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Effects of a Lifestyle Intervention on Body Mass Index in Patients With Bipolar Disorder

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
lifestyle intervention to increase physical activity
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults between 18 and 70 years of age were considered for inclusion if they:

    1. fulfilled the diagnostic criteria for bipolar disorder according to DSM-IV-TR,27;
    2. were on treatment with medication for at least three months with one of the following substances: lithium, valproic acid carbamazepine, oxcarbazepine, olanzapine, quetiapine, risperidone, amisulpride; and
    3. were not underweight (BMI > 20 kg/m2).

Exclusion Criteria:

  • Pregnancy
  • Actual breast feeding
  • A diagnosis of anorexia nervosa or bulimia nervosa
  • Diabetes type I or II or another serious physical disease
  • Use of substances that reduce weight (e.g., topiramate, lamotrigine as mood stabilizer in monotherapy)
  • Participants with comorbidity of acute psychosis, drug addiction, personality disorder, suicidal tendencies or a current severe manic or depressive episode were excluded only if attending the program was not possible due to the respective disorder

Sites / Locations

  • Sanatorium Kilchberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Lifestyle intervention to increase physical activity

waiting control group

Arm Description

Outcomes

Primary Outcome Measures

BMI

Secondary Outcome Measures

Full Information

First Posted
September 18, 2009
Last Updated
September 18, 2009
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT00980863
Brief Title
Effects of a Lifestyle Intervention on Body Mass Index in Patients With Bipolar Disorder
Official Title
Effects of a Lifestyle Intervention on Body Mass Index in Patients With Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with bipolar disorder are at increased risk of weight gain, which in turn, increases the risk for somatic disease and non-adherence to maintenance therapy. Therefore, interventions addressing weight gain are expedient for the management of this disorder. The investigators set out to evaluate the effects of a lifestyle intervention on body mass index, cardiovascular, glycemic and metabolic parameters in patients with bipolar disorder under mood stabilizing pharmacological treatment. 50 outpatients with bipolar disorder under mood stabilizing treatment participated in a randomized controlled trial (waiting control group N=24 and multimodal lifestyle intervention N=26). Each experimental group consisted of two cohorts. The intervention lasted five months and consisted of eleven group sessions and weekly fitness training. Body Mass Index (BMI), body weight as well as cardiovascular, glycemic and metabolic parameters were determined as baseline (March and September 2005) and after five (July 2005 and January 2006) and eleven months (January and July 2006).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle intervention to increase physical activity
Arm Type
Active Comparator
Arm Title
waiting control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
lifestyle intervention to increase physical activity
Primary Outcome Measure Information:
Title
BMI
Time Frame
11 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults between 18 and 70 years of age were considered for inclusion if they: fulfilled the diagnostic criteria for bipolar disorder according to DSM-IV-TR,27; were on treatment with medication for at least three months with one of the following substances: lithium, valproic acid carbamazepine, oxcarbazepine, olanzapine, quetiapine, risperidone, amisulpride; and were not underweight (BMI > 20 kg/m2). Exclusion Criteria: Pregnancy Actual breast feeding A diagnosis of anorexia nervosa or bulimia nervosa Diabetes type I or II or another serious physical disease Use of substances that reduce weight (e.g., topiramate, lamotrigine as mood stabilizer in monotherapy) Participants with comorbidity of acute psychosis, drug addiction, personality disorder, suicidal tendencies or a current severe manic or depressive episode were excluded only if attending the program was not possible due to the respective disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waldemar Greil, Professor
Organizational Affiliation
Sanatorium Kilchberg, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanatorium Kilchberg
City
Zuerich
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
21274359
Citation
Gillhoff K, Gaab J, Emini L, Maroni C, Tholuck J, Greil W. Effects of a multimodal lifestyle intervention on body mass index in patients with bipolar disorder: a randomized controlled trial. Prim Care Companion J Clin Psychiatry. 2010;12(5):PCC.09m00906. doi: 10.4088/PCC.09m00906yel.
Results Reference
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Effects of a Lifestyle Intervention on Body Mass Index in Patients With Bipolar Disorder

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