TREating Pediatric Obesity

Metabolic Syndrome Clinical Trial

— TREPO  

Official title:

Time Restricted Eating as a Treatment for Pediatric Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05124847
• Other study ID #: TREPO
• Status: Completed
• Phase: N/A
• Start date: September 27, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2021
• Source: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 15 Years

Eligibility

Inclusion Criteria:

1. Age between 10 and 15 at the start of the study.

2. 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.

3. 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.

4. 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)).

5. Agreement to participate in all phases and procedures of the study.

Exclusion Criteria:

1. Being diagnosed with an endocrine disorder, for example, diabetes mellitus under treatment with insulin or oral antidiabetics, thyroid disease, hypercortisolism, congenital adrenal hyperplasia.

2. Being diagnosed with a chronic digestive, rheumatological, neurological, cardiological, pneumological, autoimmune or infectious disease that affects energy metabolism.

3. Having undergone a surgical procedure that chronically alternates digestive or metabolic function.

4. Hypercholesterolemia requiring pharmacological treatment according to the Expert Consensus of the European Society of Arteriosclerosis specific to children.

5. Serum triglyceride concentration> 500 mg/dl.

6. 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].

7. 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.

8. 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).

9. Presenting neurological alterations or chromosomopathies.

10. Consuming drugs or supplements that are likely to alter energy metabolism.

11. Being participating in a nutritional intervention or treatment of any kind, or having done so during the previous 3 months.

12. Having a demonstrable personal or professional relationship with any of the members of the investigation team.

13. Any other condition that in the opinion of the research team would contraindicate their participation.

Related Conditions & MeSH terms

• Dyslipidemias
• Fatty Liver
• Hepatic Steatosis
• Infant Obesity
• Insulin Resistance
• Metabolic Syndrome
• Obesity
• Pediatric Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Regional Universitario de Málaga. Hospital Materno-Infantil.	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Country where clinical trial is conducted

Spain, 

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Wiegman A, Gidding SS, Watts GF, Chapman MJ, Ginsberg HN, Cuchel M, Ose L, Averna M, Boileau C, Boren J, Bruckert E, Catapano AL, Defesche JC, Descamps OS, Hegele RA, Hovingh GK, Humphries SE, Kovanen PT, Kuivenhoven JA, Masana L, Nordestgaard BG, Pajukanta P, Parhofer KG, Raal FJ, Ray KK, Santos RD, Stalenhoef AF, Steinhagen-Thiessen E, Stroes ES, Taskinen MR, Tybjaerg-Hansen A, Wiklund O; European Atherosclerosis Society Consensus Panel. Familial hypercholesterolaemia in children and adolescents: gaining decades of life by optimizing detection and treatment. Eur Heart J. 2015 Sep 21;36(36):2425-37. doi: 10.1093/eurheartj/ehv157. Epub 2015 May 25. — View Citation

Wilfley DE, Tibbs TL, Van Buren DJ, Reach KP, Walker MS, Epstein LH. Lifestyle interventions in the treatment of childhood overweight: a meta-analytic review of randomized controlled trials. Health Psychol. 2007 Sep;26(5):521-32. doi: 10.1037/0278-6133.26.5.521. — View Citation

* Note: There are 68 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of eating window		From week 0 to week 8
Primary	Body weight		week 8
Primary	Body fat mass		week 8
Primary	Lipid profile		week 8
Primary	HOMA-IR		week 8
Primary	Hepatic steatosis		week 8
Primary	Carotid intima-media thickness		week 8
Primary	Continuous glucose monitoring		From week 6 to week 8

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