Time-Restricted Feeding in Children and Adolescents With Obesity (TRansForm)

Fundació Sant Joan de Déu

Status: Active, not recruiting

Conditions: Obesity, Adolescent; Obesity, Childhood

Treatments: Behavioral: Lifestyle intervention; Behavioral: TRF intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05174871

PIC-130-21

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 2 patient groups

Active control

Active Comparator group

Description:

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

Treatment:

Behavioral: Lifestyle intervention

Time-Restricted Feeding

Experimental group

Description:

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.

Treatment:

Behavioral: TRF intervention

Behavioral: Lifestyle intervention