Web-MOVE!: Web-Based Delivery of MOVE! to Veterans With Serious Mental Illness (SMI)

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00983476
• Collaborator: (none)
• Enrollment: 276
• Location: 1
• Arms: 3
• Duration (Months): 39
• Patients Per Site Per Month: 7.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psychotic Disorders; Obesity; Health Behaviors	Behavioral: in-person MOVE! SMI; Behavioral: web-based MOVE! SMI	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 276 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Web-Based Delivery of MOVE! to Veterans With Serious Mental Illness
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 in-person MOVE! SMI	Behavioral: in-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))
Experimental: Arm 2 web-based MOVE! SMI	Behavioral: 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))
No Intervention: Arm 3 usual care + educational handouts regarding weight loss

Outcome Measures

Primary Outcome Measures

1. 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

2. Body Mass Index (BMI) Within Obese Sample [6 months]

   BMI = (weight in pounds * 703)/ (height in inches²); obese defined as BMI > 30

3. 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).

4. 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).

Secondary Outcome Measures

1. 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).

2. 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).

3. 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).

4. BMI [9 months]

   BMI = (weight in pounds * 703)/ height in inches²

5. BMI [12 months]

   BMI = (weight in pounds * 703)/ height in inches²

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California	United States	90073

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Alexander S Young, MD MSHS, VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• VA MOVE! Program

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00983476
• Other Study ID Numbers: IIR 09-083
• First Posted: Sep 24, 2009
• Last Update Posted: Apr 13, 2017
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by VA Office of Research and Development: Randomized controlled trial; Obesity; Comparative Effectiveness; Clinical practice guidelines; Medical Informatics Computing; Services, Mental Health; Self-care; Psychotic disorders; Mental Health Care; Veterans
• Additional relevant MeSH terms: Mental Disorders; Psychotic Disorders

Study Results

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 Detail	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.

Arm/Group Title	Arm 1: In-person MOVE! SMI	Arm 2: Web-based MOVE! SMI	Arm 3: Usual Care + Handouts
Arm/Group Description	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	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	usual care + educational handouts regarding weight loss
Period Title: Overall Study
STARTED	95	93	88
6 Month Follow up Assessment	71	62	74
COMPLETED	78	71	88
NOT COMPLETED	17	22	0

Baseline Characteristics

Arm/Group Title	Arm 1: In-person MOVE! SMI	Arm 2: Web-based MOVE! SMI	Arm 3: Usual Care + Handouts	Total
Arm/Group Description	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))	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))	usual care + educational handouts regarding weight loss	Total of all reporting groups
Overall Participants	95	93	88	276
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.7 (9.6)	54.7 (8.9)	54.2 (9.9)	54.2 (9.4)
Sex: Female, Male (Count of Participants)
Female	7 7.4%	8 8.6%	2 2.3%	17 6.2%
Male	88 92.6%	85 91.4%	86 97.7%	259 93.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1.1%	5 5.4%	1 1.1%	7 2.5%
Asian	3 3.2%	0 0%	2 2.3%	5 1.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	2 2.3%	2 0.7%
Black or African American	43 45.3%	43 46.2%	45 51.1%	131 47.5%
White	36 37.9%	35 37.6%	32 36.4%	103 37.3%
More than one race	5 5.3%	3 3.2%	3 3.4%	11 4%
Unknown or Not Reported	7 7.4%	7 7.5%	3 3.4%	17 6.2%
Education (participants) [Number]
High School, no diploma	5 5.3%	2 2.2%	6 6.8%	13 4.7%
High School diploma or some college	60 63.2%	64 68.8%	56 63.6%	180 65.2%
Degree (2 or 4 year)	27 28.4%	24 25.8%	22 25%	73 26.4%
Graduate School (Degree or no degree)	3 3.2%	3 3.2%	4 4.5%	10 3.6%
Body Mass Index (BMI) (kg/(meters squared)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/(meters squared)]	34.9 (5.0)	34.2 (5.3)	34.4 (5.6)	34.5 (5.3)

Outcome Measures

1. Primary Outcome

Title	Body Mass Index (BMI)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Arm 1: In-person MOVE! SMI	Arm 2: Web-based MOVE! SMI	Arm 3: Usual Care + Handouts
Arm/Group Description	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))	online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))	usual care + educational handouts regarding weight loss
Measure Participants	78	71	88
Mean (Standard Error) [kg/(meters squared)]	34.9 (0.4)	33.4 (0.4)	34.4 (0.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: In-person MOVE! SMI, Arm 2: Web-based MOVE! SMI, Arm 3: Usual Care + Handouts
	Comments	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 time
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.11
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	2.2
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	Reference group is Web-based MOVE SMI: In-person MOVE SMI visit x group Beta estimate is .27 (p=.08); Reference group is Web-based MOVE SMI: Usual care plus handouts visit x group Beta estimate is .29 (p=.06).

2. Primary Outcome

Title	Body Mass Index (BMI) Within Obese Sample
Description	BMI = (weight in pounds * 703)/ (height in inches²); obese defined as BMI > 30
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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/Group Title	Arm 1: In-person MOVE! SMI	Arm 2: Web-based MOVE! SMI	Arm 3: Usual Care + Handouts
Arm/Group Description	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	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	usual care + educational handouts regarding weight loss
Measure Participants	68	59	73
Mean (Standard Error) [kilogram/(meters squared)]	35.9 (0.4)	34.2 (0.4)	35.6 (0.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: In-person MOVE! SMI, Arm 2: Web-based MOVE! SMI, Arm 3: Usual Care + Handouts
	Comments	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 time
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	4.02
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	Reference group is Web-based MOVE SMI: In-person MOVE SMI visit x group Beta estimate is .40 (p=.02); Reference group is Web-based MOVE SMI: Usual care plus handouts visit x group Beta estimate is .44 (p=.01).

3. Primary Outcome

Title	Dietary Habits: Reducing Calories (Self-efficacy, Motivation, Readiness to Change)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Arm 1: In-person MOVE! SMI	Arm 2: Web-based MOVE! SMI	Arm 3: Usual Care + Handouts
Arm/Group Description	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))	online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))	usual care + educational handouts regarding weight loss
Measure Participants	68	61	74
Mean (Standard Error) [units on a scale]	4.1 (0.11)	3.9 (0.11)	4.0 (0.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: In-person MOVE! SMI, Arm 2: Web-based MOVE! SMI, Arm 3: Usual Care + Handouts
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.32
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.14
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	No comparison between groups was conducted because overall model test was not statistically significant.

4. Primary Outcome

Title	Dietary Habits: Reducing Fat (Self-efficacy, Motivation, Readiness to Change)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Arm 1: In-person MOVE! SMI	Arm 2: Web-based MOVE! SMI	Arm 3: Usual Care + Handouts
Arm/Group Description	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))	online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))	usual care + educational handouts regarding weight loss
Measure Participants	68	61	74
Mean (Standard Error) [units on a scale]	4.1 (0.11)	3.9 (0.11)	3.8 (0.11)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: In-person MOVE! SMI, Arm 2: Web-based MOVE! SMI, Arm 3: Usual Care + Handouts
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.11
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.23
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	No comparison between groups was conducted because overall model test was NS.

5. Secondary Outcome

Title	Quality of Life: Physical Functioning
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Arm 1: In-person MOVE! SMI	Arm 2: Web-based MOVE! SMI	Arm 3: Usual Care + Handouts
Arm/Group Description	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))	online sessions the deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))	usual care + educational handouts regarding weight loss
Measure Participants	68	61	74
Mean (Standard Error) [units on a scale]	2.4 (0.1)	2.4 (0.1)	2.6 (0.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: In-person MOVE! SMI, Arm 2: Web-based MOVE! SMI, Arm 3: Usual Care + Handouts
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.47
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.75
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	No comparison between groups was conducted because overall model test was NS.

