NCT03055351

Brief Summary

Stop\&Go is an intervention program aimed at promoting a healthy and physically active lifestyle for patients requiring inpatient detoxification treatment. The program includes two different phases. Phase I is aimed at understanding the variables related with adherence to healthy lifestyle interventions. Phase II will use the knowledge obtained in Phase I to develop and evaluate an intervention based on Self-determination theory to promote healthy and physically active lifestyles for patients admitted to an inpatient detoxification centre. 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) indicators of healthy habits (e.g., exercise motivation) and (3) psychological well-being and ill-being.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 16, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

February 17, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

March 1, 2019

Status Verified

February 1, 2019

Enrollment Period

1.8 years

First QC Date

January 25, 2017

Last Update Submit

February 28, 2019

Conditions

Keywords

Exercise motivationPsychological well-beingHealthy livingPhysical activityAutonomy supportSelf-determination theory

Outcome Measures

Primary Outcomes (1)

  • 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).

    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.

Study Arms (2)

Control group

NO INTERVENTION

Participants will complete the outcome measures but will not receive any intervention.

Stop&Go Intervention

EXPERIMENTAL

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.

Behavioral: Stop&Go Intervention

Interventions

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.

Stop&Go Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Mental disorders that could hinder patient assessment
  • Difficulty to answer the survey due to limited literacy or poor Spanish language proficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Substance-Related DisordersPsychological Well-BeingMotor Activity

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersPersonal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2017

First Posted

February 16, 2017

Study Start

February 17, 2017

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

March 1, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations