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SchizophreniaInSHAPENCT02090335

Health Promotion and Fitness for Younger and Older Adults With SMI

A study testing In SHAPE and Fitness Club Membership in people with Schizophrenia and Bipolar Disorder, run by Dartmouth-Hitchcock Medical Center at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this project, which has not changed, is to improve the health and fitness of persons with serious mental illness (SMI) using an innovative model: In SHAPE Lifestyles. Participants are randomly assigned to the In SHAPE program or Health Club Membership and Education only. Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
In SHAPE and Fitness Club Membership
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
3 sitesUnited States
Study dates
May 2007to 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 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 nursing home or 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

3 sites in 1 country.

United States3 sites

  • Baycove Human Services

    Boston, Massachusetts, 02114

  • Massachusetts Mental Health Center

    Boston, Massachusetts, 02115

  • Vinfen

    Cambridge, Massachusetts, 02141-1001

Other trials in United States

About this study

The goal of this project, which has not changed, is to improve the health and fitness of persons with serious mental illness (SMI) using an innovative model: In SHAPE Lifestyles. Participants are randomly assigned to the In SHAPE program or Health Club Membership and Education only.

The three specific aims of this study are to:

  1. To compare the treatment groups with respect to improvement in physical fitness outcomes, including: (a) health behaviors (engagement in exercise and diet changes); and (b) indicators of physical fitness.
  2. To compare the treatment groups with respect to improvements in mental health outcomes, including negative symptoms, depression, and self-efficacy.
  3. To explore differences in the treatment groups with respect to psychosocial functioning, health status, and acute service use, and the effects of selected demographic, clinical, and health behavior variables on primary outcomes.
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 study is testing an innovative approach to reducing these problems and developing a program that will potentially have a downstream effect on early mortality for the vulnerable population of people with SMI.

Being tested
In SHAPE, Fitness Club Membership
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.

  • Fitness Club MembershipBehavioural

    Fitness club membership with education in using the exercise equipment.

Study groups in NCT02090335
Study groupRoleWhat they receive
In SHAPEExperimentalIn 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; Behavioral: Fitness Club Membership
Fitness Club MembershipActive comparatorFitness club membership with education in using the exercise equipment.
Receives: Behavioral: Fitness Club Membership

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Weight

    Change in weight over time was measured at baseline, 3-, 6-, 9-, 12-, and 18-months. Measures were weight (kg) and body mass index (kg/m2).

    Measured: Baseline, 3-, 6-, 9-, 12-, and 18-months

Secondary outcomes (6)

  1. Change in Dietary Behaviors

    Change in dietary behaviors was assessed over time using a scale adapted from the Stages of Change Modified Motivational Interviewing instrument focused on dietary behaviors and physical activity.

    Measured: Baseline, 6-, 12-, and 18-months

  2. Change in Dietary Intake

    Change in dietary intake over time was assessed using the Brief Block Food Frequency Questionnaire and nutrient analysis was conducted with NutritionQuest using a nutrient database developed from the USDA Nutrient Database for Standard Reference.

    Measured: Baseline, 6-, 12-, and 18-months

  3. Change in Serum lipids

    Change in serum lipids over time was measured using the CardioChek PA Analyzer, a hand-held dual testing system that produces values for total cholesterol, LDL, HDL, and triglycerides using a multi-panel test strip and a single drop of blood acquired with a finger prick.

    Measured: Baseline, 6-, 12-, and 18-months

  4. Change in Blood Pressure

    Change in systolic and diastolic blood pressure over time was measured using a blood pressure cuff.

    Measured: Baseline, 6-, 12-, and 18-months

  5. Change in Cardiorespiratory Fitness

    Change in cardiorespiratory fitness over time was measured using the 6 Minute Walk Test (distance in m that a participant can walk in 6 minutes).

    Measured: Baseline, 6-, 12-, and 18-months

  6. Change in Physical Activity

    Change in self-reported physical activity was measured over time using the short-form International Physical Activity Questionnaire (IPAQ).

    Measured: Baseline, 3-, 6-, 9-, 12-, and 18-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2014 (estimated)
  2. Study startMay 2007
  3. Primary completionMay 2013
  4. Study completionMay 2013

Resources

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
210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02090335
Sponsor's protocol ID
Boston In SHAPE
Other IDs
1R01MH078052
Acronym
InSHAPE
Status last verified
Mar 2014
First submitted
13 Mar 2014
Last updated
18 Mar 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Naslund JA, Aschbrenner KA, Pratt SI, Lohman MC, Scherer EA, McHugo GJ, Marsch LA, Unutzer J, Bartels SJ. Association Between Cardiovascular Risk and Depressive Symptoms Among People With Serious Mental Illness. J Nerv Ment Dis. 2017 Aug;205(8):634-640. doi: 10.1097/NMD.0000000000000669.

    PubMed 28240625

  • Bartels SJ, Pratt SI, Aschbrenner KA, Barre LK, Naslund JA, Wolfe R, Xie H, McHugo GJ, Jimenez DE, Jue K, Feldman J, Bird BL. Pragmatic replication trial of health promotion coaching for obesity in serious mental illness and maintenance of outcomes. Am J Psychiatry. 2015 Apr;172(4):344-52. doi: 10.1176/appi.ajp.2014.14030357. Epub 2014 Dec 12.

    PubMed 25827032

Questions about this trial

What is this clinical trial studying?

A study testing In SHAPE and Fitness Club Membership in people with Schizophrenia and Bipolar Disorder, run by Dartmouth-Hitchcock Medical Center at 3 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 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 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 Weight (time frame: Baseline, 3-, 6-, 9-, 12-, and 18-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02090335, which also lists 2 linked publications.

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 18 Mar 2014.

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