- ICH GCP
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- Ensaio Clínico NCT01997060
Physiological Factors That Influence Maintenance of Lifestyle Changes and Weight Loss - a Longitudinal Study
In Denmark and the western world, there is an increasing prevalence of obesity probably due to a combination of inadequate daily physical activity and a high energy intake. One approach to achieve weight loss and change life style is to participate in an intensive supervised prolonged life style modification course. The immediate effect is often positive, but over time the overall effect is limited as the majority will not maintain weight loss and a changed life style.
The purpose of this study is therefore to characterize the physiological factors that determine/influence the capacity to maintain weight loss and a healthy lifestyle after a prolonged lifestyle intervention.
We have the following research questions:
- Are there physiological traits and characteristics that mediate better adherence to lifestyle changes and weight loss?
- Does the adaptation in muscle oxidative capacity after lifestyle intervention predict success in maintaining weight loss and lifestyle changes 3, 12 and 39 months after intervention?
- How does gender and age influence the capacity to maintain the lifestyle induced adaptation in muscle and adipose tissue and maintaining weight loss?
The study design is a longitudinal intervention and will be based on a lifestyle intervention, as it is practiced in a real life setting at Ubberup folk high school.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Copenhagen, Dinamarca, 2200
- University of Copenhagen, Department of Biomedical Sciences
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Participants at Ubberup Folk High School
Exclusion Criteria:
- Previous Gastric Bypass Surgery or Gastric Banding
- BMI<25
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Intensive Lifestyle Intervention
Intensive Lifestyle Intervention at Ubberup Folk High School for 10-14 weeks.
Daily exercise for 1-3hrs.
Calorie restriction (~-700KCal/day).
Education within nutrition, exercise and healthy living in general.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Total body weight
Prazo: Changes from baseline at 3, 6, 15 and 39 months
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Changes from baseline at 3, 6, 15 and 39 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Maximal fat oxidation during exercise
Prazo: Changes from baseline at 3, 6, 15 and 39 months
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Respiratory Exchange Ratio (RER) is measured and maximal fat oxidation is calculated.
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Changes from baseline at 3, 6, 15 and 39 months
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Anthropometry
Prazo: Changes from baseline at 3, 6, 15 and 39 months
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Body composition measured by dual x-ray absorptiometry or bio-impedance, height, weight, waist circumference.
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Changes from baseline at 3, 6, 15 and 39 months
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Maximal Oxygen Consumption
Prazo: Changes from baseline at 3, 6, 15 and 39 months
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Changes from baseline at 3, 6, 15 and 39 months
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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Adherence to physical activity
Prazo: Changes from baseline at 3, 6, 15 and 39 months
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International Physical Activity Questionaire (IPAQ) to determine adherence to physical activity.
Furthermore we will use diary and ActiHeart (accelerometer).
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Changes from baseline at 3, 6, 15 and 39 months
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Adherence to healthy diet
Prazo: Changes from baseline at 3, 6, 15 and 39 months
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Questionnaire (24hrs dietary recall) and diary to determine adherence to a healthy diet.
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Changes from baseline at 3, 6, 15 and 39 months
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Mitochondria respiration and efficiency
Prazo: Changes from baseline at 3, 6, 15 and 39 months
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Mitochondria respiration and efficiency is measured by Oreboros Oxygraph.
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Changes from baseline at 3, 6, 15 and 39 months
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Blood and plasma substrates, hormones and metabolites
Prazo: Changes from baseline at 3, 6, 15 and 39 months
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HbA1c, insulin, leptin, glucose, adiponectin, thyroid stimulating hormone (TSH), ghrelin
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Changes from baseline at 3, 6, 15 and 39 months
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Muscle lipid composition
Prazo: Changes from baseline at 3, 6, 15 and 39 months
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Muscle lipid composition will be analysed using a lipidomics approach.
