- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02741908
Fixed Diet Plan and Calorie Counting Diet in Adolescents
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
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).
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 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.
|
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실험적: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Z-score body mass index
기간: 24 weeks
|
24 weeks
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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