6. Secondary Outcome

Title	Quality of Life: Self-Esteem
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Arm 1: In-person MOVE! SMI	Arm 2: Web-based MOVE! SMI	Arm 3: Usual Care + Handouts
Arm/Group Description	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))	online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))	usual care + educational handouts regarding weight loss
Measure Participants	68	61	74
Mean (Standard Error) [units on a scale]	2.3 (0.13)	2.3 (0.14)	2.5 (0.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: In-person MOVE! SMI, Arm 2: Web-based MOVE! SMI, Arm 3: Usual Care + Handouts
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.51
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.67
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	No comparison between groups was conducted because overall model test was NS.

7. Secondary Outcome

Title	Quality of Life: Sexual Life
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Arm 1: In-person MOVE! SMI	Arm 2: Web-based MOVE! SMI	Arm 3: Usual Care + Handouts
Arm/Group Description	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))	online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))	usual care + educational handouts regarding weight loss
Measure Participants	67	61	74
Mean (Standard Error) [units on a scale]	1.7 (0.12)	1.8 (0.13)	1.7 (0.11)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: In-person MOVE! SMI, Arm 2: Web-based MOVE! SMI, Arm 3: Usual Care + Handouts
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.83
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.19
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	No comparison between groups was conducted because overall model test was NS.

8. Secondary Outcome

Title	BMI
Description	BMI = (weight in pounds * 703)/ height in inches²
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

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/Group Title	Arm 1: In-person MOVE! SMI	Arm 2: Web-based MOVE! SMI	Arm 3: Usual Care + Handouts
Arm/Group Description	in-person MOVE! SMI in-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))	web-based MOVE! SMI 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))	usual care + educational handouts regarding weight loss
Measure Participants	60	55	69
Mean (Standard Deviation) [kg/meter squared]	34.9 (6.0)	33.0 (4.8)	34.2 (6.1)

9. Secondary Outcome

Title	BMI
Description	BMI = (weight in pounds * 703)/ height in inches²
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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/Group Title	Arm 1: In-person MOVE! SMI	Arm 2: Web-based MOVE! SMI	Arm 3: Usual Care + Handouts
Arm/Group Description	in-person MOVE! SMI in-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))	web-based MOVE! SMI 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))	usual care + educational handouts regarding weight loss
Measure Participants	62	58	76
Mean (Standard Deviation) [kg/meter square]	34.7 (6.6)	32.4 (4.9)	34.0 (6.2)

Adverse Events

Time Frame	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 Event Reporting Description	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).
Arm/Group Title	Arm 1: In-person MOVE! SMI		Arm 2: Web-based MOVE! SMI		Arm 3: Usual Care + Handouts
Arm/Group Description	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		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		usual care + educational handouts regarding weight loss
All Cause Mortality
	Arm 1: In-person MOVE! SMI		Arm 2: Web-based MOVE! SMI		Arm 3: Usual Care + Handouts
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm 1: In-person MOVE! SMI		Arm 2: Web-based MOVE! SMI		Arm 3: Usual Care + Handouts
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/95 (1.1%)		2/93 (2.2%)		2/88 (2.3%)
Cardiac disorders
Patient death	0/95 (0%)	0	0/93 (0%)	0	1/88 (1.1%)	1
Hospitalization	0/95 (0%)	0	1/93 (1.1%)	1	0/88 (0%)	0
Patient death	0/95 (0%)	0	0/93 (0%)	0	1/88 (1.1%)	1
Psychiatric disorders
Hospitalization	0/95 (0%)	0	1/93 (1.1%)	1	0/88 (0%)	0
Respiratory, thoracic and mediastinal disorders
Patient death	1/95 (1.1%)	1	0/93 (0%)	0	0/88 (0%)	0
Other (Not Including Serious) Adverse Events
	Arm 1: In-person MOVE! SMI		Arm 2: Web-based MOVE! SMI		Arm 3: Usual Care + Handouts
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/95 (0%)		0/93 (0%)		0/88 (0%)

Limitations/Caveats

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.

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Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.