Fixed Diet Plan and Calorie Counting Diet in Adolescents

NCT ID: NCT02741908

Last Updated: 2016-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-12-31

Brief 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).

Conditions

Pediatric Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fixed diet plan

Intervention Type: BEHAVIORAL

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.

Group Type: EXPERIMENTAL

Calorie counting diet

Intervention Type: BEHAVIORAL

Interventions

Calorie counting diet

Intervention Type: BEHAVIORAL

Fixed diet plan

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MARCIO CORRÊA MANCINI

OTHER

Sponsor Role: lead

Responsible Party

MARCIO CORRÊA MANCINI

Head of the Obesity and Metabolic Syndrome Unit at the Department of Endocrinology and Metabolism

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

0037/11

Identifier Type: -

Identifier Source: org_study_id