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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00983476
First Posted: September 24, 2009
Last Update Posted: April 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: December 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Psychotic Disorders
Obesity
Health Behaviors
Interventions: Behavioral: in-person MOVE! SMI
Behavioral: web-based MOVE! SMI

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
7 patients were withdrawn by the PI when they were determined to be ineligible, after signing a consent.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.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Arm 1: In-person MOVE! SMI   Arm 2: Web-based MOVE! SMI   Arm 3: Usual Care + Handouts
STARTED   95   93   88 
6 Month Follow up Assessment   71   62   74 
COMPLETED   78   71   88 
NOT COMPLETED   17   22   0 
Did not receive intervention                17                22                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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))

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))

Arm 3: Usual Care + Handouts usual care + educational handouts regarding weight loss
Total Total of all reporting groups

Baseline Measures
   Arm 1: In-person MOVE! SMI   Arm 2: Web-based MOVE! SMI   Arm 3: Usual Care + Handouts   Total 
Overall Participants Analyzed 
[Units: Participants]
 95   93   88   276 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.7  (9.6)   54.7  (8.9)   54.2  (9.9)   54.2  (9.4) 
Sex: Female, Male [1] 
[Units: Participants]
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% 
[1] Observation of gender as male or female
Race (NIH/OMB) 
[Units: Participants]
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   0.0%      2   2.3%      5   1.8% 
Native Hawaiian or Other Pacific Islander      0   0.0%      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   4.0% 
Unknown or Not Reported      7   7.4%      7   7.5%      3   3.4%      17   6.2% 
Education [1] 
[Units: Participants]
       
High School, no diploma   5   2   6   13 
High School diploma or some college   60   64   56   180 
Degree (2 or 4 year)   27   24   22   73 
Graduate School (Degree or no degree)   3   3   4   10 
[1] Patient reported educational level
Body Mass Index (BMI) [1] 
[Units: Kg/(meters squared)]
Mean (Standard Deviation)
 34.9  (5.0)   34.2  (5.3)   34.4  (5.6)   34.5  (5.3) 
[1] BMI = (weight in pounds * 703)/ height in inches²


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Body Mass Index (BMI)   [ Time Frame: 6 months ]

2.  Primary:   Body Mass Index (BMI) Within Obese Sample   [ Time Frame: 6 months ]

3.  Primary:   Dietary Habits: Reducing Calories (Self-efficacy, Motivation, Readiness to Change)   [ Time Frame: 6 months ]

4.  Primary:   Dietary Habits: Reducing Fat (Self-efficacy, Motivation, Readiness to Change)   [ Time Frame: 6 months ]

5.  Secondary:   Quality of Life: Physical Functioning   [ Time Frame: 6 months ]

6.  Secondary:   Quality of Life: Self-Esteem   [ Time Frame: 6 months ]

7.  Secondary:   Quality of Life: Sexual Life   [ Time Frame: 6 months ]

8.  Secondary:   BMI   [ Time Frame: 9 months ]

9.  Secondary:   BMI   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Alexander S. Young
Organization: VA Greater Los Angeles Healthcare System, Los Angeles, CA
phone: 310-794-7219
e-mail: alexander.young@va.gov


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00983476     History of Changes
Other Study ID Numbers: IIR 09-083
First Submitted: September 22, 2009
First Posted: September 24, 2009
Results First Submitted: December 20, 2016
Results First Posted: February 13, 2017
Last Update Posted: April 13, 2017