The obesity epidemic is recognized as an increasingly significant U.S. health problem . The percentage of overweight (BMI ≥ 25-29.9 kg/m2) and obese (BMI ≥ 30) adults has increased in the U.S. from 46% in 1960 to 74% in 2007-08 . Obesity markedly increases the risk of cardiovascular disease (CVD), cancer, Type 2 diabetes, osteoarthritis, gall bladder disease, sleep apnea, respiratory disease, pain related conditions, and premature mortality [1, 2]. In addition to adverse medical consequences, obesity takes a toll on quality of life. Among veterans specifically, BMI in the obese range is significantly associated with presence of self-reported pain . Weight loss efforts are confounded by the comorbid effects of obesity, pain, and the aforementioned health conditions.
Guidelines recommending lifestyle modifications for all obese patients, including diet modification and increased physical activity have been in place for more than 40 years. Yet, fewer than 25% of U.S. adults maintain diet or physical activity in accord with these recommendations [4–6]. A decrease in weight by as little as 10% can have significant health benefits on obesity-related morbidity and mortality . Despite this, few adults can make the changes necessary to achieve even this amount of weight loss. It remains unclear to healthcare professionals what treatment works best to generate achievable weight loss that is cost-effective and easily disseminated.
There is growing evidence that behavioral treatment and lifestyle interventions are effective in moderate weight loss . National Institutes of Health (NIH) guidelines advise that weight loss and weight maintenance therapy should be based on a comprehensive weight management program, including changes to diet, physical activity, and behavior goal setting . Supporting these guidelines, studies of lifestyle interventions indicate that the most successful determinants are those that include an educational component addressing diet and physical activity, as well as behavior therapy, incentives, and health professional follow-up . It is also recommended that individualized goals be set to reduce body weight at an optimal rate of 0.5 to 1 kg per week for the first 6 months to achieve an overall 10% weight loss . Behavioral counseling has assisted overweight and obese patients to achieve clinically significant (3-5 kg) weight loss that is sustainable for up to 2 years [1, 9–11]. However, the treatments that have been proven to work present a number of barriers including cost, access, and large-scale implementation.
Barriers to Obesity Treatment
The current healthcare system cannot manage the large numbers of patients who need weight loss treatment. Evidence suggests that meaningful obesity treatment must provide individuals with frequent and immediate feedback about diet, exercise, and ways to implement new behaviors in order to achieve weight loss . The costs for these types of treatment are far beyond what individuals and the healthcare system can sustain . U.S. obesity-attributable medical expenditures are estimated at $75 billion annually, with $17 billion financed by Medicare and $21 billion financed by Medicaid . If the trend toward obesity continues, these expenditures will reach up to 16-18% of total U.S. healthcare costs by 2030, equaling $861-957 billion dollars . The challenge for interventions dealing with obesity is to identify how these treatments can be integrated into everyday care in cost effective ways that are not burdensome to patients.
Pain is also considered a barrier in healthy lifestyle interventions, especially in the older population when integrating an exercise component. In the general population and among Veterans, elevated BMI is correlated with reported pain [15, 16]. Obesity co-occurs with a number of chronic pain conditions including degenerative arthritis, low back pain, and musculoskeletal pain [17, 18]. In combination, pain and obesity have an additive negative effect on health-related quality of life, a finding demonstrated in both patients seeking treatment for obesity and patients seeking treatment for chronic pain . The impact on health care expenditures is substantial because both obesity [20–22] and pain [23, 24] are associated with increased care utilization. Healthy lifestyle change is therefore a shared focus of empirically validated treatments for both obesity and chronic pain. The proposed intervention was developed to address the aforementioned barriers to obesity care by delivering effective behavioral components while delivering high intensity, low cost obesity treatment.
