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A time-restricted feeding intervention in children and adolescents with obesity: The TRansForm study protocol
Paula Molina-Giraldo1, Serafin Murillo1, Laura Meis1
1Department of Endocrinology, Institut de Recerca Sant Joan de Déu, Hospital Sant Joan de Déu, Barcelona, Spain.
Insights
Time-restricted feeding (TRF) shows promise for treating childhood obesity, potentially improving metabolic health. This study evaluates TRF
Area of Science:
- Pediatric Endocrinology
- Metabolic Health
- Chronobiology
Background:
- Childhood obesity is a significant public health concern, tracking into adulthood and increasing risk for metabolic disorders.
- Time-restricted feeding (TRF) is a potential obesity treatment strategy, but its effects in pediatric populations are unknown.
- Understanding the impact of TRF on children's health is crucial for developing effective interventions.
Purpose of the Study:
- To determine the short- and long-term safety and effectiveness of time-restricted feeding (TRF) in children and adolescents with obesity.
- To investigate potential mechanisms, including circadian rhythm and gut microbiota, mediating the response to TRF.
- To provide evidence for TRF as a viable obesity management strategy in pediatric populations.
Main Methods:
- A randomized-controlled parallel-group clinical study involving children and adolescents (8-18 years) with obesity.
- Participants will be assigned to either a TRF group or a control group (no time restrictions) for 2 months.
- Measurements include anthropometric (BMI, body composition), metabolic parameters, circadian rhythm indicators, and gut microbiota analysis, with long-term follow-up.
Main Results:
- This section is to be filled upon study completion.
- Data analysis will focus on changes in weight, body composition, and metabolic markers.
- Exploration of correlations between TRF, circadian rhythm, and gut microbiome shifts will be conducted.
Conclusions:
- This study will establish the safety and efficacy of TRF for pediatric obesity.
- Long-term effects and underlying biological mechanisms of TRF will be elucidated.
- Findings may support the integration of TRF into clinical practice for managing childhood obesity.
Abstract:
Obesity during childhood is of special concern as adiposity is typically tracked into adult life and it constitutes a major risk factor for future obesity and associated metabolic disorders. Recent studies indicate that time-restricted feeding (TRF) interventions may provide a promising strategy for obesity treatment. However, TRF interventions have only been tested in adult subjects. This study aims to determine both short- and long-term effects of a TRF intervention in children and adolescents with obesity. We will also investigate potential mechanisms mediating the response to the intervention, including the circadian rhythm and the gut microbiota composition. We have designed a randomized-controlled parallel-group clinical study in which children and adolescents (age range 8-18 year-old) with obesity will be subjected to time-restricted eating or no time restrictions for 2 months. Follow-up visits will allow for long-term effect assessments. We will measure anthropometric (BMI, body composition) and metabolic parameters (glucose and lipid metabolism), indicators of the circadian rhythm, and gut microbiota composition will be analyzed. This study will (1) determine safety and effectiveness of the TRF intervention in children and adolescents; (2) assess its long-term effects; and (3) evaluate potential mechanisms involved in the response to the intervention.
Clinical Trial Registration:
[www.ClinicalTrials.gov], identifier [NCT05174871].
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