CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Standard Care +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05124847
NCT05124847N/ACompleted

Time Restricted Eating as a Treatment for Pediatric Obesity

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud·interventional·Posted Nov 18, 2021·Updated Feb 6, 2024

In Brief

A clinical study evaluating Standard Care and Time restricted eating for Infant Obesity and 4 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedNov 18, 2021
Enrollment StartSep 27, 2021
Primary CompletionJun 30, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 4.6 years ago

Interventions

Standard Carebehavioral

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 eatingbehavioral

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.