Time-Restricted Feeding in Children and Adolescents With Obesity (TRansForm)

January 4, 2022 updated by: Fundació Sant Joan de Déu
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08950
        • Recruiting
        • Hospital Sant Joan de Deu
        • Contact:
        • Contact:
          • Marta Ramon Krauel, MD PhD
          • Phone Number: 71263 (+34) 93 280 40 00
          • Email: marta.ramon@sjd.es
        • Sub-Investigator:
          • Marta Ramon Krauel, MD PhD
        • Principal Investigator:
          • Carles Lerin, PhD
        • Sub-Investigator:
          • Paula Molina, MD
        • Sub-Investigator:
          • Serafín Murillo, Nutr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Obesity (BMI z score > 2)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active control
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
Lifestyle intervention (usual treatment for patients with obesity). The behavioral intervention will last for 2 months.
Experimental: Time-Restricted Feeding
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 intervention
Lifestyle intervention (usual treatment for patients with obesity). The behavioral intervention will last for 2 months.
Behavioral: TRF intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BMI z score
Time Frame: Baseline, 2 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BMI z score (follow-up)
Time Frame: 1 year, 2 year
Weight and height will be combined to calculate BMI. The World Health Organization growth charts will be used to calculate BMI z scores.
1 year, 2 year
Change in Adiposity
Time Frame: Baseline, 2 months, 1 year, 2 year
Adiposity will be measured by bioimpedance
Baseline, 2 months, 1 year, 2 year
Change in glucose metabolism
Time Frame: Baseline, 2 months, 1 year, 2 year
Fasting blood test will performed at each time point to analyze glucose metabolism, including glucose, HbA1c, and insulin levels.
Baseline, 2 months, 1 year, 2 year
Change in lipid profile
Time Frame: Baseline, 2 months, 1 year, 2 year
Fasting blood test will performed at each time point to analyze the lipid profile, including triglycerides, total cholesterol, LDL-cholesterol, and HDL-cholesterol.
Baseline, 2 months, 1 year, 2 year
Change in blood pressure
Time Frame: Baseline, 2 months, 1 year, 2 year
Both systolic and diastolic blood pressure will be measure at every time point
Baseline, 2 months, 1 year, 2 year
Change in dietary composition
Time Frame: Baseline, 2 months, 1 year, 2 year
A 4-day food registry will be analyzed at every time point to determine daily energy, macronutrient and micronutrient intake.
Baseline, 2 months, 1 year, 2 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in gut microbiota
Time Frame: Baseline, 2 months, 1 year, 2 year
Fecal samples will be obtained at every time-point and gut microbiota composition analyzed.
Baseline, 2 months, 1 year, 2 year
Change in circadian rhythm
Time Frame: Baseline, 2 months, 1 year, 2 year
The circadian rhythm will be measured with an ActTrust actigraph (Condor Instruments) that participants will wear for 2 weeks before each time point.
Baseline, 2 months, 1 year, 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Sant Joan de Déu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

December 14, 2021

First Submitted That Met QC Criteria

December 14, 2021

First Posted (Actual)

January 3, 2022

Study Record Updates

Last Update Posted (Actual)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 4, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIC-130-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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