- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03055351
Stop&Go: an Intervention Program to Promote Healthy and Active Lifestyles Among Patients With Substance Use Disorders
Stop&Go: an Intervention Program to Promote Healthy and Physically Active Lifestyles Among Patients With Substance Use Disorders
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
In patients with substance use disorders, exercise could help in the treatment of substance addictions. Interventions focused on promoting physical activity and healthy lifestyle for patients in residential treatment centres and ambulatory settings have been developed in the last years. However, there is a lack of programs promoting a healthy and physically active lifestyle for patients requiring inpatient detoxification treatment. Thus, the plan is to develop an intervention program with such characteristics, namely "Stop&Go".
Stop&Go includes two different phases. Phase I is aimed at understanding the variables related with adherence to healthy lifestyle interventions. Patients with substance use disorders will be invited to participate in focus groups (Study 1) and to respond to questionnaires (Study 2) assessing variables related to exercise and healthy habits (e.g., intention to be physically active). Phase II will use the knowledge obtained in Phase I to develop and evaluate an intervention to promote healthy and physically active lifestyle for patients admitted to an inpatient detoxification centre. The intervention will be based on Self-determination theory postulates and will have two axes: to educate and to motivate. Patients will participate in four practically-oriented training sessions, focused on (1) nutrition and oral hygiene, (2) sleep habits and self-care, (3) physical activity and exercise, and (4) smoking cessation. In addition, the entire inpatient detoxification centre will be adapted to encourage autonomous physical activity and to reinforce the ideas presented in the training sessions.
The main strength of Stop&Go is expected to be the combination of perspectives included in its development (i.e., intervention led by an interdisciplinary team and based on patients' needs). The Stop&Go intervention is hypothesized to help patients move towards a healthy lifestyle and thus, may bring about changes in patients' (1) knowledge acquired, (2) variables related to healthy habits (e.g., exercise motivation) and (3) psychological well-being and ill-being.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Barcelona, Espanha, 08025
- Hospital de la Santa Creu i Sant Pau
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Meeting DSM-V criteria for substance use disorder.
- Request for treatment primarily based on substance detoxification.
- Voluntary admission to an impatient detoxification centre
- Age ≥ 18 years old.
Exclusion Criteria:
- Mental disorders that could hinder patient assessment
- Difficulty to answer the survey due to limited literacy or poor Spanish language proficiency.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Sem intervenção: Control group
Participants will complete the outcome measures but will not receive any intervention.
|
|
Experimental: Stop&Go Intervention
Participants in this group will participate in an intervention aimed at promoting a healthy and physically active lifestyle.
The intervention will be based on Self-determination theory postulates and will have two axes: training and motivation.
|
Stop&Go intervention will be based on Self-determination theory.
Patients will participate in four practically-oriented training sessions, focused on (1) nutrition and oral hygiene, (2) sleep habits and self-care, (3) physical activity and exercise, and (4) smoking cessation.
In addition, the entire inpatient detoxification centre will be adapted to encourage autonomous physical activity and to reinforce the ideas presented in the training sessions.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Changes from patients' baseline exercise motivations at the moment of discharge, measured with the Behavioural Regulation in Exercise Questionnaire (BREQ-3; Wilson et al., 2006).
Prazo: Immediately upon admission to the centre, as well as upon successful discharge, measured up to a total of 10 days.
|
The BREQ-3 measures 6 different types of exercise regulations: intrinsic motivation, integrated reg., identified reg., introjected reg., external reg., amotivation. Participants will be included in the study as they begin their inpatient detoxification treatment and will finish their participation when they are successfully discharged from the centre. Exercise motivations will be measured at 2 time points (Time 1- patient's admission to the detoxification centre, Time 2- successful discharge from the centre), but is not possible to specify in advance the exact number of days between time points due to the following main reason: This study is conducted in an inpatient detoxification unit and consequently medical criteria will prevail in order to estimate the varying duration of treatments. In any case, according to the best clinical practice, detoxification treatments usually last 11-15 days and thus it is expected that at least 10 days elapse between the aforementioned 2 time points. |
Immediately upon admission to the centre, as well as upon successful discharge, measured up to a total of 10 days.
|
Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
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
- IIBSP-STO-2016-80
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA 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 .
Ensaios clínicos em Stop&Go Intervention
-
University of TurkuDesconhecidoSaudável | Comportamento de saúdeFinlândia
-
Medtronic Spine LLCRetiradoEstenose do canal lombar
-
Munich Municipal HospitalTechnical University of Munich; University of RegensburgDesconhecidoInfarto CerebralAlemanha
-
University of MinnesotaConcluído
-
Desmond Tutu HIV FoundationAmsterdam Institute for Global Health and Development; University of Cape Town; European and Developing Countries Clinical Trials Partnership (EDCTP)ConcluídoCovid19 | Infecção por Sars-CoV-2África do Sul
-
Central Jutland Regional HospitalConcluídoPacientes médicosDinamarca
-
Henry Ford Health SystemBlue Cross Blue Shield of Michigan FoundationConcluído
-
Santa Clara Valley Health & Hospital SystemConcluídoCancer de colo | Hemorragia Gastrointestinal | DiverticuloseEstados Unidos
-
Northwestern UniversityEmory UniversityConcluídoAfasia Progressiva Primária | Esgotamento do cuidadorEstados Unidos
-
University of California, Los AngelesNational Cancer Institute (NCI); Children's Hospital of Philadelphia; University... e outros colaboradoresDesconhecido