NCT00215189

Brief Summary

This pilot study evaluates an individualized health promotion program for people with mental illness receiving services at a mental health center in Keene, NH. The study will test the following hypotheses: Hypothesis 1: Compared to baseline (pre-study) levels, participants in the In SHAPE program will demonstrate increased physical activity as indicated by self-report and observed measures. Hypothesis 2: Compared to baseline (pre-study) levels, participants in the In SHAPE program will demonstrate improved fitness and health status as indicated by greater capacity on the 6-minute walk test, one mile walk test, weight and body composition, and flexibility indexes. The following secondary (exploratory) hypotheses will be considered: Compared to baseline (pre-study) levels, participants in the In SHAPE program will demonstrate improved subjective health status, quality of life, mood, and self-efficacy. In addition, participants will demonstrate improved cardiovascular fitness as indicated by lower pulse rate and blood pressure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
145

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2004

Typical duration for all trials

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

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

September 23, 2009

Status Verified

September 1, 2009

Enrollment Period

3.3 years

First QC Date

September 15, 2005

Last Update Submit

September 22, 2009

Conditions

Mental Illness

Keywords

healthmental illnessfitness

Interventions

In SHAPE (Pilot Health Promotion Intervention)BEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community Mental Health Center

You may qualify if:

  • Age 18 or older, and enrolled in the In SHAPE program. Mental illness Receiving mental health services for 3 months or longer Voluntary informed consent or guardian consent Signed letter of permission to participate by a physician for individuals with a history of a medical illness or indications of health problems during the evaluation -

You may not qualify if:

  • Inability to give informed, voluntary consent. Primary diagnosis of dementia or a diagnosis of a psychiatric disorder secondary to a medical condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monadnock Family Services

Keene, New Hampshire, 03431, United States

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Stephen J Bartels, MD

    Professor in Psychiatry, Dartmouth Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 22, 2005

Study Start

August 1, 2004

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

September 23, 2009

Record last verified: 2009-09

Locations

US(1)