Design of the Rural LEAP randomized trial: An evaluation of extended-care programs for weight management delivered via group or individual telephone counseling.

Obesity is a major contributor to the greater prevalence of chronic disease morbidity and mortality observed in rural versus nonrural areas of the U.S. Nonetheless, little research attention has been given to modifying this important driver of rural/urban disparities in health outcomes. Although lifestyle treatments produce weight reductions of sufficient magnitude to improve health, the existing research is limited with respect to the long-term maintenance of treatment effects and the dissemination of services to underserved populations. Recent studies have demonstrated the feasibility of delivering lifestyle programs through the infrastructure of the U.S. Cooperative Extension Service (CES), which has >2900 offices nationwide and whose mission includes nutrition education and health promotion. In addition, several randomized trials have shown that supplementing lifestyle treatment with extended-care programs consisting of either face-to-face sessions or individual telephone counseling can improve the maintenance of weight loss. However, both options entail relatively high costs that inhibit adoption in rural communities. The delivery of extended care via group-based telephone intervention may represent a promising, cost-effective alternative that is well suited to rural residents who tend to be isolated, have heightened concerns about privacy, and report lower quality of life. The Rural Lifestyle Eating and Activity Program (Rural LEAP) is a randomized trial, conducted via CES offices in rural communities, targeted to adults with obesity (n = 528), and designed to evaluate the effectiveness and cost-effectiveness of extended-care programs delivered via group or individual telephone counseling compared to an education control condition on long-term changes in body weight.

Comparing Costs of Telephone vs Face-to-Face Extended-Care Programs for the Management of Obesity in Rural Settings.

BACKGROUND: A major challenge after successful weight loss is continuing the behaviors required for long-term weight maintenance. This challenge can be exacerbated in rural areas with limited local support resources. OBJECTIVE: This study describes and compares program costs and cost effectiveness for 12-month extended-care lifestyle maintenance programs after an initial 6-month weight-loss program. DESIGN: We conducted a 1-year prospective randomized controlled clinical trial. PARTICIPANTS/SETTING: The study included 215 female participants age 50 years or older from rural areas who completed an initial 6-month lifestyle program for weight loss. The study was conducted from June 1, 2003 to May 31, 2007. INTERVENTION: The intervention was delivered through local Cooperative Extension Service offices in rural Florida. Participants were randomly assigned to a 12-month extended-care program using either individual telephone counseling (n=67), group face-to-face counseling (n=74), or a mail/control group (n=74). MAIN OUTCOME MEASURES: Program delivery costs, weight loss, and self-reported health status were directly assessed through questionnaires and program activity logs. Costs were estimated across a range of enrollment sizes to allow inferences beyond the study sample. STATISTICAL ANALYSES PERFORMED: Nonparametric and parametric tests of differences across groups for program outcomes were combined with direct program cost estimates and expected value calculations to determine which scales of operation favored alternative formats for lifestyle maintenance. RESULTS: Median weight regain during the intervention year was 1.7 kg for participants in the face-to-face format, 2.1 kg for the telephone format, and 3.1 kg for the mail/control format. For a typical group size of 13 participants, the face-to-face format had higher fixed costs, which translated into higher overall program costs ($420 per participant) when compared with individual telephone counseling ($268 per participant) and control ($226 per participant) programs. Although the net weight lost after the 12-month maintenance program was higher for the face-to-face and telephone programs compared with the control group, the average cost per expected kilogram of weight lost was higher for the face-to-face program ($47/kg) compared with the other two programs (approximately $33/kg for telephone and control). CONCLUSIONS: Both the scale of operations and local demand for programs are important considerations in selecting a delivery format for lifestyle maintenance. In this study, the telephone format had a lower cost but similar outcomes compared with the face-to-face format.