Obesity, ChildhoodTRansFormNCT05174871
Time-Restricted Feeding in Children and Adolescents With Obesity
A study testing Lifestyle intervention and TRF intervention in people with Obesity, Childhood and Obesity, Adolescent, run by Fundació Sant Joan de Déu at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Obesity, Childhood, Obesity, Adolescent
- What is being tested?
- Lifestyle intervention and TRF intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteSpain
- Study dates
- 4 Jan 2022to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Obesity (BMI z score > 2)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Obesity, Childhood, Obesity, Adolescent
- Being tested
- Lifestyle intervention, TRF intervention
- Keywords
- Obesity, Time restricted feeding
- Medical subject headings
- Pediatric Obesity, Obesity, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionBehavioural
Lifestyle intervention (usual treatment for patients with obesity). The behavioral intervention will last for 2 months.
TRF interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Lifestyle intervention; Behavioral: TRF intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2 months
Secondary outcomes (6)
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.
Measured: 1 year, 2 year
Change in Adiposity
Adiposity will be measured by bioimpedance
Measured: Baseline, 2 months, 1 year, 2 year
Change in glucose metabolism
Fasting blood test will performed at each time point to analyze glucose metabolism, including glucose, HbA1c, and insulin levels.
Measured: Baseline, 2 months, 1 year, 2 year
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.
Measured: Baseline, 2 months, 1 year, 2 year
Change in blood pressure
Both systolic and diastolic blood pressure will be measure at every time point
Measured: Baseline, 2 months, 1 year, 2 year
Change in dietary composition
A 4-day food registry will be analyzed at every time point to determine daily energy, macronutrient and micronutrient intake.
Measured: Baseline, 2 months, 1 year, 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start4 Jan 2022
- Primary completion31 May 2023
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174871
- Sponsor's protocol ID
- PIC-130-21
- Acronym
- TRansForm
- Status last verified
- Mar 2026
- First submitted
- 14 Dec 2021
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36386926
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-Restricted Feeding in Children and Adolescents With Obesity
- ClinicalTrials.gov ID
- NCT05174871
- Acronym / sponsor ID
- TRansForm / PIC-130-21
- Conditions
- Obesity, Childhood, Obesity, Adolescent
- Keywords
- Obesity, Time restricted feeding
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 3 Jan 2022 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active control | Active comparator | Behavioral: Lifestyle interventionParticipants 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 |
| Time-Restricted Feeding | Experimental | Behavioral: Lifestyle intervention, Behavioral: TRF interventionParticipants 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Obesity (BMI z score > 2)
Key exclusion criteria (6 listed)
- Bariatric surgery
- Spontaneous time-restricted feeding for > 12 hours
- Diabetes with insulin treatment
- Pregnancy
- Intellectual disability
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 |
|---|---|---|
| Lifestyle interventionLifestyle intervention (usual treatment for patients with obesity). The behavioral intervention will last for 2 months. | Behavioural | Active control, Time-Restricted Feeding |
| TRF interventionFood 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. | Behavioural | Time-Restricted Feeding |
Primary outcome
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.
6 secondary outcomes
Change in BMI z score (follow-up)
Time frame: 1 year, 2 year
Change in Adiposity
Time frame: Baseline, 2 months, 1 year, 2 year
Change in glucose metabolism
Time frame: Baseline, 2 months, 1 year, 2 year
Change in lipid profile
Time frame: Baseline, 2 months, 1 year, 2 year
Change in blood pressure
Time frame: Baseline, 2 months, 1 year, 2 year
Change in dietary composition
Time frame: Baseline, 2 months, 1 year, 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Derived from this study: PubMed 36386926Molina-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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention and TRF intervention in people with Obesity, Childhood and Obesity, Adolescent, run by Fundació Sant Joan de Déu at 1 site in Spain.
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 1 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 23 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in BMI z score (time frame: Baseline, 2 months). 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 NCT05174871, which also lists 1 linked publication.
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 23 Mar 2026.