Trial Outcomes & Findings for PDA+: A Personal Digital Assistant for Obesity Treatment (NCT NCT00371462)
NCT ID: NCT00371462
Last Updated: 2016-10-07
Results Overview
Study was terminated by VA. No VA outcome data to report.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
baseline, 3, 6, 9, and 12 months
Results posted on
2016-10-07
Participant Flow
Participant milestones
| Measure |
+ 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.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
27
|
27
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
Reasons for withdrawal
| Measure |
+ 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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Other
|
7
|
8
|
Baseline Characteristics
PDA+: A Personal Digital Assistant for Obesity Treatment
Baseline characteristics by cohort
| Measure |
Arm 1
n=34 Participants
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
n=35 Participants
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
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.7 years
STANDARD_DEVIATION 13.5 • n=99 Participants
|
57.7 years
STANDARD_DEVIATION 10.2 • n=107 Participants
|
57.7 years
STANDARD_DEVIATION 11.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=99 Participants
|
35 participants
n=107 Participants
|
69 participants
n=206 Participants
|
|
Weight (kg)
|
113.7 kg
STANDARD_DEVIATION 16.1 • n=99 Participants
|
110.1 kg
STANDARD_DEVIATION 15.1 • n=107 Participants
|
111.1 kg
STANDARD_DEVIATION 15.6 • n=206 Participants
|
|
BMI
|
36.9 kg/m2
STANDARD_DEVIATION 5.4 • n=99 Participants
|
35.8 kg/m2
STANDARD_DEVIATION 3.8 • n=107 Participants
|
36.3 kg/m2
STANDARD_DEVIATION 4.6 • n=206 Participants
|
|
Waist circumference (cm)
|
120.4 cm
STANDARD_DEVIATION 14.0 • n=99 Participants
|
120.4 cm
STANDARD_DEVIATION 8.9 • n=107 Participants
|
120.4 cm
STANDARD_DEVIATION 11.7 • n=206 Participants
|
PRIMARY outcome
Timeframe: baseline, 3, 6, 9, and 12 monthsPopulation: No data were analyzed due to termination of the study.
Study was terminated by VA. No VA outcome data to report.
Outcome measures
Outcome data not reported
Adverse Events
+ Mobile
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard-of-care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Associate Chief of Staff for Research
Edward Hines Jr., VA Hospital
Phone: 708-202-5689
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place