NCT02334228

Brief Summary

Few studies targeting obesity in serious mental illness have reported clinically significant risk reduction, and non have been replicated in community settings or demonstrated sustained outcomes after intervention withdrawal. The researchers sought to replicate positive health outcomes demonstrated in a previous randomized effectiveness study of the In SHAPE program across urban community mental health organizations serving an ethnically diverse population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
133

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Sep 2006

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

September 1, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2015

Completed
Last Updated

January 8, 2015

Status Verified

January 1, 2015

Enrollment Period

2.9 years

First QC Date

January 6, 2015

Last Update Submit

January 7, 2015

Conditions

SchizophreniaBipolar DisorderSchizoaffective DisorderMajor Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Change in Exercise Capacity

    Change in fitness as measured by the 6-minute walk test.

    Baseline, 3-, 6-, 9-, and 12-months

Secondary Outcomes (10)

  • Body Mass Index

    Baseline, 3-, 6-, 9-, and 12-months

  • Change in Weight

    Baseline, 3-, 6-, 9-, and 12-months

  • Change in Triglycerides and Cholesterol

    Baseline, 3-, 6-, 9-, and 12-months

  • Change in Health Status

    Baseline, 3-, 6-, 9-, and 12-months

  • Change in Community Functioning

    Baseline, 9-, and 12-months

  • +5 more secondary outcomes

Study Arms (2)

In SHAPE Lifestyles

EXPERIMENTAL

In SHAPE Lifestyle is a health promotion intervention consisting of a fitness club membership and a health promotion coach with basic certification as a fitness trainer, instruction on principles of healthy eating and nutrition, and training in tailoring individual wellness plans to the needs of persons with serious mental illness.

Behavioral: In SHAPE Lifestyles

Health Club Membership and Education

ACTIVE COMPARATOR

Fitness club membership with education in using the exercise equipment.

Behavioral: Health Club Membership and Education

Interventions

In SHAPE LifestylesBEHAVIORAL

In SHAPE Lifestyles is a health promotion intervention consisting of a fitness club membership and a health promotion coach with basic certification as a fitness trainer, instruction on principles of healthy eating and nutrition, and training in tailoring individual wellness plans to the needs of persons with serious mental illness.

In SHAPE Lifestyles
Health Club Membership and EducationBEHAVIORAL

Fitness club membership with education in using the exercise equipment.

Health Club Membership and Education

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 21 or older
  • Serious mental illness defined by an axis I diagnosis of major depression, bipolar disorder, schizoaffective disorder, or schizophrenia
  • Persistent impairment in multiple areas of functioning (e.g., work, school, self-care)
  • Body mass index (BMI) greater than 25
  • Able and willing to provide informed consent
  • On stable pharmacological treatment (same psychiatric medications over prior 2 months)

You may not qualify if:

  • Residing in a nursing home of other institution
  • Diagnosis of dementia or significant cognitive impairment (MMSE\<24)
  • Unable to walk one city block
  • Pregnant or planning to become pregnant within the next 18 months
  • Unable to speak English
  • Terminal illness with life expectancy \<1 year
  • Current diagnosis of an active substance dependence disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riverbend Community Mental Health

Concord, New Hampshire, 03301, United States

Location

MeSH Terms

Conditions

SchizophreniaBipolar DisorderPsychotic DisordersDepressive Disorder, Major

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood DisordersDepressive Disorder

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Stephen J Bartels, MD,MS

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2015

First Posted

January 8, 2015

Study Start

September 1, 2006

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

January 8, 2015

Record last verified: 2015-01

Locations

US(1)