Overweight and obesity are leading health indicators targeted by the US Department of Health and Human Services (U.S. Department of Health and Human Services, 2002) and have been identified by the US Surgeon General as a problem of epidemic proportion (Satcher, 2001). According to 2002 figures 65% of adult Americans are overweight or obese (defined as a body mass index [BMI] >= 25 or BMI >= 30, respectively) (National Center for Health Statistics, 2002). National costs of overweight and obesity total more than $100 billion annually and comprise 6 to 7% of total healthcare expenditure in the US (Colditz, 1999; ). Most of the direct healthcare costs of obesity are due to comorbid conditions, including type 2 diabetes mellitus, coronary heart disease, and hypertension, among others. Indeed, as an individual's BMI increases, the number of chronic medical conditions increases and quality of life decreases (Sturn and Wells, 2001).
Among rural populations, obesity also presents a significant public health problem. Rural areas have a higher self-reported incidence of adult obesity than urban areas (Eberhardt et al, 2001). In a recent study of rural women, for example, body weight was found to be inversely related to socioeconomic status and specific factors contributed to weight gain (Bove and Olson, 1994). These include living in areas with less opportunity for physical activity; transportation difficulties that confine women to their homes; food insecurity associated with fluctuating income; variable food supply that contributes to disordered eating patterns; and isolation, leading to negative emotions that some women resolve through eating.
Obesity is a complex, multifactorial disease of appetite regulation and energy metabolism. While its etiology is not well understood, several factors appear to be involved. These include heredity; individual variations in physiology, biochemistry, and the nervous system; and the individual's living environment, psychosocial issues, socioeconomic status, and culture. Obese individuals do not need to attain non-obese weight to decrease their health risks. Several studies have demonstrated that maintaining even a modest weight loss (10% of initial body weight) can significantly affect obesity-related comorbid conditions (Foster et al, 1992; Kanders and Blackburn, 1992; Bjorntorp, 1987; VanItallie and Lew, 1992). Although treating obesity may be difficult, successful weight loss programs are available.
The purpose of this study is to assess the efficacy of three outreach (telehealth) weight loss strategies in adults living in rural South Dakota, and to compare these strategies with a conventional, clinic-based, structured weight loss program.
The experimental outreach protocols are equally effective as the clinic-based protocol (control) in achieving weight loss and weight maintenance in an adult population living in rural and frontier areas of South Dakota. is defined as "ZIP code areas whose calculated population centers are more than 60 minutes or 60 miles along the fastest paved road trip to a short-term, non-federal general hospital of 75 beds or more, and are not part of a large rural town with a concentration of over 20,000 population" (Center for Rural Health, 2006). Efficacy is based on the following primary outcomes:
In its guidelines for the assessment and treatment of obesity, the National Heart, Lung, and Blood Institute, and the North American Association for the Study of Obesity recommend a treatment algorithm of diet, exercise, and behavior therapy (National Heart Lung and Blood Institute & North American Association for the Study of Obesity, 2000). Because serious complications, including death, have been reported in obese persons who consumed very-low-calorie diets without medical supervision (Wadden et al, 1990) we selected the OPTIFAST weight loss program for its medical supervision component. OPTIFAST is one of several low-calorie ( >= 800 kcal/d), proprietary programs that includes mandatory medical monitoring and behavior support elements, thus making it suitable for use with persons who have obesity-related complications. Studies of OPTIFAST and similar programs indicate it induces a 15-25% weight loss in persons who complete 3 to 6 months of treatment (Anderson, Brinkman-Kaplan, Hamilton et al, 1994; Anderson, Brinkman-Kaplan, Lee et al, 1994; Anderson et al, 1991; Wadden et al, 1992; Walsh and Flynn, 1995). In a 22-week study of 20,000 patients a 21% mean weight loss was achieved with OPTIFAST and in a five-year follow-up study, approximately 50% of patients maintained medically significant weight loss (reduction of initial weight by 5% or more and maintained for at least 1 year) (Drawert, 1996; Institute of Medicine, Committee to Develop Criteria for Evaluating the Outcomes of Approaches to Prevent and Treat Obesity, 1995).
