Serious Mental Illness
Conditions
Keywords
weight loss, mental illness, exercise
Brief summary
This project addresses obesity in the population with SMI by evaluating a weight management program that is not only evidence-based, it is sustainable, transportable, appealing to patients, easy to use, and minimally burdensome to the healthcare system. This effort addresses two HSR&D priority areas: 1) Mental Health: Testing new models of care to improve access, cost, and/or outcomes, and 2) Health Care Informatics: Building the evidence base for ehealth/mhealth tools. Innovation: CoachToFit's use of mobile technology is an important innovation in VA service delivery and its user-centered design involving individuals with SMI was the first of its kind. CoachToFit is enhanced by data visualization in real-time via a web-based dashboard used by VA peer specialists and their supervisor. The Investigators are aware of no other evidence-based mobile platforms to help people with SMI reduce their weight
Detailed description
Between 40% to 60% of individuals with serious mental illness (SMI) are obese. Obesity and physical inactivity result in increased rates of chronic diseases, increased risk of death, and substantial health care costs. Treatment guidelines recommend that individuals with SMI who are overweight should be offered evidence-based weight loss interventions, including psychosocial interventions. The VA's weight management program, MOVE!, is attended by less than 5% of the overweight population and is not adapted to the cognitive needs and patient preferences for the population with SMI. Effective adapted weight management programs are not offered in VA because the programs are time-intensive and require the skills of trained providers who are often in short-supply. CoachToFit can address this gap in care. CoachToFit is a weight management program, adapted for the population with SMI, that includes a smartphone app delivering evidence-based weight management services with weekly telephonic support from a VA peer specialist who acts as a wellness coach. Peer specialists are individuals who draw upon lived experiences with SMI to provide services to others with SMI in clinical settings. CoachToFit was shown to have high rates of acceptability and usability and was efficacious for weight loss in a small sample. VA has an opportunity to address obesity in the population with serious mental illness, currently a substantial gap in care. Significance/Impact: This project addresses obesity in the population with SMI by evaluating a weight management program that is not only evidence-based, it is sustainable, transportable, appealing to patients, easy to use, and minimally burdensome to the healthcare system. This effort addresses two HSR&D priority areas: 1) Mental Health: Testing new models of care to improve access, cost, and/or outcomes, and 2) Health Care Informatics: Building the evidence base for ehealth/mhealth tools. Innovation: CoachToFit's use of mobile technology is an important innovation in VA service delivery and its user-centered design involving individuals with SMI was the first of its kind. CoachToFit is enhanced by data visualization in real-time via a web-based dashboard used by VA peer specialists and their supervisor. The investigators are aware of no other evidence-based mobile platforms to help people with SMI reduce their weight.
Interventions
BEHAVIORALCoach to FIt
CoachToFit: Those randomized to CoachToFit will have the CoachToFit app downloaded to their phone by the peer coach and will work with the coach to initialize the app. Individuals will receive an activity tracker compatible with Android OS and iOS (Amazfit Bit) and a Bluetooth scale (Smart Body scale). Participants will be instructed by the peer to complete at least two CoachToFit modules per week. Modules take about 15 minutes to complete and have embedded knowledge quizzes and end with a choice of three goals to practice over the next week. They will also set up a time for the first 20-minute coaching call, which will then continue weekly.
BEHAVIORALTreatment as Usual
Veterans randomized to the treatment as usual arm will continue to access all services of the VA Pittsburgh, and will participate in three research interviews. After the first meeting, all participants will meet with a peer coach (peer specialists) who will discuss with them the importance of losing weight (using a structured conversation that follows a handout which is provided to the participant). The handout was developed with input from a VA dietitian as well as Veterans and is graphically appealing, with a simple layout, and provides information on diet and activity as well as the local MOVE! schedule
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Methodology: The study design includes a randomized controlled trial to test the efficacy of CoachToFit and assess the hypothesized mechanisms of action. This will include enrollment of obese Veterans with SMI from the mental health clinics at one VA medical center (n=256). Individuals will be randomized to CoachToFit or usual care. Those in CoachToFit will have access to the app and coaching for 6 months. Outcomes are assessed at 6- and 12-months. Efficacy outcomes utilize objective measures. The design also includes a multi- stakeholder qualitative post-intervention evaluation guided by the RE-AIM framework to characterize factors that will inform future implementation and maintenance of CoachToFit. This will include interviews with Veterans randomized to CoachToFit (n=30); interviews with staff stakeholders (n=18); a discussion with Veterans in local Veteran groups (n=2 groups; n=11 Veterans), and interviews with national leadership (n=3).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* chart diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or recurrent major depressive disorder with psychosis; * age 18 and over; * BMI \>= 30.0 (obese); and * ownership of a phone running Android OS or iOS (iPhone).
