Infant ObesityTREPONCT05124847

TREating Pediatric Obesity

A study testing Time restricted eating in people with Infant Obesity and Hepatic Steatosis, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 10 to 15 years
Conditions the study is for: Infant Obesity, Hepatic Steatosis, Metabolic Syndrome
What is being tested?: Time restricted eating
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteSpain
Study dates: 27 Sep 2021to 30 Jun 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 15 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Show all 10Show fewer

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.

Who cannot join

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].

Show all 13Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Regional Universitario de Málaga. Hospital Materno-Infantil.
Málaga, 29011

Other trials in Spain

About this study

Official title: Time Restricted Eating as a Treatment for Pediatric Obesity

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.

Conditions: Infant Obesity, Hepatic Steatosis, Metabolic Syndrome, Insulin Resistance, Dyslipidemias
Being tested: Standard Care, Time restricted eating
Medical subject headings: Pediatric Obesity, Fatty Liver, Metabolic Syndrome, Insulin Resistance, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard CareBehavioural
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 eatingBehavioural
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.

Study groups in NCT05124847
Study group	Role	What they receive
TRE-Control	Experimental	Not described Receives: Behavioral: Standard Care; Behavioral: Time restricted eating
Control-TRE	Experimental	Not described Receives: Behavioral: Standard Care; Behavioral: Time restricted eating