Weight loss programs, such as OPTIFAST, generally are easily accessible in urban settings; however, their effectiveness in rural states, such as South Dakota, has not been studied. The OPTIFAST Program employs a physician-directed weight loss clinic where patients see a specified physician for weight loss and for long-term weight maintenance. This component is difficult to provide in a rural setting, due to long travel distances and limited health care resources. A telehealth outreach protocol may provide more flexibility with this type of program by allowing patients to participate via their own primary care providers and other local health care professionals.
The 3 experimental groups and 1 control group each enrolled 10 total subjects who are members of the South Dakota School District Benefit Fund (SDSDBF), a self-insured health plan provided by many school districts throughout South Dakota. Subjects aged 18-65 years who met the following criteria were invited to participate:
All subjects (n = 40) were considered low-risk for health complications and were subject to exclusion criteria. All subjects were given a thorough physical examination and individualized behavioral assessment prior to initiating the study. Based on these initial assessments, we determined that the control group and the experimental groups were equivalent at study baseline. Each participant completed all phases of the study and received the same health education during the program. Twenty-two health care clinics in South Dakota and Nebraska participated in the study.
The 6-month (26-week) clinic-based OPTIFAST Program was modified to achieve outreach for rural populations. Outreach strategies included utilizing participants' primary care physicians for medical monitoring and providing behavioral, dietary, and exercise program support through 1) video conferencing, 2) group teleconference, and 3) home teleconference. An additional 6 months of individual weight management support was provided for experimental and control groups via telephone and/or e-health (email and Matria Healthcare's Healthy Living Program [web-based]) for a total 12-month program (). Program effectiveness and patient satisfaction (SF36) were measured at 6 months and at 12 months. Subjects completed self-report diaries to monitor for side effects. Laboratory values were obtained at weeks 2, 3, 4, 8, 12, 18, 26, and 52 to monitor for adverse events.
The office-based OPTIFAST Program consists of 3 phases throughout a 26-week period. The control and experimental protocols for this study also included these 3 phases; however, support activities were extended by 26 weeks to comprise a 4th phase (see Table 2).
Subjects in the control group received medical follow-up (weekly, in-person visits) according to the weight-loss program already in place at Avera Center for Medical Nutrition. Subjects in the experimental groups received slightly fewer in-person physician visits.
In this rural healthcare setting, primary care providers included physicians, nurse practitioners and/or physician assistants. Research staff included a study physician, nurse practitioner, registered nurse, exercise specialist, psychologist, dietitian, and research associate affiliated with Avera Research Institute and with Avera McKennan Hospital, Sioux Falls, South Dakota. Training for primary care providers regarding medical requirements of the research study was provided via an educational DVD from Novartis Nutrition Corporation and by the study physician. Project coordinators provided clinical, dietary, and behavioral assessments; monitored lab results; offered logistical support; coordinated care for participants with primary care providers; and provided group education and support.
| Phase | Weeks | Dietary requirements | Behavioral, dietary & activity support |
|---|---|---|---|
| Active weight loss | 1-12 | Subjects consume 100% OPTIFAST nutritional products (beginning at 960 calories), with no consumption of other foods. | Behavioral support provided in weekly group sessions, focusing on increasing physical activity and instituting behavior changes. |
| Transition | 13-18 | Subjects decrease OPTIFAST nutritional products, with gradual increases in limited, healthy food choices. Caloric intake is increased from 960 calories to 1200 calories throughout this phase. | Weekly group support sessions, focusing on principles of healthy food consumption and staying active, provided by a dietitian. |
| Maintenance | 19-26 | OPTIFAST products discontinued, subjects consume limited healthy food choices. | Subjects increase activity levels (this varies for each individual). Subjects attend weekly group support, including behavior modification, exercise consultation, and nutrition education. |
| Long-term weight management | 27-52 | Subjects follow a balance-deficit nutrition program of limited healthy food choices. | Subjects given continuous support regarding physical activity, stress management, and health coaching via e-health and/or telephone support. |
Participant compliance with weight loss programs is an important aspect to ensure an adequate sample size and validity of the data. In this study, percentage attendance is calculated as the total attendance at group sessions. Average attendance for the four groups is represented in Figure 1. A statistical analysis of variance (ANOVA) for attendance percentages and a logistic regression for the total attendance over the total sessions indicates no statistically significant difference (P = 0.82) for attendance among the groups (Faraway, 2005; Faraway, 2006). We conclude, therefore, that the control group and the experimental groups have similar compliance regarding attendance.
