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Open Access Study protocol

PDA+: A Personal Digital Assistant for Obesity Treatment - An RCT testing the use of technology to enhance weight loss treatment for veterans

Jennifer M Duncan12*, E Amy Janke13, Andrea T Kozak4, Megan Roehrig12, Stephanie W Russell12, H Gene McFadden12, Andrew Demott12, Alex Pictor12, Don Hedeker5 and Bonnie Spring12

Author Affiliations

1 Center for Management of Complex Chronic Care, Hines VA Medical Center, Hines, IL,USA

2 Department of Preventive Medicine, Northwestern University, Chicago, IL,USA

3 Department of Behavioral and Social Sciences, University of the Sciences, Philadelphia, PA,USA

4 Department of Psychology, Oakland University, Rochester, MI,USA

5 Department of Epidemiology and Biostatistics, University of Illinois-Chicago, Chicago, IL,USA

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BMC Public Health 2011, 11:223  doi:10.1186/1471-2458-11-223

Published: 11 April 2011

Abstract

Background

Obese adults struggle to make the changes necessary to achieve even modest weight loss, though a decrease in weight by as little as 10% can have significant health benefits. Failure to meet weight loss goals may in part be associated with barriers to obesity treatment. Wide-spread dissemination of evidence-based obesity treatment faces multiple challenges including cost, access, and implementing the programmatic characteristics on a large scale.

Aims

The PDA+: A Personal Digital Assistant for Obesity Treatment randomized controlled trial (RCT) was designed to test whether a PDA-based behavioral intervention enhances the effectiveness of the existing group weight loss treatment program at VA Medical Centers Managing Overweight/Obese Veterans Everywhere (MOVE!). We also aim to introduce technology as a way to overcome systemic barriers of traditional obesity treatment.

Methods/Design

Veterans enrolled in the MOVE! group at the Hines Hospital VAMC with BMI ≥ 25 and ≤ 40 and weigh < 400 pounds, experience chronic pain (≥ 4 on the NRS-I scale for ≥ 6 months prior to enrollment) and are able to participate in a moderate intensity exercise program will be recruited and screened for eligibility. Participants will be randomized to receive either: a) MOVE! treatment alone (Standard Care) or b) Standard Care plus PDA (PDA+). Those randomized to PDA+ will record dietary intake, physical activity, and weight on the PDA. In addition, they will also record mood and pain intensity, and receive biweekly telephone support for the first 6-months of the 12-month study. All participants will attend in-person lab sessions every three months to complete questionnaires and for the collection of anthropomorphic data. Weight loss and decrease in pain level intensity are the primary outcomes.

Discussion

The PDA+ trial represents an important step in understanding ways to improve the use of technology in obesity treatment. The trial will address barriers to obesity care by implementing effective behavioral components of a weight loss intervention and delivering high intensity, low cost obesity treatment. This RCT also tests an intervention approach supported by handheld technology in a population traditionally considered to have lower levels of technology literacy.

Trial Registration

ClinicalTrials.gov: NCT00371462