Time-Restricted Feeding in Children and Adolescents With Obesity

Not Applicable

Active, not recruiting

• Conditions: Obesity, Childhood; Obesity, Adolescent
• Interventions: Behavioral: Lifestyle intervention; Behavioral: TRF intervention

• Registration Number: NCT05174871
• Lead Sponsor: Fundació Sant Joan de Déu

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2021-12-14
• Study First Posted: 2022-01-03
• Study Start: 2022-01-04
• Primary Completion: 2023-05-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-05
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active control	Lifestyle intervention	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
Time-Restricted Feeding	TRF intervention	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.
Time-Restricted Feeding	Lifestyle intervention	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.

Primary Outcome Measures

Name	Time	Method
Change in BMI z score	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 Outcome Measures

Name	Time	Method
Change in BMI z score (follow-up)	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 lipid profile	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 dietary composition	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.
Change in blood pressure	Baseline, 2 months, 1 year, 2 year	Both systolic and diastolic blood pressure will be measure at every time point
Change in glucose metabolism	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 Adiposity	Baseline, 2 months, 1 year, 2 year	Adiposity will be measured by bioimpedance

Trial Locations

Locations (1)

Hospital Sant Joan de Deu; 🇪🇸 Barcelona, Spain