SchizophreniaNCT02334280
Evaluation of A Statewide Program to Prevent Early Mortality and to Promote Fitness in Persons With SMI
A study testing In SHAPE in people with Schizophrenia and Bipolar Disorder, run by Dartmouth-Hitchcock Medical Center at 4 sites in United States.
Trial summary
The goal of this project, which has not changed, is to evaluate the statewide implementation of a two-component intervention (health promotion plus academic detailing) with respect to consumer outcomes and changes in provider prescribing. 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2009to May 2013
- 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 (a) an axis I diagnosis of major depression, bipolar disorder, schizoaffective disorder, or schizophrenia, (b) moderate impairment across multiple areas of psychological functioning, or (c) Global Assessment of Functioning (GAF) score less than 61
- Able to provide voluntary informed consent for participation in the study by the participant or by the participant's legally designated guardian or conservator
- Poor fitness as indicated by BMI > 25 or failure to adhere to the US Department of Health and Human Services Physical Activity Guidelines for Americans, i.e., at least 2.5 hr/week of moderate or 75 min/week of vigorous activity in more than one session
- Medical clearance for participation in an exercise and dietary modification program by a physician, physician assistant, or nurse practitioner
- An expressed willingness to participate in a diet and exercise program
Show all 9Show fewer
- Currently taking an atypical antipsychotic medication
- Able to walk a city block
- Responsible for choice of foods and how they are prepared
Who cannot join
- Currently residing in a nursing home or group home
- Terminal physical illness expected to result in the death of the study subject within one year
- Primary diagnosis of dementia, co-morbid diagnosis of dementia, or significant cognitive impairment as indicated by a Mini-Mental State Examination (MMSE) score < 24
- Inability to speak and understand English
- Pregnancy
Trial locations and contacts
4 sites in 1 country.
United States4 sites
West Central Behavioral Health
Lebanon, New Hampshire, 03766
Mental Health Center of Greater Manchester
Manchester, New Hampshire, 03103
Greater Nashua Mental Health Center at Community Council
Nashua, New Hampshire, 03060
Center for Life Management
Salem, New Hampshire, 03079
About this study
The goal of this project, which has not changed, is to evaluate the statewide implementation of a two-component intervention (health promotion plus academic detailing) with respect to consumer outcomes and changes in provider prescribing. The intervention, called In SHAPE, is delivered to people with serious mental illness (SMI) by two community mental health clinics (CMHCs). These CMHCs are compared to two CMHCs delivering usual-care to individuals with SMI. The specific aims of this study are:
- Evaluate person-level and provider-level outcomes including: (a) consumer health behaviors, health indicators, mental health indicators, and acute health service utilization, (b) provider prescribing practices and program fidelity, and (c) program costs.
- Evaluate system-level outcomes including: (a) consumer health behaviors and health indicators, (b) provider prescribing and program fidelity, and (c) acute services use.
Read the detailed description
Individuals with SMI die 10-25 years earlier than the general population and have disproportionately greater rates of medical comorbidity and disability associated with high rates of obesity, sedentary lifestyle, metabolic syndrome, and poor dietary habits. Despite greater costs and adverse outcomes associated with the combination of mental illness and poor physical health, little attention has been paid to the development of health promotion interventions designed to address the needs of the high-risk group of people with SMI. This natural experiment presents an unprecedented opportunity to evaluate the public health impact of a statewide health-promotion program for persons with SMI, a potential model for reducing early mortality among persons with SMI served by state mental-health systems nationwide.
- Conditions
- Schizophrenia, Bipolar Disorder, Schizoaffective Disorder
- Being tested
- In SHAPE
- Keywords
- Community mental health, Health coach, Weight loss, Fitness, Serious mental illness, Health promotion
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Psychotic Disorders, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In SHAPEBehavioural
In SHAPE 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.
| Study group | Role | What they receive |
|---|---|---|
| In SHAPE | Experimental | In SHAPE 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 |
| Usual-Care Control | No intervention | Usual-care consumers agreed to delay participation in In SHAPE for 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in exercise capacity
Change in exercise capacity measured by the 6-minute walk test.
