Also known as: CGM
LSC + blinded CGMLSC+TLE + blinded CGMLSC+TLE+ real time feedback via CGM

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age 14-18
  • BMI\> 85th percentile
  • parent, guardian or family member ages 18 years and older willing to participate

You may not qualify if:

  • Insulin requirement
  • previous diagnosis of Prader Willi Syndrome, brain tumor or hypothalamic obesity
  • serious mental conditions (e.g. developmental or intellectual disability or previously diagnosed eating disorder or positive screen at consent visit)
  • physical, mental of other inability to participate in the assessments (e.g. inability to wear CGM, inability to be in the imaging modality without sedation, or inability to eat by mouth)
  • previous or planned bariatric surgery
  • current use of medication that impacts weight or executive functioning (e.g., antipsychotics, sedatives, hypnotics, off-label obesity medication)
  • current psychotherapy regarding weight or eating behavior
  • current participation in other interventional studies. In our experience, children younger than 13 years of age and older than 21 years would require different intervention/counseling strategies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

Related Publications (2)

  • Naguib MN, Hegedus E, Raymond JK, Goran MI, Salvy SJ, Wee CP, Durazo-Arvizu R, Moss L, Vidmar AP. Continuous Glucose Monitoring in Adolescents With Obesity: Monitoring of Glucose Profiles, Glycemic Excursions, and Adherence to Time Restricted Eating Programs. Front Endocrinol (Lausanne). 2022 Feb 25;13:841838. doi: 10.3389/fendo.2022.841838. eCollection 2022.

    PMID: 35282464DERIVED

  • Vidmar AP, Goran MI, Naguib M, Fink C, Wee CP, Hegedus E, Lopez K, Gonzalez J, Raymond JK. Time limited eating in adolescents with obesity (time LEAd): Study protocol. Contemp Clin Trials. 2020 Aug;95:106082. doi: 10.1016/j.cct.2020.106082. Epub 2020 Jul 16.

    PMID: 32682994DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Alaina Vidmar, MD
Organization
Children's Hospital Los Angeles
avidmar@chla.usc.edu
323-361-3385

Study Officials

  • Alaina Vidmar, MD

    Children's Hospital Los Angeles

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
Assistant Professor of Clinical Pediartrics

Study Record Dates

First Submitted

May 15, 2019

First Posted

May 17, 2019

Study Start

March 1, 2020

Primary Completion

January 30, 2022

Study Completion

March 1, 2022

Last Updated

March 4, 2024

Results First Posted

April 6, 2023

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)