Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Obesity and physical inactivity have reached epidemic proportions, resulting in increased rates of a variety of chronic diseases, increased risk of death, and substantial health care costs. Individuals with serious mental illness are even more likely to be overweight or obese, which contributes to the high rate of co-morbid medical disease and early mortality found among this population. Specific individual and group-based psychoeducational interventions have repeatedly and consistently been shown to help adults with serious mental illness improve their weight. However, these require substantial time from mental health clinicians, and frequent visits by patients to mental health clinics. This creates challenges for patients who may need to travel to a medical center that provides these services, and who often have limited transportation options. It is likely that these barriers can be addressed with a computerized, web-based intervention focused on diet and exercise education, and tailored for veterans with serious mental illness. Web-based systems can deliver content that is intensive, engaging, and tailored to the needs and preferences of specific patients. Web-based systems can be delivered using computers at community-based outpatient Clinics or other settings in the community. The objective of this project is to develop and evaluate the effectiveness of a web-based intervention to help patients with serious mental illness lose weight.
Background: Obesity has reached epidemic proportions, and often has serious adverse health consequences. The VA has deployed a "MOVE! Weight Management Program" nationally in the general patient population. Since individuals with serious mental illness (SMI) often have cognitive deficits, specialized psychoeducational interventions are needed in this population. Specialized psychoeducational interventions for weight have been developed and studied in populations with SMI. This evidence-based practice has been adapted for use in VA, resulting in a "MOVE! SMI" intervention. However, it has proven to be quite difficult to disseminate this intervention. Patients with SMI often have limited transportation options, and may not want to participate in groups. Also, in-person MOVE! SMI requires substantial time from mental health clinicians. This clinician time has been difficult to deploy or is not available at many clinic locations. It is likely that these barriers can be addressed with a computerized, web-based version of MOVE! . Specialized web-based approaches have been studied and found to be successful in people with SMI, and can deliver content that is intensive and engaging with minimal requirements for staff time.
Objectives: The VA Network 5 and 22 Mental Illness Research, Education, and Clinical Centers (MIRECCs) developed a web-based system that provides computerized counseling regarding diet to individuals with SMI. The proposed project expanded this system. This project's objectives are to: 1) develop a comprehensive web-based system that delivers MOVE! using design features that meet the needs of individuals with mental illness; 2) evaluate the effectiveness, in patients with serious mental illness, of web-based MOVE! compared with in-person MOVE! and a control group; and, 3) characterize, from the patient's perspective, the strengths, weaknesses, and barriers to the use of in-person and web-based MOVE!.
Methods: This is a prospective, randomized, controlled trial in patients with SMI who are obese and receiving treatment with medications that often have weight gain as a major side-effect. Participants are assigned to in-person MOVE! SMI, web-based MOVE! SMI with support from peer coaches, or a comparison group. Research assessments occur at 0, 3, 6, 9 and 12 months. Changes in outcomes are compared over time between the three groups. Comparative effectiveness is evaluated at 6 months. A secondary objective is to evaluate the extent to which gains are maintained at 9 and 12 months.
