PDA+: A Personal Digital Assistant for Obesity Treatment
PDA+: A Personal Digital Assistant for Obesity Treatment
Sponsors
Source
VA Office of Research and Development
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 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.
Overall Status
Terminated
Start Date
2007-10-01
Completion Date
2011-09-01
Primary Completion Date
2009-09-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Weight (Measured at Assessment Visits) and Pain Intensity and Pain Related Disability (NRS-I) |
baseline, 3, 6, 9, and 12 months |
Enrollment
70
Conditions
Intervention
Intervention Type
Behavioral
Intervention Name
Description
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 Group Label
Arm 1
Intervention Type
Behavioral
Intervention Name
Description
Participants will attend the MOVE! group and will be asked to complete assessments at 3, 6, 9, and 12 months.
Arm Group Label
Arm 2
Eligibility
Criteria
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
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Location
Facility |
|
Edward Hines, Jr. VA Hospital Hines Illinois 60141-5000 United States |
Location Countries
Country
United States
Verification Date
2016-08-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
Arm 1
Arm Group Type
Active Comparator
Description
MOVE! level 2 group weight loss counseling, the VA standard of care alone (Standard Care);
Arm Group Label
Arm 2
Arm Group Type
Experimental
Description
MOVE! level 2 + Personal Digital Assistant decision support tool (PDA) (Treatment)
Firstreceived Results Date
N/A
Why Stopped
PI no longer has an appointment and has seperated from Hines VAH and project was not
transferred to another PI?
Acronym
PDA+
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
August 31, 2006
Study First Submitted Qc
August 31, 2006
Study First Posted
September 4, 2006
Last Update Submitted
August 8, 2016
Last Update Submitted Qc
August 8, 2016
Last Update Posted
October 7, 2016
Results First Submitted
May 24, 2016
Results First Submitted Qc
August 8, 2016
Results First Posted
October 7, 2016
ClinicalTrials.gov processed this data on December 09, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.