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临床试验/NCT02741908
NCT02741908已完成不适用

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

MARCIO CORRÊA MANCINI0 个研究点目标入组 66 人开始时间: 2011年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
主要终点
Z-score body mass index

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 15 Years(Child)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

Fixed diet plan

Experimental

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.

干预措施: Fixed diet plan (Behavioral)

Calorie counting diet

Experimental

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.

干预措施: Calorie counting diet (Behavioral)

结局指标

主要结局

Z-score body mass index

时间窗: 24 weeks

次要结局

未报告次要终点

研究者

发起方
MARCIO CORRÊA MANCINI
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

MARCIO CORRÊA MANCINI

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

University of Sao Paulo

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