Fixed Diet Plan and Calorie Counting Diet in Adolescents

Pediatric Obesity Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02741908
• Other study ID #: 0037/11
• Status: Completed
• Phase: N/A
• First received: April 13, 2016
• Last updated: April 15, 2016
• Start date: July 2011
• Est. completion date: December 2013

Study information

• Verified date: April 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pediatric Obesity

Intervention

Behavioral:
• Calorie counting diet

• Fixed diet plan

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MARCIO CORRÊA MANCINI

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Z-score body mass index		24 weeks	No