MOVE! Obesity Treatment
Large scale institutions such as Medicare, the National Institutes of Health (NIH), the National Centers for Prevention (NCP), and the Veterans Affairs Medical Centers (VAMC) have all recognized the impact of the obesity epidemic and have developed community-based treatment interventions. One such development is the nationally based Managing Obese Veterans Everywhere (MOVE!) program offered at VA medical centers. MOVE! is a response to the obesity crisis affecting the veteran population at a significantly higher rate (73% males and 68% females) than the general population (67% males, 62% females) . MOVE! is a stepped care program for obesity treatment, using 5-level treatment model. Level 1 implements self-assessment (MOVE! 23 questionnaire) and guided self-care. Level 2, targeted for this study, addresses patients who have indicated to their primary care physician or dieticians that they are ready to make behavioral changes in diet and physical activity. Patients receiving Level 2 treatment utilize the Level 1 assessment and self-care strategies, but also participate in group sessions and consultation addressing nutrition, physical activity, and behavior change. MOVE! Levels 3 - 5 involve pharmacological, inpatient, and surgical treatments respectively. Levels 1-2 are the most widely implemented delivery formats of MOVE!; however they present some practical barriers for those requiring treatment. Veterans identify barriers to participation that includes the time of day the program is offered, and an inability to travel to the hospitals where the program is offered. One potential way to overcome these obstacles is to introduce novel technology that enables cheaper, distance participation and swifter response times as part of obesity treatment.
Improving Obesity Treatment with Handheld Technology
Self-monitoring has emerged as a critical skill for obesity management [26–28]. Those who report monitoring their weight on a daily or weekly basis have greater success in achieving weight loss goals [7, 29–31]. Several studies have shown that PDAs are a reliable tool for dietary self-monitoring and have improved compliance and health indicators (i.e. dietary intake, glucose monitoring, blood pressure) [12, 32–34] In spite of these findings, research on the use of handheld technology for self-monitoring behavior, and the impact of integrating a PDA on weight loss into behavioral weight control programs is limited . Handheld technology holds great promise as a mechanism for supporting and disseminating behavioral interventions because they can deliver tailored messages at the point of decision-making in response to the needs of the user at that moment [36, 37].
The PDA platform we have developed automatically codes dietary data, and has algorithms that immediately provide real-time feedback about calorie consumption and daily physical activity. Recording dietary intake and activity onto a PDA can motivate timely reporting namely because the user receives immediate feedback relative to their goals. Our technology circumvents the need for pencil and paper reports, which is cumbersome because it requires patients to carry and record onto forms, is prone to significant inaccuracies, and is not subject to timely feedback [26, 38]. Another advantage to using handheld technology is that the safety of distance communication may enable patients to feel less self-conscious and freer to report accurately and communicate openly [12, 26, 33, 38]. Installing decision-support tools on the PDA reduces the costs associated with face-to-face meetings with professionals and encourages the regular practice necessary to maintain skill acquisition over time. As a delivery vehicle, the PDA is convenient, removes access barriers, allows tailoring, and disseminates knowledge and expertise in a manner that empowers patients. Our study will implement a PDA that can be integrated into existing care, which may substantially increase the accessibility of an intervention while eliminating the costs associated with intensive weight loss treatment. What is particularly exciting about our study is that we hope to develop a modularized treatment tool that can be independently introduced to programs to increase efficacy and decrease costs.
The primary aims of the proposed study are to determine whether overweight and obese patients with chronic pain who are randomized to the Standard Care + PDA group (PDA+) show more weight loss over a 6-month period, greater maintenance of weight loss at 12 months, and greater reduction in pain intensity and pain-related disability than those randomized to receive Standard Care only. We hypothesize that the addition of a PDA weight loss decision-support tool for patients plus personalized coaching will improve weight loss, weight loss maintenance, and pain reduction for obese patients with chronic pain, as compared to MOVE! standard care.
The secondary aims are to determine whether overweight/obese patients with chronic pain who are randomized to the PDA+ group will show significantly improved quality of life, greater treatment adherence, and reduced care utilization as compared to Standard Care only.
Secondary hypotheses are that the addition of a PDA weight loss decision-support tool for patients plus personalized coaching will improve quality of life and treatment adherence and will reduce health care utilization, as compared to MOVE! standard care alone. Ancillary outcomes that will be collected are patient satisfaction, mood, and waist circumference.