Portion control for the treatment of obesity in the primary care setting

<p>Abstract</p> <p>Background</p> <p>The increasing prevalence of obesity is a significant health threat and a major public health challenge. A critical need exists to develop and evaluate practical methods for the treatment of obesity in the clinical setting. One of the factors contributing to the obesity epidemic is food portion sizes. Limited data are available on the efficacy of visual or tactile devices designed to enhance patient understanding and control of portion sizes. A portion control plate is a commercially-available product that can provide visual cues of portion size and potentially contribute to weight loss by enhancing portion size control among obese patients. This tool holds promise as a useful adjunct to dietary counseling. Our objective was to evaluate a portion control intervention including dietary counseling and a portion control plate to facilitate weight loss among obese patients in a primary care practice.</p> <p>Findings</p> <p>We randomized 65 obese patients [body mass index (BMI) ≥ 30 and < 40] to an intervention including counseling by a dietitian incorporating a portion control plate or to usual care. Following initial consultation, patients in the intervention arm were contacted at 1, 3, and 5 months by the dietician for brief follow-up counseling. Usual care subjects received instructional handouts on diet and exercise. Forty-two (65%) subjects returned to have weight assessed at 6 months. Subjects in the portion control intervention had a greater percentage change (± SD) in weight from baseline at 3 months (-2.4% ± 3.7% <it>vs</it>. -0.5% ± 2.2%; p = 0.041) and a non significant trend in weight change from baseline at 6 months (-2.1% ± 3.8% vs. -0.7% ± 3.7%; p = 0.232) compared with usual care. Nearly one-half of patients assigned to the portion control intervention who completed the study reported the overall intervention was helpful and the majority would recommend it to others.</p> <p>Conclusions</p> <p>Our findings suggest that a portion control intervention incorporating dietary counseling and a portion control plate may be effective for enhancing weight loss among obese subjects. A portion control intervention deserves further evaluation as a weight control strategy in the primary care setting.</p> <p>Trial registration</p> <p>Current controlled trials <a href="http://clinicaltrials.gov/ct2/show/NCT01451554">NCT01451554</a></p

Protocol for the <it>Osteoporosis Choice </it>trial. A pilot randomized trial of a decision aid in primary care practice

Abstract Background Bisphosphonates can reduce fracture risk in patients with osteoporosis, but many at-risk patients do not start or adhere to these medications. The aims of this study are to: (1) preliminarily evaluate the effect of an individualized 10-year osteoporotic fracture risk calculator and decision aid (OSTEOPOROSIS CHOICE) for postmenopausal women at risk for osteoporotic fractures; and (2) assess the feasibility and validity (i.e., absence of contamination) of patient-level randomization (vs. cluster randomization) in pilot trials of decision aid efficacy. Methods/Design This is a protocol for a parallel, 2-arm, randomized trial to compare an intervention group receiving OSTEOPOROSIS CHOICE to a control group receiving usual primary care. Postmenopausal women with bone mineral density T-scores of STEOPOROSIS CHOICE on five outcomes: (a) patient knowledge regarding osteoporosis risk factors and treatment; (b) quality of the decision-making process for both the patient and clinician; (c) patient and clinician acceptability and satisfaction with the decision aid; (d) rate of bisphosphonate use and adherence, and (e) trial processes (e.g., ability to recruit participants, collect patient outcomes). To capture these outcomes, we will use patient and clinician surveys following each visit and video recordings of the clinical encounters. These video recordings will also allow us to determine the extent to which clinicians previously exposed to the decision aid were able to recreate elements of the decision aid with control patients (i.e., contamination). Pharmacy prescription profiles and follow-up phone interviews will assess medication start and adherence at 6 months. Discussion This pilot trial will provide evidence of feasibility, validity of patient randomization, and preliminary efficacy of a novel approach -- decision aids -- to improving medication adherence for postmenopausal women at risk of osteoporotic fractures. The results will inform the design of a larger trial that could provide more precise estimates of the efficacy of the decision aid. Trial registration Clinical Trials.gov Identifier: NCT00578981</p