ObesityPDA+NCT00371462
PDA+: A Personal Digital Assistant for Obesity Treatment
A study testing Use of PDA + support to reduce weight and pain and MOVE! level 2 group weight loss counseling in people with Obesity and Pain, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Use of PDA + support to reduce weight and pain and MOVE! level 2 group weight loss counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141-5000
About this study
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.
Read the 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.
- Being tested
- Use of PDA + support to reduce weight and pain, MOVE! level 2 group weight loss counseling
- Keywords
- intervention study, technology, weight loss
- Medical subject headings
- Obesity, Pain, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of PDA + support to reduce weight and painBehavioural
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 counselingBehavioural
Participants will attend the MOVE! group and will be asked to complete assessments at 3, 6, 9, and 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | MOVE! level 2 group weight loss counseling, the VA standard of care alone (Standard Care); Receives: Behavioral: Use of PDA + support to reduce weight and pain |
| Arm 2 | Experimental | MOVE! level 2 + Personal Digital Assistant decision support tool (PDA) (Treatment) Receives: Behavioral: MOVE! level 2 group weight loss counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight (Measured at Assessment Visits) and Pain Intensity and Pain Related Disability (NRS-I)
Study was terminated by VA. No VA outcome data to report.
Measured: baseline, 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2006 (estimated)
- Study startOct 2007
- Primary completionSep 2009
- Study completionSep 2011
Why it stopped: PI no longer has an appointment and has seperated from Hines VAH and project was not transferred to another PI?
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371462
- Sponsor's protocol ID
- F4429-I
- Acronym
- PDA+
- Status last verified
- Aug 2016
- First submitted
- 31 Aug 2006
- Last updated
- 7 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Spring B, Duncan JM, Janke EA, Kozak AT, McFadden HG, DeMott A, Pictor A, Epstein LH, Siddique J, Pellegrini CA, Buscemi J, Hedeker D. Integrating technology into standard weight loss treatment: a randomized controlled trial. JAMA Intern Med. 2013 Jan 28;173(2):105-11. doi: 10.1001/jamainternmed.2013.1221.
PubMed 23229890Duncan JM, Janke EA, Kozak AT, Roehrig M, Russell SW, McFadden HG, Demott A, Pictor A, Hedeker D, Spring B. PDA+: A Personal Digital Assistant for Obesity Treatment - an RCT testing the use of technology to enhance weight loss treatment for veterans. BMC Public Health. 2011 Apr 11;11:223. doi: 10.1186/1471-2458-11-223.
PubMed 21481253
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PDA+: A Personal Digital Assistant for Obesity Treatment
- ClinicalTrials.gov ID
- NCT00371462
- Acronym / sponsor ID
- PDA+ / F4429-I
- Keywords
- intervention study, technology, weight loss
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI no longer has an appointment and has seperated from Hines VAH and project was not transferred to another PI?
- Enrolment
- 70 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Oct 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 4 Sep 2006 (estimated)
- Results
- Posted 7 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Behavioral: Use of PDA + support to reduce weight and painMOVE! level 2 group weight loss counseling, the VA standard of care alone (Standard Care); |
| Arm 2 | Experimental | Behavioral: MOVE! level 2 group weight loss counselingMOVE! level 2 + Personal Digital Assistant decision support tool (PDA) (Treatment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of PDA + support to reduce weight and painparticipants 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. | Behavioural | Arm 1 |
| MOVE! level 2 group weight loss counselingParticipants will attend the MOVE! group and will be asked to complete assessments at 3, 6, 9, and 12 months. | Behavioural | Arm 2 |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23229890Spring B, Duncan JM, Janke EA, Kozak AT, McFadden HG, DeMott A, Pictor A, Epstein LH, Siddique J, Pellegrini CA, Buscemi J, Hedeker D. Integrating technology into standard weight loss treatment: a randomized controlled trial. JAMA Intern Med. 2013 Jan 28;173(2):105-11. doi: 10.1001/jamainternmed.2013.1221.
- Derived from this study: PubMed 21481253Duncan JM, Janke EA, Kozak AT, Roehrig M, Russell SW, McFadden HG, Demott A, Pictor A, Hedeker D, Spring B. PDA+: A Personal Digital Assistant for Obesity Treatment - an RCT testing the use of technology to enhance weight loss treatment for veterans. BMC Public Health. 2011 Apr 11;11:223. doi: 10.1186/1471-2458-11-223.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of PDA + support to reduce weight and pain and MOVE! level 2 group weight loss counseling in people with Obesity and Pain, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00371462, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2016.