Health Behaviors, Obesity, Psychotic Disorders
Conditions
Keywords
Randomized controlled trial, Obesity, Comparative Effectiveness, Clinical practice guidelines, Medical Informatics Computing, Services, Mental Health, Self-care, Psychotic disorders, Mental Health Care, Veterans
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALin-person MOVE! SMI
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))
BEHAVIORALweb-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))
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnostic and Statistical Manual (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, recurrent major depressive disorder with psychosis, or PTSD; * age 18 and over; * no psychiatric hospitalization during the month prior to enrollment; * receipt of an antipsychotic medication for at least 3 months prior to enrollment; * BMI of 30 or higher, or BMI of 28 or higher if 10 pounds of recent weight gain; * medical clearance to participate from a VA physician; * control over diet.
Exclusion criteria
* any medical condition for which a weight program is contraindicated; * history of bariatric surgery; * pregnant and nursing mothers; * a diagnosis of dementia; * not able to provide informed consent by self or legally appointed representative.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dietary Habits: Reducing Fat (Self-efficacy, Motivation, Readiness to Change) | 6 months | 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). |
| Body Mass Index (BMI) | 6 months | BMI = (weight in pounds \* 703)/ (height in inches²) at 6 month follow-up as predicted by the mixed model described in Statistical Analysis 1 |
| Body Mass Index (BMI) Within Obese Sample | 6 months | BMI = (weight in pounds \* 703)/ (height in inches²); obese defined as BMI \> 30 |
| Dietary Habits: Reducing Calories (Self-efficacy, Motivation, Readiness to Change) | 6 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life: Physical Functioning | 6 months | 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). |
| Quality of Life: Self-Esteem | 6 months | 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). |
| Quality of Life: Sexual Life | 6 months | 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). |
| BMI | 9 months | BMI = (weight in pounds \* 703)/ height in inches² |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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)) | 95 |
| Arm 2: Web-based MOVE! SMI 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)) | 93 |
| Arm 3: Usual Care + Handouts usual care + educational handouts regarding weight loss | 88 |
| Total | 276 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Did not receive intervention | 17 | 22 | 0 |
Baseline characteristics
| Characteristic | Total | Arm 1: In-person MOVE! SMI | Arm 3: Usual Care + Handouts | Arm 2: Web-based MOVE! SMI |
|---|---|---|---|---|
| Age, Continuous | 54.2 years STANDARD_DEVIATION 9.4 | 53.7 years STANDARD_DEVIATION 9.6 | 54.2 years STANDARD_DEVIATION 9.9 | 54.7 years STANDARD_DEVIATION 8.9 |
| Body Mass Index (BMI) | 34.5 kg/(meters squared) STANDARD_DEVIATION 5.3 | 34.9 kg/(meters squared) STANDARD_DEVIATION 5 | 34.4 kg/(meters squared) STANDARD_DEVIATION 5.6 | 34.2 kg/(meters squared) STANDARD_DEVIATION 5.3 |
| Education Degree (2 or 4 year) | 73 participants | 27 participants | 22 participants | 24 participants |
| Education Graduate School (Degree or no degree) | 10 participants | 3 participants | 4 participants | 3 participants |
| Education High School diploma or some college | 180 participants | 60 participants | 56 participants | 64 participants |
| Education High School, no diploma | 13 participants | 5 participants | 6 participants | 2 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 7 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 3 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 131 Participants | 43 Participants | 45 Participants | 43 Participants |
| Race (NIH/OMB) More than one race | 11 Participants | 5 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 17 Participants | 7 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) White | 103 Participants | 36 Participants | 32 Participants | 35 Participants |
| Sex: Female, Male Female | 17 Participants | 7 Participants | 2 Participants | 8 Participants |
| Sex: Female, Male Male | 259 Participants | 88 Participants | 86 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 95 | 0 / 93 | 0 / 88 |
| serious Total, serious adverse events | 1 / 95 | 2 / 93 | 2 / 88 |
Outcome results
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
Time frame: 6 months
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: In-person MOVE! SMI | Body Mass Index (BMI) | 34.9 kg/(meters squared) | Standard Error 0.4 |
| Arm 2: Web-based MOVE! SMI | Body Mass Index (BMI) | 33.4 kg/(meters squared) | Standard Error 0.4 |
| Arm 3: Usual Care + Handouts | Body Mass Index (BMI) | 34.4 kg/(meters squared) | Standard Error 0.4 |
Comparison: Difference in Body Mass Index (BMI) by study arm at 6 months after controlling for BMI 6 months prior to baseline using a repeated measures mixed model with arm, time, and the interaction of arm by timep-value: 0.11Mixed Models Analysis
Primary
Body Mass Index (BMI) Within Obese Sample
BMI = (weight in pounds \* 703)/ (height in inches²); obese defined as BMI \> 30
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: In-person MOVE! SMI | Body Mass Index (BMI) Within Obese Sample | 35.9 kilogram/(meters squared) | Standard Error 0.4 |
| Arm 2: Web-based MOVE! SMI | Body Mass Index (BMI) Within Obese Sample | 34.2 kilogram/(meters squared) | Standard Error 0.4 |
| Arm 3: Usual Care + Handouts | Body Mass Index (BMI) Within Obese Sample | 35.6 kilogram/(meters squared) | Standard Error 0.4 |
Comparison: In the obese sample, difference in Body Mass Index (BMI) by study arm at 6 months after controlling for BMI 6 months prior to baseline using a repeated measures mixed model with arm, time, and the interaction of arm by timep-value: 0.02Mixed Models Analysis
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).
