PDA+: A Personal Digital Assistant for Obesity Treatment

NCT00371462 | Terminated Results

• 1 other identifier: F4429-I
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Pain

Keywords

intervention study; technology; weight loss

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, 3, 6, 9, and 12 months

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

MOVE! level 2 group weight loss counseling, the VA standard of care alone (Standard Care);

Behavioral: Use of PDA + support to reduce weight and pain

Arm 2

EXPERIMENTAL

MOVE! level 2 + Personal Digital Assistant decision support tool (PDA) (Treatment)

Behavioral: MOVE! level 2 group weight loss counseling

Interventions

Use of PDA + support to reduce weight and pain BEHAVIORAL

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 1

MOVE! level 2 group weight loss counseling BEHAVIORAL

Participants will attend the MOVE! group and will be asked to complete assessments at 3, 6, 9, and 12 months.

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Edward Hines, Jr. VA Hospital

Hines, Illinois, 60141-5000, United States

Location

Related Publications (2)

• 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.

  PMID: 23229890 DERIVED

• Duncan 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.

  PMID: 21481253 DERIVED

MeSH Terms

Conditions

Obesity; Pain; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Body Weight Changes

Results Point of Contact

• Title: Associate Chief of Staff for Research
• Organization: Edward Hines Jr., VA Hospital

eileen.collins@va.gov

708-202-5689

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2006
• First Posted: September 4, 2006
• Study Start: October 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2011
• Last Updated: October 7, 2016
• Results First Posted: October 7, 2016

Record last verified: 2016-08

Locations

US (1)