Status: The project team developed the needed materials, methods, and informatics systems. Patients were enrolled, and study enrollment and interventions are complete. Follow up interviews are complete and the interventions have been evaluated.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | in-person MOVE! SMI |
|
| Arm 2 | Experimental | web-based MOVE! SMI |
|
| Arm 3 | No Intervention | usual care + educational handouts regarding weight loss |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| in-person MOVE! SMI | Behavioral | Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI)) |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) | BMI = (weight in pounds * 703)/ (height in inches²) at 6 month follow-up as predicted by the mixed model described in Statistical Analysis 1 | 6 months |
| Body Mass Index (BMI) Within Obese Sample | BMI = (weight in pounds * 703)/ (height in inches²); obese defined as BMI > 30 | 6 months |
| Dietary Habits: Reducing Calories (Self-efficacy, Motivation, Readiness to Change) | Self-Efficacy and Eating Habits Survey (Sallis et al., 1988): Reducing Calories Factor. The Reducing Calories factor includes survey items 6-10, which are each scored on a scale from 1-5. The factor score is an average of the scores on those items. Higher scores indicate more confidence in making the change in reducing calories. Range in the factor scores can be from 1 (min) to 5 (max). | 6 months |
| Dietary Habits: Reducing Fat (Self-efficacy, Motivation, Readiness to Change) | Self-Efficacy and Eating Habits Survey (Sallis et al., 1988): Reducing Fat Factor. The Reducing Fat factor includes survey items 16-20, which are each scored on a scale from 1-5. The factor score is an average of the scores on those items. Higher scores indicate more confidence in making the change in reducing fat in the diet. Range in the factor scores can be from 1 (min) to 5 (max). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life: Physical Functioning | Impact of Weight on Quality of Life (IWQOL; Kolotkin et al., 2008): Physical Functioning subscale. The Physical Functioning subscale includes survey items 1-11, which are each scored on a scale from 1-5. The subscale score is an average of the scores on those items. Lower scores indicate greater impairment. Range in the subscale scores can be from 1 (min) to 5 (max). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alexander S Young, MD MSHS | VA Greater Los Angeles Healthcare System, West Los Angeles, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California | 90073 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24382767 | Result | Cohen AN, Golden JF, Young AS. Peer wellness coaches for adults with mental illness. Psychiatr Serv. 2014 Jan 1;65(1):129-30. doi: 10.1176/appi.ps.650101. No abstract available. | |
| 31741204 | Derived | Muralidharan A, Brown CH, Zhang Y, Niv N, Cohen AN, Kreyenbuhl J, Oberman RS, Goldberg RW, Young AS. Quality of life outcomes of web-based and in-person weight management for adults with serious mental illness. J Behav Med. 2020 Oct;43(5):865-872. doi: 10.1007/s10865-019-00117-1. Epub 2019 Nov 18. |
| Label | URL |
|---|---|
| VA MOVE! Program | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
7 patients were withdrawn by the PI when they were determined to be ineligible, after signing a consent. Ineligibility reasons included: not being prescribed inclusion criteria medication, not receiving approval from primary care physician, non-veteran status, and unable to consent to participation. 2 patients disenrolled prior to group assignment.
Between February 2012 and April 2014, we obtained a list of individuals at the study site who met inclusion criteria for psychiatric diagnosis, age, and psychotropic medication. Study flyers were also posted in mental health clinics. 1429 individuals were screened for eligibility, and 19% were eligible, interested, enrolled, and randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: In-person MOVE! SMI | In-person MOVE! SMI: Individual and group in-person sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits |
| FG001 | Arm 2: Web-based MOVE! SMI | Web-based MOVE! SMI: online sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits; plus peer coaching |
| FG002 | Arm 3: Usual Care + Handouts | usual care + educational handouts regarding weight loss |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: In-person MOVE! SMI | in-person MOVE! SMI in-person MOVE! SMI: Individual and group in-person sessions the deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI)) |
| BG001 | Arm 2: Web-based MOVE! SMI |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Body Mass Index (BMI) | BMI = (weight in pounds * 703)/ (height in inches²) at 6 month follow-up as predicted by the mixed model described in Statistical Analysis 1 | All randomized participants who received any intervention as randomized were included in the primary analyses, regardless of the number of assessments completed. Receiving intervention as randomized was defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care). | Posted | Mean | Standard Error | kg/(meters squared) | 6 months |
|
Adverse event data were collected for a period of 3 years, from the start of recruitment in 2012 through the completion of all data collection in 2015.
