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- Ensaio Clínico 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).
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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Experimental: 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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Z-score body mass index
Prazo: 24 weeks
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24 weeks
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 0037/11
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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