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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active control | Active Comparator | 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 |
|
| Time-Restricted Feeding | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle intervention | Behavioral | Lifestyle intervention (usual treatment for patients with obesity). The behavioral intervention will last for 2 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year, 2 year |
| Change in Adiposity |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gut microbiota | Fecal samples will be obtained at every time-point and gut microbiota composition analyzed. | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sant Joan de Deu | Barcelona | Barcelona | 08950 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36386926 | Derived | Molina-Giraldo P, Murillo S, Meis L, Sans O, Amat-Bou M, Llobet M, Jimenez-Chillaron JC, Ramon-Krauel M, Lerin C. A time-restricted feeding intervention in children and adolescents with obesity: The TRansForm study protocol. Front Nutr. 2022 Oct 26;9:1026694. doi: 10.3389/fnut.2022.1026694. eCollection 2022. |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D009765 | Obesity |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| TRF intervention | Behavioral | 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. |
|
Adiposity will be measured by bioimpedance
| 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. | 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. | Baseline, 2 months, 1 year, 2 year |
| Change in blood pressure | Both systolic and diastolic blood pressure will be measure at every time point | 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. | Baseline, 2 months, 1 year, 2 year |
| Baseline, 2 months, 1 year, 2 year |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |