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Completed

NCT Number: NCT02741908

Fixed Diet Plan and Calorie Counting Diet in Adolescents

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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Key information

Age range

12 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Calorie counting diet

Behavioral

Fixed diet plan

Behavioral

Primary outcomes

  1. Z-score body mass index

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

MARCIO CORRÊA MANCINI

Other

Registry information

Official study title

Effects of Two Diet Techniques and Delivery Mode on Weight Loss, Metabolic Profile and Food Intake of Obese Adolescents: a Fixed Diet Plan and a Calorie Counting Diet

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 18, 2016
Registry last updated
Apr 18, 2016

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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