search
Back to results

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

Primary Purpose

Obesity, Childhood, Obesity, Adolescent

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Lifestyle intervention
TRF intervention
Sponsored by
Fundació Sant Joan de Déu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Childhood focused on measuring Obesity, Time restricted feeding

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Sant Joan de DeuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Active control

Time-Restricted Feeding

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 14, 2021
Last Updated
January 4, 2022
Sponsor
Fundació Sant Joan de Déu
search

1. Study Identification

Unique Protocol Identification Number
NCT05174871
Brief Title
Time-Restricted Feeding in Children and Adolescents With Obesity
Acronym
TRansForm
Official Title
Time-Restricted Feeding in Children and Adolescents With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Sant Joan de Déu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood, Obesity, Adolescent
Keywords
Obesity, Time restricted feeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active control
Arm Type
Active Comparator
Arm Description
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
Arm Title
Time-Restricted Feeding
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention
Intervention Description
Lifestyle intervention (usual treatment for patients with obesity). The behavioral intervention will last for 2 months.
Intervention Type
Behavioral
Intervention Name(s)
TRF intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in BMI z score
Description
Weight and height will be combined to calculate BMI. The World Health Organization growth charts will be used to calculate BMI z scores.
Time Frame
Baseline, 2 months
Secondary Outcome Measure Information:
Title
Change in BMI z score (follow-up)
Description
Weight and height will be combined to calculate BMI. The World Health Organization growth charts will be used to calculate BMI z scores.
Time Frame
1 year, 2 year
Title
Change in Adiposity
Description
Adiposity will be measured by bioimpedance
Time Frame
Baseline, 2 months, 1 year, 2 year
Title
Change in glucose metabolism
Description
Fasting blood test will performed at each time point to analyze glucose metabolism, including glucose, HbA1c, and insulin levels.
Time Frame
Baseline, 2 months, 1 year, 2 year
Title
Change in lipid profile
Description
Fasting blood test will performed at each time point to analyze the lipid profile, including triglycerides, total cholesterol, LDL-cholesterol, and HDL-cholesterol.
Time Frame
Baseline, 2 months, 1 year, 2 year
Title
Change in blood pressure
Description
Both systolic and diastolic blood pressure will be measure at every time point
Time Frame
Baseline, 2 months, 1 year, 2 year
Title
Change in dietary composition
Description
A 4-day food registry will be analyzed at every time point to determine daily energy, macronutrient and micronutrient intake.
Time Frame
Baseline, 2 months, 1 year, 2 year
Other Pre-specified Outcome Measures:
Title
Change in gut microbiota
Description
Fecal samples will be obtained at every time-point and gut microbiota composition analyzed.
Time Frame
Baseline, 2 months, 1 year, 2 year
Title
Change in circadian rhythm
Description
The circadian rhythm will be measured with an ActTrust actigraph (Condor Instruments) that participants will wear for 2 weeks before each time point.
Time Frame
Baseline, 2 months, 1 year, 2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Sant Joan de Deu
City
Barcelona
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carles Lerin, PhD
Phone
(+34) 93 600 97 51
Ext
4427
Email
carles.lerin@sjd.es
First Name & Middle Initial & Last Name & Degree
Marta Ramon Krauel, MD PhD
Phone
(+34) 93 280 40 00
Ext
71263
Email
marta.ramon@sjd.es
First Name & Middle Initial & Last Name & Degree
Marta Ramon Krauel, MD PhD
First Name & Middle Initial & Last Name & Degree
Carles Lerin, PhD
First Name & Middle Initial & Last Name & Degree
Paula Molina, MD
First Name & Middle Initial & Last Name & Degree
Serafín Murillo, Nutr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36386926
Citation
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.
Results Reference
derived

Learn more about this trial

Time-Restricted Feeding in Children and Adolescents With Obesity

We'll reach out to this number within 24 hrs