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

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ClinicalTrials.gov Identifier: NCT03954223
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : February 17, 2021
Sponsor:
Information provided by (Responsible Party):
Alaina P. Vidmar, MD, Children's Hospital Los Angeles

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).

Condition or disease Intervention/treatment Phase
Obesity, Childhood Behavioral: Low sugar and carbohydrate diet Behavioral: Time Limited Eating Device: Continuous Glucose Monitor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Time Limited Eating in Adolescents (Time LEAd): a Pilot Study
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : January 30, 2022
Estimated Study Completion Date : August 30, 2023

Arm Intervention/treatment
Experimental: LSC + blinded CGM
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 diet
Low sugar and carbohydrate diet (LSC, <90 gm carbohydrate (CHO)/day, <25 gm added sugar/day)
Other Name: LSC

Device: Continuous Glucose Monitor
CGM (used to monitor adherence and glycemic outcomes without real time feedback)
Other Name: CGM

Experimental: LSC+TLE + blinded CGM
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 diet
Low sugar and carbohydrate diet (LSC, <90 gm carbohydrate (CHO)/day, <25 gm added sugar/day)
Other Name: LSC

Behavioral: Time Limited Eating
16-hour fast/8-hour feed for 3 days per week
Other Name: TLE

Device: Continuous Glucose Monitor
CGM (used to monitor adherence and glycemic outcomes without real time feedback)
Other Name: CGM

Experimental: LSC+TLE+ real time feedback via CGM
Group 3) LSC+TLE+ real time feedback via CGM (to evaluate effect of providing CGM data on intervention efficacy).
Behavioral: Low sugar and carbohydrate diet
Low sugar and carbohydrate diet (LSC, <90 gm carbohydrate (CHO)/day, <25 gm added sugar/day)
Other Name: LSC

Behavioral: Time Limited Eating
16-hour fast/8-hour feed for 3 days per week
Other Name: TLE

Device: Continuous Glucose Monitor
CGM (used to monitor adherence and glycemic outcomes without real time feedback)
Other Name: CGM




Primary Outcome Measures :
  1. Change in Total Body Fat [ Time Frame: Baseline compared to week 13. ]
    Affect of dietary intervention on decrease in total body fat measured via DEXA scan.

  2. Change in BMI [ Time Frame: Baseline compared to week 13. ]
    Affect of dietary intervention on decrease in BMI z -score compared to baseline.


Secondary Outcome Measures :
  1. Beta cell dysfunction [ Time Frame: Baseline compared to week 13. ]
    Affect of dietary intervention on beta cell function as assessed fasting blood glucose level



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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age 14-18
  2. BMI> 85th percentile
  3. parent, guardian or family member ages 18 years and older willing to participate

Exclusion Criteria:

  • Insulin requirement

    1. previous diagnosis of Prader Willi Syndrome, brain tumor or hypothalamic obesity
    2. serious mental conditions (e.g. developmental or intellectual disability or previously diagnosed eating disorder or positive screen at consent visit)
    3. 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)
    4. previous or planned bariatric surgery
    5. current use of medication that impacts weight or executive functioning (e.g., antipsychotics, sedatives, hypnotics, off-label obesity medication)
    6. current psychotherapy regarding weight or eating behavior
    7. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03954223


Contacts
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Contact: Alaina Vidmar, MD 323-361-3385 avidmar@chla.usc.edu
Contact: Michael Goran, pHD 323-361-8571 mgoran@chla.usc.edu

Locations
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United States, California
Children's Hospital of Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Alaina P Vidmar, MD    323-361-3385    avidmar@chla.usc.edu   
Sponsors and Collaborators
Children's Hospital Los Angeles
Investigators
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Principal Investigator: Alaina Vidmar, MD Children's Hospital Los Angeles
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alaina P. Vidmar, MD, Assistant Professor of Clinical Pediartrics, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT03954223    
Other Study ID Numbers: CHLA-19-00193
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight