NCT00474227

Brief Summary

Based on previous findings that mentally ill inpatients are interested in losing treatment associate weight gain and are capable of adhering to a weight reduction program, this study will investigate the effects of participation in nutrition intervention, physical exercise and will monitor measurement of metabolic profiles (cholesterol, triglycerides and glucose). Hypothesis: participants will reduce weight, maintain weight loss and experience reduction in metabolic values and will experience improved quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Apr 2007

Shorter than P25 for not_applicable obesity

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

May 2, 2008

Status Verified

May 1, 2008

Enrollment Period

6 months

First QC Date

May 15, 2007

Last Update Submit

May 1, 2008

Conditions

Keywords

obesityweight gainschizophreniaschizoaffective disorderantipsychotic induced weight gain

Outcome Measures

Primary Outcomes (1)

  • weight reduction

    three months

Secondary Outcomes (1)

  • improved metabolic profile

    3 months

Study Arms (2)

A

EXPERIMENTAL

behavioral intervention, group therapy including nutritional guidance and physical exercise

Behavioral: group therapy, physical exercise, nutrition lectures

B

NO INTERVENTION

comparison group, one time explanation of importance of proper nutrition. This group receives no group therapy or organized exercise sessions or nutritional guidance. They are wait listed for this program.

Interventions

weekly group therapy, physical exercize, nutrition guidance

A

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18 and older
  • Men or women
  • Schizophrenia or schizoaffective disorder
  • BMI greater than 26
  • Agreement to participate and capacity to provide written informed consent

You may not qualify if:

  • Pregnancy
  • Severe physical illness
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lev Hasharon Mental Health Center

Netanya, 42100, Israel

Location

Related Links

MeSH Terms

Conditions

ObesityWeight GainSchizophreniaPsychotic Disorders

Interventions

Psychotherapy, GroupExercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Socioenvironmental TherapyPsychotherapyBehavioral Disciplines and ActivitiesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Gloria Ilievici, MD

    Lev HaSharon Mental Health Center

    PRINCIPAL INVESTIGATOR
  • Yuval Melamed, MD, MHA

    Lev HaSharon Mental Health Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 15, 2007

First Posted

May 16, 2007

Study Start

April 1, 2007

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

May 2, 2008

Record last verified: 2008-05

Locations