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Sep 202130 Jun 2023

First posted18 Nov 2021
Study start27 Sep 2021
Primary completion30 Jun 2023
Study completion30 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (68)Papers the sponsor has linked to this study.
Other trials for Infant ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05124847
Sponsor's protocol ID: TREPO
Acronym: TREPO
Status last verified: Oct 2021
First submitted: 8 Nov 2021
Last updated: 6 Feb 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Freedman DS, Sherry B. The validity of BMI as an indicator of body fatness and risk among children. Pediatrics. 2009 Sep;124 Suppl 1:S23-34. doi: 10.1542/peds.2008-3586E.
PubMed 19720664
Barlow SE; Expert Committee. Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report. Pediatrics. 2007 Dec;120 Suppl 4:S164-92. doi: 10.1542/peds.2007-2329C.
PubMed 18055651
Gregg EW, Shaw JE. Global Health Effects of Overweight and Obesity. N Engl J Med. 2017 Jul 6;377(1):80-81. doi: 10.1056/NEJMe1706095. Epub 2017 Jun 12. No abstract available.
PubMed 28604226
GBD 2015 Obesity Collaborators; Afshin A, Forouzanfar MH, Reitsma MB, Sur P, Estep K, Lee A, Marczak L, Mokdad AH, Moradi-Lakeh M, Naghavi M, Salama JS, Vos T, Abate KH, Abbafati C, Ahmed MB, Al-Aly Z, Alkerwi A, Al-Raddadi R, Amare AT, Amberbir A, Amegah AK, Amini E, Amrock SM, Anjana RM, Arnlov J, Asayesh H, Banerjee A, Barac A, Baye E, Bennett DA, Beyene AS, Biadgilign S, Biryukov S, Bjertness E, Boneya DJ, Campos-Nonato I, Carrero JJ, Cecilio P, Cercy K, Ciobanu LG, Cornaby L, Damtew SA, Dandona L, Dandona R, Dharmaratne SD, Duncan BB, Eshrati B, Esteghamati A, Feigin VL, Fernandes JC, Furst T, Gebrehiwot TT, Gold A, Gona PN, Goto A, Habtewold TD, Hadush KT, Hafezi-Nejad N, Hay SI, Horino M, Islami F, Kamal R, Kasaeian A, Katikireddi SV, Kengne AP, Kesavachandran CN, Khader YS, Khang YH, Khubchandani J, Kim D, Kim YJ, Kinfu Y, Kosen S, Ku T, Defo BK, Kumar GA, Larson HJ, Leinsalu M, Liang X, Lim SS, Liu P, Lopez AD, Lozano R, Majeed A, Malekzadeh R, Malta DC, Mazidi M, McAlinden C, McGarvey ST, Mengistu DT, Mensah GA, Mensink GBM, Mezgebe HB, Mirrakhimov EM, Mueller UO, Noubiap JJ, Obermeyer CM, Ogbo FA, Owolabi MO, Patton GC, Pourmalek F, Qorbani M, Rafay A, Rai RK, Ranabhat CL, Reinig N, Safiri S, Salomon JA, Sanabria JR, Santos IS, Sartorius B, Sawhney M, Schmidhuber J, Schutte AE, Schmidt MI, Sepanlou SG, Shamsizadeh M, Sheikhbahaei S, Shin MJ, Shiri R, Shiue I, Roba HS, Silva DAS, Silverberg JI, Singh JA, Stranges S, Swaminathan S, Tabares-Seisdedos R, Tadese F, Tedla BA, Tegegne BS, Terkawi AS, Thakur JS, Tonelli M, Topor-Madry R, Tyrovolas S, Ukwaja KN, Uthman OA, Vaezghasemi M, Vasankari T, Vlassov VV, Vollset SE, Weiderpass E, Werdecker A, Wesana J, Westerman R, Yano Y, Yonemoto N, Yonga G, Zaidi Z, Zenebe ZM, Zipkin B, Murray CJL. Health Effects of Overweight and Obesity in 195 Countries over 25 Years. N Engl J Med. 2017 Jul 6;377(1):13-27. doi: 10.1056/NEJMoa1614362. Epub 2017 Jun 12.
PubMed 28604169
Swinburn BA, Sacks G, Hall KD, McPherson K, Finegood DT, Moodie ML, Gortmaker SL. The global obesity pandemic: shaped by global drivers and local environments. Lancet. 2011 Aug 27;378(9793):804-14. doi: 10.1016/S0140-6736(11)60813-1.
PubMed 21872749
Albaladejo-Vicente R, Villanueva-Orbaiz R, Carabantes-Alarcon D, Santos-Sancho J, Jimenez-Garcia R, Regidor E. Reversal of the Upward Trend of Obesity in Boys, but Not in Girls, in Spain. Int J Environ Res Public Health. 2021 Feb 14;18(4):1842. doi: 10.3390/ijerph18041842.
PubMed 33672817
Geserick M, Vogel M, Gausche R, Lipek T, Spielau U, Keller E, Pfaffle R, Kiess W, Korner A. Acceleration of BMI in Early Childhood and Risk of Sustained Obesity. N Engl J Med. 2018 Oct 4;379(14):1303-1312. doi: 10.1056/NEJMoa1803527.
PubMed 30281992
Perng W, Hajj H, Belfort MB, Rifas-Shiman SL, Kramer MS, Gillman MW, Oken E. Birth Size, Early Life Weight Gain, and Midchildhood Cardiometabolic Health. J Pediatr. 2016 Jun;173:122-130.e1. doi: 10.1016/j.jpeds.2016.02.053. Epub 2016 Mar 16.
PubMed 26995700
Armstrong S, Li JS, Skinner AC. Flattening the (BMI) Curve: Timing of Child Obesity Onset and Cardiovascular Risk. Pediatrics. 2020 Aug;146(2):e20201353. doi: 10.1542/peds.2020-1353. Epub 2020 Jul 6. No abstract available.
PubMed 32632022
Andes LJ, Cheng YJ, Rolka DB, Gregg EW, Imperatore G. Prevalence of Prediabetes Among Adolescents and Young Adults in the United States, 2005-2016. JAMA Pediatr. 2020 Feb 1;174(2):e194498. doi: 10.1001/jamapediatrics.2019.4498. Epub 2020 Feb 3.
PubMed 31790544
Hartman C, Rennert HS, Rennert G, Elenberg Y, Zuckerman E. Prevalence of elevated liver enzymes and comorbidities in children and adolescents with overweight and obesity. Acta Paediatr. 2021 Mar;110(3):985-992. doi: 10.1111/apa.15469. Epub 2020 Jul 28.
PubMed 32649794
Lycett K, Juonala M, Magnussen CG, Norrish D, Mensah FK, Liu R, Clifford SA, Carlin JB, Olds T, Saffery R, Kerr JA, Ranganathan S, Baur LA, Sabin MA, Cheung M, Dwyer T, Liu M, Burgner D, Wake M. Body Mass Index From Early to Late Childhood and Cardiometabolic Measurements at 11 to 12 Years. Pediatrics. 2020 Aug;146(2):e20193666. doi: 10.1542/peds.2019-3666. Epub 2020 Jul 6.
PubMed 32632021
Spear BA, Barlow SE, Ervin C, Ludwig DS, Saelens BE, Schetzina KE, Taveras EM. Recommendations for treatment of child and adolescent overweight and obesity. Pediatrics. 2007 Dec;120 Suppl 4:S254-88. doi: 10.1542/peds.2007-2329F.
PubMed 18055654
Styne DM, Arslanian SA, Connor EL, Farooqi IS, Murad MH, Silverstein JH, Yanovski JA. Pediatric Obesity-Assessment, Treatment, and Prevention: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2017 Mar 1;102(3):709-757. doi: 10.1210/jc.2016-2573.
PubMed 28359099
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.
PubMed 17845100

