Weight management in rural health clinics: The Midwest diet and exercise trial.

Anna M Gorczyca, Richard A Washburn, Lauren Ptomey, Matthew S Mayo, Debra K Sullivan, Cheryl A Gibson, Robert Lee, Sarah Stolte, Joseph E Donnelly

Journal: Contemporary clinical trials 2019;67():37-46

PMID: 29454140

Abstract

UNLABELLED

Obesity prevalence is higher in rural compared to urban residents. Rural health clinics offer a potential venue for delivery of weight management. However, traditional programs require travel to attend on-site meetings which is impractical or inconvenient for rural residents. Clinic staff in most rural settings are unlikely to be trained to provide effective weight management. Remote delivery using group phone conferences (GP) or individual phone calls (IP), by staff associated with rural clinics eliminates the need for travel to attend on-site meetings. The effectiveness of these approaches will be the focus of this trial. Staff at five primary care clinics, serving primarily rural residents, will be trained to deliver GP and IP interventions and an enhanced usual care (EUC), (i.e., individual face-to-face meetings (~45 min) at clinic site, four times across 18 mos.). Two hundred overweight/obese adults (BMI ≥ 25.0-45.0 kg/m, age ≥ 21 yrs.) will be recruited through each clinic and randomized to GP (n = 80), IP (n = 80), or EUC (n = 40) to compare weight loss (0-6 mos.), weight maintenance (7-18 mos.), and weight change during a 6 mo. no contact follow-up (19-24 mos.) between intervention arms. The GP and IP interventions will be identical in lesson plan content, diet, and physical activity. The only difference between groups will be the delivery format (group vs. individual) and session duration (GP ~45 min/session; IP ~15 min/session). Primary (body weight) and secondary outcomes (waist circumference, energy/macronutrient intake, physical activity) will be assessed at baseline, 6, 12, 18 and 24 mos. Cost and contingent valuation analyses will also be completed.

NCT REGISTRATION

NCT02932748.

Copyright © 2018 Elsevier Inc. All rights reserved.

Address: Cardiovascular Research Center, Division of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS 66160, USA. Electronic address: [email protected].; Cardiovascular Research Center, Division of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS 66160, USA. Electronic address: [email protected].; Cardiovascular Research Center, Division of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS 66160, USA. Electronic address: [email protected].; Department of Biostatistics, The University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS 66160, USA. Electronic address: [email protected].; Department of Dietetics and Nutrition, The University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS 66160, USA. Electronic address: [email protected].; Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS 66160, USA. Electronic address: [email protected].; Department of Health Policy and Management, The University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS 66160, USA. Electronic address: [email protected].; Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS 66160, USA. Electronic address: [email protected].; Cardiovascular Research Center, Division of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS 66160, USA. Electronic address: [email protected].
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