NCT01414907

Brief Summary

The purpose of this study is to evaluate the effect of adding the Health Promotion activities and rehabilitation to the usual alcohol and drug interventions on the outcome for alcohol and drug abusers compared to the usual intervention alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2010

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

4.9 years

First QC Date

August 9, 2011

Last Update Submit

June 4, 2017

Conditions

Keywords

Drinking BehaviorHarm ReductionTobacco Use CessationSmoking CessationRehabilitationHealth PromotionNutrition TherapyFeeding BehaviorExercise

Outcome Measures

Primary Outcomes (1)

  • Change from abuser to non-abuser

    6 weeks, 3, 6, 9, 12 and 24 months

Secondary Outcomes (4)

  • Health status

    6 weeks, 3, 6, 9, 12 and 24 months

  • Quality of life

    6 weeks, 3,6,9,12 and 24 months

  • Harm reduction

    6 weeks, 3,6,9,12 and 24 months

  • Cost-effectiveness

    24 months

Study Arms (2)

Health Promotion activities

ACTIVE COMPARATOR
Behavioral: Health promotion activities

No Intervention

NO INTERVENTION

Interventions

Counselled activities on tobacco smoking secession, diet correlation and physical activities

Also known as: smoking secession, physical activity, diet
Health Promotion activities

Eligibility Criteria

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

You may qualify if:

  • alcohol or drug dependency

You may not qualify if:

  • withdrawal of informed consent
  • missing competence to give informed consent
  • pregnant or nursing women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addiction Center Malmo, Psychiatry Skane, Skane University Hospital

Malmo, Skåne County, 20502, Sweden

Location

Related Publications (1)

  • Tønnesen H, Hovhannisyan K, Ehrnström M, Skibelund D, Kovacs J, Thornqvist K, Skagert E. Co-morbidity in drug and alcohol addicts - a VIP project. 19th International Conference on Health Promotion Hospitals and Health Services, June 2011, Turku, Finland

    BACKGROUND

Related Links

MeSH Terms

Conditions

AlcoholismSubstance-Related DisordersSmokingChronic DiseaseMalnutritionDrinking BehaviorHarm ReductionTobacco Use CessationSmoking CessationFeeding BehaviorMotor Activity

Interventions

ExerciseDiet

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersMental DisordersBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic DiseasesHealth BehaviorBehavior, Animal

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Hanne Tønnesen, MD, PhD

    WHO-CC, Bispebjerg University Hopital, Copenhagen, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 9, 2011

First Posted

August 11, 2011

Study Start

October 1, 2010

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

June 6, 2017

Record last verified: 2017-06

Locations