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Infant Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Time Restricted Eating as a Treatment for Pediatric Obesity
ClinicalTrials.gov ID: NCT05124847
Acronym / sponsor ID: TREPO / TREPO
Conditions: Infant Obesity, Hepatic Steatosis, Metabolic Syndrome, Insulin Resistance, Dyslipidemias
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
Study start: 27 Sep 2021 (actual)
Primary completion: 30 Jun 2023 (actual)
Study completion: 30 Jun 2023 (actual)
First posted: 18 Nov 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
TRE-Control	Experimental	Behavioral: Standard Care, Behavioral: Time restricted eating
Control-TRE	Experimental	Behavioral: Standard Care, Behavioral: Time restricted eating

Who may qualify

Ages: 10 to 15 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (10 listed)

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.

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Standard CareParticipants 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.	Behavioural	Control-TRE, TRE-Control
Time restricted eatingA 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.	Behavioural	Control-TRE, TRE-Control

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
Background: PubMed 19720664Freedman DS, Sherry B. The validity of BMI as an indicator of body fatness and risk among children. Pediatrics. 2009 Sep;124 Suppl 1:S23-34. doi: 10.1542/peds.2008-3586E.
Background: PubMed 18055651Barlow SE; Expert Committee. Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report. Pediatrics. 2007 Dec;120 Suppl 4:S164-92. doi: 10.1542/peds.2007-2329C.
Background: PubMed 28604226Gregg EW, Shaw JE. Global Health Effects of Overweight and Obesity. N Engl J Med. 2017 Jul 6;377(1):80-81. doi: 10.1056/NEJMe1706095. Epub 2017 Jun 12. No abstract available.
Background: PubMed 28604169GBD 2015 Obesity Collaborators; Afshin A, Forouzanfar MH, Reitsma MB, Sur P, Estep K, Lee A, Marczak L, Mokdad AH, Moradi-Lakeh M, Naghavi M, Salama JS, Vos T, Abate KH, Abbafati C, Ahmed MB, Al-Aly Z, Alkerwi A, Al-Raddadi R, Amare AT, Amberbir A, Amegah AK, Amini E, Amrock SM, Anjana RM, Arnlov J, Asayesh H, Banerjee A, Barac A, Baye E, Bennett DA, Beyene AS, Biadgilign S, Biryukov S, Bjertness E, Boneya DJ, Campos-Nonato I, Carrero JJ, Cecilio P, Cercy K, Ciobanu LG, Cornaby L, Damtew SA, Dandona L, Dandona R, Dharmaratne SD, Duncan BB, Eshrati B, Esteghamati A, Feigin VL, Fernandes JC, Furst T, Gebrehiwot TT, Gold A, Gona PN, Goto A, Habtewold TD, Hadush KT, Hafezi-Nejad N, Hay SI, Horino M, Islami F, Kamal R, Kasaeian A, Katikireddi SV, Kengne AP, Kesavachandran CN, Khader YS, Khang YH, Khubchandani J, Kim D, Kim YJ, Kinfu Y, Kosen S, Ku T, Defo BK, Kumar GA, Larson HJ, Leinsalu M, Liang X, Lim SS, Liu P, Lopez AD, Lozano R, Majeed A, Malekzadeh R, Malta DC, Mazidi M, McAlinden C, McGarvey ST, Mengistu DT, Mensah GA, Mensink GBM, Mezgebe HB, Mirrakhimov EM, Mueller UO, Noubiap JJ, Obermeyer CM, Ogbo FA, Owolabi MO, Patton GC, Pourmalek F, Qorbani M, Rafay A, Rai RK, Ranabhat CL, Reinig N, Safiri S, Salomon JA, Sanabria JR, Santos IS, Sartorius B, Sawhney M, Schmidhuber J, Schutte AE, Schmidt MI, Sepanlou SG, Shamsizadeh M, Sheikhbahaei S, Shin MJ, Shiri R, Shiue