NCT00969384

Brief Summary

Aim of the study: To investigate if the intervention described in this protocol has an effect on patients' and staff's physical health. Null hypothesis: There is no difference in waist circumference, body weight, quality of life and the rate of polypharmacy between the intervention and control groups after six months.

Trial Health

55
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Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2009

Completed
Last Updated

September 1, 2009

Status Verified

August 1, 2009

Enrollment Period

6 months

First QC Date

August 31, 2009

Last Update Submit

August 31, 2009

Conditions

Physical Health

Keywords

Physical healthMental illnesspreventionWaist circumference

Outcome Measures

Primary Outcomes (1)

  • waist circumferences

    9 months

Study Arms (2)

waist circumferences

EXPERIMENTAL

Intervention (active awareness): In the intervention institutions, a detailed feedback of all index measures will be distributed to the patients and the staff. The project leader and a medical specialist in psychiatry will advise on medical aspects and health promotion. In connection with this feedback, guidance on psycho-pharmacological treatment will be provided.

Behavioral: Active awareness/Lifestyle counseling

Lifestyle counseling

EXPERIMENTAL

Intervention (active awareness): In the intervention institutions, a detailed feedback of all index measures will be distributed to the patients and the staff. The project leader and a medical specialist in psychiatry will advise on medical aspects and health promotion. In connection with this feedback, guidance on psycho-pharmacological treatment will be provided.

Behavioral: Active awareness/Lifestyle counseling

Interventions

Active awareness/Lifestyle counselingBEHAVIORAL

Intervention (active awareness): In the intervention institutions, a detailed feedback of all index measures will be distributed to the patients and the staff. The project leader and a medical specialist in psychiatry will advise on medical aspects and health promotion. In connection with this feedback, guidance on psycho-pharmacological treatment will be provided.

Lifestyle counselingwaist circumferences

Eligibility Criteria

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

You may qualify if:

  • Living in one of the 6 institutions in Region Nordjylland

You may not qualify if:

  • Not capable of speaking Danish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Enheden for psykiatrisk forskning

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Peter Mr Hjorth, MPH

    Unit for Psychiatric research North Jutland

    PRINCIPAL INVESTIGATOR

  • Povl Mr Munk Joergensen, Professor

    Unit for psychiatric research North Jutland

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2009

First Posted

September 1, 2009

Study Start

February 1, 2009

Primary Completion

August 1, 2009

Last Updated

September 1, 2009

Record last verified: 2009-08

Locations

DK(1)