NCT05124847

TREating Pediatric Obesity

Time Restricted Eating as a Treatment for Pediatric Obesity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Academic / Other
• Sex: All
• Age: 10 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

The main aim of the study is to collect preliminary information on the feasibility and efficacy of a time restricted eating intervention in Spanish children and adolescents with obesity and metabolic comorbidities. Two 8-week interventions will performed in a randomized crossover controlled design: a) reduction of the habitual eating window; b) standard care. Different measurements of body composition and cardiometabolic health markers will be performed along those weeks.

Conditions

• Infant Obesity
• Hepatic Steatosis
• Metabolic Syndrome
• Insulin Resistance
• Dyslipidemias

Interventions

Type	Name	Description
BEHAVIORAL	Standard Care	Participants will receive nutritional education sessions and will be instructed to maintain an intake window of at least 13 hours a day, preferably every day of the week and in any case at least 6 days a week.
BEHAVIORAL	Time restricted eating	A personalized progression will be established to progressively reduce the intake window during the first 10 days of intervention. After these first 10 days, the participants will be prescribed to limit food intake to a maximum of 10 hours a day, at least 5 days a week. Participant can freely select the time of day to place the intake window. However, it will be recommended to avoid making the last intake in the 3 hours before going to bed. After 4 weeks of intervention, the dietitian will invite them to reduce the intake window to 9 or 8 hours, if they consider it feasible, maintaining this new intake window during the last 4 weeks of intervention. The intake window can be maintained at 10 hours until the end of the study.

Timeline

• Start date: 2021-09-27
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2021-11-18
• Last updated: 2024-02-06

Locations

1 site across 1 country: Spain