NCT01409590

Brief Summary

In this study the investigators will recruit patients with the diagnosis of schizophrenia that are taking atypical neuroleptics and that are willing to participate in an exercise and diet program. The investigators will measure weight and abdomen circumference.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started May 2005

Typical duration for not_applicable schizophrenia

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

May 1, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2011

Completed
Last Updated

August 4, 2011

Status Verified

August 1, 2011

Enrollment Period

1.3 years

First QC Date

August 3, 2011

Last Update Submit

August 3, 2011

Conditions

Schizophrenia

Keywords

Schizophreniaweight gainatypical neuroleptics

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    The weight of the participants of the trial was monitored during the trial, while they were following the exercise program and the diet, starting from the baseline until end of study/early withdrawal.

    One year

Secondary Outcomes (1)

  • Abdomen circumference

    One year

Study Arms (1)

Exercise and Diet program

OTHER

All patients recruited in the study, participated in an homogeneous exercise program and diet.

Behavioral: Exercise programBehavioral: Diet

Interventions

Exercise programBEHAVIORAL

Homogenous exercise program in local fitness centers

Exercise and Diet program
DietBEHAVIORAL

Weigh loss diet program prescribed by a professional nutritionist

Exercise and Diet program

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Schizophrenia
  • Atypical neuroleptics

You may not qualify if:

  • Medical illness preventing exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, Ramat Gan, 52621, Israel

Location

MeSH Terms

Conditions

SchizophreniaWeight Gain

Interventions

Resistance TrainingDiet

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Revital Amiaz, MD

    Sackler School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 3, 2011

First Posted

August 4, 2011

Study Start

May 1, 2005

Primary Completion

September 1, 2006

Study Completion

August 1, 2009

Last Updated

August 4, 2011

Record last verified: 2011-08

Locations

IL(1)