Time frame: 6 months
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: In-person MOVE! SMI | Dietary Habits: Reducing Calories (Self-efficacy, Motivation, Readiness to Change) | 4.1 units on a scale | Standard Error 0.11 |
| Arm 2: Web-based MOVE! SMI | Dietary Habits: Reducing Calories (Self-efficacy, Motivation, Readiness to Change) | 3.9 units on a scale | Standard Error 0.11 |
| Arm 3: Usual Care + Handouts | Dietary Habits: Reducing Calories (Self-efficacy, Motivation, Readiness to Change) | 4.0 units on a scale | Standard Error 0.1 |
p-value: 0.32ANOVA
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).
Time frame: 6 months
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: In-person MOVE! SMI | Dietary Habits: Reducing Fat (Self-efficacy, Motivation, Readiness to Change) | 4.1 units on a scale | Standard Error 0.11 |
| Arm 2: Web-based MOVE! SMI | Dietary Habits: Reducing Fat (Self-efficacy, Motivation, Readiness to Change) | 3.9 units on a scale | Standard Error 0.11 |
| Arm 3: Usual Care + Handouts | Dietary Habits: Reducing Fat (Self-efficacy, Motivation, Readiness to Change) | 3.8 units on a scale | Standard Error 0.11 |
p-value: 0.11ANOVA
Secondary
BMI
BMI = (weight in pounds \* 703)/ height in inches²
Time frame: 12 months
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: In-person MOVE! SMI | BMI | 34.7 kg/meter square | Standard Deviation 6.6 |
| Arm 2: Web-based MOVE! SMI | BMI | 32.4 kg/meter square | Standard Deviation 4.9 |
| Arm 3: Usual Care + Handouts | BMI | 34.0 kg/meter square | Standard Deviation 6.2 |
Secondary
BMI
BMI = (weight in pounds \* 703)/ height in inches²
Time frame: 9 months
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: In-person MOVE! SMI | BMI | 34.9 kg/meter squared | Standard Deviation 6 |
| Arm 2: Web-based MOVE! SMI | BMI | 33.0 kg/meter squared | Standard Deviation 4.8 |
| Arm 3: Usual Care + Handouts | BMI | 34.2 kg/meter squared | Standard Deviation 6.1 |
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).
Time frame: 6 months
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: In-person MOVE! SMI | Quality of Life: Physical Functioning | 2.4 units on a scale | Standard Error 0.1 |
| Arm 2: Web-based MOVE! SMI | Quality of Life: Physical Functioning | 2.4 units on a scale | Standard Error 0.1 |
| Arm 3: Usual Care + Handouts | Quality of Life: Physical Functioning | 2.6 units on a scale | Standard Error 0.1 |
p-value: 0.47ANOVA
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).
Time frame: 6 months
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: In-person MOVE! SMI | Quality of Life: Self-Esteem | 2.3 units on a scale | Standard Error 0.13 |
| Arm 2: Web-based MOVE! SMI | Quality of Life: Self-Esteem | 2.3 units on a scale | Standard Error 0.14 |
| Arm 3: Usual Care + Handouts | Quality of Life: Self-Esteem | 2.5 units on a scale | Standard Error 0.13 |
p-value: 0.51ANOVA
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).
Time frame: 6 months
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: In-person MOVE! SMI | Quality of Life: Sexual Life | 1.7 units on a scale | Standard Error 0.12 |
| Arm 2: Web-based MOVE! SMI | Quality of Life: Sexual Life | 1.8 units on a scale | Standard Error 0.13 |
| Arm 3: Usual Care + Handouts | Quality of Life: Sexual Life | 1.7 units on a scale | Standard Error 0.11 |
p-value: 0.83ANOVA