SchizophreniaNCT02334228
Evaluation of the In SHAPE Fitness Intervention for Adults With Serious Mental Illness
A study testing In SHAPE Lifestyles and Health Club Membership and Education in people with Schizophrenia and Bipolar Disorder, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, Schizoaffective Disorder
- What is being tested?
- In SHAPE Lifestyles and Health Club Membership and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Riverbend Community Mental Health
Concord, New Hampshire, 03301
About this study
Official title: Promoting Health and Functioning in Persons With SMI
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.
Read the detailed description
In this randomized, controlled study, 133 adults age 21 and older with serious mental illness (SMI) and poor physical fitness (BMI>25, or <10 minutes of exercise 2x over the past month) were randomized to either: a) In SHAPE Lifestyles (ISL) intervention or b) Health Club Membership and Education (HCME): consisting of a YMCA membership, educational materials on exercise and healthy diet, and an on-site introduction to the health club. The following three specific aims were addressed: 1) To compare ISL and HCME with respect to: a) participation in regular exercise and dietary change; (b) participation in preventive health care; and (c) improved fitness and health; (2) to compare ISL and HCME with respect to: (a) indicators of mental health and (b) personal self-efficacy; and (3) to explore differences in ISL and HCME with respect to (a) selected physical, metabolic, dietary, and community functioning secondary outcomes; and (b) the relationship of demographic variables and readiness to change to outcomes. ISL participants received a 6-month intensive program of one-to-one health mentoring, followed by a 3-month period of transitioning to self-directed individual and group programming, with assessments conducted at baseline, 3, 6, 9, and 12 months. If found to be effective, ISL will provide a practical approach to improving health, independent functioning, and longevity in disabled persons with SMI.
- Being tested
- In SHAPE Lifestyles, Health Club Membership and Education
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Psychotic Disorders, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In SHAPE LifestylesBehavioural
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.
Health Club Membership and EducationBehavioural
Fitness club membership with education in using the exercise equipment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: In SHAPE Lifestyles |
| Health Club Membership and Education | Active comparator | Fitness club membership with education in using the exercise equipment. Receives: Behavioral: Health Club Membership and Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Exercise Capacity
Change in fitness as measured by the 6-minute walk test.
Measured: Baseline, 3-, 6-, 9-, and 12-months
Secondary outcomes (10)
Body Mass Index
Measured: Baseline, 3-, 6-, 9-, and 12-months
Change in Weight
Change in weight over time was measured at baseline, 3-, 6-, 9-, and 12-months. Measures were weight (lbs).
Measured: Baseline, 3-, 6-, 9-, and 12-months
Change in Triglycerides and Cholesterol
Change in triglycerides and cholesterol measured with the CardioChek PA Analyzer: Fasting blood glucose and lipids.
Measured: Baseline, 3-, 6-, 9-, and 12-months
Change in Health Status
Change in health status was measured by the SF-12: Medical Outcomes Study Short Form -12
Measured: Baseline, 3-, 6-, 9-, and 12-months
Change in Community Functioning
Change in community functioning was measured by the ILSS: Independent Living Skills Scale
Measured: Baseline, 9-, and 12-months
Change in Physical Measurements (Fitness)
Change is physical measurements was determined by measuring waist circumference and resting pulse
Measured: Baseline, 3-, 6-, 9-, and 12-months
Change in Psychological State
Change in psychological state was measured using the CESD: Cntr Epid Studies Dep; SANS: Scale Assess Neg Sx; R-SES: Revised Self-efficacy Scale
Measured: Baseline, 3-, 6-, 9-, and 12-months
Change in Participation in Exercise
Change in participation in exercise was determined by measuring weekly exercise at 3-, 6-, 9-, and 12-months using a physical activity log; weekly health club attendance at 3-, 6-, 9-, and 12-months based on frequency of YMCA visits; total physical activity at baseline, 3-, 6-, 9-, and 12-months based on the YPAS: Yale Physical Activity Scale.
Measured: Baseline, 3-, 6-, 9-, and 12-months
Change in Diet Behaviors
Change in diet behaviors was measured based on the WLB-SOC: Weight Loss Behavior State of Change Scale.
Measured: Baseline, 3-, 6-, 9-, and 12-months
Change in Preventative Health Care
Change in preventative health care was based on the PHC: Preventative Healthcare Checklist
Measured: Baseline and 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study startSep 2006
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen J Bartels, MD,MS, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334228
- Sponsor's protocol ID
- Concord InSHAPE
- Status last verified
- Jan 2015
- First submitted
- 6 Jan 2015
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Health and Functioning in Persons With SMI
- ClinicalTrials.gov ID
- NCT02334228
- Acronym / sponsor ID
- Concord InSHAPE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 8 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this randomized, controlled study, 133 adults age 21 and older with serious mental illness (SMI) and poor physical fitness (BMI>25, or <10 minutes of exercise 2x over the past month) were randomized to either: a) In SHAPE Lifestyles (ISL) intervention or b) Health Club Membership and Education (HCME): consisting of a YMCA membership, educational materials on exercise and healthy diet, and an on-site introduction to the health club. The following three specific aims were addressed: 1) To compare ISL and HCME with respect to: a) participation in regular exercise and dietary change; (b) participation in preventive health care; and (c) improved fitness and health; (2) to compare ISL and HCME with respect to: (a) indicators of mental health and (b) personal self-efficacy; and (3) to explore differences in ISL and HCME with respect to (a) selected physical, metabolic, dietary, and community functioning secondary outcomes; and (b) the relationship of demographic variables and readiness to change to outcomes. ISL participants received a 6-month intensive program of one-to-one health mentoring, followed by a 3-month period of transitioning to self-directed individual and group programming, with assessments conducted at baseline, 3, 6, 9, and 12 months. If found to be effective, ISL will provide a practical approach to improving health, independent functioning, and longevity in disabled persons with SMI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In SHAPE Lifestyles | Experimental | Behavioral: In SHAPE LifestylesIn 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. |
| Health Club Membership and Education | Active comparator | Behavioral: Health Club Membership and EducationFitness club membership with education in using the exercise equipment. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In SHAPE LifestylesIn 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. | Behavioural | In SHAPE Lifestyles |
| Health Club Membership and EducationFitness club membership with education in using the exercise equipment. | Behavioural | Health Club Membership and Education |
Primary outcome
Change in Exercise Capacity
Time frame: Baseline, 3-, 6-, 9-, and 12-months
Change in fitness as measured by the 6-minute walk test.
10 secondary outcomes
Body Mass Index
Time frame: Baseline, 3-, 6-, 9-, and 12-months
Change in Weight
Time frame: Baseline, 3-, 6-, 9-, and 12-months
Change in Triglycerides and Cholesterol
Time frame: Baseline, 3-, 6-, 9-, and 12-months
Change in Health Status
Time frame: Baseline, 3-, 6-, 9-, and 12-months
Change in Community Functioning
Time frame: Baseline, 9-, and 12-months
Change in Physical Measurements (Fitness)
Time frame: Baseline, 3-, 6-, 9-, and 12-months
Change in Psychological State
Time frame: Baseline, 3-, 6-, 9-, and 12-months
Change in Participation in Exercise
Time frame: Baseline, 3-, 6-, 9-, and 12-months
Change in Diet Behaviors
Time frame: Baseline, 3-, 6-, 9-, and 12-months
Change in Preventative Health Care
Time frame: Baseline and 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen J Bartels, MD,MS principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In SHAPE Lifestyles and Health Club Membership and Education in people with Schizophrenia and Bipolar Disorder, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Exercise Capacity (time frame: Baseline, 3-, 6-, 9-, and 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2015.