Both objective and subjective measurable outcomes are important to the success of a weight loss program. Primary objective outcomes for this study include: total weight loss, BMI, and hip and waist measurement (central anthropometric measurements that are key markers of lifestyle changes resulting from the program); and physiologic indicators, such as blood pressure; blood glucose; and lipids as measured by total cholesterol, HDL, LDL, and triglycerides.
Percentage changes in these objective outcomes are summarized in Tables 4 and 5 and illustrated in Figure 2. The hypothesis for statistical analysis and testing is whether the three experimental groups are as effective as the control group. Statistical data analyses were initially performed using ANOVA for each time period (12-weeks, 26-weeks and 52-weeks) (Faraway, 2005). There was no statistically significant difference for the majority of primary outcomes among these groups. There was, however, statistically significant variation for weight change at 12 weeks (P = 0.005), and LDL changes at 26 weeks (P = 0.04) and at 52 weeks (P = 0.009). We further investigated these three indicators using the Tukey multiple testing technique. We found that the significance in weight loss at 12 weeks resulted from the difference between the groups B and D (P = 0.006) and there was no statistically significant difference between groups A and B (P = 0.172), A and C (P = 0.941), and A and D (P = 0.320). Therefore, the experimental protocols are as effective as the control protocol for weight loss.
Similarly, differences in LDL at 26 weeks resulted in groups B and C (P = 0.027) and there is no statistically significant difference between groups A and B (P = 0.652), between groups A and C (P = 0.193), and between groups A and D (P = 0.999). Differences in LDL at 52 weeks existed between groups C and D (P = 0.005) and there was no statistically significant difference between groups A and B (P = 0.946), between groups A and C (P = 0.242), and between groups A and D (P = 0.305). Hence, the experimental protocols are as effective as the control protocol for LDL changes.
A more advanced longitudinal statistical data analysis (Pinhero and Bates, 2000) using mixed model technique was conducted using all the data in these three time periods to test the temporal change and the group difference for all the risk indicators listed in Tables 4 and 5. This analysis confirmed, again, that there was no statistically significant difference among the outreach groups and the office-based group. However, we found a statistically significant temporal change in HDL (P = 0.009), LDL (P = 0.032), and total cholesterol (P = 0.029). This temporal change is illustrated in Figure 2 and will require further analysis in a future study.
Minor, transient side effects were reported by some study participants. Those most often reported included headache, fatigue, lightheadedness, diarrhea, and constipation. A serious adverse event is defined as death, prolongation or initial hospitalization, life-threatening experience, persistence of significant disability, or congenital abnormality. There was 1 serious adverse event of pre-existing biliary tract disease, leading to cholecystectomy. No other adverse events were reported. Such side effects and adverse events are consequent to significant dietary change and are not unexpected in a weight loss program of this nature. Subjects in the experimental groups did not appear to require more medical care than subjects in the control group.
Results indicate no statistically significant difference in efficacy between the control group and the experimental groups, and no statistically significant difference in efficacy among the three experimental groups. Thus, the outreach protocols are equally effective in achieving weight loss and weight maintenance in a rural adult population, as is a clinic-based protocol.
This result is important to patients and to providers, since reducing body weight from an obese status may contribute to improved health and reduced risk for cardiovascular disease, diabetes, cancer, musculoskeletal disorders, stroke, hypertension, and behavioral sequelae. This, in turn, may result in decreased demand for health services, diminished reliance on medications, and, ultimately, reduced insurance costs.
From a rural health care perspective, these results indicate that it is possible to provide a comprehensive, multidisciplinary weight loss program for low-risk obese patients that involves local and at-distance care providers using telehealth outreach measures.
