PDA+: A Personal Digital Assistant for Obesity Treatment (PDA+)
|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Obesity Pain||Behavioral: Use of PDA + support to reduce weight and pain Behavioral: MOVE! level 2 group weight loss counseling||Not Applicable|
An obesity epidemic is gaining momentum in the U.S. and the VA in particular. Among Veterans receiving care at VA outpatient centers in the year 2000, the prevalence of overweight was 73% and obesity was 33%. Obesity is an expensive condition partly because it contributes to the development of other chronic diseases. In addition to its adverse medical consequences, obesity takes a toll on quality of life. In general and among veterans specifically, obesity is associated with chronic pain conditions. Pain and obesity in combination adversely affect health-related quality of life and increase care utilization. To treat obesity, VA patient services has implemented MOVE! (Managing Obesity for Veterans Everywhere), a nationwide, pre-inpatient, pre-surgical standard of care. MOVE! Level 2 (MOVE2!), the platform for this study, enrolls in group treatment patients who are ready to make behavioral changes in diet and physical activity. The current study interfaces with and adds to MOVE2! treatment in order to maximize utility and sustainability in VA. The intervention in the current study involves provision of a personal digital assistant (PDA), a hand-held computer decision support tool to self-regulate diet and activity along with staff support (via telephone or e-mail per patient's preference).
Experimental Design. The current study is a 2-group prospective randomized controlled trial comparing the effects of (1) Standard Care: MOVE2! group weight loss counseling alone and (2) MOVE2! + PDA + Support. Specific aims are to enroll from VA primary care a sample of 150 obese patients who meet study criteria for chronic pain and are ready to make behavioral changes, including enrolling in MOVE2!. Primary outcomes (weight and pain) and secondary outcomes (quality of life, treatment adherence, healthcare utilization) will be measured every 3 months (baseline, treatment months 3 and 6, and follow-up months 9 and 12). Before beginning the current study, we will conduct two types of formative research. Part 1A: We will recruit 15 Veterans who are obese and have chronic pain for the purpose of pilot testing the PDA. Veterans will participate in one focus group before and one after they use the PDA for one week. Part 1B: We will also conduct focus groups with 10 MOVE! personnel and 10 staff who work in Hines Primary Care Clinic to identify perceived needs and barriers regarding implementing our PDA intervention.
Objective & Hypotheses. To determine whether the provision of a PDA decision support tool plus distance support enhance the outcomes attainable by the MOVE2! standard care alone. Primary hypotheses are that obese patients with chronic pain who are randomized to MOVE2! + PDA + Support will a) lose more weight by 6 months, b) show greater maintenance of weight loss at 12 months, and c) display greater reduction in pain intensity and pain-related disability than those randomized to Standard Care. Secondary hypotheses are that MOVE2! + PDA + Support, compared to Standard Care will result in: a) improved quality of life, b) greater treatment adherence, and c) reduced care utilization.
Data Analysis. Outcomes will be analyzed longitudinally on an intent to treat basis. The general analytic approach will be to use longitudinal mixed-effects regression models implemented via SAS PROC MIXED. Stratification variables (age, BMI, gender) will be included in all analyses.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||PDA+: A Personal Digital Assistant for Obesity Treatment|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2011|
Active Comparator: Arm 1
MOVE! level 2 group weight loss counseling, the VA standard of care alone (Standard Care);
Behavioral: 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.
Experimental: Arm 2
MOVE! level 2 + Personal Digital Assistant decision support tool (PDA) (Treatment)
Behavioral: 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.
- Weight (Measured at Assessment Visits) and Pain Intensity and Pain Related Disability (NRS-I) [ Time Frame: baseline, 3, 6, 9, and 12 months ]Study was terminated by VA. No VA outcome data to report.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00371462
|United States, Illinois|
|Edward Hines, Jr. VA Hospital|
|Hines, Illinois, United States, 60141-5000|