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Randomized Controlled Trial
. 2019 Jan:76:55-63.
doi: 10.1016/j.cct.2018.11.006. Epub 2018 Nov 6.

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

Michael G Perri  1 , Aviva H Ariel-Donges  1 , Meena N Shankar  2 , Marian C Limacher  1 , Michael J Daniels  1 , David M Janicke  1 , Kathryn M Ross  1 , Linda B Bobroff  1 , A Daniel Martin  1 , Tiffany A Radcliff  3 , Christie A Befort  4
Affiliations
Randomized Controlled Trial

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

Michael G Perri et al. Contemp Clin Trials. 2019 Jan.

Abstract

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.

Trial registration: ClinicalTrials.gov NCT02054624.

Keywords: Cost-benefit analysis; Obesity; Obesity management; Rural health services; Weight loss.

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Conflict of interest statement

Disclosure statement

The authors have no conflicts of interest to disclose.

Figures

Fig. 1.
Fig. 1.
Participant flow during screening, enrollment, and randomization.
See this image and copyright information in PMC

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