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CompletedNCT02741908Updated Apr 18, 2016

Fixed Diet Plan and Calorie Counting Diet in Adolescents

An interventional study of Calorie counting diet and Fixed diet plan in Pediatric Obesity, sponsored by MARCIO CORRÊA MANCINI. Completed. Open to participants aged 12 Years to 15 Years. Per ClinicalTrials.gov, last updated 2016-04-18.

Sponsored by MARCIO CORRÊA MANCINI · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
12 Years to 15 Years
Sex
All
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Study summary

Obesity is a chronic illness and multifactorial etiology, related to genetic factors, environmental and behavioral. Features association with several metabolic abnormalities in childhood, leading to increased risk of cardiovascular disease in adult life. The treatment involves lifestyle change, with balanced diet guidance and encouraging physical activity. The treatment in this age group have brought limited data, in addition to high drop-out rates. A unique type of food guidance is the equivalent calorie count, where calories are converted into points. The objective of this study was to evaluate the variance of Z score of body mass index (ZIMC) of obese adolescents undergoing orientation of two groups of low-calorie diet: traditional and based on the points system, as well as evaluate anthropometric variables, body composition, food intake, metabolic changes and self-monitoring.

METHODS: randomized clinical study with duration of 24 weeks, with 66 adolescents with an average age of 13.7 ± 0.7 years of both genders, with scores of BMI >= 2 to \<= 4 curve adjusted for gender and age of the World Health Organization. Were verified weight, height, blood pressure and waist circumference, intensity of physical activity and self- monitoring, as well as performed the nutritional guidance to each visit. Laboratory parameters, applying the scale of binge eating, pubertal, stage and body composition were evaluated at the beginning and end of the action. The patients were divided into two groups: one that received guidance of traditional low-calorie diet and meet the food consumption record (RCA), three days (Group A) and another that received low-calorie diet guidance based on the system of points and meet the daily RCA (Group B).

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Conditions studied

  • Pediatric Obesity

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In context

Pediatric Obesity

1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.

This study's enrollment of 66 is below the median of 103 across 862 interventional studies indexed under Pediatric Obesity.

Browse Pediatric Obesity studies →

Lead sponsor

This is the only study on the registry with MARCIO CORRÊA MANCINI as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 12 to 15 years old
  • ZBMI ≥+2.0 according to World Health Organization

Exclusion criteria

Exclusion Criteria:

  • ZBMI≥+4
  • obesity related to genetic syndromes
  • End-organ damage
  • Taking drugs that promote weight changes
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    Fixed diet plan

    Patients received a fixed diet plan to assist in the choice of foods aimed at changing eating behavior. Dietary intake was evaluated by using 3 nonconsecutive 24-hour dietary recalls collected at each visit. Received a reduction of 500 calories in the total energy expenditure calculated by the equation predicted by Dietary Reference Intake (DRI) from the Institute of Medicine (2005). Also received qualitative information regarding healthy food behaviours, by a same dietitian, based on the DRI for Acceptable Macronutrient Ranges, appropriated for age and gender.

    Behavioral: Fixed diet plan

  • Experimental
    Calorie counting diet

    Patients underwent a calorie counting diet, in which each patient has received a table list with equivalent points for food and drinks, and was instructed to record all daily food or drink intake and calculate the total score of points consumed (1 point = 3.6 calories). They were allowed to eat any food but were limited to the recommended amount of points (or calories equivalents). Received a reduction of 500 calories in the total energy expenditure calculated by the equation predicted by Dietary Reference Intake (DRI) from the Institute of Medicine (2005). Also received qualitative information regarding healthy food behaviours, by a same dietitian, based on the DRI for Acceptable Macronutrient Ranges, appropriated for age and gender.

    Behavioral: Calorie counting diet

Interventions

  • BehavioralCalorie counting diet
  • BehavioralFixed diet plan
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What researchers measure

Primary outcomes

  1. Z-score body mass index

    Time frame: 24 weeks

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02741908
Lead sponsor
MARCIO CORRÊA MANCINI
Responsible party
MARCIO CORRÊA MANCINI (Head of the Obesity and Metabolic Syndrome Unit at the Department of Endocrinology and Metabolism, University of Sao Paulo) — Sponsor-investigator
First posted
Apr 18, 2016
Start date
Jul 2011
Primary completion
Jun 2013
Completion
Dec 2013
Last update
Apr 18, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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