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

This study has been terminated.
(PI no longer has an appointment and has seperated from Hines VAH and project was not transferred to another PI?)
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00371462
First received: August 31, 2006
Last updated: August 8, 2016
Last verified: August 2016
Results First Received: May 24, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Obesity
Pain
Interventions: Behavioral: Use of PDA + support to reduce weight and pain
Behavioral: MOVE! level 2 group weight loss counseling

  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
No text entered.

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
  Description
+ 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 
NOT COMPLETED   8   8 
Withdrawal by Subject                1                0 
Other                7                8 



  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.
One subject withdrew from the study.

Reporting Groups
  Description
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 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.7  (13.5)   57.7  (10.2)   57.7  (11.9) 
Gender 
[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) 
BMI 
[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
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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
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  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: Associate Chief of Staff for Research
Organization: Edward Hines Jr., VA Hospital
phone: 708-202-5689
e-mail: eileen.collins@va.gov


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

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00371462     History of Changes
Other Study ID Numbers: F4429-I
Study First Received: August 31, 2006
Results First Received: May 24, 2016
Last Updated: August 8, 2016
Health Authority: United States: Federal Government