Adverse events were likely not related to the interventions or the study and therefore were not further categorized beyond the outcome of the event (i.e., hospitalization, death).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: In-person MOVE! SMI | In-person MOVE! SMI: Individual and group in-person sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Patient death | Cardiac disorders | Non-systematic Assessment | On 08/13/2012 while attempting to reach the patient for f/u interview, research staff was notified that the patient died on 7/25/12. This Event is anticipated in this population, and was unrelated to the study (heart failure). |
Not provided
This study was conducted at one VA medical center in an urban, metropolitan area. Sites can vary markedly in contextual factors; There was a large proportion of overweight patients with SMI who declined to participate.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alexander S. Young | VA Greater Los Angeles Healthcare System, Los Angeles, CA | 310-794-7219 | alexander.young@va.gov |
Not provided
| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D009765 | Obesity |
| D015438 | Health Behavior |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D050177 | Overweight |
| D044343 | Overnutrition |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| web-based MOVE! SMI | Behavioral | online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI)) |
|
| 6 months |
| Quality of Life: Self-Esteem | Impact of Weight on Quality of Life (IWQOL; Kolotkin et al. 2008): Self-Esteem subscale. The Self-Esteem subscale includes survey items 12-18, which are each scored on a scale from 1-5. The subscale score is an average of the scores on those items. Lower scores indicate greater impairment. Range in the subscale scores can be from 1 (min) to 5 (max). | 6 months |
| Quality of Life: Sexual Life | Impact of Weight on Quality of Life (IWQOL; Kolotkin et al 2008): Sexual Life subscale. The Sexual Life subscale includes survey items 19-22, which are each scored on a scale from 1-5. The subscale score is an average of the scores on those items. Lower scores indicate greater impairment. Range in the subscale scores can be from 1 (min) to 5 (max). | 6 months |
| BMI | BMI = (weight in pounds * 703)/ height in inches² | 9 months |
| BMI | BMI = (weight in pounds * 703)/ height in inches² | 12 months |
web-based MOVE! SMI web-based MOVE! SMI: online sessions the deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI)) |
| BG002 | Arm 3: Usual Care + Handouts | usual care + educational handouts regarding weight loss |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Observation of gender as male or female | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Education | Patient reported educational level | Number | participants |
|
| Body Mass Index (BMI) | BMI = (weight in pounds * 703)/ height in inches² | Mean | Standard Deviation | kg/(meters squared) |
|
| OG001 |
| Arm 2: Web-based MOVE! SMI |
online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI)) |
| OG002 | Arm 3: Usual Care + Handouts | usual care + educational handouts regarding weight loss |
|
|
|
| Primary | Body Mass Index (BMI) Within Obese Sample | BMI = (weight in pounds * 703)/ (height in inches²); obese defined as BMI > 30 | Analyses excluded participants with BMI of 28-29.9 (overweight) at baseline, leaving only those with BMI >= 30 at baseline who received the intervention as randomized. | Posted | Mean | Standard Error | kilogram/(meters squared) | 6 months |
|
|
|
|
| Primary | Dietary Habits: Reducing Calories (Self-efficacy, Motivation, Readiness to Change) | Self-Efficacy and Eating Habits Survey (Sallis et al., 1988): Reducing Calories Factor. The Reducing Calories factor includes survey items 6-10, which are each scored on a scale from 1-5. The factor score is an average of the scores on those items. Higher scores indicate more confidence in making the change in reducing calories. Range in the factor scores can be from 1 (min) to 5 (max). | All randomized participants who received the intervention as randomized and completed this measure at 6 months were included in the analysis. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care). | Posted | Mean | Standard Error | units on a scale | 6 months |
|
|
|
|
| Primary | Dietary Habits: Reducing Fat (Self-efficacy, Motivation, Readiness to Change) | Self-Efficacy and Eating Habits Survey (Sallis et al., 1988): Reducing Fat Factor. The Reducing Fat factor includes survey items 16-20, which are each scored on a scale from 1-5. The factor score is an average of the scores on those items. Higher scores indicate more confidence in making the change in reducing fat in the diet. Range in the factor scores can be from 1 (min) to 5 (max). | All randomized participants who received the intervention as randomized and completed this measure at 6 months were included in the analysis. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care). | Posted | Mean | Standard Error | units on a scale | 6 months |
