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The effect of intermittent energy restriction diet on pediatrics obesity

The effect of intermittent energy restriction diet based on meal replacement on changes in body mass index in overweight and obese children: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180721040552N2
Enrollment
60
Registered
2026-01-29
Start date
2025-12-22
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Title: Obesity and Overweight in Children and AdolescentsDescription:Children and adolescents aged 12–18 years with a body mass index (BMI) above the 95th percentile for age and sex or between the 85th and 95th percentiles with at least one comorbidity (based on WHO and CDC criteria). Obesity due to excess calories

Interventions

Intervention 1: Intervention group: In this group, participants received an intermittent energy restriction (IER) diet with a 4:3 pattern. Three days a week (alternating) they followed a very low-calo

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 18 Years

Inclusion criteria

Inclusion criteria: • Children aged 12 to 18 years (based on similar studies (19) and the homogeneity of studies, this age group was selected, and according to the definition of the World Health Organization, the age group of 10 to 19 years is considered adolescence) • Body mass index (BMI) above the 95th percentile for age and sex according to the World Health Organization criteria or between the 85th and 95th percentiles with at least one comorbidity including:- Prediabetes: impaired fasting glucose 5.6 to 6.9 mmol/L and/or impaired glucose tolerance: glucose 2 hours after eating 7.8 to 11.1 mmol/L- Insulin resistance (defined as a fasting insulin (pmol/L)/glucose (mmol/L) ratio > 20- Presence of acanthosis nigricans- High blood pressure (defined as systolic and/or diastolic blood pressure above the 90th percentile for sex, age, and height)- Low HDL cholesterol (defined as <1.03 mmol/L)- High triglycerides (defined as =1.7 mmol/L)- High alanine transaminase (ALT) or gamma-glutamyl transferase (GGT) (defined as ALT or GGT <45 U/L)- Diagnosis of polycystic ovary syndrome Willingness to participate and adherence to the study protocol Written informed consent from parents and verbal assent from children

Exclusion criteria

Exclusion criteria: Obesity due to secondary causes (such as endocrine diseases) Taking medications that affect weight (except metformin if necessary) Participating in other weight loss programs Inability to adhere to the diet Body mass index greater than 140% of the 99th percentile (These children will not be eligible to participate in the study due to the higher risk of developing comorbidities that require additional multidisciplinary specialist care during the trial period)

Design outcomes

Primary

MeasureTime frame
Body mass index. Timepoint: Before intervention and weeks 4, 8, and 12. Method of measurement: Standard scales and height gauges.

Secondary

MeasureTime frame
Body composition. Timepoint: Before intervention and week 12. Method of measurement: tanita BC418.;Biochemical factors include: lipid profile, liver enzymes, glycosylated hemoglobin, insulin, fasting blood sugar. Timepoint: Before intervention and week 12. Method of measurement: Blood test.;Anthropometrics including: waist circumference, hip circumference, and neck circumference. Timepoint: Before intervention and week 12. Method of measurement: Standard tape measure.;Quality of life score. Timepoint: Before intervention and week 12. Method of measurement: Pediatric Quality of Life Questionnaire.;Eating behavior. Timepoint: Before intervention and week 12. Method of measurement: Children’s Eating Behavior Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahdi shekari

Mashhad University of Medical Sciences

shekarim4022@mums.ac.ir+98 51 3882 7034

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026