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Changes from baseline at 3, 6, 15 and 39 months
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Expression of muscle lipases
Prazo: Changes from baseline at 3, 6, 15 and 39 months
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Western blot analysis will be applied to analyse expression of muscle lipases; hormone sensitive lipase (HSL), adipose triglyceride lipase (ATGL) and lipoprotein lipase (LPL) as well as muscle PAT proteins; PLIN 2 (ADRP), PLIN 3 (TIP47) and PLIN 5 (OXPAT)
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Changes from baseline at 3, 6, 15 and 39 months
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Intramuscular lipid droplet content and size, glycogen content and ceramide content and location
Prazo: Changes from baseline at 3, 6, 15 and 39 months
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Intramuscular lipid droplet content and size, glycogen content and ceramide content and location will be quantified by immunohistochemical staining of serial cryo-sections of muscle tissue samples that are visualized by confocal microscopy
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Changes from baseline at 3, 6, 15 and 39 months
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Adipose tissue macrophage inflammation and cytokine production
Prazo: Changes from baseline at 3, 6, 15 and 39 months
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Changes from baseline at 3, 6, 15 and 39 months
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Motivation for lifestyle changes and sociological factors involved
Prazo: Changes from baseline at 3, 6, 15 and 39 months
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Questionnaires
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Changes from baseline at 3, 6, 15 and 39 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jørn W Helge, PhD, University of Copenhagen, Department of Biomedical Sciences
Publicações e links úteis
Publicações Gerais
- Karlsen TI, Sohagen M, Hjelmesaeth J. Predictors of weight loss after an intensive lifestyle intervention program in obese patients: a 1-year prospective cohort study. Health Qual Life Outcomes. 2013 Oct 3;11:165. doi: 10.1186/1477-7525-11-165.
- McCormack SE, McCarthy MA, Harrington SG, Farilla L, Hrovat MI, Systrom DM, Thomas BJ, Torriani M, McInnis K, Grinspoon SK, Fleischman A. Effects of exercise and lifestyle modification on fitness, insulin resistance, skeletal muscle oxidative phosphorylation and intramyocellular lipid content in obese children and adolescents. Pediatr Obes. 2014 Aug;9(4):281-91. doi: 10.1111/j.2047-6310.2013.00180.x. Epub 2013 Jun 25.
- Danielsen KK, Svendsen M, Maehlum S, Sundgot-Borgen J. Changes in body composition, cardiovascular disease risk factors, and eating behavior after an intensive lifestyle intervention with high volume of physical activity in severely obese subjects: a prospective clinical controlled trial. J Obes. 2013;2013:325464. doi: 10.1155/2013/325464. Epub 2013 Apr 22.
- Bruun JM, Helge JW, Richelsen B, Stallknecht B. Diet and exercise reduce low-grade inflammation and macrophage infiltration in adipose tissue but not in skeletal muscle in severely obese subjects. Am J Physiol Endocrinol Metab. 2006 May;290(5):E961-7. doi: 10.1152/ajpendo.00506.2005. Epub 2005 Dec 13.
- Pedersen JO, Zimmermann E, Stallknecht BM, Bruun JM, Kroustrup JP, Larsen JF, Helge JW. [Lifestyle intervention in the treatment of severe obesity]. Ugeskr Laeger. 2006 Jan 9;168(2):167-72. Danish.
- Bruun JM, Stallknecht B, Helge JW, Richelsen B. Interleukin-18 in plasma and adipose tissue: effects of obesity, insulin resistance, and weight loss. Eur J Endocrinol. 2007 Oct;157(4):465-71. doi: 10.1530/EJE-07-0206.
- Christiansen T, Bruun JM, Madsen EL, Richelsen B. Weight loss maintenance in severely obese adults after an intensive lifestyle intervention: 2- to 4-year follow-up. Obesity (Silver Spring). 2007 Feb;15(2):413-20. doi: 10.1038/oby.2007.530.
- Elsborg P, Elbe AM. Exercise-specific volition and motivation for weight loss maintenance following an intensive lifestyle intervention. Health Psychol. 2018 Aug;37(8):759-766. doi: 10.1037/hea0000636.
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- UBBERUP2
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