Measured: baseline, 6-, 12-, and 24-months
Secondary outcomes (14)
Self-reported physical activity
Change in self-reported physical activity measured with International Physical Activity Questionnaire (IPAQ)
Measured: baseline, 6-, 12-, and 24-months
Change in dietary behaviors
Change in dietary behaviors measured with the Block Food Frequency Questionnaire (FFQ)21 and the Questionnaire on Eating and Weight Patterns (QEWP).
Measured: baseline, 6-, 12-, and 24-months
Change in stage of change
Change in stage of change measured with the Weight Loss Behavior-Stage of Change Scale (WLB-SOC) 23 to assess stage of change for engaging in healthy eating and exercise behaviors.
Measured: baseline, 6-, 12-, and 24-months
Change in eating behavior
Change in eating behavior measured with the Dutch Eating Behavior Questionnaire which includes 13 questions assessing emotional eating and 10 questions related to external eating behaviors
Measured: baseline, 6-, 12-, and 24-months
Change in physical measurement
Including height, weight, pulse, CO2 level, lung capacity from spirometer, variables from impedance measure such as percentage of body fat and percentage of lean muscle mass, cholesterol and triglyceride levels from finger stick (cholesterol data for data points that have already passed will be collected from participants' clinic and hospital records), waist circumference: BMI derived from height and weight.
Measured: baseline, 6-, 12-, and 24-months
Change in smoking and substance use
Change in smoking and substance use measured by questions developed for R01DA021245, "Smoking Cessation and Smoking Relapse Prevention in Patients with Schizophrenia," and questions from the "Quit Smoking Decision Aid"( developed by Ferron and Brunette, CPHS # 180) to ascertain smoking frequency, quantity, and cessation attempts
Measured: baseline, 6-, 12-, and 24-months
Change in psychological functioning (depression, negative symptoms, and self-efficacy).
Change in psychological functioning measured by the Center for Epidemiologic Studies Depression Scale,Scale to Assess Negative Symptoms,16 and the Self-Rated Abilities for Health Practices Scale will be used to assess these constructs.
Measured: baseline, 6-, 12-, and 24-months
Change in social functioning
Change in social functioning measured by the Social Network Questionnaire and Lehman Social Contact Scale.
Measured: baseline, 6-, 12-, and 24-months
Change in family contact
Change in family contact measured by the Revised Family Contact Questionnaire.
Measured: baseline, 6-, 12-, and 24-months
Change in social support and eating habits
Change in the impact of social support on eating habits measured by the Social Support and Eating Habits Survey
Measured: baseline, 6-, 12-, and 24-months
Change in social support and exercise
Change in the impact of social support on exercise behaviors measured by the Social Support and Exercise Survey
Measured: baseline, 6-, 12-, and 24-months
Change in comorbid medical illness
Change in comorbid medical illness measured using a medical problems list.
Measured: baseline, 6-, 12-, and 24-months
Change in medications
Change in medications measured by gathering information from participants about type, dose, and frequency of all prescribed medications.
Measured: baseline, 6-, 12-, and 24-months
Change in service use
Measured change in service use based on a measured designed for the In SHAPE studies to collect self-reported use of emergency services and hospitalizations.
Measured: baseline, 6-, 12-, and 24-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 2009
- Primary completionMay 2013
- Study completionMay 2013
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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 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
- NCT02334280
- Sponsor's protocol ID
- InSHAPE Implementation Study
- 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
- Evaluation of A Statewide Program to Prevent Early Mortality and to Promote Fitness in Persons With SMI
- ClinicalTrials.gov ID
- NCT02334280
- Acronym / sponsor ID
- InSHAPE Implementation Study
- Conditions
- Schizophrenia, Bipolar Disorder, Schizoaffective Disorder
- Keywords
- Community mental health, Health coach, Weight loss, Fitness, Serious mental illness, Health promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (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.
