- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Barcelona, Spanien, 08025
- Hospital de la Santa Creu i Sant Pau
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Control group
Participants will complete the outcome measures but will not receive any intervention.
|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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).
Tidsramme: 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.
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IIBSP-STO-2016-80
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Stop&Go Intervention
-
University of WashingtonAktiv, ikke rekrutterendeAldring | Utilsigtet faldForenede Stater
-
University of WashingtonNational Institute on Aging (NIA)Aktiv, ikke rekrutterendeDemensForenede Stater
-
University of California, Los AngelesNational Cancer Institute (NCI); Children's Hospital of Philadelphia; University... og andre samarbejdspartnereAfsluttetVaccination | ImmuniseringForenede Stater
-
University of California, Los AngelesNational Cancer Institute (NCI); Children's Hospital of Philadelphia; University... og andre samarbejdspartnereAktiv, ikke rekrutterende
-
Wetenschappelijk Onderzoek en DatacentrumLeiden University; Utrecht UniversityRekrutteringKriminalitet | Kriminelt tilbagefald | Antisocial adfærdHolland
-
Zuyderland Medisch CentrumRekruttering
-
University of MinnesotaAfsluttet
-
University of AmsterdamZonMw: The Netherlands Organisation for Health Research and Development; YIM Foundation Netherlands (JIMwerkt.nl) og andre samarbejdspartnereRekrutteringUngdomskriminalitet | Youth Initiated Mentoring (YIM) tilgangHolland
-
Northwestern UniversityAfsluttet