N/A
N=50
Time Limited Eating in Adolescents (Time LEAd): a Pilot Study
Obesity, Childhood
Bottom Line
View on ClinicalTrials.gov: NCT03954223 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Percent Change in BMI in Excess of the 95th Percentile (%BMIp95) — -3.27; -3.76; -4.85 percent — p=0.4
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Low sugar and carbohydrate diet (Behavioral); Time Limited Eating (Behavioral); Continuous Glucose Monitor (Device)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Los Angeles
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in BMI in Excess of the 95th Percentile (%BMIp95) |
-3.27; -3.76; -4.85 | 0.4 |
| SECONDARY Average Glucose |
0.5; -7.1; -4.2 | 0.2 |
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).
Eligibility Criteria
Inclusion Criteria
- age 14-18
- BMI> 85th percentile
- parent, guardian or family member ages 18 years and older willing to participate
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03954223). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.