The goal of this project, which has not changed, is to evaluate the statewide implementation of a two-component intervention (health promotion plus academic detailing) with respect to consumer outcomes and changes in provider prescribing. The intervention, called In SHAPE, is delivered to people with serious mental illness (SMI) by two community mental health clinics (CMHCs). These CMHCs are compared to two CMHCs delivering usual-care to individuals with SMI. The specific aims of this study are:
- Evaluate person-level and provider-level outcomes including: (a) consumer health behaviors, health indicators, mental health indicators, and acute health service utilization, (b) provider prescribing practices and program fidelity, and (c) program costs.
- Evaluate system-level outcomes including: (a) consumer health behaviors and health indicators, (b) provider prescribing and program fidelity, and (c) acute services use.
Detailed description
Individuals with SMI die 10-25 years earlier than the general population and have disproportionately greater rates of medical comorbidity and disability associated with high rates of obesity, sedentary lifestyle, metabolic syndrome, and poor dietary habits. Despite greater costs and adverse outcomes associated with the combination of mental illness and poor physical health, little attention has been paid to the development of health promotion interventions designed to address the needs of the high-risk group of people with SMI. This natural experiment presents an unprecedented opportunity to evaluate the public health impact of a statewide health-promotion program for persons with SMI, a potential model for reducing early mortality among persons with SMI served by state mental-health systems nationwide.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In SHAPE | Experimental | Behavioral: In SHAPEIn SHAPE 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. |
| Usual-Care Control | No intervention | –Usual-care consumers agreed to delay participation in In SHAPE for 12 months. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 21 or older
- Serious mental illness defined by (a) an axis I diagnosis of major depression, bipolar disorder, schizoaffective disorder, or schizophrenia, (b) moderate impairment across multiple areas of psychological functioning, or (c) Global Assessment of Functioning (GAF) score less than 61
- Able to provide voluntary informed consent for participation in the study by the participant or by the participant's legally designated guardian or conservator
- Poor fitness as indicated by BMI > 25 or failure to adhere to the US Department of Health and Human Services Physical Activity Guidelines for Americans, i.e., at least 2.5 hr/week of moderate or 75 min/week of vigorous activity in more than one session
- Medical clearance for participation in an exercise and dietary modification program by a physician, physician assistant, or nurse practitioner
Key exclusion criteria (5 listed)
- Currently residing in a nursing home or group home
- Terminal physical illness expected to result in the death of the study subject within one year
- Primary diagnosis of dementia, co-morbid diagnosis of dementia, or significant cognitive impairment as indicated by a Mini-Mental State Examination (MMSE) score < 24
- Inability to speak and understand English
- Pregnancy
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 SHAPEIn SHAPE 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 |
Primary outcome
Change in exercise capacity
Time frame: baseline, 6-, 12-, and 24-months
Change in exercise capacity measured by the 6-minute walk test.
14 secondary outcomes
Self-reported physical activity
Time frame: baseline, 6-, 12-, and 24-months
Change in dietary behaviors
Time frame: baseline, 6-, 12-, and 24-months
Change in stage of change
Time frame: baseline, 6-, 12-, and 24-months
Change in eating behavior
Time frame: baseline, 6-, 12-, and 24-months
Change in physical measurement
Time frame: baseline, 6-, 12-, and 24-months
Change in smoking and substance use
Time frame: baseline, 6-, 12-, and 24-months
Change in psychological functioning (depression, negative symptoms, and self-efficacy).
Time frame: baseline, 6-, 12-, and 24-months
Change in social functioning
Time frame: baseline, 6-, 12-, and 24-months
Change in family contact
Time frame: baseline, 6-, 12-, and 24-months
Change in social support and eating habits
Time frame: baseline, 6-, 12-, and 24-months
Change in social support and exercise
Time frame: baseline, 6-, 12-, and 24-months
Change in comorbid medical illness
Time frame: baseline, 6-, 12-, and 24-months
Change in medications
Time frame: baseline, 6-, 12-, and 24-months
Change in service use
Time frame: baseline, 6-, 12-, and 24-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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In SHAPE in people with Schizophrenia and Bipolar Disorder, run by Dartmouth-Hitchcock Medical Center at 4 sites 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 9 inclusion and 5 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 4 sites 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, 6-, 12-, and 24-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.