PDA+: A Personal Digital Assistant for Obesity Treatment

Obesity Clinical Trial

— PDA+  

Official title:

PDA+: A Personal Digital Assistant for Obesity Treatment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00371462
• Other study ID #: F4429-I
• Status: Terminated
• Phase: N/A
• First received: August 31, 2006
• Last updated: October 17, 2014
• Start date: October 2007
• Est. completion date: September 2011

Study information

• Verified date: October 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: September 2011
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Edward Hines, Jr. VA Hospital	Hines	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight (measured at assessment visits) and pain intensity and pain related disability (NRS-I)		baseline, 3, 6, 9, and 12 months	No