PDA+: A Personal Digital Assistant for Obesity Treatment

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):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00371462
First received: August 31, 2006
Last updated: October 17, 2014
Last verified: October 2014

August 31, 2006
October 17, 2014
October 2007
September 2009   (final data collection date for primary outcome measure)
weight (measured at assessment visits) and pain intensity and pain related disability (NRS-I) [ Time Frame: baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
Weight, pain intensity, and pain-related disability at 12 months.
Complete list of historical versions of study NCT00371462 on ClinicalTrials.gov Archive Site
Not Provided
Quality of life, behavioral adherence, and care utilization at 12 months.
Not Provided
Not Provided
 
PDA+: A Personal Digital Assistant for Obesity Treatment
PDA+: A Personal Digital Assistant for Obesity Treatment

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obesity
  • Pain
  • 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.
  • 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.
  • Active Comparator: Arm 1
    MOVE! level 2 group weight loss counseling, the VA standard of care alone (Standard Care);
    Intervention: Behavioral: Use of PDA + support to reduce weight and pain
  • Experimental: Arm 2
    MOVE! level 2 + Personal Digital Assistant decision support tool (PDA) (Treatment)
    Intervention: Behavioral: MOVE! level 2 group weight loss counseling

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
150
September 2011
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with BMI >25 will be recruited from the primary care clinics at Hines Hospital VAMC. Enrollment of patients with this BMI criteria allows comparability with other obesity behavioral treatment trials. The enrollment policy is also consistent with the 2005 VA/DoD Practice Guideline that recommends obesity treatment for all Veterans with BMI >25.
  • Male or female Veterans
  • Age >18
  • With chronic pain (Numeric Rating Scale of pain intensity [NRS-I] > 4 for > 6 months prior to enrollment)
  • Ready to make a weight loss effort involving diet and activity change
  • Able to communicate comfortably in English.
  • The primary pain complaint must be possibly related to obesity (e.g., back, knee, leg, neck, arm, or full-body pain, and not exclusively headache or cancer-related pain).

Exclusion Criteria:

  • Has an active eating disorder or substance abuse disorder --Participating in another VA-funded research project -Significant cognitive or sensorimotor impairment precluding use of the PDA
  • Already participating in a structured diet or exercise program or plans to begin such a program outside the study during the next year; requires use of an assistive device for mobility
  • At risk for adverse cardiovascular events with moderate intensity activity
  • Plans to relocate within the upcoming year
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00371462
F4429-I
Not Provided
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Not Provided
Department of Veterans Affairs
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP