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Comparison of Supervised and Unsupervised Physical Activity Programs During a Weight Loss Intervention for Adults (REACH)

27 de novembro de 2018 atualizado por: John M. Jakicic, PhD, University of Pittsburgh

Comparison of Supervised and Unsupervised Physical Activity Programs During a Standard Behavioral Weight Loss Intervention for Adults Who Are Overweight or Obese

Adults who are overweight or obese are typically prescribed a calorie-restricted diet and physical activity to promote weight loss and improve health. The manner in which physical activity is prescribed and monitored may influence physical activity engagement. Within the context of clinical research, physical activity has been prescribed in either a supervised or unsupervised manner. Supervised physical activity is typically done in a health-fitness facility under the direct supervision of trained staff. The alternative, unsupervised physical activity, promotes physical activity participation in a setting that is convenient to the individual. Unsupervised activity can be done in any environment or at any time that best suits the individual. Knowing the effects of unsupervised physical activity is important because of the translation of this type of physical activity to non-research settings. Therefore, knowing the magnitude of the physiological effects of unsupervised physical activity compared to supervised physical activity at the same prescribed intensity and dose is of clinical and public health importance. This study is designed to provide insight on these important research questions that can inform future research and the application to clinical, public health, and health-fitness settings.

Visão geral do estudo

Descrição detalhada

Approximately 69% of the U.S. adult population is overweight, defined by a body mass index (BMI) of ≥ 25.0 kg/m2, and 35% are obese (BMI ≥ 30.0 kg/m2), with the prevalence of overweight and obesity rising drastically over the past several decades. Adults who are overweight or obese are typically recommended to change lifestyle factors (e.g. diet, physical activity, etc.) to lose weight and improve health. When evaluating the effects of these lifestyle changes on weight and health in a research setting, physical activity is supervised (i.e. physical activity completed in a health-fitness facility with direct supervision from trained staff). With supervised physical activity, researchers are able to quantify the frequency, intensity, duration, and type of physical activity. Thus, supervised physical activity is considered the gold-standard when evaluating the effects of physical activity on weight and other physiological parameters. However, the results of supervised physical activity trials may not translate to clinical settings. A typical clinical approach prescribes physical activity in an unsupervised manner (i.e. physician tells patient to be more physically active or take more steps/day). Unsupervised physical activity can be done in any environment or at any time that best suits the individual. Knowing the effects of unsupervised physical activity is important because of the translation of this type of physical activity to non-research settings. Therefore, knowing the magnitude of the physiological effects of unsupervised physical activity compared to supervised physical activity at the same prescribed intensity and dose is of clinical and public health importance especially in an overweight and obese population. This study is designed to provide insight on these important research questions that can inform future research and the application to clinical, public health, and health-fitness settings.

Participants will be randomized to one of three groups: supervised physical activity prescribed in min/week (SUP-PA), unsupervised physical activity prescribed in min/week (UNSUP-PA), and unsupervised physical activity prescribed in steps/day (STEP). Participants in all three groups will participate in a behavioral weight loss intervention which includes dietary counseling and weekly group sessions during the 12-week program. SUP-PA will be prescribed 150 minutes/week of moderate-to-vigorous physical activity (MVPA) completed under direct supervision of trained staff at a designated health-fitness facility. UNSUP-PA will be prescribed a physical activity dose matched to SUP-PA. STEP will be prescribed a 10,000 step/day recommendation with 2,500 of those steps completed at a "brisk" pace. The primary aim of this study is to compare the effects of all three groups on moderate-to-vigorous physical activity (MVPA) accumulated in bouts of at least 10 minutes. The primary outcome will be assessed at baseline, week 4, week 8, and week 12. Secondary aims of this trial include comparing light intensity physical activity, sedentary time, cardiorespiratory fitness, weight, body composition, waist circumference measures, physical activity self-efficacy, blood pressure, and dietary intake across all three groups. Secondary aims will be assessed at baseline and week 12.

