Clinical trial NCT03055351: Stop&Go: an Intervention Program to Promote Healthy and Active Lifestyles Among Patients With Substance Use Disorders
Official title: Stop&Go: an Intervention Program to Promote Healthy and Physically Active Lifestyles Among Patients With Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorder
Motivation
Keywords: Exercise motivation
Psychological well-being
Healthy living
Physical activity
Autonomy support
Self-determination theory
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2017-02-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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).
timeFrame: Immediately upon admission to the centre, as well as upon successful discharge, measured up to a total of 10 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References: