Time Limited Eating in Adolescents (Time LEAd): a Pilot Study
(TimeLEAd Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAlaina Vidmar, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Children's Hospital Los Angeles

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

Research Team

Alaina Vidmar, MD

Principal Investigator

Children's Hospital Los Angeles

Eligibility Criteria

Inclusion Criteria

age 14-18

BMI> 85th percentile

parent, guardian or family member ages 18 years and older willing to participate

Treatment Details

Interventions

Continuous Glucose Monitor (Device)
Low sugar and carbohydrate diet (Behavioral Intervention)
Time Limited Eating (Behavioral Intervention)

Participant Groups

3Treatment groups

Experimental Treatment

Group I: LSC+TLE+ real time feedback via CGMExperimental Treatment3 Interventions

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

Group II: LSC+TLE + blinded CGMExperimental Treatment3 Interventions

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

Group III: LSC + blinded CGMExperimental Treatment2 Interventions

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)