Tipo de estudo

Intervencional

Inscrição (Real)

52

Estágio

  • Não aplicável

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

    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15261
        • Physical Activity and Weight Management Research Center

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

18 anos a 55 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Male or Female
  • Aged 18-55 years old
  • BMI of 25.0 to <40.0 kg/m2
  • Ability to provide informed consent
  • Ability to provide physician's clearance to participate in a weight loss intervention

Exclusion Criteria:

  • Engaging in >60 min/wk (accumulated in bouts of ≥10 minutes) of moderate-to-vigorous physical activity over the past month
  • Presence of contraindications to physical activity as identified on a physical activity readiness questionnaire (PAR-Q)
  • History of metabolic, cardiac, or pulmonary disease that classifies the individual as high risk by the American College of Sports Medicine (e.g., coronary heart disease, diabetes mellitus, uncontrolled hypertension, etc.)
  • History of myocardial infarction, coronary bypass surgery, angioplasty, or other cardiovascular- related surgeries.
  • Taking medication that may affect heart rate or blood pressure responses to physical activity
  • Resting systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg.
  • Medication that may affect body weight/metabolism (e.g., synthroid).
  • Current or previous participation in a physical activity or weight management research project in the past 6 months
  • Weight loss of ≥5% or 15 pounds total of current body weight in the previous 6 months.
  • Currently being treated for an eating disorder (e.g., anorexia, bulimia, etc.)
  • Previously undergone bariatric surgery (e.g., lap-band, gastric bypass, etc.)
  • For women, those currently pregnant, pregnant during the previous 6 months, or plan on becoming pregnant in the next 6 months
  • Currently being treated for any psychological issues or problems, taking any psychotropic medications, or receiving treatment with psychotropic medications within the previous 6 months.
  • Being out of town during for an extended amount of time during the weight loss intervention which may affect participation in the study
  • Currently using a physical activity monitor to track activity (e.g., Jawbone UP, Fitbit, etc.)

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: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Supervised (SUP-PA)
Weight loss intervention that focuses on supervised physical activity and involves an energy restricted diet. Physical activity will be supervised by trained staff.
Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of supervised moderate-to-vigorous intensity physical activity.
Experimental: Unsupervised (UNSUP-PA)
Weight loss intervention that focuses on unsupervised physical activity (identical dose to SUP-PA) and involves an energy restricted diet (identical diet to SUP-PA). Physical activity will be self-monitored but no activity tracker will be used as an intervention tool.
Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of unsupervised moderate-to-vigorous intensity physical activity.
Experimental: Step-based (STEP)
Weight loss intervention that focuses on unsupervised physical activity prescribed as steps/day and involves an energy restricted diet (identical diet to SUP-PA and UNSUP-PA). Physical activity will be self-monitored and a pedometer will be used to track steps/day.
Weight loss intervention that involves an energy restricted diet plus the inclusion of physical activity in the form of 10,000 steps/day with 2,500 "brisk" steps/day.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Moderate-to-Vigorous Physical Activity (Accumulated in Bouts of at Least 10 Minutes)
Prazo: Baseline (0 weeks), 4 Weeks, 8 Weeks, 12 Weeks
Measured using a wearable device and by questionnaire
Baseline (0 weeks), 4 Weeks, 8 Weeks, 12 Weeks

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Cardiorespiratory Fitness
Prazo: Baseline (0 weeks),12 Weeks
Measured using a submaximal graded exercise test on a treadmill, with termination occurring at 85% of age-predicted maximal heart rate (computed at [220-age]*0.85]). The outcome was measures as oxygen consumption (ml/kg/min) at the point of test termination.
Baseline (0 weeks),12 Weeks
Change in Body Weight
Prazo: Baseline (0 weeks),12 Weeks
Measured in kilograms using a digital scale
Baseline (0 weeks),12 Weeks
Change in Fat Mass
Prazo: Baseline (0 weeks),12 Weeks
Measured as fat mass (kg) using dual-energy x-ray absorptiometry (DXA)
Baseline (0 weeks),12 Weeks
Change in Energy Intake
Prazo: Baseline (0 weeks),12 Weeks
Measured as kcal/day using a questionnaire
Baseline (0 weeks),12 Weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Seth A Creasy, University of Pittsburgh
  • Cadeira de estudo: John M Jakicic, University of Pittsburgh

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 fevereiro de 2016

Conclusão Primária (Real)

1 de agosto de 2016

Conclusão do estudo (Real)

1 de agosto de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

23 de fevereiro de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de fevereiro de 2016

Primeira postagem (Estimativa)

26 de fevereiro de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

29 de novembro de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de novembro de 2018

Última verificação

1 de novembro de 2018

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • PRO15110570

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

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