Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00371462
Status:
TERMINATED
Last Update Posted:
2016-10-07
First Post:
2006-08-31
Brief Title:
PDA A Personal Digital Assistant for Obesity Treatment
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
PDA A Personal Digital Assistant for Obesity Treatment
Status:
TERMINATED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI no longer has an appointment and has seperated from Hines VAH and project was not transferred to another PI
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PDA
Brief Summary:
The purpose of this study is to determine whether including a PDA decision support tool plus distance support enhances the outcomes attainable by the MOVE2 Managing Obesity for Veterans Everywhere 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
Detailed Description:
An obesity epidemic is gaining momentum in the US 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 patients 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None