Exclusion criteria
* chart diagnosis of dementia; * history of bariatric surgery; * pregnant and nursing mothers; * patient has a conservator/legally authorized representative who makes their medical decisions; * psychiatric hospitalization during the month prior to enrollment. Additionally, we will follow the American College of Sports Medicine recommendations for health screening and risk stratification in preparation for starting a moderate intensity exercise program to ensure that participants enrolled are capable of safely engaging in the app's recommendations regarding physical activity. Specifically, all potential participants will be given the Physical Activity Readiness Questionnaire (PAR-Q), a screening tool often used in weight management trials. If they endorse symptoms or major signs suggestive of cardiopulmonary disease (i.e., angina, anginal equivalent, dyspnea, syncope, orthopnea, edema, palpitations or claudication), which is a score \>=1 on the PAR-Q, they will need clearance from a VA physician before enrolling.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight. Mean Pounds | Change from Baseline to 6 months | Measurement of weight (in pounds) will be obtained for all participants using a hospital quality scale. Less pounds is better. |
| Body Weight. 5% Weight Loss | Baseline to 6 months | Number of Veterans who achieved 5% total weight loss at 6 months |
| Body Weight. 7% Total Weight Loss | Baseline to 6 months | Number of Veterans who achieved a 7% total weight loss by 6 months |
| BMI | Baseline to 6 months | Change in mean BMI from baseline to 6 months |
| 6 Minute Walk Test | baseline to 6 months | How many meters a person can walk in 6 minutes. More is better |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMatthew J Chinman, PhD
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Participant flow
Recruitment details
We included adult Veterans (age ≥18) who had a chart diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder with or without psychosis; a BMI ≥ 30.0 (obese); owned an Android or iPhone. Exclusion criteria included being pregnant or nursing, inpatient psychiatric hospitalization within ≤30 days, history of bariatric surgery, medical record diagnosis of dementia, or having a conservator/legally authorized representative make their medical decisions.
Pre-assignment details
Peer specialists, staff stakeholders, Veterans in local veteran groups, and/or national leadership were not considered enrolled.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 53.5 years STANDARD_DEVIATION 13 |
| Diagnosis Bipolar Disorder - any type | 24 Participants |
| Diagnosis Major Depressive Disorder without psychosis | 101 Participants |
| Diagnosis Schizoaffective Disorder - any type | 6 Participants |
| Diagnosis Schizophrenia Disorder - any type | 2 Participants |
| Physical Activity High (90, 120, 150+ minutes) | 13 Participants |
| Physical Activity Low (10, 20, 30 minutes) | 124 Participants |
| Physical Activity Medium (40, 50, 60 minutes) | 28 Participants |
| Physical Activity None (0 minutes) | 25 Participants |
| Psychosis | 17 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black | 27 Participants |
| Race/Ethnicity, Customized Multiple | 3 Participants |
| Race/Ethnicity, Customized Unknown | 3 Participants |
| Race/Ethnicity, Customized White | 178 Participants |
| Region of Enrollment United States | 256 Participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 176 Participants |
| Use of Weight Loss Treatment, past 6 months GLP-1 medication in the past 6 months | 33 Participants |
| Use of Weight Loss Treatment, past 6 months MOVE! weight management program in the past 6 months | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 128 | 0 / 129 |
| other Total, other adverse events | 0 / 128 | 0 / 129 |
| serious Total, serious adverse events | 0 / 128 | 0 / 129 |
Outcome results
None listed