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OpenTrials
Active, Not Recruiting

NCT Number: NCT05174871

Time-Restricted Feeding in Children and Adolescents With Obesity

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obesity, Childhood Behavior Body Weight Fasting Feeding Behavior Intermittent Fasting Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Adolescent Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sant Joan de Deu

Barcelona, 08950, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Intervention

Behavioral

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

TRF intervention

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Change in Adiposity

    Time frame: Baseline, 2 months, 1 year, 2 year

    Adiposity will be measured by bioimpedance

  3. 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.

  4. 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.

  5. 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

  6. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Fundació Sant Joan de Déu

Other

Registry information

Acronym: TRansForm

Important dates

Study start
2022
Primary completion
2023
Study completion
2026
First posted
Jan 3, 2022
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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