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

University of Zurich (UZH) logo

University of Zurich (UZH)

Status

Completed

Conditions

Bipolar Disorder

Treatments

Behavioral: lifestyle intervention to increase physical activity

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Enrollment

50 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Lifestyle intervention to increase physical activity
Active Comparator group
Treatment:
Behavioral: lifestyle intervention to increase physical activity
waiting control group
No Intervention group
Treatment:
Behavioral: lifestyle intervention to increase physical activity

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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