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Comparative effectiveness of three doses of weight-loss counseling: two-year findings from the rural LITE trial.

ABSTRACT: To evaluate the effects and costs of three doses of behavioral weight-loss treatment delivered via Cooperative Extension Offices in rural communities.Obese adults (N?=?612) were randomly assigned to low, moderate, or high doses of behavioral treatment (i.e., 16, 32, or 48 sessions over two years) or to a control condition that received nutrition education without instruction in behavior modification strategies.Two-year mean reductions in initial body weight were 2.9% (95% Credible Interval?=?1.7-4.3), 3.5% (2.0-4.8), 6.7% (5.3-7.9), and 6.8% (5.5-8.1) for the control, low-, moderate-, and high-dose conditions, respectively. The moderate-dose treatment produced weight losses similar to the high-dose condition and significantly larger than the low-dose and control conditions (posterior probability?>?0.996). The percentages of participants who achieved weight reductions ? 5% at two years were significantly higher in the moderate-dose (58%) and high-dose (58%) conditions compared with low-dose (43%) and control (40%) conditions (posterior probability?>?0.996). Cost-effectiveness analyses favored the moderate-dose treatment over all other conditions.A moderate dose of behavioral treatment produced two-year weight reductions comparable to high-dose treatment but at a lower cost. These findings have important policy implications for the dissemination of weight-loss interventions into communities with limited resources.

SUBMITTER: Perri MG

PROVIDER: S-EPMC4225635 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature

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Comparative effectiveness of three doses of weight-loss counseling: two-year findings from the rural LITE trial.

Perri Michael G MG Limacher Marian C MC von Castel-Roberts Kristina K Daniels Michael J MJ Durning Patricia E PE Janicke David M DM Bobroff Linda B LB Radcliff Tiffany A TA Milsom Vanessa A VA Kim Chanmin C Martin A Daniel AD

Obesity (Silver Spring, Md.) 20141101 11

<h4>Objective</h4>To evaluate the effects and costs of three doses of behavioral weight-loss treatment delivered via Cooperative Extension Offices in rural communities.<h4>Methods</h4>Obese adults (N = 612) were randomly assigned to low, moderate, or high doses of behavioral treatment (i.e., 16, 32, or 48 sessions over two years) or to a control condition that received nutrition education without instruction in behavior modification strategies.<h4>Results</h4>Two-year mean reductions in initial ...[more]

PMID: 25376396

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Project description:BackgroundRural Americans have higher prevalence of obesity and type 2 diabetes (T2D) than urban populations and more limited access to behavioral programs to promote healthy lifestyle habits. Descriptive evidence from the Rural Lifestyle Intervention Treatment Effectiveness trial delivered through local cooperative extension service offices in rural areas previously identified that behavioral modification with both nutrition education and coaching resulted in a lower program delivery cost per kilogram of weight loss maintained at 2-years compared with an education-only comparator intervention.ObjectiveThis analysis extended earlier Rural Lifestyle Intervention Treatment Effectiveness trial research regarding weight loss outcomes to assess whether nutrition education with behavioral coaching delivered through cooperative extension service offices is cost-effective relative to nutrition education only in reducing T2D cases in rural areas.DesignA cost-utility analysis was conducted.Participants/settingTrial participants (n=317) from June 2008 through June 2014 were adults residing in rural Florida counties with a baseline body mass index between 30 and 45, but otherwise identified as healthy.InterventionTrial participants were randomly assigned to low, moderate, or high doses of behavioral coaching with nutrition education (ie, 16, 32, or 48 sessions over 24 months) or a comparator intervention that included 16 sessions of nutrition education without coaching. Participant glycated hemoglobin level was measured at baseline and the end of the trial to assess T2D status.Main outcome measuresT2D categories by treatment arm were used to estimate participants' expected annual health care expenditures and expected health-related utility measured as quality adjusted life years (ie, QALYs) over a 5-year time horizon. Discounted incremental costs and QALYs were used to calculate incremental cost-effectiveness ratios for each behavioral coaching intervention dose relative to the education-only comparator.Statistical analyses performedUsing a third-party payer perspective, Markov transition matrices were used to model participant transitions between T2D states. Replications of the individual participant behavior were conducted using Monte Carlo simulation.ResultsAll three doses of the behavioral coaching intervention had lower expected total costs and higher estimated QALYs than the education-only comparator. The moderate dose behavioral coaching intervention was associated with higher estimated QALYs but was costlier than the low dose; the moderate dose was favored over the low dose with willingness to pay thresholds over $107,895/QALY. The low dose behavioral coaching intervention was otherwise favored.ConclusionsBecause most rural Americans live in counties with cooperative extension service offices, nutrition education with behavioral coaching programs similar to those delivered through this trial may be effective and efficient in preventing or delaying T2D-associated consequences of obesity for rural adults.

Project description:Phase 3 clinical trial results reveal that Qsymia is a clinically effective long-term treatment for obesity, but whether this treatment is cost-effective compared to a diet and lifestyle intervention has yet to be explored.To quantify the incremental cost-effectiveness of Qsymia (phentermine and topiramate extended-release) for health-related quality of life improvements.Estimates are based on cost and quality of life outcomes from a 56-week, multicenter, placebo-controlled, phase 3 clinical trial undertaken in 93 health centers in the US. Participants were overweight and obese adults (aged 18-70 years) with a body-mass index of 27-45 kg/m(2) and two or more comorbidities (hypertension, dyslipidemia, diabetes or pre-diabetes or abdominal obesity). The intervention was diet and lifestyle advice plus the recommended dose of Qsymia (phentermine 7.5 mg plus topiramate 46.0 mg) vs. control, which included diet and lifestyle advice plus placebo. The study was from the payer perspective. Costs included the prescription cost, medication cost offsets and physician appointment costs. Effectiveness was measured in terms of quality-adjusted life years gained (QALYs). The main outcome measure was incremental cost per QALY gained of the intervention relative to control.Our base-case model, in which participants take Qsymia for 1 year with benefits linearly decaying over the subsequent 2 years, generates an incremental cost-effectiveness ratio (ICER) of $48,340 per QALY gained. Using the base-case assumptions, probabilistic sensitivity analyses reveal that the ICER is below $50,000 per QALY in 54 % of simulations. However, results are highly dependent on the extent to which benefits are maintained post medication cessation. If benefits persist for only 1 year post cessation, the ICER increases to $74,480.Although base-case results suggest that Qsymia is cost-effective, this result hinges on the time on Qsymia and the extent to which benefits are maintained post medication cessation. This should be an area of future research.

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Comparative effectiveness of three doses of weight-loss counseling: two-year findings from the rural LITE trial.

Publications

Comparative effectiveness of three doses of weight-loss counseling: two-year findings from the rural LITE trial.

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