- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00030160
Strength Training for Obesity Prevention
12 de janeiro de 2010 atualizado por: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Recent obesity prevalence increases have made obesity prevention a clear and pressing public health issue.
The average US.
woman gains about 0.5 kg per year.
Overweight women aged 25 to 44 have a higher prevalence of significant weight gains (BMI increases of > 5 kg/m2) than men or older or thinner women.
The difficulty in successfully losing weight and maintaining weight loss has resulted in recommendations from several expert panels to advise overweight and mildly obese individuals free of co-morbidities to avoid weight gains rather than to lose weight.
Physical activity is observed to decline with age while caloric intake remains stable or declines slightly.
There is strong observational evidence that physical activity could prevent or attenuate age associated fat gains.
This randomized, controlled behavioral intervention trial will test the hypothesis that regular participation in a twice weekly strength training program over 2 years, can prevent age associated body fat increases (total and abdominal fat) in 80 overweight to mildly obese premenopausal women between the ages of 25 and 44 years, compared to a 'standard care' group (n=80).
The overall aim of the study is to prevent body fat gains and to reduce health risks associated with obesity.
Treatment effects will be assessed for insulin sensitivity, blood pressure, blood lipids, muscle strength, and psychosocial predictors of strength training adherence.
The innovation of this approach rests in its simplicity and the minimal time requirement for full participation (2 exercise sessions weekly).
A preliminary study of this innovative approach resulted in 88% exercise session attendance over 12 months and maintenance of treatment effects on total body fat percentage to the end of pilot study measurements (9 months).
This supports the feasibility and potential for long term efficacy of the proposed intervention approach.
The long-term implication of success in this efficacy trial would be that this modest behavior change could prevent the fat gains and associated co-morbidities commonly observed in midlife women.
Visão geral do estudo
Descrição detalhada
Recent obesity prevalence increases have made obesity prevention a clear and pressing public health issue.
The average US.
woman gains about 0.5 kg per year, 60 to 80% of which can be assumed to be fat.
Overweight women aged 25 to 44 have a higher prevalence of significant weight gains (BMI increases of > 5 kg/m2) than men or older or thinner women.
Total and visceral abdominal fat gains are associated with a variety of obesity co-morbidities, including insulin resistance, hypertension, and dyslipidemia.
The difficulty in successfully losing weight and maintaining weight loss has resulted in recommendations from several expert panels to advise overweight and mildly obese individuals free of co-morbidities to avoid weight gains rather than to lose weight.
Physical activity is observed to decline with age while caloric intake remains stable or declines slightly.
There is strong observational evidence that physical activity could prevent or attenuate age associated fat gains.
This randomized, controlled behavioral intervention trial will test the hypothesis that regular participation in a twice weekly strength training program over 2 years, can prevent age associated body fat increases (total and visceral abdominal fat) in 80 overweight to mildly obese premenopausal women (BMI 25-35 kg/m2) between the ages of 25 and 44 years, compared to a 'standard care' group (n=80).
The overall aim of the study is to prevent body fat gains and to reduce health risks associated with obesity.
Treatment effects will be assessed for insulin sensitivity, blood pressure, blood lipids, muscle strength, and psychosocial predictors of strength training adherence.
The innovation of this approach rests in its simplicity and the minimal time requirement for full participation (2 exercise sessions weekly).
A preliminary study of this innovative approach resulted in 88% exercise session attendance over 12 months and maintenance of treatment effects on total body fat percentage to the end of pilot study measurements (9 months).
This supports the feasibility and potential for long term efficacy of the proposed intervention approach.
The long-term implication of success in this efficacy trial would be that this modest behavior change could prevent the fat gains and associated co-morbidities commonly observed in midlife women.
Tipo de estudo
Intervencional
Inscrição
160
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55454
- University of Minnesota, Division of Epidemiology
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
25 anos a 44 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Eligible participants will include women between the ages of 25 and 44, BMI between 25 and 35 (inclusive).
Other inclusion/exclusion criteria:
- Weight stable (<5% body weight change over past year)
- No medical conditions or medications that would prohibit participation in an exercise program or would negatively impact our ability to test our primary aims (e.g. fibromyalgia, chronic fatigue syndrome, metabolic disorders, recent cardiovascular event, orthopedic limitations, any drug expected to impact body weight, psychiatric disorders requiring anti-psychotic drugs)
- Uncontrolled hypertension (systolic blood pressure over 160 and/or diastolic blood pressure over 99)
- No history of cancer within the past 5 years, excepting non-melanoma skin cancers
- Not currently or recently (past 6 months) pregnant
- Not planning to become pregnant during the study period
- Not currently or recently (past 2 months) lactating
- No history of physician diagnosed menstrual irregularities or significant gynecologic conditions (e.g. fibroids, endometriosis)
- Pre-menopausal
- Current non-smokers (for at least the past 2 years)
- Sedentary to modestly physically active (up to 3 sessions weekly of physical activity of no greater intensity than brisk walking) with no history of strength training within the past 6 months
- Not planning to move away from the Twin Cities area over the next 2 years
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de abril de 2002
Conclusão do estudo
1 de julho de 2005
Datas de inscrição no estudo
Enviado pela primeira vez
7 de fevereiro de 2002
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de fevereiro de 2002
Primeira postagem (Estimativa)
8 de fevereiro de 2002
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
13 de janeiro de 2010
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de janeiro de 2010
Última verificação
1 de janeiro de 2010
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Schmitzm (completed)
- 1R01DK060743-01 (Concessão/Contrato do NIH dos EUA)
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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