Time-Restricted Feeding in Children and Adolescents With Obesity

Overview

This study will evaluate the effectiveness of a 2-month time-restricted feeding (TRF) intervention in children and adolescents with obesity. The investigators will determine whether the potential beneficial effects of the intervention in this population are maintained over time. Furthermore, potential mechanisms mediating TRF effects will be explored, specifically focusing on the potential role of the gut microbiome and the circadian rhythm.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2022

Interventions

  • Behavioral: Lifestyle intervention
    • Lifestyle intervention (usual treatment for patients with obesity). The behavioral intervention will last for 2 months.
  • Behavioral: TRF intervention
    • Food intake restricted to 8 hours per day during the window between 10h and 22h. Time restricted feeding will take place 6 days per week, with the seventh day unrestricted. The intervention will last for 2 months.

Arms, Groups and Cohorts

  • Active Comparator: Active control
    • Participants in this arm will receive the usual treatment for obesity at our hospital, based on lifestyle changes (encouraging a healthy diet and physical activity) for 2 months
  • Experimental: Time-Restricted Feeding
    • Participants in this arm will receive the usual treatment for obesity at our hospital, based on lifestyle changes (encouraging a healthy diet and physical activity) for 2 months. During this time, participants will have their feeding time restricted to 8 hours per day.

Clinical Trial Outcome Measures

Primary Measures

  • Change in BMI z score
    • Time Frame: Baseline, 2 months
    • Weight and height will be combined to calculate BMI. The World Health Organization growth charts will be used to calculate BMI z scores.

Secondary Measures

  • Change in BMI z score (follow-up)
    • Time Frame: 1 year, 2 year
    • Weight and height will be combined to calculate BMI. The World Health Organization growth charts will be used to calculate BMI z scores.
  • Change in Adiposity
    • Time Frame: Baseline, 2 months, 1 year, 2 year
    • Adiposity will be measured by bioimpedance
  • Change in glucose metabolism
    • Time Frame: Baseline, 2 months, 1 year, 2 year
    • Fasting blood test will performed at each time point to analyze glucose metabolism, including glucose, HbA1c, and insulin levels.
  • Change in lipid profile
    • Time Frame: Baseline, 2 months, 1 year, 2 year
    • Fasting blood test will performed at each time point to analyze the lipid profile, including triglycerides, total cholesterol, LDL-cholesterol, and HDL-cholesterol.
  • Change in blood pressure
    • Time Frame: Baseline, 2 months, 1 year, 2 year
    • Both systolic and diastolic blood pressure will be measure at every time point
  • Change in dietary composition
    • Time Frame: Baseline, 2 months, 1 year, 2 year
    • A 4-day food registry will be analyzed at every time point to determine daily energy, macronutrient and micronutrient intake.

Participating in This Clinical Trial

Inclusion Criteria

  • Obesity (BMI z score > 2) Exclusion Criteria:

  • Bariatric surgery – Spontaneous time-restricted feeding for > 12 hours – Diabetes with insulin treatment – Pregnancy – Intellectual disability – Under drug treatment with a prescription change in the last 3 months

Gender Eligibility: All

Minimum Age: 8 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fundació Sant Joan de Déu
  • Provider of Information About this Clinical Study
    • Sponsor

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