|
|
|
|
| Secondary | Quality of Life: Physical Functioning | Impact of Weight on Quality of Life (IWQOL; Kolotkin et al., 2008): Physical Functioning subscale. The Physical Functioning subscale includes survey items 1-11, which are each scored on a scale from 1-5. The subscale score is an average of the scores on those items. Lower scores indicate greater impairment. Range in the subscale scores can be from 1 (min) to 5 (max). | All randomized participants who received the intervention as randomized and completed this measure at 6 months were included in the analysis. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care). | Posted | Mean | Standard Error | units on a scale | 6 months |
|
|
|
|
| Secondary | Quality of Life: Self-Esteem | Impact of Weight on Quality of Life (IWQOL; Kolotkin et al. 2008): Self-Esteem subscale. The Self-Esteem subscale includes survey items 12-18, which are each scored on a scale from 1-5. The subscale score is an average of the scores on those items. Lower scores indicate greater impairment. Range in the subscale scores can be from 1 (min) to 5 (max). | All randomized participants who received the intervention as randomized and had data at 6 months were included in the analyses. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care). | Posted | Mean | Standard Error | units on a scale | 6 months |
|
|
|
|
| Secondary | Quality of Life: Sexual Life | Impact of Weight on Quality of Life (IWQOL; Kolotkin et al 2008): Sexual Life subscale. The Sexual Life subscale includes survey items 19-22, which are each scored on a scale from 1-5. The subscale score is an average of the scores on those items. Lower scores indicate greater impairment. Range in the subscale scores can be from 1 (min) to 5 (max). | All randomized participants who received the intervention as randomized and completed this measure at 6 months were included in the analysis. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care). | Posted | Mean | Standard Error | units on a scale | 6 months |
|
|
|
|
| Secondary | BMI | BMI = (weight in pounds * 703)/ height in inches² | All randomized participants who received the intervention as randomized and who completed a 9 month follow-up weight were included in this summary. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care). | Posted | Mean | Standard Deviation | kg/meter squared | 9 months |
|
|
|
| Secondary | BMI | BMI = (weight in pounds * 703)/ height in inches² | All randomized participants who received the intervention as randomized and who completed a 12 month follow-up weight were included in this summary. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care). | Posted | Mean | Standard Deviation | kg/meter square | 12 months |
|
|
|
| 1 |
| 95 |
| 0 |
| 95 |
| EG001 | Arm 2: Web-based MOVE! SMI | Web-based MOVE! SMI: online sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits; plus peer coaching | 2 | 93 | 0 | 93 |
| EG002 | Arm 3: Usual Care + Handouts | usual care + educational handouts regarding weight loss | 2 | 88 | 0 | 88 |
|
| Hospitalization | Cardiac disorders | Non-systematic Assessment | Subject was meeting with study staff and mentioned that he had been experiencing chest pain since the previous night. Staff escorted subject to main hospital for assessment, where he was later admitted. |
|
| Hospitalization | Psychiatric disorders | Non-systematic Assessment | Subject's psychiatrist informed research staff that subject was admitted for psychiatric stabilization, as he has been poorly adherent to his psychiatric medication regimen and demonstrating increasingly inappropriate behaviors. |
|
| Patient death | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | On 1/14/14 while attempting to reach the patient for f/u interview, research staff was notified by the patient's sister that he died "around Christmas". This adverse event was unrelated to the study- patient was undergoing treatment for lung cancer. |
|
| Patient death | Cardiac disorders | Non-systematic Assessment | On 7/2/14 while conducting routine chart review, research staff noted that the patient passed away on 6/22/14 from a cardiac event. This adverse event was unrelated to the study- patient had a history of cardiac problems and active cocaine use. |
|
Not provided
Not provided
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D010549 | Personal Satisfaction |