Given the small sample size of this study (n = 40), statistically significant conclusions are limited. For example, we were unable to assess the influence of variables, such as age, gender, socioeconomic status, ethnicity, or access to technology on outcome measures. Although we collected data for subjective measures (SF36) in order to assess patient satisfaction and to compare the relative efficacy among the 3 outreach protocols, the study size and length limit the usefulness of this data. This will be useful data to examine in future studies of the outreach protocols.
Successful weight loss programs for low-risk, overweight and obese patients require participation from many health care providers, including primary care physicians/extenders, nurses, dietitians, behavioral health clinicians, and exercise consultants. The difficulty in developing a successful multidisciplinary team approach is exacerbated in rural areas due to scarcity of providers, travel distances, and particular socioeconomic influences of rural economies. Primary care physicians in rural areas, therefore, often have few resources to devote to the intensive requirements of such programs and patients. For this reason, physicians generally responded positively to the multidisciplinary outreach support for their patients. It is interesting to note that although the outreach protocols used in this study involved fewer physician visits (see Table 3), there were no statistical differences in outcome measures between the control group and the experimental groups.
Although the primary care physicians involved in the outreach protocols had little direct involvement with the telehealth technology, they were supported with background educational material from Novartis, and consultation with the study physician and research staff throughout the program.
The behavioral health clinicians in this study had more direct involvement with the outreach protocols. They met weekly with patients in a group setting, providing directive, psychoeducational assistance, as well as support in lifestyle, nutrition, and exercise changes. These clinicians successfully adapted to telehealth technology, but observed that a lack of face-to-face contact was challenging, due to reduced visual cues to patients' affect. Clinicians also noted minor technological drawbacks of the outreach protocols, such as reduced visibility of patients using videoconference tools; disruptions in group settings for participants using at-home telephone contact; and poor telephone connection for some participants using cell phones for telephone contact.
From a behavioral point of view, clinicians observed that telephone contact impeded some patients' participation in group processes, if those patients felt they might interrupt another group member. Some patients, however, informed clinicians that they were more likely to divulge information via telephone contact than in a face-to-face group. Clinicians also noted that the lack of interpersonal contact among patients in the outreach groups only slightly reduced patients' ability to benefit one another. Although clinicians found the outreach protocols beneficial, they also note such protocols may be less useful for patients with more significant compliance-related problems or psychological diagnoses.
A successful multidisciplinary, outreach weight loss and weight management program implemented in rural and frontier areas has not previously been reported. The outreach protocols developed for this study may become a model for other rural areas, thus enhancing regional health practitioners' ability to serve their patients.
Future areas for study might include: assessing the impact of various telehealth protocols on patient compliance; measuring the specific impact of different telehealth protocols on subpopulations, such as Native Americans, senior citizens, and adolescents; modifications to telehealth protocols that may ensure their success within specific mental health diagnoses; and identifying specific attributes of the telehealth protocols that afford their success in providing successful patient care with reduced resources available to rural areas. In addition, an extensive cost-benefit analysis of the outreach protocols in comparison with the clinic-based protocol will be useful; for example, assessing system-wide savings that may be achieved if fewer physician visits are required with outreach protocols. Avera staff are continuing to implement and refine the telehealth outreach protocols, and have enrolled 72 patients since May, 2005.
The Surgeon General's response to the issue of obesity emphasizes a multidimensional strategy that includes addressing obesity within five social settings: family and community, school, health care, media, and worksites (Gamm et al, 2003). This strategy is outlined in the national health promotion and disease prevention initiative, Healthy People 2010. Three specific objectives of this report were addressed in this study: (19-1) increase the proportion of adults who are at a healthy weight; (19-2) decrease the proportion of adults who are obese; and (19-16) increase the number of worksites offering nutrition or weight management classes or counseling. It is evident, from this study, that these national objectives may be achieved in rural and frontier areas by adapting multidisciplinary weight loss programs via telehealth protocols to achieve successful outreach in these areas.
Monetary support provided by Avera Health Foundation Community Service Fund Grant. The South Dakota School Board Benefits Fund contributed reimbursement for physician visits and laboratory work, and partial program costs for patients involved in the program. Novartis Pharmaceutical donated the OPTIFAST product and educational materials used throughout the project. Honeywell HomeMed donated home medical monitors used by participants to record weight, blood pressure, heart rate, and additional symptoms.
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