Obesity, Adolescent, Obesity, Childhood
Conditions
Keywords
Obesity, Time restricted feeding
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.
Interventions
BEHAVIORALLifestyle intervention
Lifestyle intervention (usual treatment for patients with obesity). The behavioral intervention will last for 2 months.
BEHAVIORALTRF intervention
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.
Sponsors
Fundació Sant Joan de Déu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 Adiposity | Baseline, 2 months, 1 year, 2 year | Adiposity will be measured by bioimpedance |
| 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 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 blood pressure | Baseline, 2 months, 1 year, 2 year | Both systolic and diastolic blood pressure will be measure at every time point |
| 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. |
Countries
Spain
Outcome results
None listed