NCT05174871

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Jan 2022Jun 2026

First Submitted

Initial submission to the registry

December 14, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 3, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

January 4, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

December 14, 2021

Last Update Submit

March 19, 2026

Conditions

Obesity, ChildhoodObesity, Adolescent

Keywords

ObesityTime restricted feeding

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Change in BMI z score (follow-up)

    1 year, 2 year

  • Change in Adiposity

    Baseline, 2 months, 1 year, 2 year

  • Change in glucose metabolism

    Baseline, 2 months, 1 year, 2 year

  • Change in lipid profile

    Baseline, 2 months, 1 year, 2 year

  • Change in blood pressure

    Baseline, 2 months, 1 year, 2 year

  • +1 more secondary outcomes

Other Outcomes (2)

  • Change in gut microbiota

    Baseline, 2 months, 1 year, 2 year

  • Change in circadian rhythm

    Baseline, 2 months, 1 year, 2 year

Study Arms (2)

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

Behavioral: Lifestyle intervention

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.

Behavioral: Lifestyle interventionBehavioral: TRF intervention

Interventions

TRF interventionBEHAVIORAL

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.

Time-Restricted Feeding
Lifestyle interventionBEHAVIORAL

Lifestyle intervention (usual treatment for patients with obesity). The behavioral intervention will last for 2 months.

Active controlTime-Restricted Feeding

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Obesity (BMI z score \> 2)

You may not qualify if:

  • Bariatric surgery
  • Spontaneous time-restricted feeding for \> 12 hours
  • Diabetes with insulin treatment
  • Pregnancy
  • Intellectual disability
  • Under drug treatment with a prescription change in the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Sant Joan de Deu

Barcelona, Barcelona, 08950, Spain

Location

Related Publications (1)

  • 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.

    PMID: 36386926DERIVED

MeSH Terms

Conditions

Pediatric ObesityObesityIntermittent Fasting

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFastingFeeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2021

First Posted

January 3, 2022

Study Start

January 4, 2022

Primary Completion

May 31, 2023

Study Completion (Estimated)

June 30, 2026

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)