PDA+: A Personal Digital Assistant for Obesity Treatment (PDA+)

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. Identifier: NCT00371462
Recruitment Status : Terminated (PI no longer has an appointment and has seperated from Hines VAH and project was not transferred to another PI?)
First Posted : September 4, 2006
Results First Posted : October 7, 2016
Last Update Posted : October 7, 2016
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Obesity
Interventions: Behavioral: Use of PDA + support to reduce weight and pain
Behavioral: MOVE! level 2 group weight loss counseling

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
+ Mobile Participants were provided standard-of-care (participation in VA MOVE program) plus a connective mobile technology system. Participants were provided a personal digital assistant to self-monitor diet and physical activity; they also received biweekly coaching calls for 6 months.
Standard-of-care Participants were provided standard-of-care (participation in VA MOVE program) for weight loss.

Participant Flow:   Overall Study
    + Mobile   Standard-of-care
STARTED   35   35 
COMPLETED   27   27 
Withdrawal by Subject                1                0 
Other                7                8 

  Baseline Characteristics

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.
One subject withdrew from the study.

Reporting Groups
Arm 1

MOVE! level 2 group weight loss counseling, the VA standard of care alone (Standard Care);

Use of PDA + support to reduce weight and pain: participants will attend the MOVE! group, record their food, activity, mood, pain, and weight daily via a PDA. Participants will be assigned a coach to help them set physical activity and calorie goals in order to produce a weight loss of .5%-1% per week on average over the course of 6 months. Participants will continue to log using the PDA during the 2nd 6-months for follow-up. They will also be asked to attend assessments at 3, 6, 9, and 12 months.

Arm 2

MOVE! level 2 + Personal Digital Assistant decision support tool (PDA) (Treatment)

MOVE! level 2 group weight loss counseling: Participants will attend the MOVE! group and will be asked to complete assessments at 3, 6, 9, and 12 months.

Total Total of all reporting groups

Baseline Measures
   Arm 1   Arm 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 34   35   69 
[Units: Years]
Mean (Standard Deviation)
 57.7  (13.5)   57.7  (10.2)   57.7  (11.9) 
[Units: Participants]
Female   5   5   10 
Male   29   30   59 
Ethnicity (NIH/OMB) 
[Units: Participants]
Hispanic or Latino   1   3   4 
Not Hispanic or Latino   33   32   65 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   9   8   17 
White   25   27   52 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
United States   34   35   69 
Weight (kg) 
[Units: Kg]
Mean (Standard Deviation)
 113.7  (16.1)   110.1  (15.1)   111.1  (15.6) 
[Units: Kg/m2]
Mean (Standard Deviation)
 36.9  (5.4)   35.8  (3.8)   36.3  (4.6) 
Waist circumference (cm) 
[Units: Cm]
Mean (Standard Deviation)
 120.4  (14.0)   120.4  (8.9)   120.4  (11.7) 

  Outcome Measures

1.  Primary:   Weight (Measured at Assessment Visits) and Pain Intensity and Pain Related Disability (NRS-I)   [ Time Frame: baseline, 3, 6, 9, and 12 months ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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
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  More Information

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

Results Point of Contact:  
Name/Title: Associate Chief of Staff for Research
Organization: Edward Hines Jr., VA Hospital
phone: 708-202-5689

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: VA Office of Research and Development Identifier: NCT00371462     History of Changes
Other Study ID Numbers: F4429-I
First Submitted: August 31, 2006
First Posted: September 4, 2006
Results First Submitted: May 24, 2016
Results First Posted: October 7, 2016
Last Update Posted: October 7, 2016