An interventional study of Lifestyle intervention and TRF intervention in Obesity, Childhood and Obesity, Adolescent, sponsored by Fundació Sant Joan de Déu. Active, not recruiting at 1 site in Spain. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-03-23.
Sponsored by Fundació Sant Joan de Déu · Not applicable, Interventional, and Treatment
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.
1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.
This study's enrollment of 67 is below the median of 103 across 862 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →Fundació Sant Joan de Déu is the lead sponsor of 68 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 · Behavioral: TRF intervention
Lifestyle intervention (usual treatment for patients with obesity). The behavioral intervention will last for 2 months.
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.
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.
Time frame: Baseline, 2 months
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.
Time frame: 1 year, 2 year
Change in Adiposity
Adiposity will be measured by bioimpedance
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 2 months, 1 year, 2 year
Change in blood pressure
Both systolic and diastolic blood pressure will be measure at every time point
Time frame: 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.
Time frame: Baseline, 2 months, 1 year, 2 year
Change in gut microbiota
Fecal samples will be obtained at every time-point and gut microbiota composition analyzed.
Time frame: Baseline, 2 months, 1 year, 2 year
Change in circadian rhythm
The circadian rhythm will be measured with an ActTrust actigraph (Condor Instruments) that participants will wear for 2 weeks before each time point.
Time frame: Baseline, 2 months, 1 year, 2 year
Plan to share: No
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Fundació Sant Joan de Déu