Time-Restricted Feeding in Children and Adolescents With Obesity

Study Overview
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Brief Summary
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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.

Official Title
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Time-Restricted Feeding in Children and Adolescents With Obesity

Conditions
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Obesity, Childhood, Obesity, Adolescent

Intervention / Treatment
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* Behavioral: Lifestyle intervention
* Behavioral: TRF intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active control<br>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 | Behavioral: Lifestyle intervention<br>* Lifestyle intervention (usual treatment for patients with obesity). The behavioral intervention will last for 2 months.<br>|
| Experimental: Time-Restricted Feeding<br>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. | Behavioral: Lifestyle intervention<br>* Lifestyle intervention (usual treatment for patients with obesity). The behavioral intervention will last for 2 months.<br>Behavioral: TRF intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Time restricted feeding