Alaina P Vidmar1, Michael I Goran2, Monica Naguib2, Cassandra Fink2, Choo Phei Wee3, Elizabeth Hegedus2, Kelleen Lopez2, Janelle Gonzalez2, Jennifer K Raymond2. 1. Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States of America. Electronic address: avidmar@chla.usc.edu. 2. Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States of America. 3. CTSI Biostatics Core, Saban Research Institute, Los Angeles, CA, United States of America.
Abstract
BACKGROUND: Time limited eating (TLE) has been shown to be effective for weight loss and improvement of glycemic control in adults with obesity and type 2 diabetes (T2D), but has not been well studied in adolescents. TLE may be a more feasible, flexible and effective dietary intervention for adolescents because it removes the need for intensive counting of calories or macronutrients, and emphasizes eating during a specified time period. OBJECTIVES: The aim of this study is to assess the feasibility of a TLE approach in adolescents with obesity using acontinuous glucose monitor (CGM) to promote adherence to the intervention. METHODS: We propose a prospective, randomized controlled trial, in 60 adolescents (ages 14-18) with obesity (BMI% ≥ 95th percentile). Youth will be randomized to one of three treatment groups for a 12-week intervention: Group 1) Low sugar and carbohydrate education (LSC, 5% of total daily calories from sugar (<35 g)/day; <90 g carbohydrate (CHO)/day) + blinded CGM (used to monitor adherence and glycemic outcomes without real time feedback), Group 2) LSC + TLE (16-h fast/8-h feed for 5 days per week) + blinded CGM, and Group 3) LSC + TLE+ real time feedback via CGM (to evaluate effect of providing CGM data on intervention efficacy). Outcomes will include change in total body fat (TBF) percentage measured on DEXA scan, BMI status and fasting blood glucose at 12 weeks compared to baseline. CONCLUSIONS:TLE is a potentially powerful lifestyle intervention that could be readily integrated into pediatric weight management programs to optimize their impact and accelerate healthy changes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03954223.
RCT Entities:
BACKGROUND: Time limited eating (TLE) has been shown to be effective for weight loss and improvement of glycemic control in adults with obesity and type 2 diabetes (T2D), but has not been well studied in adolescents. TLE may be a more feasible, flexible and effective dietary intervention for adolescents because it removes the need for intensive counting of calories or macronutrients, and emphasizes eating during a specified time period. OBJECTIVES: The aim of this study is to assess the feasibility of a TLE approach in adolescents with obesity using a continuous glucose monitor (CGM) to promote adherence to the intervention. METHODS: We propose a prospective, randomized controlled trial, in 60 adolescents (ages 14-18) with obesity (BMI% ≥ 95th percentile). Youth will be randomized to one of three treatment groups for a 12-week intervention: Group 1) Low sugar and carbohydrate education (LSC, 5% of total daily calories from sugar (<35 g)/day; <90 g carbohydrate (CHO)/day) + blinded CGM (used to monitor adherence and glycemic outcomes without real time feedback), Group 2) LSC + TLE (16-h fast/8-h feed for 5 days per week) + blinded CGM, and Group 3) LSC + TLE+ real time feedback via CGM (to evaluate effect of providing CGM data on intervention efficacy). Outcomes will include change in total body fat (TBF) percentage measured on DEXA scan, BMI status and fasting blood glucose at 12 weeks compared to baseline. CONCLUSIONS:TLE is a potentially powerful lifestyle intervention that could be readily integrated into pediatric weight management programs to optimize their impact and accelerate healthy changes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03954223.
Authors: Alaina P Vidmar; Monica Naguib; Jennifer K Raymond; Sarah Jeanne Salvy; Elizabeth Hegedus; Choo Phei Wee; Michael I Goran Journal: Nutrients Date: 2021-10-21 Impact factor: 5.717
Authors: Monica N Naguib; Elizabeth Hegedus; Jennifer K Raymond; Michael I Goran; Sarah-Jeanne Salvy; Choo Phei Wee; Ramon Durazo-Arvizu; Lilith Moss; Alaina P Vidmar Journal: Front Endocrinol (Lausanne) Date: 2022-02-25 Impact factor: 5.555
Authors: Jared M Tucker; Robert Siegel; Pamela J Murray; Joan C Han; Katherine Boyer; Nichole Reed; Taylor Allenby; Marsha Novick Journal: Front Endocrinol (Lausanne) Date: 2022-04-21 Impact factor: 6.055