I, Roba HS, Silva DAS, Silverberg JI, Singh JA, Stranges S, Swaminathan S, Tabares-Seisdedos R, Tadese F, Tedla BA, Tegegne BS, Terkawi AS, Thakur JS, Tonelli M, Topor-Madry R, Tyrovolas S, Ukwaja KN, Uthman OA, Vaezghasemi M, Vasankari T, Vlassov VV, Vollset SE, Weiderpass E, Werdecker A, Wesana J, Westerman R, Yano Y, Yonemoto N, Yonga G, Zaidi Z, Zenebe ZM, Zipkin B, Murray CJL. Health Effects of Overweight and Obesity in 195 Countries over 25 Years. N Engl J Med. 2017 Jul 6;377(1):13-27. doi: 10.1056/NEJMoa1614362. Epub 2017 Jun 12.
Background: PubMed 21872749Swinburn BA, Sacks G, Hall KD, McPherson K, Finegood DT, Moodie ML, Gortmaker SL. The global obesity pandemic: shaped by global drivers and local environments. Lancet. 2011 Aug 27;378(9793):804-14. doi: 10.1016/S0140-6736(11)60813-1.
Background: PubMed 33672817Albaladejo-Vicente R, Villanueva-Orbaiz R, Carabantes-Alarcon D, Santos-Sancho J, Jimenez-Garcia R, Regidor E. Reversal of the Upward Trend of Obesity in Boys, but Not in Girls, in Spain. Int J Environ Res Public Health. 2021 Feb 14;18(4):1842. doi: 10.3390/ijerph18041842.
Background: PubMed 30281992Geserick M, Vogel M, Gausche R, Lipek T, Spielau U, Keller E, Pfaffle R, Kiess W, Korner A. Acceleration of BMI in Early Childhood and Risk of Sustained Obesity. N Engl J Med. 2018 Oct 4;379(14):1303-1312. doi: 10.1056/NEJMoa1803527.
Background: PubMed 26995700Perng W, Hajj H, Belfort MB, Rifas-Shiman SL, Kramer MS, Gillman MW, Oken E. Birth Size, Early Life Weight Gain, and Midchildhood Cardiometabolic Health. J Pediatr. 2016 Jun;173:122-130.e1. doi: 10.1016/j.jpeds.2016.02.053. Epub 2016 Mar 16.
Background: PubMed 32632022Armstrong S, Li JS, Skinner AC. Flattening the (BMI) Curve: Timing of Child Obesity Onset and Cardiovascular Risk. Pediatrics. 2020 Aug;146(2):e20201353. doi: 10.1542/peds.2020-1353. Epub 2020 Jul 6. No abstract available.
Background: PubMed 31790544Andes LJ, Cheng YJ, Rolka DB, Gregg EW, Imperatore G. Prevalence of Prediabetes Among Adolescents and Young Adults in the United States, 2005-2016. JAMA Pediatr. 2020 Feb 1;174(2):e194498. doi: 10.1001/jamapediatrics.2019.4498. Epub 2020 Feb 3.
Background: PubMed 32649794Hartman C, Rennert HS, Rennert G, Elenberg Y, Zuckerman E. Prevalence of elevated liver enzymes and comorbidities in children and adolescents with overweight and obesity. Acta Paediatr. 2021 Mar;110(3):985-992. doi: 10.1111/apa.15469. Epub 2020 Jul 28.
Background: PubMed 32632021Lycett K, Juonala M, Magnussen CG, Norrish D, Mensah FK, Liu R, Clifford SA, Carlin JB, Olds T, Saffery R, Kerr JA, Ranganathan S, Baur LA, Sabin MA, Cheung M, Dwyer T, Liu M, Burgner D, Wake M. Body Mass Index From Early to Late Childhood and Cardiometabolic Measurements at 11 to 12 Years. Pediatrics. 2020 Aug;146(2):e20193666. doi: 10.1542/peds.2019-3666. Epub 2020 Jul 6.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rafael Martín Masot, MD PhD principal investigator

Hospital Regional Universitario de Málaga. Hospital Materno-Infantil.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Length of eating window (time frame: From week 0 to week 8). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05124847, which also lists 68 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.