Trial Outcomes & Findings for Web-Based Delivery of MOVE! to Veterans With Serious Mental Illness (SMI) (NCT NCT00983476)

NCT ID: NCT00983476

Last Updated: 2017-04-13

Results Overview

BMI = (weight in pounds \* 703)/ (height in inches²) at 6 month follow-up as predicted by the mixed model described in Statistical Analysis 1

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 276 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2017-04-13

Participant Flow

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.

7 patients were withdrawn by the PI when they were determined to be ineligible, after signing a consent.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.

Participant milestones

Measure	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	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	Arm 3: Usual Care + Handouts usual care + educational handouts regarding weight loss
Overall Study STARTED	95	93	88
Overall Study 6 Month Follow up Assessment	71	62	74
Overall Study COMPLETED	78	71	88
Overall Study NOT COMPLETED	17	22	0

Reasons for withdrawal

Measure	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	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	Arm 3: Usual Care + Handouts usual care + educational handouts regarding weight loss
Overall Study Did not receive intervention	17	22	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Arm 1: In-person MOVE! SMI n=95 Participants 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))	Arm 2: Web-based MOVE! SMI n=93 Participants 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))	Arm 3: Usual Care + Handouts n=88 Participants usual care + educational handouts regarding weight loss	Total n=276 Participants Total of all reporting groups
Age, Continuous	53.7 years STANDARD_DEVIATION 9.6 • n=5 Participants	54.7 years STANDARD_DEVIATION 8.9 • n=7 Participants	54.2 years STANDARD_DEVIATION 9.9 • n=5 Participants	54.2 years STANDARD_DEVIATION 9.4 • n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	2 Participants n=5 Participants	17 Participants n=4 Participants
Sex: Female, Male Male	88 Participants n=5 Participants	85 Participants n=7 Participants	86 Participants n=5 Participants	259 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Black or African American	43 Participants n=5 Participants	43 Participants n=7 Participants	45 Participants n=5 Participants	131 Participants n=4 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants	35 Participants n=7 Participants	32 Participants n=5 Participants	103 Participants n=4 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	11 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	17 Participants n=4 Participants
Education High School, no diploma	5 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants	13 participants n=4 Participants
Education High School diploma or some college	60 participants n=5 Participants	64 participants n=7 Participants	56 participants n=5 Participants	180 participants n=4 Participants
Education Degree (2 or 4 year)	27 participants n=5 Participants	24 participants n=7 Participants	22 participants n=5 Participants	73 participants n=4 Participants
Education Graduate School (Degree or no degree)	3 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants	10 participants n=4 Participants
Body Mass Index (BMI)	34.9 kg/(meters squared) STANDARD_DEVIATION 5.0 • n=5 Participants	34.2 kg/(meters squared) STANDARD_DEVIATION 5.3 • n=7 Participants	34.4 kg/(meters squared) STANDARD_DEVIATION 5.6 • n=5 Participants	34.5 kg/(meters squared) STANDARD_DEVIATION 5.3 • n=4 Participants

PRIMARY outcome

Timeframe: 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).

BMI = (weight in pounds * 703)/ (height in inches²) at 6 month follow-up as predicted by the mixed model described in Statistical Analysis 1

Outcome measures

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

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Arm 1: In-person MOVE! SMI n=68 Participants 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))	Arm 2: Web-based MOVE! SMI n=59 Participants online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))	Arm 3: Usual Care + Handouts n=73 Participants usual care + educational handouts regarding weight loss
Body Mass Index (BMI) Within Obese Sample	35.9 kilogram/(meters squared) Standard Error 0.4	34.2 kilogram/(meters squared) Standard Error 0.4	35.6 kilogram/(meters squared) Standard Error 0.4

PRIMARY outcome

Timeframe: 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).

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).

Outcome measures

Measure	Arm 1: In-person MOVE! SMI n=68 Participants 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))	Arm 2: Web-based MOVE! SMI n=61 Participants online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))	Arm 3: Usual Care + Handouts n=74 Participants usual care + educational handouts regarding weight loss
Dietary Habits: Reducing Calories (Self-efficacy, Motivation, Readiness to Change)	4.1 units on a scale Standard Error 0.11	3.9 units on a scale Standard Error 0.11	4.0 units on a scale Standard Error 0.10

PRIMARY outcome

Timeframe: 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).

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).

Outcome measures

Measure	Arm 1: In-person MOVE! SMI n=68 Participants 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))	Arm 2: Web-based MOVE! SMI n=61 Participants online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))	Arm 3: Usual Care + Handouts n=74 Participants usual care + educational handouts regarding weight loss
Dietary Habits: Reducing Fat (Self-efficacy, Motivation, Readiness to Change)	4.1 units on a scale Standard Error 0.11	3.9 units on a scale Standard Error 0.11	3.8 units on a scale Standard Error 0.11

SECONDARY outcome

Timeframe: 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).

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).

Outcome measures

Measure	Arm 1: In-person MOVE! SMI n=68 Participants 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))	Arm 2: Web-based MOVE! SMI n=61 Participants online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))	Arm 3: Usual Care + Handouts n=74 Participants usual care + educational handouts regarding weight loss
Quality of Life: Physical Functioning	2.4 units on a scale Standard Error 0.1	2.4 units on a scale Standard Error 0.1	2.6 units on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: 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).

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).

Outcome measures

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

SECONDARY outcome

Timeframe: 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).

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).

Outcome measures

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

SECONDARY outcome

Timeframe: 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).

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

Outcome measures

Measure	Arm 1: In-person MOVE! SMI n=60 Participants 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))	Arm 2: Web-based MOVE! SMI n=55 Participants online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))	Arm 3: Usual Care + Handouts n=69 Participants usual care + educational handouts regarding weight loss
BMI	34.9 kg/meter squared Standard Deviation 6.0	33.0 kg/meter squared Standard Deviation 4.8	34.2 kg/meter squared Standard Deviation 6.1

SECONDARY outcome

Timeframe: 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).

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

Outcome measures

Measure	Arm 1: In-person MOVE! SMI n=62 Participants 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))	Arm 2: Web-based MOVE! SMI n=58 Participants online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))	Arm 3: Usual Care + Handouts n=76 Participants usual care + educational handouts regarding weight loss
BMI	34.7 kg/meter square Standard Deviation 6.6	32.4 kg/meter square Standard Deviation 4.9	34.0 kg/meter square Standard Deviation 6.2

Adverse Events

Arm 1: In-person MOVE! SMI

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2: Web-based MOVE! SMI

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 3: Usual Care + Handouts

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm 1: In-person MOVE! SMI n=95 participants at risk 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	Arm 2: Web-based MOVE! SMI n=93 participants at risk 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	Arm 3: Usual Care + Handouts n=88 participants at risk usual care + educational handouts regarding weight loss
Cardiac disorders Patient death	0.00% 0/95 • 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).	0.00% 0/93 • 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).	1.1% 1/88 • Number of events 1 • 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).
Cardiac disorders Hospitalization	0.00% 0/95 • 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).	1.1% 1/93 • Number of events 1 • 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).	0.00% 0/88 • 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).
Psychiatric disorders Hospitalization	0.00% 0/95 • 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).	1.1% 1/93 • Number of events 1 • 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).	0.00% 0/88 • 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).
Respiratory, thoracic and mediastinal disorders Patient death	1.1% 1/95 • Number of events 1 • 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).	0.00% 0/93 • 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).	0.00% 0/88 • 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).

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alexander S. Young

VA Greater Los Angeles Healthcare System, Los Angeles, CA

Phone: 310-794-7219

Email: alexander.young@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place