TREPO: TREating Pediatric Obesity

Sponsor

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (Other)

Overall Status

Recruiting

CT.gov ID

NCT05124847

Collaborator

(none)

Enrollment

Location

Arms

21.1

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main aim of the study is to collect preliminary information on the feasibility and efficacy of a time restricted eating intervention in Spanish children and adolescents with obesity and metabolic comorbidities. Two 8-week interventions will performed in a randomized crossover controlled design: a) reduction of the habitual eating window; b) standard care. Different measurements of body composition and cardiometabolic health markers will be performed along those weeks.

Condition or Disease	Intervention/Treatment	Phase
Infant Obesity Hepatic Steatosis Metabolic Syndrome Insulin Resistance Dyslipidemias	Behavioral: Standard Care Behavioral: Time restricted eating	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Time Restricted Eating as a Treatment for Pediatric Obesity

Actual Study Start Date :

Sep 27, 2021

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TRE-Control	Behavioral: Standard Care Participants will receive nutritional education sessions and will be instructed to maintain an intake window of at least 13 hours a day, preferably every day of the week and in any case at least 6 days a week. Behavioral: Time restricted eating A personalized progression will be established to progressively reduce the intake window during the first 10 days of intervention. After these first 10 days, the participants will be prescribed to limit food intake to a maximum of 10 hours a day, at least 5 days a week. Participant can freely select the time of day to place the intake window. However, it will be recommended to avoid making the last intake in the 3 hours before going to bed. After 4 weeks of intervention, the dietitian will invite them to reduce the intake window to 9 or 8 hours, if they consider it feasible, maintaining this new intake window during the last 4 weeks of intervention. The intake window can be maintained at 10 hours until the end of the study.
Experimental: Control-TRE	Behavioral: Standard Care Participants will receive nutritional education sessions and will be instructed to maintain an intake window of at least 13 hours a day, preferably every day of the week and in any case at least 6 days a week. Behavioral: Time restricted eating A personalized progression will be established to progressively reduce the intake window during the first 10 days of intervention. After these first 10 days, the participants will be prescribed to limit food intake to a maximum of 10 hours a day, at least 5 days a week. Participant can freely select the time of day to place the intake window. However, it will be recommended to avoid making the last intake in the 3 hours before going to bed. After 4 weeks of intervention, the dietitian will invite them to reduce the intake window to 9 or 8 hours, if they consider it feasible, maintaining this new intake window during the last 4 weeks of intervention. The intake window can be maintained at 10 hours until the end of the study.

Arm

Intervention/Treatment

Experimental: TRE-Control

Behavioral: Standard Care

Participants will receive nutritional education sessions and will be instructed to maintain an intake window of at least 13 hours a day, preferably every day of the week and in any case at least 6 days a week.

Behavioral: Time restricted eating

A personalized progression will be established to progressively reduce the intake window during the first 10 days of intervention. After these first 10 days, the participants will be prescribed to limit food intake to a maximum of 10 hours a day, at least 5 days a week. Participant can freely select the time of day to place the intake window. However, it will be recommended to avoid making the last intake in the 3 hours before going to bed. After 4 weeks of intervention, the dietitian will invite them to reduce the intake window to 9 or 8 hours, if they consider it feasible, maintaining this new intake window during the last 4 weeks of intervention. The intake window can be maintained at 10 hours until the end of the study.

Experimental: Control-TRE

Behavioral: Standard Care

Behavioral: Time restricted eating

Outcome Measures

Primary Outcome Measures

Length of eating window [From week 0 to week 8]
Body weight [week 8]
Body fat mass [week 8]
Lipid profile [week 8]
HOMA-IR [week 8]
Hepatic steatosis [week 8]
Carotid intima-media thickness [week 8]
Continuous glucose monitoring [From week 6 to week 8]

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age between 10 and 15 at the start of the study.
Obesity defined according to the criteria of the World Health Organization (BMI≥p95) and at least one of the following conditions:

2.1. Hepatic steatosis confirmed by abdominal ultrasound in the previous 12 months.

2.2. Triglycerides> 150 mg/dl, confirmed in analytical determination in the 4 weeks prior to the start of the study.

2.3. HDL cholesterol <40 mg/dl, confirmed in analytical determination in the 4 weeks prior to the start of the study.

2.4. LDL cholesterol> 135 mg/dl, confirmed in analytical determination in the 4 weeks prior to the start of the study.

2.5. Insulin resistance, determined by elevated HOMA-IR confirmed by analytical determination in the 4 weeks prior to the start of the study.

Habitual eating window equal to or greater than 13 hours, with a response rate greater than 85%. Habitual eating window will be determined by self-registration during the screening process. Participants must properly record the habitual eating window in at least 12 of the 14 days that self-registration will be requested, and it must be equal to or greather than 13 hours at least 6 days a week.
Reporting to have maintained a stable weight and height status during the last two months (changes of less than 2 points in BMI (kg / m2)).
Agreement to participate in all phases and procedures of the study.

Exclusion Criteria:

Being diagnosed with an endocrine disorder, for example, diabetes mellitus under treatment with insulin or oral antidiabetics, thyroid disease, hypercortisolism, congenital adrenal hyperplasia.
Being diagnosed with a chronic digestive, rheumatological, neurological, cardiological, pneumological, autoimmune or infectious disease that affects energy metabolism.
Having undergone a surgical procedure that chronically alternates digestive or metabolic function.
Hypercholesterolemia requiring pharmacological treatment according to the Expert Consensus of the European Society of Arteriosclerosis specific to children.
Serum triglyceride concentration> 500 mg/dl.
Systolic or diastolic blood pressure values equal to or greater than the specific 95th percentile for age, sixth, and height, on 3 different occasions [42].
Hypertransaminasemia> 200 IU / L (5 times higher than the upper normal value in the laboratory), which would make it necessary to rule out other causes of liver disease.
Being diagnosed with an eating disorder or being at risk of developing these disorders, determined using the SCOFF questionnaire (two or more questions answered positively).
Presenting neurological alterations or chromosomopathies.
Consuming drugs or supplements that are likely to alter energy metabolism.
Being participating in a nutritional intervention or treatment of any kind, or having done so during the previous 3 months.
Having a demonstrable personal or professional relationship with any of the members of the investigation team.
Any other condition that in the opinion of the research team would contraindicate their participation.